§ 26.169 Reporting Results.
(a) The HHS-certified laboratory shall report test results to the licensee's or other entity's MRO within 5 business days after receiving the specimen from the licensee or other entity. Before reporting any test result to the MRO, the laboratory's certifying scientist shall certify the result as correct. The report must identify the substances for which testing was performed; the results of the validity and drug tests; the cutoff levels for each; any indications of tampering, adulteration, or substitution that may be present; the specimen identification number assigned by the licensee or other entity; and the specimen identification number assigned by the laboratory.
(b) If licensees or other entities specify cutoff levels for drugs or drug metabolites that are more stringent than those specified in this part, the laboratory need only conduct the more stringent tests and shall report the results of the initial and confirmatory tests only for the more stringent cutoff levels.
(c) The HHS-certified laboratory shall report as negative all specimens that are negative on the initial or confirmatory drug and validity tests. Specimens that test as positive, adulterated, substituted, dilute, or invalid on the confirmatory analysis must be reported to the MRO as positive for a specific drug(s) or drug metabolite(s), or as meeting the criteria for an adulterated, substituted, dilute, or invalid specimen.
(1) The laboratory shall report all positive, adulterated, substituted, dilute, and invalid test results for each specimen to the MRO. For example, a specimen may be both adulterated and positive for one or more specific drugs.
(2) For a specimen that has a positive test result, the laboratory shall provide numerical values if the MRO requests such information. The MRO's request for positive confirmatory test results may be either a general request covering all such results or a specific case-by-case request. The laboratory shall routinely provide quantitative values for confirmatory opiate test results for morphine or codeine that are greater than or equal to 15,000 ng/mL, even if the MRO has not requested quantitative values for the test result.
(3) For a specimen that has an adulterated or substituted test result, the laboratory shall provide the MRO with the numerical values that support the reported result. The MRO may not disclose the numerical values to the licensee or other entity, except as permitted in § 26.37(b). If the numerical values for creatinine are below the LOD, the laboratory shall report to the MRO "creatinine: none detected" (i.e., substituted) along with the numerical values of the specific gravity test.
(4) For a specimen that has an invalid result, the laboratory shall contact the MRO and both will decide whether testing by another certified laboratory would be useful in being able to report a positive or adulterated result. This contact may occur through any secure electronic means (e.g., telephone, fax, e-mail). If no further testing is necessary, the laboratory shall report the invalid result to the MRO.
(5) When the concentration of a drug, metabolite, or adulterant exceeds the linear range of the standard curve, the laboratory may report to the MRO that the quantitative value "exceeds the linear range of the test," that the quantitative value is "equal to or greater than <insert the value for the upper limit of the linear range>," or may report an accurate quantitative value above the upper limit of the linear range that was obtained by diluting an aliquot of the specimen.
(d) The MRO and MRO staff may not disclose quantitative test results to a licensee or other entity, but shall report only whether the specimen was positive (and for which analyte), adulterated, substituted, dilute, invalid, or negative, except as permitted under § 26.37(b). This paragraph does not preclude either the HHS-certified laboratory or the MRO from providing program performance data, as required under § 26.717.
(e) The laboratory may transmit results to the MRO by various electronic means (e.g., teleprinters, facsimile, or computer) in a manner designed to ensure the confidentiality of the information. The laboratory may not provide results orally by telephone. The licensee or other entity, directly or through the HHS-certified laboratory, shall ensure the security of the data transmission and ensure only authorized access to any data transmission, storage, and retrieval system.
(f) For negative test results, the HHS-certified laboratory may fax, courier, mail, or electronically transmit a computer-generated electronic report and/or a legible image or copy of the completed custody-and-control form to the MRO. However, for positive, adulterated, substituted, dilute, and invalid results, the laboratory shall fax, courier, mail, or electronically transmit a legible image or copy of the completed custody-and-control form to the MRO.
(g) For a specimen that has a positive, adulterated, substituted, dilute, or invalid result, the laboratory shall retain the original custody-and-control form and transmit to the MRO a copy of the original custody-and-control form signed by a certifying scientist.
(h) The HHS-certified laboratory shall provide to the licensee's or other entity's official responsible for coordination of the FFD program an annual statistical summary of urinalysis testing, which may not include any personal identifying information. To avoid sending data from which it is likely that information about a donor's test result can be readily inferred, the laboratory may not send a summary report if the licensee or other entity has fewer than 10 specimen test results in a 1-year period. The summary report must include test results that were reported within the year period. The laboratory shall send the summary report to the licensee or other entity within 14 calendar days after the end of the 1-year period covered by the report. The statistics must be presented either for the cutoff levels specified in this part or for any more stringent cutoff levels that the licensee or other entity may specify. The HHS-certified laboratory shall make available quantitative results for all specimens tested when requested by the NRC, licensee, or other entity for whom the laboratory is performing drug-testing services. If the FFD program tests for additional drugs beyond those listed in § 26.31(d), the summary must include drug test results for the additional drugs. The summary report must contain the following information:
(1) Total number of specimens received;
(2) Number of specimens reported as—
(i) Negative, and
(ii) Negative and dilute;
(3) Number of specimens reported as positive on confirmatory tests by drug or drug metabolite for which testing is conducted, including, but not limited to—
(i) Marijuana metabolite;
(ii) Cocaine metabolite;
(iii) Opiates (total);
(B) Morphine; and
(v) Amphetamines (total);
(A) Amphetamine; and
(4) Total number of specimens reported as adulterated;
(5) Total number of specimens reported as substituted;
(6) Total number of specimens reported as positive and dilute [including an indication as to whether the specimen was subject to the special analysis permitted in § 26.163(a)(2)];
(7) Total number of specimens reported as invalid; and
(8) Number of specimens reported as rejected for testing and the reason for the rejection.
[73 FR 17217 Mar. 31, 2008]