Drug Collection Procedures Quiz

Oral Fluid Specimen Collector Qualification Training

• Training is mandatory, adhering to US DOT (Department of Transportation) 49 CFR Part 40 guidelines.
• Training objectives include ensuring all collectors fully complete the course curriculum in compliance with CFR 49 part 40 requirements, and providing a source of information for collectors to use during the oral fluid specimen collection process.

Section I: Introduction

• Qualification requirements for collectors
• Qualification requirements for trainers
• Training records

What is Oral Fluid?

• Oral fluid and saliva are used interchangeably, but oral fluid testing for drugs and saliva testing for alcohol are distinct.
• Oral fluid is a combination of three major glandular fluids (with some minor glands)
• Blood/serum-like fluid
• Drugs cross from the bloodstream into oral fluid.

Definition: Collector

• A collector instructs and assists employees at a collection site.
• They receive and make an initial inspection of specimens from those employees.
• The collector initiates and completes the Collection Custody Form (CCF).
• An immediate supervisor may not act as collector unless no other collector is available, and permitted under DOT operating administration's drug and alcohol regulation.

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.
• Three main requirements: basic information, qualification training, and initial proficiency demonstration.

Qualification Requirements for Collectors: Basic Information

• Collectors and trainers must be knowledgeable about DOT Oral Fluid Specimen Collection Procedures Guidelines and DOT agency regulations.
• DOT agency regulations, guidelines, and other materials are available from ODAPC. (Contact information for ODAPC is included)

Responsibilities for Collectors and Trainers

• Collectors and trainers must be subscribed to the ODAPC list-serve to stay updated on DOT Workplace Drug and Alcohol Testing Rules.

Qualification Requirements for Collectors: Documents

• Basic information includes two documents: 49 CFR Part 40 and DOT Oral Fluid Specimen Collection Procedures.

Qualification Requirements for Collectors: Training

• Collectors must receive qualification training that includes instruction on testing procedures, operating oral fluid collection devices, and correctly completing and transmitting the CCF.
• Training must cover fatal flaws and correctable flaws, including how to correct any problems.
• It covers the collector's responsibility to maintain collection process integrity, ensuring employee privacy and specimen security.

Refresher Training Requirements

• Refresher training is required every five years.
• It covers basic information, qualification training, and proficiency demonstrations identical to initial collector training.

Error Correction Training Requirements

• Error correction training is needed after a mistake that cancels a test.
• It must include basic information, qualification training, proficiency demonstration (including 3 error-free, one normal and two pertaining mocks).
• Error correction training must take place within 30 days.

Qualification Requirements for Trainers

• Trainer qualifications aren't specifically defined.
• A qualified collector who demonstrates knowledge, skills, and abilities becomes a trainer.
• Regular DOT oral fluid drug test collections for 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.
• (Note: The flexibility criteria for trainers for mock oral fluid collections are mentioned as a possible alternative or supplemental requirement.)

Training Records

• Collectors must maintain and provide DOT agency, employers, or service agents with training documentation.
• Records must be kept indefinitely while the collector works at the site, plus two years after they leave employment. This will include training manuals, exams, mock C CFS, and certificates.

Protecting the security and integrity of the specimen collection process

• Collection facilities: Collectors are responsible for testing materials, supervision, and security for specimen integrity.
• Authorized participants: These include donors, company representatives, union, DOT agency representatives and interpreters. The rules on authorized persons must be strictly enforced to prevent the collection procedures from being impeded.
• Maintaining control of the specimen:Collectors must ensure the integrity of the collection process.

Collection Site Facilities

• The site may be medical, mobile or dedicated.
• Collectors are responsible for testing materials, supervision and security.
• The integrity of the collection must be maintained. Access to materials and specimens must be restricted to minimize tampering/disturbances.

Collection Site Security and Integrity

• Limiting to one collection per collector
• Keeping the sample in view
• Only the donor and collector handling the specimen
• Limiting the number of staff/employees handling specimens

Collection Site Security and Integrity: Authorized Personnel

• Donor, Company representative, Union Representative, Designated Employee Representative, DOT Agency Representative, Interpreter

Collecting The Specimen

• Federal Custody and Control Form (CCF)
• Routine collections
• Sequential order for collections
• Difficult collections
• Refusals to Test
• Fatal flaws & correctable flaws
• Making the corrections

Federal Custody and Control Form (CCF)

• 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.

• NEVER use a non-DOT/Oral Fluid form or expired Federal form for a DOT Oral Fluid collection.

• Step 1 of every DOT CCF must include (employer, DER, address, phone numbers, MRO information, pre-printed collector's company name, and address)

The Kit - The Quantisal II

• Simultaneous collection of A and B specimens
• Provides sufficient (1 mL) oral fluid and preservative buffer for adequate testing.
• FDA 510(k) cleared device.
• This includes the Components: Barcode, expiry dates, Cellulose tail, Volume adequacy indicator, Cellulose pad, Buffer fluid, and transport tubes

The Quantisal II Kit: How it Works

• Cellulose collection pad extends into a "cellulose tail".
• Blue dye is placed on the cellulose tail below the window.
• Saliva saturates the pad, fluid migrates, and dye dissolves.
• Dye migrates further up until it becomes visible as blue in the window.

Routine Collections: The Quantisal Kit: How it Works

• Ensure the blue dye appears completely in the adequacy indicator window.
• Collect one milliliter of oral fluid on the collection pad.

Routine Collection Processes and Procedures

• Procedures for routine collection of specimens using the Quantisal II kit.
• Detailed steps for preparing the donor, positioning the collection device, and handling the collected specimens.

Securing the Donor

• Collector must follow guidelines; this may include removing outer garments, emptying the pockets, ensuring no contraband materials, etc.
• Collector is responsible for ensuring the doner's mouth is clear of materials that may interfere with the collection (per the guidelines and the type of kit being used).
• Waiting period of 10 minutes.
• If the donor refuses, this must be documented in the “Remarks” section and reported to the proper regulatory officers as required.

Securing the Donor: If an item is present that might impede or interfere with the collection of an Oral Fluid specimen

• Collector must request the employee remove the item.
• If the donor's mouth is deemed not appropriate, offer water, until 8 ounces, and for a wait period, of 10 minutes prior to starting and then collect the specimen if appropriate.

Securing the Donor: If the employee refuses to remove the item or rinse their mouth when requested

• Collector terminates collection.
• Document the circumstances.
• Collector must report the occurrence to DER.

The Kit - The Quantisal II: Features

• Simultaneous collection of A and B specimens
• Provides sufficient (1 mL) oral fluid and preservative buffer for adequate testing

Problem Collections: Dry Mouth

• If the donor states inability to provide a sufficient sample, collector must make one attempt.
• If donor does not provide amount after 10 minutes, the use of a new device is required.
• The collector can offer up to 8 ounces of water to rinse before the second attempt.
• Refusal of water is not considered a refusal to provide a test.

Problem Collections: Donor has something in their mouth

• Collector asks the donor to remove the item.
• Donor may use up to 8 ounces of water to rinse their mouth.
• A 10-minute wait period begins once the rinse is complete.
• Refusal to remove, results in terminating collection and noting circumstances in the "remarks" section, then reporting to DER.

Problem Collections: Donor attempts to tamper

• If the collector observes materials brought to the collection site or the donor's conduct clearly indicates an attempt to alter/tamper with the specimen; the collection is terminated.
• Note these occurrences in the "Remarks" section, and report to DER.

Problem Collections: Donor refuses to sign

• If the donor refuses to sign the CCF, it is NOT a refusal to test, but only to sign.
• Collector prints the donor's name on the CCF.
• Note "Donor refused to sign" in the remarks section for step 2 and proceeds with Step 4.

Problem Collections: Donor is Uncooperative

• Explaining to the donor their refusal to follow instructions can be a refusal.
• Explaining to the donor that refusal to comply impacts the SAP & RTD procedures, can help.
• If the collection is unsuccessful, the collector notes in the remarks, asks the donor to complete their section, completes and sends the CCF.
• Collector provides supplemental notes for support (to DER).

Problem Collections: insufficient sample

• If the initial sample (urine) is insufficient; the test will proceed to oral fluid.
• If a shy bladder procedure is followed, and the donor does not provide a sample after 3 hours you cannot switch to oral fluid.
• Collector always documents any issue and follow the requirements as written in the order for the test procedures.

Problem Collections: Direct Observation

• Observer must watch the donor urinate.
• Entire void from body to cup must be witnessed.
• If not the collector who performs the collection, the observer must not handle the specimen.
• Note the observer's name in "remarks".

How to Perform a Specimen Change

• The collection should start with a urine test.
• If the initial specimen is insufficient or improper for any reason (temperature, color, amount), refer to the standing order for the correct next collection steps.
• The collector must properly document the issue(s).
• The collector must note the correct specimens and types of tests.
• Always follow the standing order for next steps for problem collections.

Fatal Flaws

• Uncorrectable errors leading to specimen rejection.
• Nine fatal flaws, which negatively impact the validity and acceptability of a specimen.

Correctable Flaws

• Errors that can be corrected.
• The lab retains the specimen for five business days.
• If the correctable flaw is uncorrected, the sample is rejected for testing.

Correctable Flaws: What to Do?

• If a correctable flaw occurred due to an omission of required information; the missing information must be supplied in writing, and a statement that it is true and accurate.
• If a correctable flaw occurred due to the use of a non-Federal or expired Federal Form; a signed statement (affidavit/memorandum for record) must be supplied.
• Supply necessary information on the same business day as being notified.
• Provide corrective actions that ensure incorrect form use is not repeated again.

Final Thoughts

• Confirm Next Steps (Urine testing, oral, etc.): Ensure you do not collect a second urine sample without confirmation that the next test is, in fact, oral. The order for testing will specify whether to move to oral fluid or continue with a second urine sample.
• In cases of insufficient/failed urine sample collections the collector immediately notifies all necessary parties (per the standing orders) and will proceed to oral fluid if appropriate.
• If a donor is booked for both drug and alcohol collections, alcohol collections must be completed first.
• Medical treatment comes first!!
• Testing documentation and paperwork will be kept in secure locations (locked file cabinets/rooms).
• Follow all procedures as listed in the Test Requisition procedures and the documentation.

Initial Proficiency Demonstration

• For each mock device, check the expiration date and record the date on the CCF.
• The collector ensures that expiration dates are not covered when applying labels to the device or CCF.
• A second person monitors/observes the collection procedure.
• Ensuring that the mock collections are error-free is important. The monitor/observer provides documentation to attest.
• Five mock collections are required.

Distributing CCF and Shipping Sample

• A crucial step in transferring documentation and specimen information from the collection site to the laboratory. Accurate distribution ensures proper record-keeping and successful processing of the specimens. Proper distribution procedures must be followed to ensure all copies arrive.

Problem Collections: Insufficient Sample: Special Notes

If a collector's facility closes at 5 pm, and the 3-hour time limit for collection is not until 6 pm, the collector will stay at the site until the 3-hour time limit is met. If the collector must leave before that, the collector notes this and hands the collection off to another trained professional.

Problem Collections: Direct Observation

• Provide direct observation of the patient's voiding. Must ensure that the entire process (body to specimen container) is witnessed by the observer.
• Only the collector can handle the specimen.

Problem Collections: Refusals

• A refusal of testing procedures (which is not a positive test result) will need to be promptly noted, documented, and notified to the proper personnel. This includes if the donor doesn't appear, refuses the inspection, fails to provide a required amount, or refuses to comply with any other testing protocol/instructions.

Problem Collections: Insufficient Sample

• If the donor is unable to provide or provides an insufficient sample, the collector must continue to attempt one collection, with the help of offering water, and allowing a maximum of 60 minutes.
• A second oral fluid collection is a possible next step.

Additional Information

• Standard 5 Panel drugs may be tested, which includes Marijuana, Opioids, Amphetamines, Phencyclidine, and Cocaine.
• Problem Collections.

Test your knowledge on standard drug collection procedures and regulations. This quiz covers best practices, security requirements, and actions collectors must take to ensure specimen integrity. Perfect for those in the field of drug testing and compliance.