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Employee Drug Testing:
Protocol for Forensic Drug Abuse Testing
Because South Bend Medical Foundation is a nationally certified drug abuse testing facility, specimens are put through a broad range of tests: more than would be performed at most smaller laboratories.
As a matter of standard practice, each time a laboratory specimen is handled, the transaction is documented on a chain of custody form. This form identifies all individuals handling the specimen, the date, manner and purpose of the transaction.
The South Bend Medical Foundation maintains Security personnel 24 hours a day, seven days a week to monitor employees entering the laboratory testing areas. The Department of Forensic Toxicology is a restricted access area. Every entry and exit is controlled by a Biometrics system. Authorized department personnel gain entry through fingerprint identification or a personal identification number. Unauthorized personnel must sign a visitor's log and be escorted by authorized personnel.
| Specimen Receiving |
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Urine drug abuse specimens are submitted directly to the Toxicology Secure Room accompanied by any shipping documentation that arrived with each specimen.
Once specimens are received in the Secure Room, authorized Toxicology personnel:
- Check the condition of the package and verify the shipping documentation
- Verify acceptable specimen volume
- Inspect the Custody and Control Form (CCF) for completeness
- Note anything unusual or unacceptable about the specimen, the shipping container or the chain of custody documentation on the CCF
- Sign the CCF and record the date
- Assign a number to the specimen(s) and the accompanying documentation
- Hold the specimen in the Secure Room refrigerator if it does not pass the chain of custody inspection or meet specimen requirements
- Pour a small portion of the original specimen into a tube labeled with its proper number for analysis by a trained technologist
- Store the specimen in the Secure Room refrigerator throughout the testing process, pending final specimen disposition
| Adulteration Testing |
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All specimens are routinely analyzed for creatinine pH and oxidants. A specific gravity analysis is performed on any specimen with a creatinine concentration less than 20 mg/dL. Any specimen testing outside the acceptable range goes through additional testing procedures.
| Specimen Tracking |
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All forensic drug screen specimens are received on a Custody and Control Form (CCF). Once the specimen is received in the laboratory, an internal chain of custody is initiated to track the handling of the specimen throughout the testing process and storage of the specimen. The laboratory tracks the specimen, any portioning of it and all pertinent documents throughout the testing process by means of a computer system which positively links the specimen identification number to a laboratory assigned accession number.
A portion of the specimen is initially screened using an Enzyme Immunoassay (EIA) testing method. Before the testing process is begun, daily maintenance is performed on the screening instrument. Calibrators are set to verify the instrument performance. All EIA test runs contain a minimum of 10% quality control specimens and include at least one blind specimen submitted by the South Bend Medical Foundation Clinical Testing, Regulatory Compliance and Technical Support (CTRCTS) Department. Once the initial test run is complete, a certified technologist will verify the accuracy of the result through a number of verification steps.
| GC/MS Confirmation |
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All specimens identified as EIA positive are subsequently analyzed by Gas Chromatography/Mass Spectrometry (GC/MS). This analysis is considered the "Gold Standard" in drug testing due to its specificity and sensitivity. It provides the technologist with a "fingerprint" of the drug. GC/MS testing is highly technical and performed only by certified GC/MS operators. Positive specimens are kept for one year at -20ºC.
Forensic blood alcohol specimens are legally valid for establishing intoxication. They are also the specimens of choice for employers whose company policies specifically address intoxication and/or impairment.
Blood alcohol specimens are screened by an Alcohol Dehydrogenase (ADH) method. Any specimen that screens positive is confirmed by Gas Chromatography Headspace analysis. Internal chain of custody documentation is used to track the specimen from storage through testing and back to storage. Positive specimens are kept for one year at 2º - 8º C.
Prior to the release of any forensic drug test result, all pertinent data from the screening and confirmation testing is reviewed by a certifying scientist who has extensive training and experience in drug abuse testing procedures. This person is never the same person who performed the screening and confirmation testing.
The certifying scientist verifies that all quality-control procedures have been followed, confirms that no technical or clerical errors exist and verifies that all chain of custody documentation has been properly executed. Once the review process is completed, the results are signed out by the certifying scientist and reported to the client.
| Reporting Test Results |
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Specimens that screen negative are made available to the client within 24 hours of receipt in the laboratory. Specimens that screen positive are taken to confirmation and the results made available to the client within three working days (not including weekends or holidays) from the time of the screening test. It is important to note that if a specimen has not been reported within 24 hours of receipt in the laboratory, assumptions of a positive result should not be made. Occasionally, a specimen will screen positive due to other substances found in the donor's system. These false positives are ruled out when the specimen is taken to confirmation testing. When a specimen screens positive but fails to be confirmed by a second analytically discreet method, the specimen is reported by the laboratory as "negative". Confirmation testing provides the final test result.
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