PROCEDURE



EDUCATION

TITLE: Specimen Rejection & Adulteration

Specimen Rejection

Each sample is inspected before testing. There are certain conditions under which the TASCLabs reserves the right to reject specimens. The integrity of the sample must be insured so that the reportable results have meaning to the referring agencies. In those instances where we cannot validate the integrity of the specimen, the laboratory will notify the agency and discard the specimen.

The following examples are possible causes for the laboratory to determine a specimen's unacceptability for testing. ("*" denotes a "Fatal Flaw")

Incorrectly completed Test Request Form. *

Contaminated Test Request Form or Transportation Log.

Insufficient quantity of specimen to test. (QNS) *

Chain of custody procedures not followed. (missing signatures) *

The specimen appears to be tampered in any way. (broken or missing seal) *

If the numbers on the Security Seal and voucher do not match or have been changed or tampered with in any way. *

There is no specimen in container due to improper closing of the lid. (leakage)

Note: The laboratory will notify the agency's office when the specimen is in question.

"*" Fatal Flaw is the term used by the U.S. Department of Transportation (USDOT) to designate a sample is unacceptable for testing.

Specimen Tampering / Adulteration

Generally, clients will be cooperative and provide a satisfactory specimen. Others, however, will attempt to adulterate (contaminate) or substitute the specimen. One method is to dilute the specimen with water, or adulterate it with bleach, soap, etc. (Bleach, for example, is a strong oxidizing agent, which reacts with the drugs and lowers the amount detected.) Another is to substitute "clean" urine during collection. An individual might obtain urine from friends or relatives that they know have no recent drug use. Some have even purchased "clean" urine obtained from babies. One way to smuggle the urine into the collection area is to tape a "zip-lock" style bag containing the clean urine somewhere on the body. The urine would reach body temperature and the bag could pass casual observations of the client. Once out of sight, the clean sample is used to fill the specimen cup.

There are also a number of Web Sites offering a variety of urine adulteration products, such as , , , and . Please check one of these sites to acquaint yourself with such products.

Techniques to Tighten Collection Control:

▪ Secure the collection site (washroom) by removing any cleaning products from the area.

▪ Prohibit the washing of hands until the sample has been sealed in the presence of the client.

▪ Do not allow purses, bags, or coats to be taken into the collection site as they are convenient hiding places for adulteration products. (Wallets are permitted)

▪ If substitution is suspected, you can demand the client to provide a second sample, even it requires them to wait. Drinking water (16-24 oz) in 15-30 minutes will usually generate enough urine for a repeat sample. In this manner, any product that was used to dilute, contaminate or replace the sample may have been spent on the first sample and most likely, can't be duplicated by the client.

▪ Perform an "Observed" collection. This requires someone of the same sex to physically observe the actual urination into the container. Although this may seem demeaning to the client or the collector, it is a positive way to insure the sample is not contaminated.

Federal Precedents

The USDOT requires basic adulterant tests be performed on every sample for transportation workers. These are the Creatinine and Specific Gravity determinations described below. Since our clientele is non-DOT related, these tests are not routinely provided. IF the sample is suspect that it may have been adulterated, there are tests to indicate if this did occur. The test may be ordered by marking the "Tests Requested" area of the Chain of Custody form for "Adulterant Check". Please contact the TASC Laboratory for assistance.

The USDOT also states that BOTH the Creatinine and Specific Gravity must be below normal for the sample to be considered as diluted. If the sample is diluted or otherwise adulterated, the results are treated in the same way as "...you treat the laboratory's report of a confirmed positive test for a drug or drug metabolite". The USDOT states that the employee (client) "...has the burden of proof that there may be a legitimate medical explanation". To meet this burden in the case of an adulterated specimen, the (client) "...must demonstrate that the adulterant found by the laboratory entered the specimen through physiological means". The regulations also make it clear that we are not responsible "...for arranging, conducting, or paying for any studies, examinations or analysis to determine whether a legitimate medical explanation exists".

(Ref: 65 FR 79462, Dec 19, 2000 - Section 40.145)

The State of Illinois General Assembly enacted Public Act 093-0691 effective July 9, 2004. Essentially, this act makes it a "Class 4 Felony for which the court shall impose a minimum fine of $1,000" for someone who adulterates a urine sample for drug testing. The law also applies to the purchase, sale, re-sale and instructions on how to use or perform the adulteration of the samples. Not only is the law aimed at preventing intentional adulteration of the sample by the client, but also to eliminate or reduce the availability of adulteration products to the public. TASC Labs will report any suspected adulteration of the sample on computer report. Any further action is the responsibility of the outside agency. A "NOTICE" sign is available for posting at the Collection Site advising clients of the new law. (Reference Doc. No. FM-071)

Laboratory Tests:

TASC Labs uses the "Rapid Check (" dipstick, which is a series of six "qualitative" tests as the Adulterant Check to help to evaluate the sample. The Rapid Check strip is capable of detecting the presence of some of the popular adulterants, such as: Stealth, Urine Luck, Whizzes, Klear, Clear Choice, Insta-Clean, Add-It-ive, Lucky Lab, Visine, Drano, Bleach, Liquid Hand Soap, Vinegar and Detoxify Cleansers. The test does not identify what is the contamination product or dilution, only that something is present, which can interfere with the test results.

If the sample is suspected of being diluted, the liquid used cannot be easily identified. Water is the most convenient solution, but some clients have managed to use other beverages, such as tea or soda. There are two tests that are recognized as the indicators of the dilution of a sample, Creatinine (pronounced cre-at-tin-neen) and Specific Gravity (Sp.Grav). If BOTH these tests are LOW, the urine is considered diluted.

Creatinine is normally found in the urine because it is a product of muscle function. As muscles (including the heart) use sugars and other nutrients for energy, creatinine is formed as a waste product. The more your muscles work, be it walking, exercising, etc., the more creatinine is created. The body, like all factories, needs to get rid of the waste to keep itself clean. Excess creatinine is then excreted in the urine. Creatinine is always generated, whether the body is awake or sleeping and it is always present in the urine. The body also keeps itself in chemical balance, by not losing, or by keeping too much, fluids. The creatinine level in the urine will almost always be within a narrow range. It cannot be below this range in a normally healthy person.

There can be a low urine creatinine in some diseases or after kidney dialysis. Drinking excessive amount water (over a quart at one time) might cause a low creatinine, but Government studies indicate this is relatively rare. Diuretic drugs, like Lasix, cause the body to excrete more water and therefore can cause a low creatinine.

Kidney disease or congestive heart failure usually causes high creatinine levels. Many body builders will take supplemental Creatine (Crea-tine) because it helps build muscle mass and lubricates the joints. This supplement then breaks down into creatinine and can cause a high result on the screening test. Too much creatinine can lead to kidney disease, so using the supplement can be dangerous.

Specific Gravity is the other test for dilution. Basically it is a measure of the amount of waste products (like creatinine, proteins, calcium, salt, etc.) are dissolved in the urine. Plain water has a Specific Gravity of 1.000. If you remember your high school science or health class, you know that the body is slightly salty. So, it is impossible for the urine to have a value of 1.000. The lowest value, even in a medically ill person, is 1.003, so anything below that must be diluted.

The TASCLabs screening tests for adulterants are as follows:

|Test |Adulterant |Notes |Reported As |

|Creatinine |Creatinine is related to muscle mass and |A low value indicates possible dilution with |>20 = Normal |

| |function. Normally there is a constant |water or other liquid. | |

| |excretion in the urine. There is not a | | 11 = Abnormal |

| | |pH. Hydrogen Peroxide will also alter the pH. | |

| | | |Normal = 4 - 11 |

|Specific Gravity (Spec. |Normal Urine Specific Gravity is 1.003 to |A low Specific Gravity and low Creatinine |1.020 = Abnormal |

| |of 1.000 !! |The DOT states if the level is below 1.003 or | |

| | |above 1.020, it is considered adulterated. | |

|Oxidants |These are NOT products normally found in |Bleach may also be detected by smelling the |POS = Abnormal |

| |the urine. For example, Bleach is a |urine. "Stealth" is a two-part adulterant that | |

| |readily available product. Pyridium |can be detected. Other adulterants might be |NEG = Negative |

| |Chlorochromate is present in several |"Insta-Clean", "ADD-IT-IVE", "Urine Luck" and | |

| |commercial adulterants. Others include |"Lucky Lab" | |

| |ferricyanide, persulfate, iodate. | | |

Reference:

"Rapid Check" Product Literature, Branan Medical Corporation, Irvine, CA for technical bibliography

Federal Register: August 21, 2001 (Volume 66, Number 162)] re: DOT Testing Requirements.

65 FR (Fed. Register) 79462, Dec. 19, 2000

Related Documents:

Adulteration NOTICE Sign - Doc. No. FM-071 (15.008)

Revision History:

|Date |Rev. No. |Change Description: |Author: |

|5/9/01 |0 |Original Document on Rejection |John Little |

|1/22/02 |1 |Added Adulterant Chart |Bill Salas |

|2/15/02 |2 |Moved Rejection & Adulteration from Collection SOP |Bill Salas |

|3/11/02 |3 |Added "Reported As" column to Adulterant Table |Bill Salas |

|4/18/02 |4 |Changed Doc. No. from 18.509 (training) to Handling & Delivery section. |Bill Salas |

|9/3/02 |5 |Added disclaimer to last paragraph of text. |Bill Salas |

|7/2/03 |6 |Changed "Tainted?" entries in "Reported As" to simply abnormal to avoid |Bill Salas |

| | |question "Tainted with what?" | |

|10/23/03 |7 |Revised for new testing product. |Bill Salas |

|3/22/04 |8 |Added explanation of Creatinine & Sp. Grav. testing. |Bill Salas |

|7/27/04 |9 |Added NOTICE of new Illinois Adulteration Law and Precedence set by USDOT |Bill Salas |

|6/13/12 |9 |Reviewed – No content changes |B. Salas |

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