Donor Information and Courses from MediaLab, Inc.

The last type of collection is the observed collection. In this type of collection both the donor and "observer" enter the collection stall. Observed collections afford less privacy in order to guard against the donor using items which are designed specifically to beat the testing process. After entering the stall the observer requests the donor to: Raise shirt, blouse, dress / skirt as appropriate, above the waist, just above the navel, Lower clothing and underwear to mid-thigh, and, Then turn around to show the observer that the donor does not have a prosthetic device. After the observer has determined that the donor does not have a prosthetic device, the donor is permitted to return clothing to proper position. The observer must personally watch the urine go from the donor's body into the collection container.

If the observer is not the collector, the observer may not accept the specimen after observing its collection. It is, however, the responsibility of the observer to watch and make sure the donor takes the specimen to the collector.After the donor has given the specimen to the collector, the observer must write in the REMARKS section of the Custody and Control form: "I (Observer's name) observed the collection of this specimen" then note the date and time.

Regardless whether you are collecting a Federally Regulated or a Non-Federally Regulated urine drug screen, there are five areas which demand specific prerequisites or conditions prior to performing a proper collection. These are: Requirements for the collection site. Supplies needed to conduct a collection. Criteria that must be met by collectors. Complete and accurate documentation. Proper identification of the donor.We will explore each of these in more detail over the next several pages.

All collection sites must meet the following security requirements: Must be able to prevent unauthorized access to the site during collection. Ensure that the donor does not have access to items that could be used to adulterate or dilute the specimen (e.g. soap, water, cleaning agents, etc.) Secure faucets, toilet tank tops, and other appropriate areas with tamper-evident tape if necessary. Ensure that the donor is at all times under the supervision of the collector or other collection site personnel. Provide for the secure handling and storage of specimens. (Specimens should be stored at 4-6º C. The refrigerator used should not be readily accessible to the general public and should be used only for the storage of urine drug screens and other clinical specimens. The refrigerator should be marked with a biohazard sign. No food or drink should ever be placed in the refrigerator.)

As collector: You can process only ONE donor at a time. You may not act as the collector for anyone whom you immediately supervise unless no other qualified collector is immediately available. You can not collect your own urine specimen. You should have appropriate identification available should the donor request it. This identification is limited to your name and the collection company where you work. You are not required to show documentation of training unless requested by a DOT representative, state government representative, or an employer. You should keep a file of the names and telephone numbers of Designated Employee Representatives (DER) to contact about any problems or issues that may arise during the collection process.

There are rare situations in which the donor cannot produce proper identification, such as a self-employed individual. In these cases, the collector should make a note in the Remarks section of the CCF that the positive identification was not available. The individual is then asked to provide two items of identification bearing his or her signature. The collector then proceeds with the collection. When the donor signs the certification statement (pink copy of the CCF), the collector compares the signature on the CCF with the signature on the identification presented. If the signatures appear consistent, the collection process continues. If the signature on the CCF does not match the signatures on the identification presented, the collector must make an additional statement in the Remarks section noting that the signature identification is unconfirmed.

Let the donor select a collection kit. There should be 10 or more kits available from which the donor may chose. The kit is comprised of a collection cup, leak resistant plastic bag, and two specimen vials. You or the donor may open the collection kit in the other's presence. The donor is given the collection cup. It is the only item that can be taken into the restroom. The specimen vials remain with the collector. Do not open these vials until you are ready to disperse the urine specimen.

After the donor has handed the specimen to the collector, the donor is given permission to wash his or her hands and to flush the commode. While the donor is accomplishing these tasks, the collector may be making the necessary observations discussed previous.It is important to remember that once the donor has handed his or her specimen to the collector, the donor must always be able to have visual contact to the greatest extent possible with the collector and the specimen.

The collector now directs the donor to read, sign, and date the certification statement located on the "pink" page of the control form. The donor must provide date of birth, printed name, and day and evening contact telephone numbers.The collector completes the collector's portion of the chain of custody on the control form by printing his or her name, signing where indicated, and recording the date and time of the collection. The collector must also enter the specific name of the delivery or courier service transferring the specimens to the laboratory if applicable.

After dispensing the urine specimen into the specimen vials, the collector, not the donor, removes the tamper-evidence seals from the control form and places them on the specimen vials. Seal "A" goes over the primary vial containing 30 mL; seal "B" goes over the secondary vial containing 15 mL. (When doing a Non-Regulated drug screen, since only one vial would be used, "A" would be the appropriate tamper-evidence seal to use.)The seal must be centered over the lid and down the sides of the vial to ensure that the lid cannot be removed without destroying the seal.

After a positive identification has been made, invite the donor into the area where the collection will be conducted. Be pleasant, but professional. Introduce yourself and generally explain the collection procedure. Be prepared to accommodate donors who do not speak English. Never argue with the donor or be judgmental. Always remember that you are a professional. Conduct yourself in that manner. Ask the donor to remove any unnecessary out clothing such as a coat, jacket, hat, etc., and to leave any briefcase, purse, or other personal belongings with the outer clothing. The donor may retain his or her wallet. If the donor asks for a receipt for any belongings left with the collector, the collector must provide one. Direct the donor to empty his or her pockets and display the items to ensure that no items are present that could be used to adulterate or dilute the specimen or be used as a substitute. If nothing is there, the donor may return the items to his or her pockets.

Instruct the donor to wash and dry his or her hands. Observe this step. Tell the donor not to wash or dry hands again until after the donor has provided and handed you a specimen. The donor may use soap to wash hands but it must be a liquid. Solid or bar soap gives the donor a chance to conceal soap shavings under the fingernails and subsequently use them to attempt to adulterate the specimen.

Make sure that all copies of the Custody and Control Form are legible and complete.Place the specimen vials and white copy of the CCF inside the appropriate pouches of the leak resistant plastic bag. Make sure to seal both pouches. The donor may now leave the collection site.

When a donor behaves in a confrontational way that disrupts the collection process, such as refusing to empty pockets or refusing to wash hands after being directed to do so by the collector, this is considered interfering with the testing process and is considered a refusal to test. The collector must contact the Designated Employer Representative (DER) about the refusal as soon as is practical.If a donor makes an attempt to provide a specimen and the quantity is not sufficient (QNS) and the donor refuses to make a second attempt to provide another urine specimen or leaves the collection site before the collection process is completed, this is considered a refusal to test. The collector must contact the DER about the refusal as soon as is practical.

Refusal to Complete Donor Certification on Pink Copy of CCF or Initial Security Strips.If the donor refuses to complete the donor certification on the pink copy of the CCF, or refuses to initial the security strips after they have been affixed to the specimen vials, this is not considered a refusal to test. Do not debate with the donor. It is the responsibility of the collector to note the fact in the "Remarks" section of the CCF. Failure to do so may result in a Fatal Flaw. The MRO may not release the results of the drug screen unless the collector has noted in the "Remarks" section why the donor certification was not completed.Refusal to Provide ID or Social Security NumberIf the donor refuses to provide the collector with an ID or Social Security Number, this is not considered a refusal to test. The collector must make a notation of the fact in the "Remarks" section of the CCF. Failure to do so may result in a Fatal Flaw. After making the notation, the collector continues with the collection.

Scenario 1:A donor was asked to wash her hands prior to picking out the drug screen collection kit. The collector noticed that the donor was washing only one hand.Collector's Response:The collector would tell the donor that washing only one hand was an indication of possible interference with the testing process and that it could be interpreted as a refusal to test.Scenario 2:The donor is asked to remove his hat before going into the restroom. As he reluctantly did so, it was noticed that he was trying to conceal that a container was hidden inside the hat.Collector's Response:The collector must tell the donor that a directly observed collection will be conducted and explain the reason why.

If a security seal is broken while being removed from the CCF or during the application of the first seal on the primary specimen vial, the collector should transfer the information to a new CCF and use the seals from the second CCF.If one seal is already in place on a specimen vial and second seal is broken while being removed from the CCF or is broken during application on the second specimen vial or while the employee is initialing either seal, the collector should initiate a new CCF and note in the "Remarks" section how the seals were broken. The seals from the second CCF should be placed perpendicular to the original seals to avoid obscuring information on the original seals. The donor must initial the second set of seals also. The initials on all the seals must match. The collector should then draw a line through the specimen ID number (and bar code if present) on the original seals to ensure that the laboratory does not use that number for reporting the results. The collector must not pour the specimen into new vials.

In an observed collection, the observer must be the same gender as the donor. If an observed collection must be made, and the collector is not the same gender as the donor, it is the responsibility of the collector to locate someone who is the same gender as the donor to act as the observer. If the collector is not the observer, the donor can not hand the specimen to the observer. It is, however, the responsibility of the observer to make sure the donor directly hands the specimen to the collector.In an observed collection, the donor must raise and lower clothing and turn around to permit the observer to determine if a prosthetic or other device is present. The observer must physically watch the donor urinate into the collection container.The collector must mark on the CCF that the collection was observed and state why in the Remarks section.If the collector learns that a directly observed collection should have taken place, but did not, the collector must inform the employer that the donor must be directed to return for an immediate recollection under direct observation.

Scenario 5:The collector noticed that the urine the donor had just handed to her had a very strong smell like that of a cleaning product, such as bleach.Collector's Response:The collector completed the collection in the usual manner, and then explained to the donor that, because of the strong, unusual smell, the first specimen was suspected for adulteration. The collector then told the donor that an observed collection would now be done. Both the "suspect" specimen and the specimen collected by direct observation are sent to the laboratory for testing.Besides an unusual smell, other indications of adulteration might be an unusual color that cannot be explained my medication, particles, or debris in the urine, and a heavy or thick foam that is inconsistent with urine.

Under the new Department of Transportation rules for the collection of urine for drug testing, a lot more responsibility has been placed on the collector. It is imperative that you know, understand, and stay current with the rules and regulations. Do the very best you can to make every collection "error free."The examination that follows simply tests your grasp of the concepts of urine collection. It does not qualify you as a Drug Screen Collector!

For the most part, subgroups are merely of academic interest, but occasionally they present clinical problems. The antigen may be so weak that it is not detected and the red cells are mistyped as group O. This is especially dangerous if the cells are those of a donor. Problems may arise because the serum of an A2 or A2B, A3 or Ax individual might contain anti-A1. This antibody may be detected in serum typing and cause confusion. You would not expect to find a person with A antigen on his red cells and anti-A in his serum. Anti-A1 is produced by about 1-2% of group A2 persons and about 25% of group A2B persons. Subgroups may be determined by reactions with antisera as seen in the table on the next page.

Specialists in immunohematology perform all testing prior to blood transfusions and work to prevent transfusion infections. They also investigate any post-transfusion reactions. This specialty includes all lab procedures performed in the specialty of histocompatibility. Specialists in clinical chemistry analyze body fluids such as blood, urine, and spinal fluid to determine the chemical makeup, including the amount of carbohydrates, proteins, enzymes, and trace elements. The special covers urine microscopics and chemical evaluation of the liver, kidneys, lungs, heart, and other vital organ systems. This specialty also covers all testing performed in the specialties of radioassay and blood gas analysis. Specialists in blood banking can perform all immunohematology testing as well as testing from the specialties of clinical chemistry, hematology and serology/immunology that relates to donor blood. Specialists in immunohematology, clinical chemistry, hematology, and serology / immunology may perform all tests in the blood banking specialty.

If a urine specimen is require, instruct the donor on its collection.Escort him or her to the restroom.The donor breaks the seal on the urine container and produces a specimen.

You may be required to measure the temperature of the urine, and to check it visually for tampering.Apply a tamper-evident seal to the specimen, and label it appropriately in the presence of the donor individual.