Section 9140.30  Collection of Urine

 

The following procedures shall be used to obtain a urine sample from a subject to determine alcohol concentration and the presence of drugs or intoxicating compounds:

 

a)         Urine Collector

 

1)         Urine specimens shall be collected by any of the following:  a collector meeting the training requirements of 49 CFR 40.33 (2012), licensed physician, advanced practice nurse, registered nurse or licensed practical nurse. 

 

2)         The following persons shall not serve as a collector:

 

A)        the immediate supervisor of the employee being tested, unless no other collector is available;

 

B)        or a person employed by a laboratory who could link the employee with a urine specimen, testing result or laboratory report.

 

b)         Collection Site.  A collection site may be in a medical facility, a mobile facility, a dedicated collection facility, or any other location meeting the requirements of this Section.  The collection site must have a source of water for washing hands that, if practicable, should be external to the closed room where urination occurs.

 

c)         Prevention of Sample Adulteration.  Collectors shall make all attempts to do the following before each collection to deter tampering with specimens:

 

1)         Secure any water sources or otherwise make them unavailable to the employee providing the specimen;

 

2)         Ensure that the water in the toilet is blue or secure any movable toilet tank top;

 

3)         Ensure that no soap, disinfectants, cleaning agents or other possible adulterants are accessible to the employee at the collection site;

 

4)         Inspect the collection site to ensure that no foreign or unauthorized substances are present;

 

5)         Ensure that undetected access to the site is not possible; and

 

6)         Secure areas and items that appear suitable for concealing contaminants.

 

d)         Prevention of Sample Contamination.  Collectors shall follow the following procedures to prevent contamination of the sample:

 

1)         To avoid distraction that could compromise security, conduct only one collection for one employee at a time;

 

2)         To the greatest extent possible, keep an employee's collection container within view of both the collector and the employee between the time the employee has urinated and the time the specimen is sealed;

 

3)         Ensure that the collector is 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;

 

4)         Maintain personal control over each specimen throughout the collection process; and

 

5)         Minimize the number of persons handling the specimen.

 

e)         Collection Materials

 

1)         Urine shall be collected in containers that:

 

A)        are a single-use container, made of plastic, large enough to easily catch and hold at least 55 mL of urine voided from the body;

 

B)        have graduated volume markings clearly noting levels of 45 mL and above;

 

C)        have a temperature strip providing graduated temperature readings 32-38 degrees Celsius or 90-100 degrees Fahrenheit, that is affixed or can be affixed at a proper level on the outside of the collection container. Other methodologies are acceptable, provided that the temperature measurement is accurate and that there is no potential for contamination of the specimen; and

 

D)        are individually wrapped in a sealed plastic bag or shrink wrapping or must have a peelable, sealed lid or other easily visible tamper-evident system.

 

2)         Urine shall be placed in specimen bottles that:

 

A)        are large enough to hold at least 35 mL or, alternatively, they may be two distinct sizes of specimen bottles provided that the bottle designed to hold the primary specimen holds at least 35 mL of urine and the bottle designed to hold the split specimen holds at least 20 mL;

 

B)        have screw-on or snap-on caps that prevent seepage of the urine from the bottles during shipment;

 

C)        have markings clearly indicating the appropriate levels (30 mL for the primary specimen and 15 mL for the split specimen) of urine that must be poured into the bottles;

 

D)        meet the following specifications:

 

i)          are wrapped (with caps) together in a sealed plastic bag or shrink wrapping separate from the collection container; or

 

ii)         are wrapped (with cap) individually in sealed plastic bags or shrink wrapping; or

 

iii)        have peelable, sealed lid or other easily visible tamper-evident system; and

 

E)        if made of plastic, are leach resistant.

 

3)         Specimen bottles shall be placed in a plastic bag that:

 

A)        has two sealable compartments or pouches that are leak-resistant or a single bag that is large enough to hold two specimen bottles;

 

B)        demonstrates that any tampering or attempts to open either compartment have occurred; and

 

C)        contain enough absorbent material to absorb the entire contents of both specimen bottles.

 

f)         Collection Procedures.  The collection of urine shall be performed in accordance with the following guidelines:

 

1)         When the employee enters the collection site, the testing process shall start without undue delay. If the employee needs medical attention, this treatment shall not be delayed to collect a specimen.

 

2)         The employee must provide identification to the collector before testing.

 

3)         The collector shall explain the basic collection procedure to the employee.

 

4)         If an employee normally voids through self-catheterization, the collector shall instruct the employee that he or she is required to provide a specimen in that manner.

 

5)         The collector shall instruct the employee to wash and dry his or her hands at this time and instruct the employee not to wash his or her hands again until after delivering the specimen to the collector.

 

6)         The employee may provide his or her urine specimen in a stall or otherwise partitioned enclosure that allows for individual privacy. The collector shall remain in the restroom or area, but outside the stall or partitioned enclosure.

 

7)         The collector shall 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 the collector and the employee present, must unwrap or break the seal of the collection container. The collector shall not unwrap or break the seal on any specimen bottle at this time.

 

8)         The employee shall only take the collection container into the room used for urination.

 

9)         The collector shall collect a specimen of at least 45 mL.

 

g)         Steps Following Collection of Urine Specimen.  The collector shall perform the following after the collection of the urine specimen:

 

1)         The collector shall check the temperature of the specimen no later than four minutes after the employee has given the specimen to the collector by reading the temperature strip attached to the collection container and report this information on the Chain of Custody Form. 

 

2)         The collector shall inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering.

 

h)         Direct Observation Collection Procedure.  The collector shall initiate a direct observation collection procedure if:  the temperature of the urine is outside of the temperature range of 32-38 degrees Celsius or 90-100 degrees Fahrenheit; the collector determines that material appears to be brought to the collection site with the intent to alter the specimen; or it is apparent from this inspection that the employee has tampered with the specimen. The direct observation collection procedure shall be performed in accordance with the following guidelines:

 

1)         The collector shall explain to the employee the reason for a directly observed collection. 

 

2)         The observer shall be the same gender as the employee.  The observer may be a different person from the collector and need not be a qualified collector.

 

3)         The observer must request the employee to raise his or her shirt, blouse, dress or skirt, as appropriate, above the waist and lower clothing and underpants to show the collector, by turning around, that the employee does not have a prosthetic device. After the collector has determined that the employee does not have such a device, the employee may return his or her clothing to its proper position for observed urination.

 

4)         The observer shall watch the employee urinate into the collection container. 

 

5)         The observer shall watch the specimen as the employee takes it to the collector. If the observer is not the collector, the observer shall not take the collection container from the employee. 

 

6)         If another person has acted as the observer, his or her name shall be recorded on the Chain of Custody Form.

 

i)          Preparation of Urine Specimen.  The collector shall take the follow steps after collection in the presence of the employee:

 

1)         Pour at least 30 mL of urine from the collection container into one specimen bottle, to be used for the primary specimen.

 

2)         Pour at least 15 mL of urine from the collection container into the second

specimen bottle to be used for the split specimen.

 

3)         Place and secure the lids or caps on the bottles.

 

4)         Seal the bottles by placing the tamper-evident bottle seals over the bottle caps/lids and down the sides of the bottles.

 

5)         Write the date on the tamper-evident bottle seals.

 

6)         Discard any urine left over in the collection container after both specimen bottles have been appropriately filled and sealed.

 

7)         Allow the employee to initial the tamper-evident bottle seals for the purpose of certifying that the bottles contain the specimens provided.

 

j)          Completion of Collection Process. To complete the collection process, the collector shall follow the following procedure:

 

1)         The collector shall secure the pouches of the plastic bag containing the specimens in the presence of the employee.

 

2)         The collector shall place the sealed plastic bag in a shipping container designed to minimize the possibility of damage during shipment and seal the shipping container as appropriate.

 

3)         The collector shall complete all applicable portions of the Chain of Custody Form as specified in Section 9140.10.

 

4)         The collector shall ensure that each specimen collected is shipped to a laboratory as quickly as possible, but no later than 24 hours after collection or during the next business day after collection.