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Urine Drug Screen Procedures for Random and Observed Specimen Collection

Article By: MichaelS76
Health and fitness



My SOP that I made from my own experience as a Laboratory Manager and DOT guidelines and patient feedback. This is a comprehensive procedure for the collection of random or observed urine drug screens, to ensure validity of the sample and prevent tampering or adulteration. This procedure was first written when I was Lab Manager at Eastern Virginia Medical School and has been updated to current standards as of 2013.


Submitted:Nov 10, 2014    Reads: 99    Comments: 0    Likes: 0   


Revised 2/14/13

Urine Drug Screen Procedures for Random and Observed Specimen Collection.

Random drug screen collection procedure:

Before starting the collection process the following should be done to ensure the correct and accurate collection of a urine specimen.

1. Pay careful attention to the patient throughout the collection process.

2. Ensure that there is no unauthorized access into the collection areas and that undetected access is not possible.

3. Make sure the patient shows a proper id or has a signed drug screen slip, this ensures the correct patient is providing the specimen.

4. Fill out drug screen information with correct patient information and have the patient review the information to ensure the information of the drug screen form is correct. Have the patient initial the drug screen form, but not the seal until it is affixed on the completed specimen. This eliminates the possibility that someone else's seal or label is placed on the patient's specimen bottle.

5. Make sure the patient empties his or her pockets; remove outer garments (e.g., coveralls, jacket, coat, hat); leave briefcases, purses, and bags behind; and wash their hands thoroughly with warm soapy water, this is crucial to prevent adulteration of the specimen by substances under the nails.

6. Maintain personal control of the specimen and documentation at all times during the collection.

7. Secure any water sources or otherwise make them unavailable to the patient in the collection area.

8. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank.

9. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present.

10. Inspect the site to ensure that no foreign or unauthorized substances are present before allowing the patient to enter the specimen collection area.

11. Secure areas and items (e.g., trash receptacles, paper towel holders, under-sink areas, ceiling tiles) that appears suitable for concealing contaminants.

12. Give the patient a clean urine collection container, but do not give the patient the sealed container to be sent for analysis. This helps to ensure that the sealed specimen container is unadulterated and the patient cannot claim that their container was opened and a substance added since it will be sealed with a seal bearing the patients initials and date by them after collection of the specimen.

13. Upon the patient exiting the collection area the specimen temperature should be checked within 4 minutes to assure that a valid specimen has been obtained. This helps to ensure the specimen actually came from inside the body of the patient and not a container or reservoir concealed on or in the patient. The acceptable temperature reading after 4 minutes of leaving the collection area is 32° -38° C/ 90° -100° F. Any specimen that falls outside of this range should be considered adulterated and not acceptable for analysis. This range is the acceptable range set by DOT standards and is considered the Gold Standard for urine drug screen temperatures.

14. Pop the seal on the urine specimen container and while the patient watches, pour the urine into the urine collection container and place the seal on the container and have the patient finish the adhering of the seal themselves. Then have the patient initial and date the seal on their specimen container. Lastly, have the patient review the drug screen analysis form one last time to reaffirm that the information is correct and that the signature or initials on the seal matches the paper work accompanying the specimen.

Observed drug screen collection procedure:

Before starting the collection process the following should be done to ensure the correct and accurate collection of a urine specimen.

1. For observed urine specimens a male or female observer is selected based upon the sex of the patient.

2. Pay careful attention to the patient throughout the collection process.

3. Ensure that there is no unauthorized access into the collection areas and that undetected access is not possible.

4. Make sure the patient shows a proper id or has a signed drug screen slip, this ensures the correct patient is providing the specimen.

5. Fill out drug screen information with correct patient information and have the patient review the information to ensure the information of the drug screen request form is correct. Have the patient initial the drug screen request form. The collector should initial the bottle in permanent marker to ensure the same bottle that is given to the patient is the one that is given to the observer upon collection.

6. Make sure the patient empties his or her pockets; remove outer garments (e.g., coveralls, jacket, coat, hat); leave briefcases, purses, and bags behind; and wash their hands thoroughly with warm soapy water, this is crucial to prevent adulteration of the specimen by substances under the nails.

7. Maintain personal control of the specimen and documentation at all times during the collection.

8. The collector should don a pair of latex gloves and hand the patient the urine specimen collection container, not the container that is to be sent for analysis.

9. The collector and the patient are to enter the specimen collection area together and at that time the collector shall give the patient the specimen container which has been initialed or labeled with the patient's information. The collector will then stand so that he or she has a direct line of site to the patient's genitalia and or urethra and observe the urine flow into the provided specimen container. The patient should begin urinating into the toilet and while urinating move the specimen container into position to catch the urine. This helps to ensure that the flow is consistent with normal urine flow and not from a device or tubing connected to the patient's body.

10. Directly upon completion of filling the specimen container the patient is to hand the specimen to the collector who has already donned latex gloves. The collector must note the time when the specimen is handed to the collector and proceed directly to the specimen processing area to check the temperature of the urine within 4 minutes. This does not give the patient a lot of time so the patient should be given all information prior to the collection process to ensure the patient understands what is to be expected of them at the time of collection.

11. Upon returning to the specimen processing area the temperature should be checked within 4 minutes to assure that a valid specimen has been obtained. This helps to ensure the specimen came from inside the body of the patient and not a container or reservoir concealed on or even in the patient. The acceptable temperature reading after 4 minutes of leaving the collection area is 32° -38° C/ 90° -100° F. Any specimen that falls outside of this range should be considered adulterated and not acceptable for analysis. This range is the acceptable range set by DOT standards and is considered the Gold Standard for urine drug screen temperatures.

12. After checking the validity of the specimen, pop the seal on the urine specimen container and while the patient watches, pour the urine into the urine collection container and place the seal on the container and have the patient finish adhering the seal themselves. Then have the patient initial and date the seal on their specimen container. Lastly, have the patient review the drug screen analysis form one last time to reaffirm that the information is correct and that the signature or initials on the seal matches the paper work accompanying the specimen.

Facts about proper urine specimen collection and quality of specimen:

Proper urine collection methods must be used to avoid false-negative results. Urine should be collected in a tamper-evident container under supervision if necessary. Criteria for legitimate urine samples include:

A volume of 30 mL or more

Temperature between 32▫C and 38▫C

pH of 4.5 to 8.5

Nitrates <500 mcg/mL

Specific gravity >1.002 and <1.020

Creatinine >20 mg/dL

Urine samples with characteristics outside of these ranges, or with a cloudy or dark appearance, may be adulterated in some manner, either diluted or substituted.

To minimize opportunities for tampering, a direct line of sight between the observer and the specimen bottle must be maintained during collection of a urine sample at all times.

Additional matters to consider when performing a urine drug screen

If an item is found that appears to have been brought to the collection site with the intent to adulterate the specimen, a directly observed collection procedure should be enacted. If the item appears to be inadvertently brought to the collection site, secure the item and continue with the normal collection procedure. For example, a bottle of eye drops may have been brought inadvertently and would have to be secured by the collector and the collection would proceed. However, a bottle of liquid or urine would suggest intent to tamper with the specimen and a directly observed collection would be required. The collector instructs the patient to wash and dry his or her hands, under the collector's observation, and informs the patient not to wash his or her hands again until after the patient provides the specimen to the collector. The patient must not be allowed any further access to water or other materials that could be used to put into the specimen.

The patient may use soap and, if practicable, it should be a liquid or cream. A solid bar of soap gives the patient the chance to conceal soap shavings under his or her fingernails and subsequently use them to attempt to adulterate the specimen.

Even if the collection kit is sealed, the collection container must still be sealed or individually wrapped in a plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system. Do not unwrap or break the seal on any specimen bottle at this time. Only un wrap the collection container if necessary.

Ensure the patient takes only the collection container into the room used for urination. The sealed specimen bottles remain with the collector.

The collector directs the patient to go into the room used for urination, provide a specimen of at least 45 mL, and return with the specimen within 4 minutes of completing the void.

The collector should pay close attention to the employee during the entire collection process to note any conduct that clearly indicates an attempt to substitute or adulterate a specimen. If the collector detects such conduct, and the patient has already provided a specimen, the collection process for this specimen is completed, and then the collector immediately begins a new collection under direct observation.

After the patient gives the specimen to the collector, the collector must check the temperature of the specimen, check the specimen volume, and inspect the specimen for adulteration or substitution. The collector should check the temperature of the specimen as soon as the employee hands over the specimen, but no later than four minutes after the employee comes out of the restroom. The acceptable temperature range is 32° -38° C/ 90° -100° F..) The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering or adulteration. If it is apparent from this inspection that the patient has adulterated or substituted the specimen (e.g., the specimen is blue, exhibits excessive foaming when shaken, has a smell of bleach), a second collection using direct observation procedures must be conducted immediately.

Both the collector and patient will maintain visual contact of the specimen to the greatest extent possible until the labels/seals are placed over the specimen bottle caps/lids. If practical, the collector may permit the patient to wash his or her hands right after the employee gives the collection container to the collector (and the collector checked the temperature), provided the patient and the collector can still maintain visual control of the specimen collection container.

The collector, not the patient, then pours at least 30 mL of urine from the collection container into a specimen bottle and places the lid/cap on the bottle..

The collector, not the patient, must then remove the tamper-evident seals and place it on top of the specimen container for the patient to finish affixing it to the container.

The collector must not ask the patient to initial the labels/seals while they are still attached to the urinalysis form, they must be initialed after they are placed on the bottles. This ensures that someone else's label is not affixed to the patient's specimen bottle.

MDSJR, MLT





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