MODULE 4 - VENDORS TPA, MRO, SAP, COLLECTION SITE

1. MODULE 4 - VENDORS(TPA, MRO, SAP, COLLECTION SITE)

2. CONSORTIUM/THIRD PARTY ADMINISTRATOR (C/TPA) § 40.3 Consortium/Third-party administrator (C/TPA). A service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers' drug and alcohol testing programs. C/TPAs are not “employers” for purposes of this part.

3. CONSORTIUM/THIRD PARTY ADMINISTRATOR -- C/TPA Categories of Services- Usually Ala Carte Conduct Random Selection Program Transmit Drug Test Results and Negative Alcohol Test Results Background and Records Checks Maintain Records/Prepare Reports Provide MRO Services Provide Collection Services Gateway to SAP Services Supervisor Reasonable Suspicion training

4. Questions to ask your C/TPA The following pages contain questions about the services provided by a C/TPA who seeks to do business with you.

5. TPA-RANDOMS Conduct Random Selections Is your system in a “consortium” pool with other companies (50% rate) or stand-alone transit (25%)? Does the C/TPA work with you to update the pool? What is the selection period (minimum quarterly)? Do the random selections arrive at the beginning of the testing period? Does the C/TPA (improperly) advise you to get the tests done as soon as possible after receipt? Are “substitutes” identified in the list?

6. TPA-TRANSMIT RECORDS Transmit Forms and Test Results Does your agreement permit the C/TPA to transmit MRO verified results? Has the TPA established a secure fax or email exclusively for receipt of test results? Does the consortium alert you to non-negative drug tests so you can take immediate action? Are the scanned/faxed forms clear and legible (can see dates, signatures and remarks)?

7. TPA-BACKGROUND REVIEWS Conduct background reviews Does your TPA conduct background/driving record reviews? If yes, does your TPA conduct prior drug and alcohol reviews as required by Part 40.25? Who asks the applicant the question required by 40.25(j) - if they have ever been denied a position after a positive pre-employment test. Does the TPA respond to Part 40.25 requests you get?

8. TPA-FILE MAINTENANCE Maintain Records-File Reports TPAs may transmit MRO reports and negative alcohol tests, but not positive alcohol tests. Does the TPA know the types of reports they are prohibited from transmitting? Can the TPA retrieve reports and get them to you in working days? Can the TPA provide all information requested by employees or needed to respond to a subpoena? Does the TPA prepare your DA/MIS report?

9. TPA - MRO MRO services through the C/TPA One MRO or several at TPA? Co-located with TPA business office or separate? MRO Assistants also perform TPA duties or no? How assure separation of functions? How notify DER immediately after a positive? How notify DER if need help contacting an employee? Available 24/7 or restricted hours and days?

10. TPA - COLLECTIONS Urine Collections Does the TPA inspect-audit-certify your collection sites? Provide copies of training certificates and EBT maintenance and calibration records? Act as a broker of concerns+corrective actions? Do the CCFs have your company contact info pre-printed and is it current including DER? Are sites under agreement to collect after-hours, weekends and on-site at your facility or hospital?

11. TPA - BREATH TESTING Breath and/or Saliva Alcohol Testing Breath testing at all of the urine collection sites? Training records and EBT maintenance records? After hours, weekend and on-site or hospital collections? Direct contact from BAT to DER required for all positive BACs (>= 0.02). Alcohol testing facility provides visual and auditory privacy?

12. TPA - SAP Substance Abuse Professional Provide lists of local SAPS with credentials (name, address, phone, certification)? Broker contact with employees needing SAP? Recognize the prohibition against TPA transmitting SAP reports to DER?

13. TPA - D&A TRAINING Supervisor Reasonable Suspicion Training Training for new supervisors should be available as needed and frequently scheduled. Min 1 hour on drugs and 1 hour on alcohol. Explain key terms “specific, contemporaneous, articulable observations” and “appearance, behavior, speech or body odors”. Provide/explain/practice with documentation forms. Certify that training complies with federal requirements.

14. MEDICAL REVIEW OFFICER § 40.3 Medical Review Officer (MRO). A person who is a licensed physician (MD or DO) and who is responsible for receiving and reviewing laboratory results generated by an employer's drug testing program and evaluating medical explanations for certain drug test results.

15. Credentials MD or DO Knowledge of substance abuse disorders Passed a MRO certification test (AAMRO American Association of Medical Review Officers or MROCC Medical Review Officer Certification Commission or ASAM American Society of Addiction Medicine) Accumulates minimum of 12 CEUs (Continuing Education Units) every 3 years

16. MRO Duties Receive drug test results directly from the laboratory (not thru TPA). Review the Custody and Control Form (CCF) for flaws, require corrective affidavits. Verify tests as Negative if no drug or if employee has a valid medical explanation (e.g. marinol, adderol prescription), or Non-Negative. Communicate safety concerns to DER i.e. “drug test result information and medical information affecting the performance of safety-sensitive duties” obtained during verification

17. MRO Verifications Negative (or Negative-Dilute) Non-Negative (with appropriate check boxes) Positive for the identified prohibited substances at levels above the cutoff on screening and confirmation (2 independent drug tests) Refused (Adulterated or Substituted) Cancelled (either Invalid (can’t get a scientifically sufficient result) or Rejected for Testing (fatal flaw by collector or bottles leaked))

18. On CCF or Separate Report May use the MRO report boxes on Copy 2 of the CCF (MRO Copy) as below Or may transmit a separate report (most MROs do)

19. MRO - Observed Testing Three instances where the MRO requires an immediate Directly Observed test Specimen is Invalid - i.e. something is blocking the chemical testing but lab can’t prove what Split sample was not available for testing as required by the employee with a non-negative result Specimen is negative but so dilute as to be suspicious DER must arrange with collection site then notify employee to go immediately Test is a Refusal if employee fails to comply

20. Observed Testing Procedure § 40.67(g) As the collector, you must ensure that the observer is the same gender as the employee. You must never permit an opposite gender person to act as the observer. The observer can be a different person from the collector and need not be a qualified collector. (h) As the collector, if someone else is to observe the collection (e.g., in order to ensure a same gender observer), you must verbally instruct that person to follow procedures at paragraphs (i) and (j) of this section. If you, the collector, are the observer, you too must follow these procedures. NOTE: TRANSIT SUPERVISOR MAY SERVE AS OBSERVER IF NO OTHER SAME-GENDER PERSON IS AVAILABLE

21. Observed Testing Procedure (i) As the observer, you must request the employee to raise his or her shirt, blouse, or dress/skirt, as appropriate, above the waist; and lower clothing and underpants to show you, by turning around, that they do not have a prosthetic device. After you have determined that the employee does not have such a device, you may permit the employee to return clothing to its proper position for observed urination. (j) As the observer, you must watch the employee urinate into the collection container. Specifically, you are to watch the urine go from the employee's body into the collection container.

22. SUBSTANCE ABUSE PROFESSIONAL (SAP) § 40.3 Substance Abuse Professional (SAP). A person who evaluates employees who have violated a DOT drug and alcohol regulation and makes recommendations concerning education, treatment, follow-up testing, and aftercare.

23. SAP- Credentials National credentials by an organization named in 49 CFR 40.281 (extensive list) Knowledge of the duties of a SAP, DOT regulations, modal regulations, SAP Guidelines. Complete a qualifications training program. Pass a SAP test accepted by the DOT. Accumulate 12 CEUs every three years thereafter.

24. SAP - FUNCTIONS Conduct a professional face-to-face evaluation of employee and determine the appropriate program of education and/or therapy. First report to DER. After employee completes program, review program attendance and do a second face-to-face evaluation to determine whether employee has successfully completed the education/therapy. Second report to DER.

25. Return-to-Duty Testing Purpose: to provide a degree of assurance to the employer that the individual is presently drug and alcohol free and is able to return to work without undue concern of continued drug abuse or alcohol misuse.

26. RTD Test (con’t) Return to Duty test; may test for both drugs and alcohol; must test for the substance for which the employee previously tested positive.

27. Follow-up Testing Plan SAP submits follow-up testing plan to the employer Unannounced Minimum: 6 tests within 12 months Up to 60 months SAP determines frequency and duration Employers cannot go beyond the SAP schedule Dates scheduled by the employer

28. Follow-up Tests All tests are by Direct Observation Follow-up testing plan follows the employee to any new employer A cancelled follow-up test must be recollected Follow-up testing is non-negotiable Employees subject to follow-up testing are also included in the random testing pool

29. Final Thoughts May require employee an on-going series of meetings after returning to duty (e.g.AA). May re-interview after one year and readjust follow-up testing plan. Employees have rights to SAP reports but not to follow-up plan (must be redacted). Employee and employers may not seek a second SAP - no SAP shopping.

30. COLLECTION SITES Facilities where applicants and employees provide urine, breath or saliva specimens for screening and confirmation tests for prohibited drug use and alcohol misuse.

31. Urine Collection Sites Facilities within a reasonable driving distance where employees provide urine specimens to be tested for the presence of drugs or their metabolites. Private stalls for providing specimens, a suitable work space for completing forms, secure storage for specimens, and an observed and monitored waiting area, and regular courier pick-up service. Open during normal transit business hours (e.g 7:30 AM) with arrangements for after-hours and weekend testing.

32. Trained and Credentialed Collectors Basic information. - Knowledge of the DOT rules, privacy consideration, your duties. Qualifications Training - Specific collector training, techniques and safeguards. Initial Proficiency Demonstration- Conduct five error-free mock collections. Refresher Training-Recertification every five years. Error Correction Training- After fatal flaw.

33. Critical Requirements Employee properly identified with photo ID (driver’s license or company ID). Collector only has one donor at a time. Donor must wash hands and remove outer garments, empty pockets. Restroom is free of potential adulterants and hiding places. Collector checks temperature strip, views specimen for signs of contamination.

34. Critical Requirements Collector dates bottle seals on bottles, asks donor to initial, checks initials. Collector asks donor to complete step 5, checks entries. Collector completes step 4, bursts the CCF, gives ONLY donor copy to donor. Specimen secured in specimen bag and in secure storage for courier pickup.

35. Shy Bladder Procedure Easily the most frequent problem collection - Collection site must have SOP KEYS: Use of REMARKS section, monitored waiting area, must stay to complete, 40 ml H2O Employee gives collector urine sample with less than 45 ml. Collector checks temperature (important). If temperature is OK, in REMARKS section, collector notes time and (usually) “QNS” (Quantity Not Sufficient) Discards Insufficient Specimen

36. Shy Bladder Procedure Instructs employee to wait in a monitored area, drink water, not leave facility (is a Refusal if leaves). Has a method to measure water consumed (up to 40 oz) - 2 x 20 oz bottles easiest (we think). Collector records time of each subsequent attempt, volume of water drunk, discards specimen if insufficient. Completes collection if sufficient sample given. If no sufficient specimen after three (3) hours, terminates collection, records time on Remarks column, notifies DER, MRO copy to MRO.

37. Custody and Control Form

38. MRO Copy - What’s Missing?

39. Collector Certificate Is OK

40. What’s Wrong

41. “Carbon Shadows” and Courier

42. Time-Lines for Testing Can you verify that the collection site performed the right test and use the Federal CCF? Collection site is required to transmit (scan, email or mail) the Company and MRO copies within 24 hours. Are they? Collection site should get specimen to lab by next-day courier. Urine breaks down in the heat and pH increases rapidly- causes “invalid” tests. MRO cannot verify a non-negative until received signed certified copy from lab. There have been delays.

43. “OMB Number”is federal

44. Speed of transmission of CCF copies and specimen

45. Breath and Saliva Alcohol Testing Basic information. - Knowledge of the DOT rules, privacy consideration, your duties. Qualifications Training - Specific collector training, techniques and safeguards. Initial Proficiency Demonstration- Conduct seven error-free mock collections with the equipment you will actually use. Refresher Training-Recertification every five years. Error Correction Training- After fatal flaw.

46. Other Issues Terminology - BAT - Breath Alcohol Test technician. STT - Saliva Test Technician. Prohibition - BAT/STT may not be direct supervisors of tested employee. Alcohol Saliva Testing is only a screening test. Presumptive positives must be confirmed thru printed results on an EBT. The Alcohol Saliva Device must remain in the mouth for 4 minutes and not have reached its expiration date. Alcohol test is ALWAYS done before the urine test if possible.

47. Problems We See on Audit Alcohol Test done after Drug Test Clock on the EBT 1 hour off (not reset at Daylight Savings Time) Not performing monthly calibration checks; checks not within accuracy limits Not sending EBT machine back to the factory every two years for factory recalibration

48. Q&A Q&A, then break to 2:45, then Practical Applications