1. Definitions
The revisions added definitions specifically associated with specimen validity testing. These include the definitions for adulterated specimen, confirmatory validity test, dilute specimen, initial validity test, invalid result, non-negative specimen, oxidizing adulterant, and substituted specimen.
2. SVT Requirement
The revisions require each Federal agency to have specimen validity tests conducted on all urine specimens collected under the Mandatory Guidelines.
3. Split Specimen Testing
The revisions grant the donor the right to request that a split (Bottle B) specimen be tested to confirm an adulteration or substitution result that was reported by the primary laboratory on the primary (Bottle A) specimen.
4. SVT Reporting Criteria
The revisions add a new section, entitled ``Validity Testing,'' to the Mandatory Guidelines. The new section requires a laboratory to conduct validity testing and establishes the criteria that must be used by a laboratory to report a specimen as adulterated, substituted, invalid, or dilute.
5. Cutoff Levels
The revisions establish a pH cutoff for reporting a specimen as adulterated and establish a creatinine cutoff and a specific gravity cutoff for reporting a specimen as substituted. The creatinine concentration cutoff is to be less than 2 mg/dL.
The specific gravity cutoff is to be less than 1.0010. The pH cutoff is to be less than 3.
6. Retesting
The revisions require a second laboratory to conduct validity tests when it is unable to reconfirm the drug or drug metabolite that was originally reported positive in a single specimen or primary (Bottle A) specimen. The revisions also add criteria for retesting a specimen for adulterants and substitution.
7. Quality Control
The revisions establish specific quality control criteria and other procedural and test requirements for performing each individual validity test.
8. MRO Qualifications and Duties
The revisions clarify the qualifications and responsibilities of the MRO and expand the MRO's duties to review adulteration, substitution, and invalid test results reported by a laboratory.
9. Donor's Right To Challenge Results
The revisions provide that a donor has the same right to challenge the accuracy of a positive, adulterated, or substituted result reported for a single specimen collection as for a split specimen collection.
10. HHS Notification of Results
The revisions state that an MRO will notify the designated regulatory office that is responsible for the laboratory certification program when a second laboratory fails to reconfirm a positive, adulterated, or substituted result reported by a first laboratory.
11. Performance Testing and Laboratory Inspection Programs
The revisions expand the performance testing program and the laboratory inspection program. The performance-testing program will include performance-testing samples to challenge each certified laboratory's ability to correctly perform validity tests. The inspection program will include inspecting and evaluating the SVT procedures used by the laboratories in a manner similar to that for all other laboratory operations.
12. List of Adulterants
HHS will begin to include a list of known adulterants in the monthly Federal Register notice that lists certified laboratories.
