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Section 10.1 What are the requirements for Federal agencies to submit blind samples to HHS-certified laboratories or IITFs?
(a) Each Federal agency is required to submit blind samples for its workplace drug testing program. The blind samples are to be sent to the HHS-certified laboratory or HHS-certified IITF to which the collector sends employee specimens for the Federal agency.
(b) Each Federal agency must submit at least 3 percent blind samples along with its donor specimens based on the projected total number of donor specimens collected per year. Every effort should be made to ensure that some of the blind samples are submitted quarterly.
(c) Of the blind samples submitted each year by an agency, approximately 75 percent of the blind samples must be negative, 15 percent must be positive for one or more drugs, and 10 percent must either be adulterated or substituted.
Section 10.2 What are the requirements for a blind sample?
(a) A blind sample that is drug positive must be validated by the supplier as to its content using appropriate initial and confirmatory tests.
(b) A blind sample that is negative (i.e., certified to contain no drug) must be validated by the supplier as negative using appropriate initial and confirmatory tests.
(c) The supplier must provide information regarding the shelf life of the blind sample.
(d) For a blind sample that is drug positive, the concentration of the drug it contains should be between 1.5 and 2 times the initial drug test cutoff concentration and must be spiked or contain one or more of the drugs or metabolites listed in Section 3.4.
(e) A blind sample that is adulterated must have the characteristics to clearly show that it is an adulterated sample at the time it is validated by the supplier.
(f) A blind sample that is substituted must have the characteristics to clearly show that it is a substituted sample at the time it is validated by the supplier.
Section 10.3 How is a blind sample submitted to an HHS-certified laboratory or IITF?
(a) A blind sample is submitted using the same Federal CCF as used for a donor specimen. The collector provides the required information to ensure that the Federal CCF has been properly completed as well as providing fictitious initials on the specimen label/ seal. The collector must indicate that the specimen is a blind sample on the MRO copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of blind samples throughout the total number of donor specimens rather than submitting all of the blind samples as a single group.
Section 10.4 What happens if an inconsistent result is reported on a blind sample?
If an HHS-certified laboratory or IITF reports a result for a blind sample that is inconsistent with the expected result (e.g., a laboratory or IITF reports a negative result for a blind sample that was supposed to be positive, a laboratory reports a positive result for a blind sample that was supposed to be negative):
(a) The MRO must contact the supplier of the blind sample and attempt to determine if the supplier made a mistake when preparing the blind sample;
(b) The MRO must contact the collector and determine if the collector made an error when preparing the blind sample for transfer to the laboratory or IITF;
(c) If there is no obvious reason for the inconsistent result, the MRO must notify both the Federal agency for which the blind sample was submitted and the Secretary; and
(d) The Secretary shall investigate the blind sample error. A report of the Secretary's investigative findings and the corrective action taken by the HHS-certified laboratory or IITF must be sent to the Federal agency. The Secretary shall ensure notification of the finding to all other Federal agencies for which the laboratory or IITF is engaged in drug testing and coordinate any necessary action to prevent the recurrence of the error.