Num.

Question

REGULATORY CITATIONS

WERE THE NORMAL PREPARATORY SPECIMEN COLLECTION PROCEDURES FOLLOWED CORRECTLY AND COMPLETELY?

Does the collector positively identify the employee by photo identification before beginning the collection process?

Section 40.61(c) states: "Require the employee to provide positive identification. You must see a photo ID issued by the employer (other than in the case of an owner-operator or other self-employed individual) or a Federal, state, or local government (e.g., a driver's license). You may not accept faxes or photocopies of identification. Positive identification by an employer representative (not a co-worker or another employee being tested) is also acceptable. If the employee cannot produce positive identification, you must contact a DER to verify the identity of the employee."

Was the employee required to sign a consent form?

Section 40.355(a) states: "Do not require an employee to sign a consent, release, waiver of liability, or indemnification agreement with respect to any part of the drug or alcohol testing process covered by this part (including, but not limited to, collections, laboratory testing, MRO, and SAP services). No one may do so on behalf of a service agent."

Does the collector direct the employee to remove any outer garments (e.g., jacket, coat, hat) and to leave personal belongings such as purses and briefcases with the outer garments?

Section 40.61(f) states: "Direct the employee to remove outer clothing (e.g., coveralls, jacket, coat, hat) that could be used to conceal items or substances that could be used to tamper with a specimen. Also direct the employee to leave these garments and any briefcase, purse, or other personal belongings with you or in a mutually agreed upon location. Advise the employee that failure to comply with your directions constitutes a refusal to test."

Does the collector direct the employee to empty his or her pockets and display the items in them to ensure that there are no items present that could be used to adulterate the specimen?

Section 40.61(f)(4) states: "Direct the employee to empty his or her pockets and display the items in them to ensure that no items are present which could be used to adulterate the specimen. If nothing is there that can be used to adulterate a specimen, the employee can place the items back into his or her pockets. The employee must allow the collector to make this observation."

Is the employee allowed to keep his/her wallet?

Section 40.61(f)(2) states: "Allow the employee to keep his or her wallet."

Does the collector explain the basic collection procedure to the employee and show the employee the instructions on the back of the CCF?

Section 40.61(e) states: "Explain the basic collection procedure to the employee, including showing the employee the instructions on the back of the CCF."

After the employee has removed any outer clothing and displayed the contents of their pockets, does the collector instruct the employee to wash and dry his/her hands?

Section 40.63 states: "As the collector, you must take the following steps before the employee provides the urine specimen: (b) Instruct the employee to wash and dry his or her hands at this time. Tell the employee not to wash his or her hands again until after delivering the specimen to you. Do not give the employee any further access to water or other materials that could be used to adulterate or dilute a specimen."

Is there a source of water for hand washing, which, if practicable, is external to the privacy enclosure?

Section 40.41(e)(2) states: "Provide a source of water for washing hands that, if practicable, should be external to the closed room where urination occurs. If an external source is not available, this requirement may be met by securing all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and providing moist towelettes outside the closed room."

Are collection containers sealed, and does the employee or collector remove the sealed wrapper in the presence of the employee?

Appendix A states: "1. Collection Container . . . (d) Must be individually wrapped in a sealed plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system."

Section 40.63(c) states: "Select, or allow the employee to select, an individually wrapped or sealed collection container from collection kit materials. Either the collector or the employee, with both present, must unwrap or break the seal of the collection container. Do not unwrap or break the seal on any specimen bottle at this time. Do not allow the employee to take anything from the collection kit into the room used for urination except the collection container."

After the employee washes his/her hands, is the employee provided with a single-use plastic container from the collection kit which can hold at least 55 mL of urine? Does the collector assure that the employee takes nothing into the room used for urination except the collection container?

Part 40 Appendix A states: "The Collection Kit. (1)(a) Contents: Single-use container, made of plastic, large enough to easily catch and hold at least 55 mL of urine voided from the body."

Section 40.63(c) states: "Do not allow the employee to take anything from the collection kit into the room used for urination except the collection container."

Is the employee then required to remain in the presence of the collector (with no access to water, soap or other adulterating agents) until entering the privacy enclosure to provide the specimen?

Section 40.63(b) states: "Instruct the employee to wash and dry his or her hands at this time. Tell the employee not to wash his or her hands again until after delivering the specimen to you. Do not give the employee any further access to water or other materials that could be used to adulterate or dilute a specimen."

Does the collector ensure that in the privacy enclosure for urination:

(1) all sources of clear water have been eliminated,

(2) possible specimen contaminants have been removed; and

(3) all places where paraphernalia could be hidden were secured or removed?

Section 40.43(b) states: "As a collector, you must do the following before each collection to deter tampering with specimens:

(1) Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets);

(2) Ensure that the water in the toilet is blue;

(3) Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present; (4) Inspect the site to ensure that no foreign or unauthorized substances are present;

(5) Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank;

(6) Ensure that undetected access (e.g., through a door not in your view) is not possible;

(7) Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants; and

(8) Recheck items in paragraphs (b)(1) through (7) of this section following each collection to ensure the site's continued integrity."

If a non-dedicated facility (public restroom or hospital examining room) is used for collections, is the location used for testing secured during drug testing by:

1) visually inspecting the privacy enclosure;

2) assuring that undetected access (e.g., through a rear door) is prevented; and

3) posting limited access signs during the collection process?

Section 40.43(c) states: "If the collection site uses a facility normally used for other purposes, like a public rest room or hospital examining room, you must, as a collector, also ensure before the collection that:

(1) Access to collection materials and specimens is effectively restricted; and

(2) The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted."

Does the water in the toilet (and toilet tank if it is not secured) contain a bluing agent?

Section 40.43(b)(2) states: "Ensure that the water in the toilet is blue."

Section 40.43(b)(5) states: "Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank."

UPON RECEIPT OF THE SPECIMEN, DID THE COLLECTOR CORRECTLY FOLLOW THE REQUIRED ACTIONS?

After the employee provides a urine specimen, does only the collector handle the urine specimen before it is poured into the specimen bottles?

Section 40.43(d)(3) states: "Ensure you are the only person in addition to the employee who handles the specimen before it is poured into the bottles and sealed with tamper-evident seals."

Once the employee provides a urine specimen to the collector, does the collector then observe that the specimen quantity is at least 45 milliliters and check the split specimen box in Step 2 of the CCF?

Section 40.65(a) states: "Sufficiency of specimen. Check to ensure that the specimen contains at least 45 mL of urine."

Section 40.71(b) states: "As a collector, you must take the following steps, in order, after the employee brings the urine specimen to you. You must take these steps in the presence of the employee. (1) Check the box on the CCF (Step 2) indicating that this was a split specimen collection."

After determining that the urine specimen is at least 45 mL, does the collector:

(1) determine the temperature of the specimen, using the temperature strip attached to the collection container within 4 minutes of receiving the specimen; and

(2) mark the appropriate temperature box on the CCF?

Section 40.65(b) states: "Temperature. The collector must check the temperature of the specimen no later than four minutes after the employee has given the collector the specimen.

(1) The acceptable temperature range is 32-38 deg. C / 90-100 deg. F.

(2) The collector must determine the temperature of the specimen by reading the temperature strip attached to the collection container.

(3) If the specimen temperature is within the acceptable range, you must mark the "Yes" box on the CCF (Step 2)."

Are the two specimen bottles sealed until it is time to pour the sample from the collection container?

Section 40.63(c) states: "Select, or allow the employee to select, an individually wrapped or sealed collection container from collection kit materials. Either you or the employee, with both of you present, must unwrap or break the seal of the collection container. You must not unwrap or break the seal on any specimen bottle at this time."

After specimen collection and temperature reading, does the collector pour at least 30 mL of urine into the primary specimen bottle?

Section 40.71(b)(2) states: "The collector, not the employee, must first pour at least 30 mL of urine from the collection container into one specimen bottle, to be used for the primary specimen."

Does the collector pour at least 15 mL of the remaining urine specimen into the second specimen bottle to be used as the split specimen?

Section 40.71(b)(3) states: "The collector, not the employee, must then pour at least 15 mL of urine from the collection container into the second specimen bottle to be used for the split specimen."

WERE THE CUSTODY AND CONTROL FORM AND SPECIMEN BOTTLES PROPERLY COMPLETED AND SEALED?

Is there a suitable clean surface for writing?

Section 40.41(c) states: "If you are operating a collection site, you must have all necessary personnel, materials, equipment, a clean writing surface, and facilities and supervision to provide for the collection, temporary storage, and shipping of urine specimens to a laboratory."

Does the employer utilize the standard five-part, carbonless, Federal Drug Testing Custody and Control Form?

Section 40.45(a) states: "The Federal Drug Testing Custody and Control Form (CCF) must be used to document every urine collection required by the DOT drug-testing program. The CCF must be a five-part carbonless manifold form. You may view this form on the Department's web site (http://www.dot.gov/ost/dapc) or the HHS web site (http://www.health.org/workplace/)."

Does the collector complete Step 1 of the custody and control form by selecting:

(1) the reason for the test (e.g., pre-employment), and

(2) the drug tests to be performed (e.g., THC, COC, PCP, OPI, AMP)?

Section 40.63(a) states: "The collector must complete Step 1 of the CCF before the employee provides the urine specimen."

Does the collector securely place tamper-evident bottle seals over the bottle caps/lids and down the sides of each specimen bottle?

Section 40.71(b)(4) states: "You [the collector], not the employee, must place and secure (i.e., tighten or snap) the lids/caps on the bottles."

Section 40.71(b)(5) states: "You [the collector], not the employee, must seal the bottles by placing the tamper-evident bottle seals over the bottle caps/lids and down the sides of the bottles."

Does the collector write the date on each tamper-evident specimen bottle seal, only after the seals are affixed to the bottles?

Section 40.71(b)(5) states: "You [the collector], not the employee, must seal the bottles by placing the tamper-evident bottle seals over the bottle caps/lids and down the sides of the bottles."

Section 40.71(b)(6) states: "You [the collector], not the employee, must then write the date on the tamper-evident bottle seals."

Does the employee initial each tamper-evident specimen bottle seal only after the seals are affixed to the bottles and dated by the collector?

Section 40.71(b)(7) states: "You must then ensure that the employee initials the tamper-evident bottle seals for the purpose of certifying that the bottles contain the specimens he or she provided. If the employee fails or refuses to do so, you must note this in the "Remarks" line of the CCF (Step 2) and complete the collection process."

After the tamper-evident specimen bottle seals are initialed by the employee, does the collector direct the employee to read and sign the certification statement on Copy 2 (Step 5) of the CCF and provide date of birth, printed name, and day and evening contact telephone numbers?

Section 40.73(a)(1) states: "The collector must do the following in the employee's presence to complete the collection. Direct the employee to read and sign the certification statement on Copy 2 (Step 5) of the CCF and provide date of birth, printed name, and day and evening contact telephone numbers. If the employee refuses to sign the CCF or to provide date of birth, printed name, or telephone numbers, you must note this in the "Remarks" line (Step 2) of the CCF, and complete the collection. If the employee refuses to fill out any information, you must print the employee's name in the appropriate place."

After the employee completes (Copy 2) Step 5 of the CCF, and before completing Step 4 of the CCF, does the collector review the information entered on the CCF for accuracy and completeness?

Section 40.73(a)(3) states: "As the collector, you must do the following things to complete the collection process …Ensure that all copies of the CCF are legible and complete."

After the employee completes (Copy 2) Step 5 of the CCF, does the collector then complete Step 4 (i.e., providing a signature, printed name, date, time of collection, and name of delivery service)?

Section 40.73(a)(2) states: "Complete the chain of custody on the CCF (Step 5) by printing your name (note: you may pre-print your name), recording the time and date of the collection, signing the statement, and entering the name of the delivery service transferring the specimen to the laboratory."

Section 40.45(b)(4) states: "As a collector, you may use a CCF with your name, address, telephone number, and fax number preprinted, but under no circumstances may you sign the form before the collection event."

After completing Step 4 of the CCF, does the collector place the sealed specimen bottles and Copy 1 of the CCF in a leak proof plastic bag, with absorbent material, and then seal the bag?

Section 40.73(a) states: "As the collector, you must do the following things to complete the collection process. You must complete the steps called for in paragraphs (a)(1) through (a)(7) of this section in the employee's presence."

Section 40.73(a)(5) states: "Place the specimen bottles and Copy 1 of the CCF in the appropriate pouches of the plastic bag."

Appendix A states: "3. Leak-Resistant Plastic Bag

a. Must have two sealable compartments or pouches which are leak-resistant; one large enough to hold two specimen bottles and the other large enough to hold the CCF paperwork.

b. The sealing methodology must be such that once the compartments are sealed, any tampering or attempts to open either compartment will be evident."

Appendix A states: "4. Absorbent material. Each kit must contain enough absorbent material to absorb the entire contents of both specimen bottles. Absorbent material must be designed to fit inside the leak-resistant plastic bag pouch into which the specimen bottles are placed."

Section 40.73(a)(6) states: "Secure both pouches of the plastic bag."

Are copies 1 through 5 of the custody and control form sent to the correct individuals:

(Copy 1) Laboratory,

(Copy 2) MRO,

(Copy 3) Collector,

(Copy 4) DER, and

(Copy 5) Employee?

Section 40.73(a) states: "As the collector, you must do the following things to complete the collection process. You must complete the steps called for in paragraphs (a)(1) through (a)(7) of this section in the employee's presence."

Section 40.73(a)(4) states: "Remove Copy 5 of the CCF and give it to the employee."

Section 40.73(a)(9) states: "Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You must fax or otherwise transmit these copies to the MRO and DER within 24 hours or during the next business day. Keep Copy 3 for at least 30 days, unless otherwise specified by applicable DOT agency regulations."

To the greatest extent possible, does the collector keep the employee's collection container within his/her and the employee’s view between the time the employee has urinated and the specimen bottle is sealed?

Section 40.43(d)(2) states: "To the greatest extent possible, the collector should keep the employee's collection container within his/her and the employee’s view between the time the employee has urinated and the specimen is sealed."

Does the collector have only one employee under his/her supervision at one time until the collection process is completed (i.e., specimen has been collected, the urine specimen bottle has been sealed and initialed, the custody and control form has been completed and the employee has departed)?

Section 40.43(d) states: "As a collector, you must take the following additional steps to ensure security during the collection process:

(1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a "shy bladder" situation (see Section 40.193(b)), you may conduct a collection for another employee."

WERE THE INFORMATION BLOCKS COMPLETED CORRECTLY BY THE COLLECTOR AND LEGIBLE ON ALL PARTS OF THE STANDARD FIVE PART DRUG TESTING CUSTODY AND CONTROL FORM?

Were the following items completed and legible on the custody and control form:

(1) employee ID No. or SSN;

(2) employer’s name, address, telephone and fax numbers; and

(3) MRO’s name, address, telephone and fax numbers (C/TPA contact information may also be included, but is not required)?

Section 40.63(a) states: "As the collector, you must take the following steps before the employee provides the urine specimen: (a) Complete Step 1 of the CCF."

Section 40.73(a)(3) states: "Ensure that all copies of the CCF are legible and complete."

Section 40.45(b)(2) states: "The CCF must include the names, addresses, telephone numbers and fax numbers of the employer and the MRO, which may be preprinted, typed, or handwritten. The MRO information must include the specific physician's name and address, as opposed to only a generic clinic, health care organization, or company name. This information is required, and it is prohibited for an employer, collector, service agent or any other party to omit it. In addition, a C/TPA's name, address, fax number, and telephone number may be included, but is not required."

Is the information entered in Step 4 of the CCF complete and legible and contain the following:

(1) Collector signature and printed name;

(2) Time of collection;

(3) Date of collection; and

(4) Name of delivery service transferring specimen to lab?

Section 40.73(a)(2) states: "Complete the chain of custody on the CCF (Step 5) by printing your name (note: you may pre-print your name), recording the time and date of the collection, signing the statement, and entering the name of the delivery service transferring the specimen to the laboratory."

DOES THE SPECIMEN COLLECTION SITE HAVE THE REQUIRED SECURITY FEATURES?

Is the facility used for urine collections securely maintained at all times?

Section 40.43(a) states: "Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections."

Section 40.43(e) states: "If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored."

Are only authorized personnel permitted in any area of the designated collection site where urine specimens are collected or stored?

Section 40.43(e) states: "If operating a collection site, the collector must implement policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored."

Is security of the collection materials and completed specimens within the collection site maintained at all times?

Section 40.43(e) states: "If operating a collection site, the collector must implement policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored."

How is your collection site secured to prevent a donor from tampering with or adulterating a specimen?

Section 40.43(b) states: "As a collector, you must do the following before each collection to deter tampering with specimens:

(1) Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets);

(2) Ensure that the water in the toilet is blue;

(3) Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present; (4) Inspect the site to ensure that no foreign or unauthorized substances are present;

(5) Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank;

(6) Ensure that undetected access (e.g., through a door not in your view) is not possible;

(7) Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants; and

(8) Recheck items in paragraphs (b)(1) through (7) of this section following each collection to ensure the site's continued integrity."

Section 40.43(c) states: "If the collection site uses a facility normally used for other purposes, like a public rest room or hospital examining room, you must, as a collector, also ensure before the collection that:

(1) Access to collection materials and specimens is effectively restricted; and

(2) The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted."

How often is the security of the designated privacy enclosure used for urine collections checked?

Section 40.43(b)(8) states: "Recheck items in paragraphs (b)(1) through (7) of this section following each collection to ensure the site's continued integrity."

Section 40.43(b) states: "As a collector, you must do the following before each collection to deter tampering with specimens:

(1) Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets);

(2) Ensure that the water in the toilet is blue;

(3) Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present (4) Inspect the site to ensure that no foreign or unauthorized substances are present;

(5) Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank;

(6) Ensure that undetected access (e.g., through a door not in your view) is not possible;

(7) Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants . . ."

THIS COMPLETES THE REVIEW OF A NORMAL URINE COLLECTION. – NOW I WOULD LIKE TO ASK YOU SOME QUESTIONS ABOUT YOUR PROCEDURES AND REFERENCE MATERIALS

ARE THE PROPER PROCEDURES USED WHEN THERE ARE PROBLEMS DURING THE COLLECTION?

Do you have:

(1) a copy of Part 40 with technical amendments (published August 9, 2001), and

(2) the current “DOT Urine Specimen Collection Guidelines?

Section 40.33(a) states: "Basic information. You must be knowledgeable about this part, the current "DOT Urine Specimen Collection Procedures Guidelines," and DOT agency regulations applicable to the employers for whom you perform collections, and you must keep current on any changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available from ODAPC (Department of Transportation, 400 7th Street, SW., Room 10403, Washington DC, 20590, 202-366-3784, or on the ODAPC web site (http://www.dot.gov/ost/dapc)."

What is done if the employee does not have a photo ID?

Section 40.61(c) states: "Require the employee to provide positive identification. You must see a photo ID issued by the employer (other than in the case of an owner-operator or other self-employed individual) or a Federal, state, or local government (e.g., a driver's license). You may not accept faxes or photocopies of identification. Positive identification by an employer representative (not a co-worker or another employee being tested) is also acceptable. If the employee cannot produce positive identification, you must contact a DER to verify the identity of the employee."

If the employee does not have a photo ID, is identification of the employee by another employee being tested accepted?

Section 40.61(c) states: ". . . Positive identification by an employer representative (not a co-worker or another employee being tested) is also acceptable. If the employee cannot produce positive identification, you must contact a DER to verify the identity of the employee."

What actions must the collection site take if an employee does not arrive to take a scheduled test?

Section 40.241(a) states: "The collector must take the following steps before actually beginning a collection: When a specific time for an employee's test has been