1. If provided sample is not within the acceptable temperature range (>90 deg F and < 100 deg F) or has been obviously adulterated in some way (strong chemical odor, uncharacteristic color, etc.), a second collection should be obtained under observed conditions (see section on Observed Collections). The requesting party generally should be notified.
2. In the remarks section in Step 2 of the CCF, indicate the observed collection was performed and why.
3. Both originally provided sample and sample obtained under direct observation (assuming it is within acceptable temperature range and free of adulterants) should be sent to the lab.

1. 1. Noncompliance with any of the steps listed in the Standard Procedure or those listed in the Observed Collection Procedure.
   2. Leaving the test site prior to providing a sample of sufficient sample volume unless permission to due so is obtained from requesting party.
   3. Failure to arrive at the collection site within the referring party’s mandated time frame.
   4. Discovery of a prosthetic device during an observed collection.
   5. Inability to produce a sufficient urine sample within three hour window unless donor is able to provide documentation from a physician of a condition an existing condition that would explain patient’s inability to produce 30 ml under condition of collection process.

Procedure: If one of these circumstances occurs, the collector will terminate the collection process, make appropriate remarks in Step 2 of the CCF and inform the requesting party.

1. Record in Step 2 on the CCF the time at which the donor made the first attempt to void. Time of any other unsuccessful attempt will also be recorded on CCF.
2. The donor will be given a three-hour window in which to provide a sample of the required volume. During this time frame, the donor will be allowed to consume up to 40 oz of fluid. The donor will remain at the testing facility under monitor until they provide an adequate sample quantity or the three-hour window elapses.
3. If the donor is unable to provide required urine volume after three hour window expires, test will be temporarily suspended (pending physician explanation of physiological condition that would cause patient to be unable to provide a urine sample within collection parameters). Requesting party will be notified of testing delay.
4. If donor is unable to produce a physician’s explanation of shy bladder within 72 hours, test will be cancelled.

1. Donor provided a sample that is out of acceptable temperature range.
2. Materials commonly known to interfere with the testing process are discovered during the collection.
3. Donor provides a sample that has physical characteristics (strong chemical odor, unusual color, excessive foaming) that suggest it was adulterated.

Procedure: Options Lab, Inc uses the following procedure for observed
collections:

1. Collector or observer will accompany donor into the bathroom.
2. Collector or observer will position themselves in a manner that allows them to visually confirm that the sample being into the collection container is originating form the donor.
3. Once donor has finished voiding, the sample will immediately be removed from the bathroom area by the collector. If a non- collector observer was used, they will not handle the urine specimen but will maintain visual contact with the sample until it is given to the collector by the donor.
4. Assuming temperature of sample is in range and volume is enough, collection will be completed as outlined in standard procedure. If sample is out of range, collection is terminated and referring party notified. If sample is less than required volume, follow Insufficient Sample Quantity procedure.