Editorial Note on Part 40
Editorial Note: Nomenclature changes to part 40 appear at 73 FR 33329, June 12, 2008.

§ 40.65 What does the collector check for when the employee presents a urine specimen? As a collector, you must check the following when the employee gives the collection container to you: ( a ) *Sufficiency of specimen.* You must check to ensure that the specimen contains at least 45 mL of urine. ( 1 ) If it does not, you must follow “shy bladder” procedures (see § 40.193(b)).
( 2 ) When you follow “shy bladder” procedures, you must discard the original specimen, unless another problem (*i.e.,* temperature out of range, signs of tampering) also exists.
( 3 ) You are never permitted to combine urine collected from separate voids to create a specimen.
( 4 ) You must discard any excess urine.
( b ) *Temperature.* You must check the temperature of the specimen no later than four minutes after the employee has given you the specimen. ( 1 ) The acceptable temperature range is 32-38 °C/90-100 °F.
( 2 ) You must determine the temperature of the specimen by reading the temperature strip attached to the collection container.
( 3 ) If the specimen temperature is within the acceptable range, you must mark the “Yes” box on the CCF (Step 2).
( 4 ) If the specimen temperature is outside the acceptable range, you must mark the “No” box and enter in the “Remarks” line (Step 2) your findings about the temperature.
( 5 ) If the specimen temperature is outside the acceptable range, you must immediately conduct a new urine collection using direct observation procedures (*see* § 40.67) or an oral fluid collection.
( 6 ) In a case where a specimen is collected under direct observation because of the temperature being out of range, you must process both the original specimen and the specimen collected using direct observation (including oral fluid) and send the two sets of specimens to their respective laboratories. This is true even in a case in which the original specimen has insufficient volume and the temperature is out of range. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
( 7 ) In a case where the employee refuses to provide another specimen (see § 40.191(a)(3)) or refuses to provide another specimen under direct observation (see § 40.191(a)(4)), you must notify the DER. As soon as you have notified the DER, you must discard any specimen the employee has provided previously during the collection procedure.
( c ) *Signs of tampering.* You must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering (*e.g.,* if you notice any unusual odor). ( 1 ) If it is apparent from this inspection that the employee has tampered with the specimen (*e.g.,* blue dye in the specimen, excessive foaming when shaken, or smell of bleach), you must immediately conduct a new urine collection using direct observation procedures (*see* § 40.67) or an oral fluid collection.
( 2 ) In a case where a specimen is collected under direct observation because of showing signs of tampering, you must process both the original specimen and the specimen collected using direct observation and send the two sets of specimens to the laboratory. This is true even in a case in which the original specimen has insufficient volume but it shows signs of tampering. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
( 3 ) In a case where the employee refuses to provide a specimen under direct observation (see § 40.191(a)(4)), you must discard any specimen the employee provided previously during the collection procedure. Then you must notify the DER as soon as practicable.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001; 88 FR 27641, May 2, 2023]