How the process works:

Specimen Collection

ScreeningOne has a network of over 11,000 qualified specimen collection sites. The network includes laboratory patient service centers (Quest Diagnostic, LabCorp and Medtox facilities), occupational health clinics, independent outpatient medical facilities, and hospital-based collections services. Many of these facilities also provide evidential breath alcohol testing services, blood alcohol testing, and other related occupational health services. All facilities in the ScreeningOne network have signed service agreements attesting that their collection/testing personnel met US Department of Health and Human Services (DHHS) or US Department of Transportation (DOT) qualifications, and that they use applicable procedures for urine specimen collection and breath or blood alcohol testing..

Laboratory Analysis

The analysis of samples will be performed by a laboratory that is certified by the Substance Abuse and Mental Health Services Administration (SAMHSA). The laboratories used by ScreeningOne have written procedures concerning sample accession, chain of custody quality control, and result certification, and they follow the guidelines prescribed by DHHS and/or DOT.

Medical Review
ScreeningOne’s fees include all MRO functions performed in receiving test results from the laboratory, review of custody and control forms and laboratory documentation, interpretation of test results, donor interviews, and reporting of test. All medical review services described below apply to negative and non-negative test results with the exception of the donor interview, which is conducted only for non-negative results (positive, adulterated, substituted, and invalid results).
ScreeningOne currently employs full time licensed physicians to perform the important tasks of the medical review of test results. All ScreeningOne MROs are certified by the American Association of Medical Review Officers and/or the Medical Review Officer Certification Council of the American College of Occupational and Environmental Medicine, and are board certified in a medical specialty. They meet the qualification training standards specified in the DOT regulations.
The medical review officer communicates directly with the designated employer contact person each time a test result is verified as a positive or when the specimen has been adulterated or substituted. ScreeningOne physicians handle the entire donor interview process as prescribed by Federal regulations.

Every test result is reported by the laboratory to ScreeningOne’s MRO Department. Each laboratory result is reviewed to ensure that the custody and control form is adequate and attests to the validity of the test result, and the proper identification of the test result with the applicant or employee.

Medical Review Process

Test results are reported to the MRO in an electronic download from the laboratory. The results are reported by social security number and specimen ID number. As required by Federal regulations, the ScreeningOne MRO must review a copy of the custody and control form, signed by the laboratory’s certifying scientist for every test result that is a non-negative report (positive, adulterated, substituted, invalid) prior to initiating the interview with the donor.

Donor Contact

Following the custody and control form review, the MRO will attempt the initial telephone contact with the specimen donor. At least 3 attempts are made in a 24-hour period to contact the donor. If the MRO cannot contact the donor after these attempts, the MRO requests assistance from the Company designated representative. If the donor does not respond to the employer’s instruction to contact the MRO within 72 hours, the result is reported to the Company without a donor interview.

Donor Interview
When the donor is contacted, the MRO will identify himself/herself and insure he/she is speaking with the correct donor. The MRO will explain the laboratory findings and ask the donor about illicit drug use, medications, and medical procedures within the recent past. If the donor admits to illicit drug use or cannot provide documentation of authorized medical use of the drug, the MRO verifies the test as positive. For opiate positive results, the MRO must establish collaborative evidence of illegal opiate use unless the laboratory finding is specific for a heroin metabolite (6 MAM) or the quantitative levels for morphine or codeine exceed 15, 000 ng/mL. The MRO may require the individual to undergo a medical examination by a qualified physician. If the laboratory reported that the specimen was adulterated or substituted, or the test was invalid, the MRO will interview the donor to offer the individual the opportunity to present any medical documentation that may explain the laboratory findings.

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Test Result Verification

Positive Results
If the donor states that he/she was prescribed a medication that explains the positive result, the MRO will require written documentation of the prescription. The MRO will review the documentation and may contact the prescribing physician and/or dispensing pharmacist to verify that the prescription is legitimate. If acceptable validation of authorized medical use is obtained, the result is reported as negative. If there is no acceptable medical explanation for the positive result, the MRO will verify the test as positive. The MRO will call the Company contact person immediately following the result determination. A written, signed test result will be transmitted to the Company following the verbal report.

Negative Results
Upon receipt of negative test results from the laboratory, a match of Employee ID Number and/or Account Number (i.e., location code) in the ScreeningOne database with the reported result is made. When the Custody and Control Form is received from the collection site, it is reviewed for completeness and the information is entered into the ScreeningOne database. This data is matched by employee ID number, specimen ID number, and the client account number to ensure the correct reporting and recording of the test result. Negative test results are reviewed by MRO staff personnel, and are generally available for reporting to the client contact person(s) within two hours of receipt from the laboratory.

Adulterated, Substituted and Other Non-Negative Results
All non-negative test results reported by the laboratory are handled by the MRO staff for resolution. These results include specimens identified as adulterated, substituted, invalid, rejected for testing, etc. For most of these atypical results, the MRO will conduct an interview with the donor to ensure that there is no medical explanation for the laboratory findings. For adulterated and substituted specimen results for which there is no acceptable medical explanation, the MRO will report the result as a “Refusal to Test”. If the MRO accepts an employee’s explanation and supporting medical documentation as the cause of the adulterated or substituted specimen result, the MRO will report the test as Canceled. Atypical specimens are handled in accordance with HHS/DOT guidance on regulated specimens, or according to the client protocol for non-regulated specimens.

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Split specimen or Reanalysis Request

If a test result is verified as positive or Refusal to Test (adulterated, substituted), the MRO will offer the applicant/employee the opportunity to have the split specimen tested at a second DHHS certified laboratory. The individual will ordinarily have 72 hours to make this decision. The expense of such additional testing is generally the responsibility of the donor, as required in the Company’s policy. If a split specimen collection is not used in the Company’s drug testing program, the donor is usually provided the opportunity to have a residual portion of the specimen tested for reconfirmation of the original findings. This reconfirmation may be done at the same, or a second, DHHS certified laboratory.

Confidentiality and Limitations on Disclosure of Medical Information
All MRO interviews with donors are conducted in accordance with DOT requirements for confidentiality and disclosure of medical information. Applicants/employees are informed of the confidentiality protections and limitations on disclosure at the start of the interview. Medical information disclosed to the MRO by the donor during the test result verification process is not provided to any third party (including the employer) without the donor’s expressed written consent, unless required by Federal law or regulation. MROs are generally required to inform employers of medications or medical conditions that may make an individual medically unqualified to perform his/her duties; or that may create a safety risk. Quantitative levels of drug or drug metabolites detected in the specimen are not ordinarily disclosed to employers; however the name of the drug or drugs detected is included on the test result.

Turnaround Time

ScreeningOne receives results 24 hours a day 7 days a week, via direct computer linkage, from several of its major laboratory providers. ScreeningOne has the ability to transmit pure negative results within two hours of receipt from the laboratories. Because of this direct computer link and constant downloads, we believe this to be the most competitive time frame available in the industry today. On the same day the results are received, the Medical Review Officer initiates the verification process for non-negative results. The donor interview is conducted to determine if there is a valid medical reason for the non-negative test. The results from a non-negative test are generally submitted to the customer in 48-72 hours after receipt of the laboratory findings.

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