The observer in an observed collection must be the same gender as the donor.  The collector may serve as the observer if and only if this condition is met.  Otherwise, another collection site employee of the appropriate gender should be selected.  If the collection site does not have an employee of the appropriate gender, the employer should be contacted and an employer-representative of the appropriate gender should be requested.  Under no circumstances can the collection be observed by someone of the opposite gender.

Special:  For FRA- and FTA-regulated employees, anyone with direct or immediate supervisory authority over the donor must NOT be the collector or observer.

An observed collection is authorized and required by Federal law if:

  • The donor attempts to tamper with his or her specimen, as evidenced by:
    • The temperature of a specimen is outside the acceptable range
    • A specimen shows signs of tampering, such as an unusual color, odor or other characteristic
    • The collector discovers an item in the donor's possession which appears to have been brought with the clear purpose of contaminating the specimen
    • The collector observes conduct by the donor suggesting tampering (including hearing noises from the bathroom during collection that suggest more than voiding is being done)
  • The Medical Review Officer (MRO) orders a direct observation collection because:
    • The donor has no verified medical reason for abnormal laboratory results, or because
    • The donor's previous Positive, Adulterated or Substituted result had to be cancelled because a split specimen test could not be performed.
    • The donor's previous Negative result had a creatinine concentration greater than or equal to 2 mg/dL, but less than or equal to 5 mg/dL.
    • The Test is a Return-to-Duty or Follow-Up test.

Required steps in a properly observed collection:

  • The observer requests the donor to raise his or her shirt, blouse or dress/skirt, as appropriate, above the navel, and to lower clothing and underpants to mid-thigh and show the observer, by turning around, that donor does not have a prosthetic urine delivery device hidden.
  • The donor is permitted to return his/her clothing to its proper position.
  • The observer must watch the urine exit the donor's body and enter the urine collection container.  This means the donor may NOT turn his/her back or otherwise obscure the observer's line of sight.
  • If the observer is not the collector, the observer must not touch the specimen cup.  The observer must watch the donor deliver the specimen directly to the collector.
  • The collector then completes the collection as normal.
  • If the donor has a prosthetic urine delivery device:  The observer notifies the collector. The collector stops the collection, thoroughly documents the events on the CCF.  This is a Refusal to Test.

If the donor refuses to comply with any part of the observation procedure, the test is a Refusal to Test.