Tools

Chain-of-Custody

Urinalysis is only one tool to help combat the drug abuse problem we face today. But if it is used correctly, urinalysis can be a formidable tool. Since the use of urinalysis is a complex matter requiring careful and thoughtful discussion and implementation, it is important to investigate this tool comprehensively. The need to ensure the protection of individual rights within the context of a drug-testing program makes essential the development of proper chain-of-custody procedures. Legal challenges focus on the accuracy of specimen handling and the accountability of specimen custody more frequently than on the accuracy of the analytical method. If the proper chain-of-custody is found lacking (i.e., if it cannot be proved that the sample that tested positive was the sample given by the person in question), legal proceedings can quickly be challenged.

 

Chain-of-Custody of Urine Samples
Starting at the time of collection, a sample’s chain-of-custody must be documented and protected. Chain-of-custody is a legal term that refers to the ability to trace and safeguard the sample, from the time it was donated, through the collection, and analysis, of the sample, to the reporting of the result. Chain-ofcustody documentation answers the question: Were the specimen and the reported result correctly matched? Sound procedure requires that the sample be secured in a manner that ensures any tampering or attempted tampering is evident. It further requires that each time the sample changes hands or is moved from one place to another, it is signed for and kept in a secure area to ensure against inadvertent or intentional switching with another sample.
 

Elements of Chain-of-Custody Procedure
The elements of a good chain-of-custody procedure include the following:

  • The donor should be supervised either directly or indirectly while delivering the specimen.
  • The specimen container should be handed directly to the person supervising the collection and labeled and sealed immediately.
  • The collector and the donor should initial the bottle to indicate that both agree that the bottle contains the donor’s urine specimen.
  • The name of each person who has access to the specimen should be noted on a form accompanying the specimen. (Access to the specimen should be limited as much as possible.)
  • The sample should be kept in a secure place, such as a locked room or refrigerator, until it is either tested or sent to the laboratory.
  • Testing performed on-site should be done in a secure location to avoid the possibility of exchanging samples with a passerby.
  • If the specimen must be transported to an outside laboratory, it should be mailed in a sealed container and placed in an external carton with an evidence seal. Government mail or licensed and bonded courier services are acceptable means of transporting specimens.
  • The specimen must be properly labeled so that laboratory personnel will not confuse it with others.
  • If the specimen is to be offered as evidence in a legal proceeding, it must be in the same condition as it was when taken—unless the change is for a justifiable purpose, such as alteration required for the testing procedure.

Chain-of-custody errors occur more easily during specimen collection than during the testing process. The donor, if a drug user, may try to tamper with the sample in a  number of ways, such as adding liquid or a foreign substance to the sample or substituting a drug-free sample for his/her own. Errors by the collector can range from improperly labeling and securing the specimen bottle to accidentally contaminating the specimen, or confusing it with another specimen.


To overcome these common errors, a specified sample collection site should be set up with the necessary materials, equipment, facilities, and supervision. This is to provide for the collection, security, temporary storage, and shipping or transportation of urine specimens to a drug-testing laboratory.


The collection site should be secure during drug testing. Only authorized personnel should be permitted in the designated collection site when urine specimens are collected or stored.


Sample Collection Materials
These are the materials needed to collect urine specimens:

  • Specimen bottles: wide-mouthed, screwcapped, 60–125 mL translucent polyethylene bottles. (Bottles will be filled 1/2 to 2/3 full of urine.) The caps should contain self-sealing, leak-proof liners. These are available through most medical or laboratory supply companies.
  • Labels for specimen bottles with spaces to write the donor’s identification number, name of the collector, and the date and time of collection.
  • Seals (evidence tape) long enough to cover the top of the cap and run partially down the sides of the bottles. The seal should have to be broken to open a sealed bottle.
  • Chain-of-custody forms to accompany each sample bottle. The form should be designed to show who had the specimen and when.
  • Boxes, seals, and labels for shipping specimens.
  • Refrigerator or freezer if specimens are to be kept longer than a few hours before analysis. This should be locked or kept in a locked room.
     

Chain-of-Custody Form
An identification label that shows the date; the individual’s specimen number; and any other identifying information required should be placed securely on the bottle. The donor should initial the identification label on the specimen bottle for the purpose of certifying that it is the specimen collected from him/her.

A chain-of-custody form should be used for maintaining control and accountability of each specimen from the point of collection to final disposition of the specimen. Each time a specimen is handled or transferred, every individual in the chain should be identified. Every effort should be made to minimize the number of persons handling specimens.

The chain-of-custody form should have the following information:

  • Donor name or ID number
  • Collection information
  • Date and time sample was collected
    – Name of person supervising collection
    – Name of person requesting collection
    – Name(s) of person(s) with access to sample
    – List of medications being taken by donor
    – Any comments about the sample
  • Laboratory information
    – Date and time sample was received
    – Name of person receiving sample
    – Tests requested
    – Name of person reviewing or certifying test results
    – Test results—initial test results and confirmation test results with calibrator cutoffs listed


Typically, these forms are pre-printed with the name of the client; the address of the person reviewing the results; and the pre-selected test panel.

 

The label that is placed on the specimen container must be designed to clearly link the labeled bottle to the chain-of-custody form. It should be non-removable, or at least tamper-evident, so that it cannot be removed, replaced, or altered. A common security feature is to integrate the label into the actual seal, thus making the seal unique. The label can be  pre-printed with the identifying number, and provide an area for the donor’s initials (which should be inscribed after the bottle is sealed); the collector’s signature; and the time and date of collection. The bottle should be labeled in the donor’s presence.

Sample Tampering Prevention
To ensure correct identification of the person giving the specimen, and to prevent donors from using a substitute, collectors should always ask the donor to present an identification card with a photo, such as an employee identification card, driver’s license, or national identity card.

 

It is not uncommon for people who know in advance that they will be donating a sample to carry a container of drug-free urine or liquid substitute (apple juice, colored water, etc.) into the restroom, and substitute this for their own urine specimen. People have also been known to add toilet or tap water to dilute the sample or add  adulterants such as bleach, salt, or vinegar in an effort to manipulate the test results.


A decision must be made on how to balance the need to prevent sample tampering by the donor with respect for the donor’s privacy. Direct observation of the donor delivering the sample can be uncomfortable for both the donor and the supervisor. One approach that reduces the chance of tampering, while affording privacy, is to have the person change into a patient’s gown, and leave purses or other articles of clothing outside the restroom while delivering the specimen.


Chances for adulterating the specimen can be further reduced by:

  • using a specified toilet facility
  • adding a colored cleaning solution to the toilet bowl
  • removing the soap from the facility
  • making the hot water tap inoperative

 

The person collecting the sample then only needs to check the color and temperature of the specimen (it should be between 33°C and 36°C) to make sure cold water wasn’t substituted or added. The donor should provide a new urine sample if any of these requirements are not met, or if particulate matter can be seen floating in the urine or settled at the bottom of the cup.


The specimen should be kept in view by both the donor and the person collecting the sample at all times prior to its being sealed and labeled. If the specimen is transferred to a second bottle, the collection-site person should request that the donor observe the transfer of the specimen and the placement of the tamperproof
seal over the bottle cap and down the sides of the bottle.

When the specimen is ready to be shipped to the drug-testing laboratory, it should be placed in a container designed to minimize the possibility of damage during shipment, for example, specimen boxes or padded mailers. This container should be securely sealed to eliminate the possibility of undetected tampering. On the tape sealing the container, the collection site supervisor may sign and enter the date that the specimens were sealed in the containers for shipment.


Chain-of-custody forms should be attached to each sealed container for shipment to the drug-testing laboratory.


Collection and Shipping Log
The specimen collector should maintain comprehensive records of all collections and shipments to the laboratory. A collection and shipping log should be a bound notebook with pre-numbered pages. Each entry should include the donor’s name and signature; the collector’s signature; the time and date of collection; the airbill number; and the date of shipment. In addition, the collection site’s copy of the airbill should be signed by the courier and retained as part of the official records.


Sample Handling Procedures
Although it seems inconceivable that someone at the laboratory would deliberately tamper with a specimen, attorneys could raise the question in a hearing. To guard against this, it is sound practice for laboratories to implement special handling procedures for drug-abuse specimens. These procedures should separate drug-abuse specimens from routine clinical specimens.

The laboratory should have in place security measures to control access to the drug-testing area, and to ensure that only authorized personnel handle the specimens and have access to areas where the records for the drug-testing specimens are stored. Laboratory personnel receiving a shipment of specimens should sign for its receipt; note in writing whether the shipping package seals are intact; and inspect the bottle or bottles to ascertain that they are sealed. The laboratory should then compare the information on the label of each bottle to that on the request form, and note any discrepancies. If discrepancies are found, or if the seals are questionable, the laboratory should have a procedure worked out with the client on how to deal with the situation.


Sample Identification
Once the container has been inspected and is found to be intact, it should be assigned a unique identifying number usually called an accession number. This number links the bottle; the request form; and the test result together for reporting purposes.


Pre-numbered identification labels that are placed on the bottle at the time of collection are convenient. The sequential number thus applied can be used to track the specimen and its test results through the testing process.


An excellent numbering system employs the placement of several copies of the same sequential number on each bottle. One of these additional labels can be placed on any test tube or other container to which the specimen is transferred for testing.


Many laboratories now use bar-coded labels to further ensure that accession numbers are not misread or entered incorrectly. Bar-coded labels with the same unique number are placed on the chain-of-custody form; the collection log; the specimen container; and the sample cup that is placed on the analyzer. Sometimes the specific destination to which each bar-coded form is sent is coded into the computer. This permits a cross-check on the authenticity of the form, and automatically creates a data file when the form’s bar code is read into the computer. These techniques have greatly reduced the number of errors attributed to manually entered information.


One way to link the sample to the donor, and, at the same time, maintain privacy, is to use the donor’s identification card number as the accession number, instead of a random sequential number.


When specimens are transferred to test tubes or cups, a separate, internal chain-of-custody document for the handling of test samples or aliquots should be initiated. Some laboratories have tried to use the external form for this purpose, but such practices expose the original chain-of-custody documents to the testing staff. Use of an internal form helps ensure that the testing is conducted anonymously. This internal custody form then accompanies the test aliquots as they are signed over to the receiving technician.

Before any test result is reported, it should be reviewed, and the test certified as an accurate report by the designated individual. The report should identify the drugs or metabolites being tested; whether the result is positive or negative; the cutoff for each; and the specimen identification number. Test results should always be reported on the chain-of-custody form; sent as confidential mail; and addressed to the person authorized to receive the results. If test results are sent electronically, such as with facsimile, or computer terminals and printers, access to the data transmission, storage, and retrieval system should be made secure. Also, a hard copy of the report should be mailed or sent to the client concurrently with the electronic report.


Sample Storage
The original specimen container should be secured at all times, preferably in a limited-access area. If this is not possible, then locked cages; locked refrigerators; or some other means may be used to secure specimens during the testing period. These temporary storage areas should have a log that fully documents who entered the area; what was entered or removed; and when the actions occurred. Since specimens may have to be retested, all positive specimens should be saved for at least one year, in case of a legal challenge. Samples kept longer than a week should be kept frozen to avoid degradation of the drug or metabolites. If extended storage affects test results, the effect is always in the direction of a positive sample becoming negative. The specimens should be kept in a secure refrigeration/freezer unit, with access to only authorized personnel. Emergency power equipment should be available in case of prolonged power failure.


Records Storage
Drug-testing records contain potentially damaging information about individuals. Although personal identification should not be included on documents sent to the laboratory, all lab records associated with drug testing should be stored in a secure manner. Security should include protection against fire and water damage, as well as unauthorized entry. The laboratory may be required to prove that no one was able to alter the records after the fact.

In summary, remember that the elements of a good chain-of-custody procedure include the following:

 

  • The donor should be supervised either directly or indirectly while delivering the specimen.
  • The specimen container should be handed directly to the person supervising the collection and labeled and sealed immediately.
  • The collector and the donor should initial the bottle to indicate that both agree that the bottle contains the donor's urine specimen.
  • The name of each person who has access to the specimen should be noted on a form accompanying the specimen. (Access to the specimen should be limited as much as possible.)
  • The sample should be kept in a secure place, such as a locked room or refrigerator, until it is either tested or sent to the laboratory.
  • Testing performed on-site should be done in a secure location to avoid the possibility of exchanging samples with a passerby.
  • If the specimen must be transported to an outside laboratory, it should be mailed in a sealed container and placed in an external carton with an evidence seal. Government mail or licensed and bonded courier services are acceptable means of transporting specimens.
  • The specimen must be properly labeled so that laboratory personnel will not confuse it with others.
  • If the specimen is to be offered as evidence in a legal proceeding, it must be in the same condition as it was when taken --unless the change is for a justifiable purpose, such as alteration required for the testing procedure.

 

Remember that starting at the time of collection, a sample’s chain-of-custody must be documented and protected. If legal proceedings are initiated, records should show that proper chain-of-custody procedures were followed. This information is not meant to substitute for legal advice. Legal advice should be obtained before initiating any drug-testing program, since laws and regulations governing drug testing vary widely.

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