1. HOW TO DEAL WITH COLLECTION SITE PROBLEMS 11 th Annual FTA Drug and Alcohol Program National Conference Presented by: Lorri Smith, C-SAPA Sacramento, CA March, 2016

2. PROBLEM SOLVING STRATEGIES  Identify the most common issues that arise at the collection site  Be proactive and develop tools to prevent problems/issues  Have a process for correctable flaws  Recognize even with the best intentions, issues can come up  Implement effective corrective action plans  Recruit the assistance of other Service Agents for better outcomes  Establish ongoing communication with your collection site

3. COLLECTION SITE § 40.41 Where does a urine collection for a DOT drug test take place? “(g) A collection site may be in a medical facility, a mobile facility (e.g., a van), a dedicated collection facility, or any other location meeting the requirements of this section”

4.  Occupational Medical Clinic  Urgent Care Clinic/Medical Clinic  Hospital/Emergency Room  Dedicated Collection Facility  Patient Service Center  Mobile Unit/Van  Onsite at Employer’s Facility

5. COLLECTION SITE SECURITY AND INTEGRITY ♦ § 40.43 What steps must operators of collection sites take to protect the security and integrity of urine collections? ♦ DOT’s 10 Steps to Collection Site Security and Integrity ♦ http://www.dot.gov/odapc/video.html http://www.dot.gov/odapc/video.html

7. THE COLLECTOR/ BREATH ALCOHOL TECHNICIAN § 40.3 A collector is a trained person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the urine specimen provided by those employees, and who initiates and completes the Federal Drug Testing Custody and Control Form (CCF). Note: DOT does not provide collector certification A Breath Alcohol Technician (BAT) is a person who instructs and assists employees in the alcohol testing process and operates an evidential breath testing device.

8.  49 CFR Part 40  Urine Collection Guidelines  Breath Alcohol Training Manual

9.  Subpart A - Administrative Provisions  Subpart B - Employer Responsibilities  Subpart C - Urine Collection Personnel  Subpart D - Collection Sites, Forms, Equipment and Supplies Used in DOT Urine Collections  Subpart E - Urine Specimen Collections  Subpart F - Drug Testing Laboratories  Subpart G - Medical Review Officers and the Verification Process  Subpart H - Split Specimen Tests  Subpart I - Problems in Drug Tests  Subpart J - Alcohol Testing Personnel  Subpart K - Testing Sites, Forms, Equipment and Supplies Used in Alcohol Testing  Subpart L - Alcohol Screening Tests  Subpart M - Alcohol Confirmation Tests  Subpart N - Problems in Alcohol Testing  Subpart O - Substance Abuse Professionals and the Return-to-Duty Process  Subpart P - Confidentiality and Release of Information  Subpart Q - Roles and Responsibilities of Service Agents  Subpart R - Public Interest Exclusions

10.  Full name of employee  Employee SSN or ID  Lab name & address*  Employer name, address, phone & fax * §  DER name & phone (and C/TPA if applicable) § 40.35 *  MRO name, address, phone & fax *  DOT Agency Name* (FAA, FMCSA, FTA, FRA, PHMSA)  Test Reason (Pre-Employment, Random, Post-Accident, RS, RTD, Follow-up)  Whether the collection is to be directly observed or not  (Optional) C/TPA name, address, phone & fax * May be preprinted on CCF

11. THE ROADMAP SOMETIMES THE COLLECTION SITE VEERS OFF COURSE … AND YOU WILL NEED TO GIVE DIRECTIONS

12. AND THEN THERE ARE THOSE SITUATIONS THAT ARE A BIT MORE COMPLICATED

13. PROBLEMS THAT OCCUR AT COLLECTION SITES  Administrative  Procedural  Operational

14. ♦ Happen most frequently ♦ FTA Conference 2015 – “How to Review Your Collection Site for Compliance” 72% were administrative – 691 Audits ♦ Typically pertain to the completion of the CCF and ATF  Most errors or omissions are correctable flaws following procedures outlined in Part 40, however may be subject to enforcement action under DOT agency regulations  In some cases if the flaw is not corrected the test must be cancelled  Worst case scenario – FATAL FLAW  Implement readily available resources to prevent errors - THE PRE-FIX Many paperwork errors are considered administrative flaws. These errors can be corrected with a memorandum for record (MFR) or affidavit completed by the collector or collector’s supervisor Many paperwork errors are considered administrative flaws. These errors can be corrected with a memorandum for record (MFR) or affidavit completed by the collector or collector’s supervisor

15. Employer’s Request for Services Form details the required tests and necessary donor information the collection site will need to perform the services Correctly §§§ (§ 40.14, § 40.35, § 40.211)

16. ♦ DER completes Step One on the CCF, sends employee/applicant to the collection site with the CCF and request for services form ♦ Employer provides preprinted and pre-marked CCFs to the collection site where Step One is completed with the exception of “Reason to Test”

17. ♦ Inform employee on the process and what to expect at the collection site including type of test and which tests will be given (drug only, drug and alcohol) ♦ When faxing the request in advance call the collection site to ensure the request for services was received and if there are any questions ♦ Upon receipt of the CCF and/or ATF review for paperwork or procedural problems

18. THE PRE-FIX (PREVENTATIVE FIX)

20. ♦ Step One: Employer Name, Address, Phone, Fax, DER MRO Name, Address, Phone, Fax Employee ID No. Testing Authority/ DOT Agency Reason for Test Type of test Clinic Information ♦ Step 2: Temperature Type of collection Observed box not marked Name of observer if other than the collector ♦ Step 3: Dating and Initialing seals while security seals still affixed to custody control form; Should be done AFTER affixed to transport bottles

21.  Step 4: Collector Printed Name Collector Signature Both Collector Printed Name and Signature Omitted – Fatal Flaw Time of collection Date of Collection Specific Courier Information  Step 5: Donor signature Printed donor name Date of collection Donor date of birth Not listing (2) contact phone numbers Collector completes Step 5 not donor Step 5 completely blank

22. ♦ Step One: Employee Name Employee ID No. Employer Name, Address DER Name, Phone Number Reason for Test Type of test ♦ Step 2: Employee Signature and Date ♦ Step 3: Technician: BAT/STT Device: Saliva/Breath 15-Minute Wait: Yes/No Alcohol Technician’s Company Company Street Address, City, State, Zip Alcohol Technician’s Printed Name Alcohol Technician’s Phone Number Alcohol Technician’s Signature and Date  Step 4: Only to be signed and dated by the Employee if confirmation results are 0.02 or higher!

23. ♦ Use of a Non-Federal Form for a DOT Test § 40.205(b)(2) and § 40.271(b)(2) states this is a correctable flaw by completing a Memorandum For Record for a DOT collection or Breath Alcohol Test ♦ Part 40 does not address the steps an employer must take when it needs to change a DOT result to a non-DOT **specifically for positive test results** ♦ Use of an Expired CCF ♦ Use of Another Employer’s CCF (ABC Transit instead of ACB Transit)

24. PROCEDURAL Examples ♦ Failure to conduct the proper tests (drug only, POCT) ♦ Performing unauthorized tests ♦ Performing the urine collection before the alcohol test ♦ Not transmitting paperwork to MRO or Employer within timeframe allotted ♦ Initialing and/dating seals while on the CCF ♦ Improperly documenting eventful collections (refusals, shy bladder, shy lung) ♦ Not resetting time on EBTs to accommodate time changes ♦ Use of tape other than evidence tape when affixing results to the ATF ♦ Handwriting in the alcohol test results on the ATF when the device prints ♦ Not fully performing the required steps for collections or BAT ♦ Employer’s form not available at Collection Site

25. OF CORRECTING PAPERWORK OR PROCEDURAL PROBLEMS WHO, WHAT AND WHY

26. WHO IS RESPONSIBLE WHO IS RESPONSIBLE For Identifying:  DAPM/DER  Collector  STT/BAT  Medical Review Officer  Laboratory  C/TPA/Service Agent  “Other person implementing the testing process”

27. WHAT NEEDS TO BE PROVIDED WHAT NEEDS TO BE PROVIDED  A signed statement by person responsible for error/omission (MFR)  Missing or correct information  Non-Federal form: All steps for a DOT test were followed, HHS lab  For a procedural error, what the error was (conducted drug test before BAT)  What steps were taken to prevent the problem from reoccurring  Must be provided on the same business day of notification  Is part of the permanent test record, all parties must keep a copy

29. MEMORANDUM FOR RECORD

30. WHY IS IT SO IMPORTANT WHY IS IT SO IMPORTANT  In order to be in compliance the correct information has to be accurately recorded  In some cases the test must be cancelled if not corrected  Acts as a “learning moment”  Otherwise subjects Employer to audit findings and/or enforcement action

31. DRUG TEST: ♦ There is no printed collector's name and no collector's signature ♦ The specimen ID numbers on the specimen bottle and the CCF do not match; ♦ The specimen bottle seal is broken or shows evidence of tampering (and a split specimen cannot be redesignated) ♦ Insufficient amount of urine in ”Bottle A” and the specimens cannot be redesignated ALCOHOL TEST: In the case of a screening test conducted on a saliva ASD or a breath tube ASD: ♦ The result is read too soon than the time allotted by the manufacturer and Part 40 ♦ The saliva ASD does not activate ♦ The device is used for a test after the expiration date printed on the device or on its package ♦ The breath tube ASD is tested with an analyzer which has not been pre-calibrated for that device's specific lot A screening or confirmation test conducted on an EBT, the sequential test number or alcohol concentration displayed on the EBT is not the same as the sequential test number or alcohol concentration on the printed result In the case of a confirmation test: ♦ Confirmation test before the end of the minimum 15-minute waiting period ♦ An air blank is not conducted before the confirmation test ♦ There is not a 0.00 result on the air blank conducted before the confirmation test ♦ EBT does not print the result ♦ An external calibration check of the EBT produces a result that differs by more than the tolerance stated in the QAP CANNOT BE CORRECTED!

32. CANCELLED TESTS ♦ Cancelled test – retest when negative result must be on file (pre-employment, return-to-duty, follow-up) ♦ Does not count toward random compliance ♦ Is not considered a positive or negative test ♦ Typically result of “fatal flaws” by collectors, issues with split samples, correctable flaws that go uncorrected ♦ May require retraining of collector or BAT ♦ Highly impacts safety in post-accident or reasonable suspicion testing events

33. FATAL FLAWS ♦ If cancellation due to collector/BAT error, error correction training is required training within 30 days of notification of error training within 30 days of notification of error  area of error  attest in writing  3 error-free mock collections can continue collections up to 30 days without error correction training can continue collections up to 30 days without error correction training training must be documented training must be documented further corrective action – use of checklists further corrective action – use of checklists

34. OPERATIONAL Examples  Proper staff training/high turnover ♦ Limited hours of operation/staff coverage ♦ Deficiencies in the collection area ♦ Accommodations for performing direct observed collections during all business hours ♦ Not identifying a responsible staff member for training, ongoing updates and process improvement

35. OPERATIONAL Examples Continued ♦ Decision to not perform manual BAT or use saliva devices for shy lung events ♦ No back-up breath alcohol devices if device out of service or not working ♦ QAP for breath alcohol equipment not followed (expired tanks, no logbook) ♦ Turning employee/applicants away ♦ Not updating internal system profiles with current employer information

36. SUGGESTIONS FOR A SMOOTH RIDE ♦ Interview the collection site when initially establishing a relationship ♦ Conduct collection site audits at least annually ♦ Engage the assistance of your MRO or TPA ♦ Make sure you keep your end of the bargain ♦ Work through any minor problems with the site Manager ♦ When necessary verify that corrective action has been implemented ♦ Establish a reward system for process improvement ♦ Share FTA and other resources to your collection site for best practices and industry updates

37. LET’S REVIEW

39. SCENARIOS WHAT WOULD YOU DO?

40. 40 REFERENCE MATERIALS  DOT 49 CFR Part 40  DOT Urine Specimen Collection Guidelines  DOT Agency Rules (e.g., Part 655 for FTA)  DOT Video – Collection Site Security & Integrity  DOT Video – Mock Collection Instructional Video  FTA Conference Sessions  FTA Website

41. THANK YOU! Lorri Smith, C-SAPA I will be available for questions after the session or by email lsmith@integritytesting.net