Oral Fluid Specimen Collector Qualification Training PDF

Oral Fluid Specimen Collector Qualification Training Mandatory Guidelines US DOT (Department of Transportation) 49 CFR Part 40 Training Objective: Have all collectors successfully complete course curriculum in compliance with CFR 49 part 40 requirements for specimen...

Oral Fluid Specimen Collector Qualification Training Mandatory Guidelines US DOT (Department of Transportation) 49 CFR Part 40 Training Objective: Have all collectors successfully complete course curriculum in compliance with CFR 49 part 40 requirements for specimen collectors Provide a source of information for all collectors to use during the Oral Fluid specimen collection process 2 Section I Introduction:  Qualification requirements for Collectors  Qualification requirements for Trainers  Training records 3  What is Oral Fluid?  Oral Fluid/Saliva – these terms are used interchangeably however:  Oral fluid drug testing and saliva alcohol testing are completely distinct from each other. The devices, procedures and outcomes are never interchangeable!!!  A combination of 3 major glandular fluids, some minor glands  Blood/serum like fluid  Drugs cross over from the blood stream into the oral fluid allowing us to test for them  Humans produce from 0.5-1.5 litres of oral fluid per day! 4 Definition: COLLECTOR:  A person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the specimen provided by those employees, and who initiates and completes the CCF.  An immediate supervisor of a particular employee may not act as the collector when that employee is tested, unless no other collector is available, and the supervisor is permitted to do so under a DOT operating administration’s drug and alcohol regulation.  To avoid a potential conflict of interest, a collector should not be someone that is related to the employee (e.g., spouse, ex-spouse, relative) or a close personal 5 friend (e.g., fiancée). Qualification Requirements for Collectors:  All collectors must be trained before conducting DOT specimen collections  Current and new collectors must be knowledgeable about the Regulations AND the Federal CCF  3 Main Requirements:  Basic Information  Qualification Training  Initial Proficiency Demonstration 6 Qualification Requirements for Collectors:  Basic information:  Collectors and Trainers must be knowledgeable about this part, the current “DOT Oral Fluid Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections. DOT agency regulations, guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue, SE., Washington DC, 20590, 202-366-3784, or on the ODAPC web site ( https://www.transportation.gov/odapc). You must keep current on any changes to these materials. 7 Responsibilities for all Collectors and Trainers:  To stay updated on DOT Workplace Drug and Alcohol Testing Rules; all collectors and trainers MUST be subscribed to the Office of Drug and Alcohol Policy and Compliance (ODAPC) list-serve prior to performing collections: https://www.transportation.gov/o dapc/get-odapc-email-updates 8  Qualification RequirementsThis document is attached in the for Collectors: email you received with the documents for review. Please be sure to go through it!!  Basic Information includes two documents… 49 CFR Part 40 DOT Oral Fluid Specimen Collection Procedures Guidelines 9  Qualification Requirements for Collectors:  Qualification training: Collectors must receive qualification training meeting the requirements of this paragraph. Qualification training must provide instruction on the following subjects: 1. Training on the testing procedures of this part; 2. Training to proficiency in the operation of the particular oral fluid collection device(s) you will be using. 3. All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF; 4. “Problem” collections (e.g., situations like “dry mouth” and attempts to tamper with10a Qualification Requirements for Collectors: 5. Fatal flaws, correctable flaws, and how to correct problems in collections; and 6. The collector's responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate. 11 Refresher Training Requirements  Refresher training is required every five years and must include the three main requirements; essentially identical to the initial collector training… Basic Information Qualification Training Proficiency Demonstration 12  Error Correction Training Requirements: Error correction training is required following a mistake in the collection process that causes a test to be cancelled. It must include the three main Must be completed with a requirements… certified trainer!  Basic Information (Review pertaining to the error)  Qualification Training (Review pertaining to the error)  Proficiency Demonstration (3 error-free mocks, 1 normal and 2 pertaining to the error that was made) 13 Error Correction Training Requirements:  Error correction training must occur within 30 days of the date that the collector is notified of the fatal flaw  This training must be provided by, and proficiently documented in writing by a qualified instructor 14 Qualification Requirements for Trainers:  Not specifically defined - No specific course  Individual who is a qualified collector and has demonstrated knowledge, skills and abilities by: Regularly conducted DOT oral fluid drug test collections for a period of at least one year; Conducted oral fluid collector training under Part 40 for at least one year*; or Successfully completed an oral fluid “train the trainer” course.* 15 Qualification Requirements for Trainers: *NOTE: Because HHS has not yet certified an oral fluid laboratory, we have amended the requirements to authorize individuals to monitor mock oral fluid collection without meeting the requirement of being a qualified oral fluid collector, as explained below. On 11/5/2024, DOT published a final rule that provides temporary regulatory flexibility regarding who can monitor mock oral fluid collections (89 FR 87798). To be a monitor for oral fluid mock collections, you need not be a qualified oral fluid collector, but you either 1) have to conduct oral fluid collector training (the one-year requirement is being waived) or 2) successfully complete an oral fluid “train the training” course. This regulatory flexibility is effective from 12/5/2024, the effective date of the November 5, 2024, final rule, until 1 year after HHS publishes a Federal Register notice of the first certified oral fluid drug testing laboratory. DOT will publish notice of the expiration date in the Federal Register. 16 Training Records  Collectors must maintain and provide to DOT agency, employers, or service agents who use collector’s services, documentation of their training.  Collector should keep training manual, exam, mock CCF’s and certificates together as proof of training. Training records must be kept indefinitely while the collector works at the site and for 2 years after they leave employment!! 17 Section II Protecting the security and integrity of the specimen collection process Collection Facilities Authorized Participants Maintaining Control of the Specimen 18  Collection Site Facilities:  Site facility may be medical, mobile or dedicated - as long as it meets DOT requirements.  Collectors are responsible for testing materials, supervision, and security for “integrity of the collection”  May remove any person who obstructs process 19  Collection Site Facilities:  An oral fluid collection for a DOT drug test must take place in a collection site meeting the requirements of this section. If you are operating an oral fluid collection site: 1. You must ensure that it meets the security requirements of § 40.48  As a collector, you must do the following before each collection to deter tampering with specimens:  Ensure that access to collection materials and specimens is effectively restricted;  Ensure that undetected access (e.g., through a door/window not in your view) is not possible; and  Ensure the security of the facility during the collection process to maintain privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted. 2. The site may be a permanent or temporary facility located either at the work site or at a remote site; 20  Collection Site Facilities: 1. The 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; 2. You must have all necessary personnel, materials, equipment, and facilities that include privacy and supervision to provide for the collection, temporary storage, and shipping of specimens to a laboratory, and a suitable clean surface for writing. 3. If a collection site is not accessible and there is an immediate requirement to collect an oral fluid specimen (e.g., an accident investigation), another site may be used for the collection, if the collection is performed by a collector who has been trained to collect oral fluid specimens in accordance with this part and the manufacturer's procedures for the collection device. 21 Collection Site Security and Integrity As the collector it is your duty to:  Limit yourself to one collection at a time  Keep the sample in view of both donor and the collector between the time the employee has provided their specimen, and the time the specimen is sealed  Only the donor and collector handle the specimen  Limit the number of staff/employees that handle specimens – Collector – Shipping person if different from collector 22 Collection Site Security and Integrity As the collector it is your duty to… Protect the security and integrity of all collections Prevent unauthorized personnel from entering the collection area Supervise all authorized personnel and remove any person who obstructs, interferes with, or causes delay in the collection process 23 Collection Site Security and Integrity Authorized personnel:  Donor  Collector/other collection site worker  Company authorized representative (e.g., Union Representative)  Designated Employer Representative  DOT Agency Representative This information should be provided when the  Interpreter (if required) appointment is booked and noted on the test requisition!!  You must ensure that all authorized persons are always under the supervision of a collector when permitted into the site. 24 Section III Collecting The Specimen Federal Custody and Control Form Routine collections Sequential Order for Collections Difficult collections Refusals to Test Fatal flaws & Correctable flaws Making the Corrections 25 Federal Custody and Control Form The CCF: The CCF must be a five-part carbonless manifold form:  Copy 1 – Laboratory/Test Facility (White)  Copy 2 – Medical Review Officer (Pink)  Copy 3 – Collector (Yellow)  Copy 4 – Employer (Blue)  Copy 5 – Donor (Green) DISTRIBUTE APPROPRIATELY Select proper pen and press firmly when writing! 26 Federal Custody and Control Form The CCF: NEVER use a non-DOT/Oral Fluid form or an expired Federal form to conduct a DOT Oral Fluid collection Step 1 of every DOT CCF must include: Employer name, DER Name, address, phone & fax MRO name, address, phone & fax (Will be pre-printed) Follow the Steps!! 1, 2, 3, 5, 4 Collector’s company name, phone & fax and actual collection site address 27 Federal Custody and Control Form (CCF): A. Employer and/or C/TPA Contact Specimen Information I.D. May be Pre-Printed from the lab or information will be on test requisition C. Donor ID# and CDL B. MRO Province contact Should be informatio taken from ID presented at n Should be Pre- time of Printed from collection the lab D. Specify Testing Authority Will be pre- printed with G. Collection site FMCSA E. Reason F. Drug information for Test Tests to be MUST include phone number for site not a call Will be found Performed centre in order to reach on test Must be 5 panel technicians directly. Should requisition for all DOT tests be pre-printed from the lab 28  The CCF:  The information in step one may be preprinted or handwritten prior to starting the collection, but under no circumstances may a collector sign the form before the collection Commercial Drivers Licence Province and # Other Oral Fluid can be marked prior to the Contact collection Options ie) email or cell # Oral Fluid specimens must be collected as a Collector must verify with the employee that single sample and then subdivided in the the collection device is within expiry and check presence of the donor Yes/No. Expiry date is to be recorded in Step 4 of the Federal CCF 29 Securing the Donor After positively identifying the donor: (Government Issue photo ID or Verbal ID by DER or C/TPA and or Owner Operator ID Procedure)  Explain the collection process – provide a copy of CCF instructions (no longer on the back of Copy 5 – will need to print from regs) site could have laminated document in the testing room  See Instructions for Completing the Federal Drug Testing Custody and Control Form for Oral Fluid Specimen Collection  The collector is to request the donor remove outer garments and empty their pockets. This is to prevent the employee from bringing in items to try to beat the test and to ensure that no items are present that could be used to adulterate the specimen.  Asking the donor to remove shirts, pants etc. is prohibited  Touching the donor is prohibited  Removing is not required, unless there is something visible through the hat that causes the collector to be concerned 30  Securing the Donor  The collector will request for the donor to open their mouth:  The collector inspects the oral cavity to ensure that it is free of any items that could impede or interfere with the collection of an oral fluid specimen (e.g. candy, gum, food, or tobacco) or could be used to adulterate, substitute or alter the specimen  The collector is not required to, but may use a flashlight (e.g. cell-phone flashlight) to inspect the donor’s mouth (“best practice”)  If collector inspects the donor’s mouth, and there is nothing of concern present, the collector must start a 10-minute wait period. The donor must be observed during this time!!  Collector may start filling out the Federal CCF during this time 31  If an alcohol test is required, a 10-minute wait will be Securing the Donor  If the collector finds indication(s) of anything that could be used to adulterate, substitute or alter the specimen:  The collector will ask the employee to lift their tongue and/or separate their cheek from their gum to permit full inspection  If this occurs, the employee may cleanse his or her hands; but must not decline the collector’s request for further inspection.  If the collector observes materials brought to the collection site or the employee’s conduct clearly indicates an attempt to adulterate, substitute, or alter the specimen, the collector must terminate the collection  Note the circumstances in the Remarks section of the CCF, and report the circumstances to the DER, so that the employer can decide whether to deem the situation a refusal 32  Securing the Donor  If an item is present that might impede or interfere with the collection of an oral fluid specimen:  The collector must request the employee remove the item  If the employee removes any item that could impede or interfere with the collection of an oral fluid specimen, the employee has abnormally colored saliva, or the employee claims to have ‘‘dry mouth,’’ then the collector must give the employee water, up to 8 ounces, to rinse their mouth.  The employee may drink the water. The collector must then wait 10 minutes before beginning the specimen collection. 33  Securing the Donor  If the employee refuses to remove the item or rinse their mouth when requested:  The collector must terminate the collection, note the circumstances in the Remarks section of the CCF, and report the information to the DER so that the employer can decide whether to deem the situation a refusal 34 The Kit - The Quantisal II:  QUANTISAL™ II ORAL FLUID COLLECTION DEVICE FEATURES üAllows simultaneous collection of A and B specimens üProvides two 4 mL samples containing: 1 mL of oral fluid and 3 mL of preservative buffer – giving adequate volume for screening and confirmation testing üProprietary FDA 510(k) cleared device 35 The Kit Buffer Fluid and Transport The Quantisal II: Tube Barcode and Expiry Dates Cellulose Cellulose Pad Tail Volume Adequacy Indicator Window 36 The Quantisal II Kit The How it works: Quantisal II is a vegan product How it Works: Ø The cellulose collection pad extends into a “cellulose tail” inside of the polypropylene stem Ø Blue dye is placed on the cellulose tail below the window in the stem Ø As the pad saturates with saliva, the fluid migrates along the tail and dissolves the dye Ø As the pad further saturates, the dye migrates further up into the tail until it becomes visible as blue in the window of the stem 37 Routine Collections The Quantisal Kit: How it Works:  When the blue dye appears fully throughout the adequacy indicator window, there has been one millilitre of oral fluid collected on the collection pad Be sure to check BOTH sides of the indicator window Ø When the sample has been collected the pad and tail will divide with added pressure to the wings on the top of the tail to the sides of the volume 38 adequacy indicator window Routine Collection Process: *If donor refuses to wash/sanitize their hands it is  Instruct Donor to wash hands a REFUSAL to o Soap and water test* o The collector is to observe this process o Hand sanitizer is also an option for this step  Donor selects kit – Why? o By the commencement of the test, we mean the actions listed in § 40.63(c), in which the collector or employee selects a collection container. Once the collection has commenced, the donor has committed to the process and must complete it o The donor cannot claim that the kit was selected for them with ill intent  Once a kit has been selected the collector always confirms the expiry date with the donor  Collectors should be wearing gloves for the collection process as best practice 39 Routine Collections: The Collection Procedure: Ø After the 10 minutes have surpassed  The collector can request the donor accumulate saliva with their mouth closed by moving their tongue side to side tilting their head downwards Ø Collector will open the outer packaging from the Quantisal kit, set the transport tubes aside, and open the package containing the collection wand  Allow donor to remove collection wand from the pouch  Donor removes the collection device by the top of the stem, never by the pad 40 Routine Collections: The Collection Procedure: Ø Instruct donor to position collection pad under their tongue and close mouth  Donor should not talk while pad is in their mouth  Donor should not bite the pad; this can cause the pad to shred  Donor should not bite on the stem; this can block the saliva from reaching the Volume Adequacy Indicator ØOnce both of the indicators (top to bottom) turn blue the collector will remove the lids from the transport tubes  Being careful not to spill the tubes ØThe Collector removes the device from the donor's mouth 41  Routine Collection Process:  The Collector subdivides the two pads by holding its "wings", pulling them apart and inserting each saturated pad into the separate transport tubes  The Collector Checks for tampering/adulteration  Foreign objects  Abnormal Color  This could be attempts to bite or break the pad, touching the pad with their hands, etc.  The Donor inserts each saturated pad into their separate transport tubes  Do not spill or empty the liquid or allow the donor to ingest the buffer fluid 42 Routine Collection Process: Complete Step 2 of CCF  AFTER the collection is complete. The Collection will be marked as Split  DOT Oral Fluid Collection type is always SUBDIVIDED  Collector will check to confirm each device was within expiry with the donor – the expiry date will be recorded in Step 4  Remarks to make notes (remarks) on anything “out of the ordinary”  Verbal Identification/dry mouth etc.  AFTER the collection is complete, the collector checks the “Volume Indicator(s) Observed” when the volume indicator shows a sufficient specimen 43 Routine Collection Process: Complete Step 3: The collector divides the oral fluid sample into the split tubes (per mfg instructions)  Collector attaches tamper evident seals SEALS MU  Seal “A” on the primary bottle THE BOTT ST BE ON L ES BEFORE  Seal “B” on the secondary bottle THEY ARE DATED OR  Collector dates labels INITIALLED  Donor initials labels  Double check vials - Make sure caps are sealed correctly - Make sure seal’s barcodes match the specimen ID # on CCF 44 Routine Collection Process: Step 5 (on copy 2):  The collector opens the CCF to Copy 2 and should read the certification statement in Step 5 to the donor and then have the donor complete all the information  Donor prints/signs and provides contact info, not the collector  If the donor refuses to sign, then theshould Collector collector read thecan fill into the statement donor, but only the DONOR should at minimum Donor email is the donor’s name complete and thethis date! section!! (Unless donor now requested refuses) 45 The CCF: Ø The expiration date is to be entered in this section of Step 4. ​ Ø Remembering under no circumstances may a collector sign the form before the collection is complete. ​ 46 Routine Collection Process: Step 4:  Time (collection complete) and Date  Complete “released to” information  Print name & sign (LAST) Only completed once the donor has provided a Sign only AFTER the collection is “sufficient” amount of complete!!! urine! Must include the Can be printed as soon as collector knows ACTUAL name of they will be completing the collection, and the courier the date of the collection company used! 47 Routine Collection Process: Make sure all information is included and correct – go  Double check paperwork through each section!  Distribute CCF copies  Secure the completed specimen until courier pick up Employee receives his/her copy at the time of collection. MRO and DER copies must be transmitted via email/fax or courier within 24 hours or the next business day and then mailed to DriverCheck on a regular basis!! 48 Routine Collection: Drugs Tested For: The US DOT has regulated which drugs can be tested for as part of their regulations, using HHS cut-offs for initial testing and confirmation testing:  Standard 5 Panel Includes the following:  Marijuana (THC) Department of Health and  Opioid (OPI) Human Services  Amphetamines (AMP)  Phencyclidine (PCP)  Cocaine (COC) 49 Problem Collections 50 Problem Collections:  Dry mouth  Donor has something in their mouth  Donor attempts to tamper with the specimen  Donor refuses to sign  Uncooperative donor 51 Dry Mouth 52  Dry Mouth Procedure  If donor states they are unable to provide or provides an insufficient specimen, the collector must continue to make one attempt to collect If a donor does not provide a sufficient amount after 10 minutes of using the device, the collector must provide another opportunity, using a new device (following the dry mouth procedures) Per the standing order, either another oral fluid specimen attempt can be made, or the collector can move to a urine collection 53  Dry Mouth Procedure (Continued)  The collector can offer the donor up to 8oz of water to drink/rinse their mouth  The collector must begin a 10-minute wait after the donor consumes water before proceeding with a second attempt at collection If the donor declines water, it is NOT a refusal to test 54 Dry Mouth Procedure (Continued)  ▪ In a 2nd oral fluid collection, provide up to one hour or until the donor provides a sufficient specimen, whichever occurs first  ▪ The donor must remain under the direct observation of the collector or with a person the collector designates (note this in the “Remarks” section) ▪ Up to 8 oz of water may be offered to the donor over the one-hour wait period ▪ Not accepting water is not a refusal ▪ The collector must inform that the donor must not put anything in their mouth during the wait period ▪Doing so could be considered grounds for a refusal 55 Dry Mouth Procedure (Continued) ▪ Second attempt must be made after encouraging donor to lower their head and move their tongue from side-to-side for 4 minutes prior to administering the 2nd test ▪ If no sufficient specimen has been provided after 1 hour, discontinue the collection ▪ Note the fact in the “Remarks” section ▪ Immediately notify the DER ▪ Send Copy 2 of the CCF to the MRO and Copy 4 to the DER Note: Once the 1 hour is up and still insufficient that is the end of testing, we would not move onto or back to Urine if Urine was original test type. 56 Donor Has Something in Their Mouth 57 Donor Has Something in Their Mouth ▪ For inadvertent material such as gum, tobacco, or a breath mint: ▪ Collector asks donor to remove the item ▪ Donor must use up to 8 oz. of water to rinse their mouth ▪ Donor may – but is not required to – drink the water ▪ Ten-minute wait period begins once the rinse is complete ▪ If donor refuses to remove an item from their mouth, collector terminates collection ▪ Note any occurrences in the “Remarks” section 58 Donor Has Something in Their Mouth ▪For something that indicates an attempt to cheat the test: ▪ Collection is terminated ▪ Collector marks “None Provided” in Step 2 ▪ Note any occurrences in the “Remarks” section ▪ Notify the DER of the circumstances that occurred ▪ DER determines the refusal, not collector ▪ Collector prints donor’s name on Step 5 and sends the CCF to the DER 59 Donor Attempts to Tamper with the Device 60 Donor Attempts to Tamper ▪ If the collector observes materials brought to the collection site or the donor's conduct clearly indicates an attempt to adulterate, substitute, or alter the specimen, the collector must terminate the collection. ▪ This could be attempts to bite or break the pad, touch the pad with their hands, etc. ▪ Note the circumstances in the “Remarks” section ▪ Report to the DER 61 Donor Refuses to Sign 62 Donor Refuses to Sign ▪ If the donor refuses to sign Step 5 of the CCF, this is not a refusal to test ▪ Collector prints the donor’s name legibly on the CCF ▪ Collector notes “Donor refused to sign” in the “Remarks” section of Step 2 and proceeds to Step 4 ▪ If the donor refuses to initial the Specimen ID seals on Bottles A & B, this is also not a refusal. Collector writes date only, and notes donor refusal to initial in the “Remarks” section 63 Donor is Uncooperative 64 Donor is Uncooperative § Explain to donor that failure to follow collector instructions may be a refusal to test § Explain that refusals have the same impact as positive test results, including the SAP and RTD process § Call employer – request their encouragement of donor to continue without incident § If the collection ends with a refusal, the collector: § Notes in the “Remarks” section § Asks the donor to complete their section of the CCF § Completes and transmits CCF § Provides supplemental narrative for support (to the DER, etc.) 65  Remember to keep and How to Perform a Specimen Change send over copies of all CCFs to DriverCheck even unsuccessful collections. EXAMPLE SCENARIO The collection begins with a urine test. The donor provides a specimen that is only 30 mL but appears to be green in color and does not register a temperature. The Standing Order indicates an oral fluid test should take place. The collector should:  Pour the specimen in a collection bottle, seal with Label “A”, note in the “Remarks” section that only 30 mL was collected but the specimen appeared green in color and did not register a temperature. Mark as specimen 1 of 2, cross reference Specimen ID numbers with new CCF, and prepare for shipping.  Move to an oral fluid test. When complete, cross reference Specimen ID numbers and mark the OF specimen as 2 of 2.  Send both specimens to the lab, with Specimen IDs cross-referenced. Make sure to note that MRO information matches. If it does not, cross-reference MRO information. Note: Always following the standing order (test requisition) for next steps for problem collections, switching to oral or urine testing. 66 Fatal Flaws 67 Fatal Flaws:  An uncorrectable error, in which the Oral Fluid sample is “rejected for testing”  These errors are fatal and always cause a drug test to cancelled 68  Fatal Flaws There are 9 Fatal Flaws: 1. No printed collector name and no collector signature at Step 4 2. Specimen ID number on the bottles and CCF do not match 3. Specimen seals are broken or show evidence of tampering 4. Insufficient quantity of Oral Fluid, due to leakage or other causes, and the lab cannot re-designate 5. No CCF accompanies the specimen to the lab. 6. No specimen accompanies the CCF to the lab 7. Two separate collections are performed using one CCF 8. Using an Expired collection device 9. For an oral fluid collection, the collector failed to enter the expiration date in Step 4 of the CCF and the laboratory confirmed that the device was expired 69 Fatal Flaws: What to do?  If a fatal flaw is found, error correction training must be completed within 30 days of the collector being notified.  Error Correction Training must be completed with a Driver Check trainer via webcam 70  Correctable Flaws The following are correctable flaws:  No collector signature  No donor signature, unless refusal to sign is noted in “Remarks”  The collector uses a non-Federal Oral Fluid CCF or an expired form Federal CCF  Date/Time of collection missing 71 Correctable Flaws: What Happens? If you make a mistake that needs to corrected by be MFR, attach a copy of the MFR to your c ollector copy of the C CF  The lab will retain the specimen for 5 business days from the date in which they initiated action to correct the flaw  If not corrected, the sample is “rejected for testing” and the MRO must cancel the test 72 Correctable Flaws: What to do?  If the problem resulted from omission of required information: You must supply in writing the missing information and a statement that it is true and accurate (Memorandum for Record/MFR) You must supply this information on the same business day you are notified, transmitting it by fax/email or courier 73 Correctable Flaws: What to do?  If the problem is the use of a non- Federal or an expired Federal form You must provide a signed statement (i.e. memorandum for record or affidavit) You must supply this information on the same business day you are notified, transmitting it by fax/email or courier 74 Correctable Flaws: What to do? With regards to improper form use, DOT is very specific on how to correct  The memorandum for record must state that the incorrect form contains all the information needed for a valid DOT drug test  It must state that the incorrect form was used inadvertently or as the only means of conducting a test, in circumstances beyond your control  It must also include what steps you have taken to prevent future use of the incorrect form 75 Final Thoughts: When completing Urine sample: If the urine sample is insufficient, temperature out of range, or shows signs of adulteration, refer to the Test Requisition Order for next steps. Confirm Next Step: Do not collect a second urine sample without confirmation. The requisition order will specify whether to move to oral fluid or continue with a second urine sample. Example: Shy Bladder Protocol: If a shy bladder process is followed and no sample is provided after 3 hours, the test is considered complete. You cannot switch to oral fluid collection after that. Always document the issue and follow the requisition order for proper handling of the test. **Same thing goes if Oral fluid was the first test and switched to Urine.** 76 Final Thoughts:  If a donor is booked for both drug and alcohol collections, alcohol collections must be completed first  Post Accident Testing  Medical treatment comes first!!  Urine drug collections MAY NOT be done “road-side”  Collection sites should file the collector copy of CCF for 12 months. (for billing purposes as well as if anything gets called into question)  Testing documentation and paperwork should be kept in a secure location. This means storing the paperwork in locked file cabinets or a locked room not accessible to the public or unauthorized individuals 77 78 79 80 OF Adulterated 81 82  Initial Proficiency  For each of the Demonstration five mock collections, the collector must check the expiration date of the device, show it to the employee, and record the date on the CCF used. The collector must ensure, when applying the labels, they do not cover the expiration dates.  Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between you and the qualified collector, who must attest in writing that the mock collections are “error-free.” This person must be a qualified collector who has demonstrated necessary knowledge, skills, and abilities by— (i) Regularly conducting DOT drug test collections for a period of at least one year; (ii) Conducting collector training under this part for at least one year; or (iii) Successfully completing a “train the trainer” course. (d) Schedule for qualification training and initial proficiency demonstration. You must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions. 83 Problem Collections: 1st Sample Insufficient Sample/Shy Bladder  1st urine sample is insufficient you will discard sample and move onto Oral Fluid.  You will start a 10-minute wait and select a OF Chain of custody form and kits for the donor to choose.  After 10-minute wait, collector performs OF collection per standard protocol. 84  Public Interest Exclusion PIE stands for Public Interest Exclusion  Knowingly disregarding compliance issues can result in the “service agent” being excluded from providing services for DOT covered employees/applicants for five years.  The DOT publishes the PIE exclusions for the whole world to see!  See 49 CFR 40 Subpart R for more information 85  Initial Proficiency Demonstration  Initial Proficiency Demonstration: Following your completion of qualification training under paragraph (b) of this section, you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections for each device you will use. 1. The five mock collections for each device must include: 1. One uneventful collection scenario 2. One insufficient specimen quantity scenario (dry mouth) 3. One scenario in which the employee has something in their mouth that might interfere with the collection 4. One scenario in which the employee attempts to tamper with the specimen; 5. One scenario in which the employee refuses 86 to sign the CCF.  Dry Mouth Procedure Dry Mouth: Ø If the donor is NOT able to provide a sample again within 15 minutes (window does not turn blue), repeat the steps previously described (document/offer water/10 minute wait etc.) Ø If necessary, continue with attempts to collect a sample for a maximum of 60 minutes Ø If at the end of 60 minutes no sample has been obtained, collector should call DriverCheck for further direction Collector can suggest that the donor tilt their head downwards to allow “gravity” to help with the collection process! 87  Problem Collections: drink A refusal to is NOT Insufficient Sample a refusal test!!! to  If oral fluid sample is insufficient. o The volume adequacy indicator does not turn fully blue after 15 minutes  Advise donor they have 1 hour and will be provided up to 8 oz of water (donor is not to get their own water as it needs to be a measured amount!!)  Responsible party must observe the donor over the entire process  Advise donor that they must not leave collection site/waiting room and if they do so it will be considered a refusal to test  The collector must inform that the donor must not put anything in their mouth during the wait period o Doing so could be considered grounds for a refusal 88 Problem Collections: Insufficient Sample Information to be included in the Remarks:  Time of 1st attempt with result Have donor select a  ie) “13:45 NSQ”, insufficient sample/dry mouth new collection kit.  Keep track of fluids provided and time Continue with the same CCF  ie) “8oz @ 13:48, @ 14:20”  Note time of subsequent attempts with result  ie) “14:45 NSQ”, insufficient sample  The time the donor provides a sufficient sample is the time of the collection that should be recorded in Step 4 on the CCF  Continue with the collection procedure as normal 89 Distributing CCF and Shipping Sample: When you know the date of a urine drug collection, call Purolator at 1-800-387-3027 to set up a pick-up time.  Ask Purolator to come late enough in the day (before you close) to pick up all your urine kits from that day.  Put all samples from the day into a PuroPak (you will have to request these from your Purolator driver). Put as many samples in one PuroPak as possible.  You will be provided with Purolator Weigh-bills. These should be pre-filled with your collection site information and the shipping/account information from Dynacare.  You will need one weigh-bill per package shipped  Most locations in Ontario and Quebec the method of shipping will be via Ground. All other locations in Canada samples will be shipped via Air (to ensure fast turn-around of results) 90 Distributing CCF and Shipping Sample: DISTRIBUTE APPROPRIATELY Gets Sent to  Copy 1 – Laboratory/Test Facility (White) Lab Email/Fax to DC  Copy 2 – Medical Review Officer (Pink) immediately after collection, mail in regularly  Copy 3 – Collector (Yellow)Stays atsite collection  Copy 4 – Employer (Blue)Mailwith to DC Regularly MRO Copy  Copy 5 – Donor (Green) collection Give to donor when is complete 91 Problem Collections: If donor is unable to provide a sufficient sample Insufficient Sample in 3 hours they must provide medical documentation Special Notes: within 5 days  If collector’s facility closes at 5pm and the 3-hour window is not up until 6pm, the collector must stay to ensure the donor has a full 3 hours to provide a sample  If the collector must leave, they can hand the collection off to another trained collector, the second collector would complete and sign the CCF  This transition must be documented in the “remarks” section  The first collectors name and the time of the first attempt should also be noted 92 Problem Collections: Direct Observation: Direct Observation – How?Temperature Ou t O f Range/Adultera ted Sample  Complete split and CCF from the first collection  Explain reason for direct observation to the employee  Use new CCF and have donor select a new kit  Keep in mind you may also need to start the shy bladder procedure 93 Problem Collections: Refusals Refusals to comply with any of the following carry the same consequences as a positive result:  Fail to appear for any test except pre-employment  Fail to remain at the testing site  Fail to permit an inspection of the employee’s oral cavity, or fail to remove objects from their mouth  Fail to provide sufficient amount (Deemed a refusal after exam w/o medical explanation)  Will not wash hands  Found to possess equipment used to interfere with the testing process (ie. Prosthetics)  Fails to follow the Collector’s instructions 94  Problem Collections: Insufficient Sample Ø If the donor states they are unable to provide or provides an insufficient specimen, the collector must continue to make one attempt to collect Ø If oral fluid sample is insufficient. (The volume adequacy indicator does not turn fully blue after 15 minutes from of using the device) o the collector must provide another opportunity, using a new device (following the dry mouth procedures) Ø Refer to the standing order or confirm with DER or C/TPA if you are continuing with a saliva collection or if you are to begin a DOT Urine Collection under the Rule 49 CFR Part 40 Ø In a 2nd oral fluid collection, provide up to one hour or until the donor provides a sufficient specimen, whichever occurs first 95 Problem Collections: Direct Observation If collector observes adulteration materials, collector must confiscate material, make a note Direct Observation – When? in the remarks section of CCF and immediately initiate a collection  Collector Initiates: under direct observation. Must notify C/TPA immediately after collection.  Temperature is out of range  Employer directed (RTD/Follow-Up)  Collector observes adulteration materials or a clear attempt to tamper with or adulterate specimen  The specimen shows signs of tampering (odd color, excessive foaming, bleach smell, floaters) 96 Problem Collections: Insufficient Sample If after the 3-hour time limit the donor has still not provided a sample the collector must:  Stop the collection process  Complete the CCF:  In step 2 check the “none provided” box  Make a note in the remarks section that no sample was provided Donor will not  Fill in donor’s name and phone number in step 5 sign as they did  Complete Step 4 not provide a sample  Distribute all copies of the CCF, except the “Test Facility Copy” this should be attached to the Collector’s Copy (Copy 3) as it is the “original” document! 97 Problem Collections: Refusals What Happens if the Donor Refuses to Sign the CCF or Initial the Seals?  If the employee fails or refuses to sign the form or initial the vials, you must note this in the “Remarks” line of the CCF (Step 2) and complete the collection process  If the employee refuses to fill out any information, you must, as a minimum, print the employee's name in the appropriate place.  Document the refusal to sign Advise employee the sample will still be sent for testing 98 Problem Collections: Direct Observation: UP/DOWN Direct Observation – How? TUR N AROUND  Observer will have the donor raise (to the naval) and lower clothing and undergarments (to the thigh), turn around, then put clothes back into place  Observer is checking for prosthetic adulteration devices  If prosthetic is found, it’s an immediate refusal to test.  Clothing is returned to proper position before the specimen is given 99 Problem Collections: Direct Observation: Direct Observation – How  The observer must watch the donor urinate in the container The entire void from body to cup must be witnessed  If not the collector, the observer must not handle the specimen Note the observer’s name in “Remarks” 100 101