My colleagues and I have discovered a series of abnormal blood alcohol tests done at the Wisconsin State Laboratory of Hygiene, which casts serious doubt about the reliability of blood alcohol tests in Wisconsin.
We call such abnormalities a “jagged hump,’’ for the way that they look on the chromatogram or blood test result graph.
The hygiene lab has not affirmatively disclosed the jagged hump to persons who may be affected. But we believe it to be exculpatory and subject to mandatory disclosure under Brady v. Maryland.
The jagged hump
Blood alcohol tests are done using a process called headspace gas chromatography. This is a process that separates the component parts of a subject’s blood and then, once separated, these component parts are measured. The result is a graph called a chromatogram.
Ideally a chromatogram will have a flat baseline with discrete peaks, each representing a substance in the sample. Normally, a peak indicates the presence of a substance (such as ethanol) in the blood sample.
These peaks should be distinct from other peaks, indicating good separation of substances, or “resolution.” It’s easy to look at a good blood alcohol chromatogram and see the thin, separate peaks (see images below).
We are, however, finding abnormal chromatograms with jagged humps at the lower left portion of the graph. The humps are not distinct or “resolved” from each other, indicating a malfunction of the instrument.
The position of the jagged humps, at the left side of the chromatograms, also indicates an instrument malfunction; as they appear to the left of the point where any peak at all should be visible. The jagged humps are very easy to spot, and we’ve been seeing them a lot.
Neither the hygiene lab, nor Perkin Elmer, the manufacturer of the test equipment, knows what causes the jagged humps; although, they admit that “they shouldn’t be there.”
On Feb. 4 in Milwaukee County Circuit Court, hygiene lab analyst Ryan Pieters testified in State v. Gummo that people from Perkin Elmer came to the lab to investigate, but they couldn’t figure it out.
The ISO 17025 laboratory standard is accepted as the consensus standard of the scientific community. ISO 17025 has been adopted by the Wisconsin State Crime Laboratory and the Wisconsin Occupational Health Laboratory (which is another department of the hygiene lab).
This standard requires that any laboratory instrument that repeatedly displays suspect results should be removed from service.
The ISO 17025 standard, although widely accepted, has not been adopted by the Forensic Toxicology Section of the hygiene lab. This section is accredited by the American Board of Forensic Toxicology, whose standards are less stringent. ABFT Criteria E-9, however, still requires a root cause analysis and corrective action for “repeated failures beyond that statistically expected.”
None of that has been done.
Concerns about the reliability of blood tests
As noted above, a hygiene lab analyst has testified that the abnormality “shouldn’t be there,” is contrary to the manufacturer’s protocols and is unexplained.
Nevertheless, the hygiene lab officially maintains confidence in its test results. It has explained that because the jagged hump appears in a different location from the ethanol peaks, and because the control results are within specification, everything is OK.
But such confidence is a mistake. The jagged hump remains a mystery, as does its effect on test results. It’s bad science to say otherwise, despite the apparent validity of the control tests.
The jagged hump may be just the tip of the iceberg: the most visible symptom of a much larger problem.
For example, it may be the result of a problem with the software that runs the system. This could cause other problems, as well, such as mixed up test results and misreported test results, the latter of which already has occurred in an Arizona laboratory using the same model instruments.
We don’t know whether the jagged hump appears randomly or in a pattern. The hygiene lab assumes that its random but even the number Pi appears on its face to be random.
The control tests are placed in a specific pattern in the run. The jagged hump may simply be appearing in a different pattern from the control samples.
If, in fact, the jagged hump is appearing randomly, it simply may have not affected the ethanol reading of a control sample, by chance. It also may be a problem with some other part of the process, such as sample preparation, that systematically excludes the manner in which control samples are handled.
To ignore these abnormal phenomena violates the scientific method. It introduces an unacceptable, unknown variable into the process. Scientific due diligence requires a proper investigation of the jagged hump phenomena.
My colleagues and I have formed an ad hoc committee for the purpose of investigating this and other issues related to blood alcohol testing. The committee consists of: myself as chairman; Lauren Stuckert of Mishlove & Stuckert LLC; Aaron Nelson of Doar, Drill and Skow SC; Todd Schroeder of Devanie, Belzer and Schroeder SC; Jeffrey Oswald of Hammet, Bellin and Oswald LLC; and Michael Cohen of Cohen Law Offices LLC.
My firm, Mishlove and Stuckert LLC, has acquired the software necessary to “re-process” or re-analyze Perkin Elmer test results. Please contact us if you have any questions or comments.
Our group submitted an open records request to the hygiene lab, which responded by stating that no root cause analysis or corrective action have occurred, nor any documented communications made to anyone regarding the abnormality; despite the testimony that Perkin Elmer, itself, has investigated.
We have retained two experts, a laboratory auditor and a pharmacologist, who have advised us that the jagged hump phenomena may be “suspect results” under the ISO 17025 standard, which requires the instruments to be removed from service.
Further, these phenomena are “repeated failures” under the ABFT Criteria E-9. Thus, the hygiene lab’s ABFT accreditation standard requires a formal, properly documented, root-cause analysis and corrective action. This has not been done; nor has the matter been reported to the ABFT.
Who is affected
The hygiene lab tests about 20,000 samples per year. We believe this jagged hump could have affected at least hundreds, probably thousands of samples over the past year.
The jagged hump casts serious doubts about the integrity of any test results that display the phenomena; and any other test results in the same batch.
The hygiene lab, however, has not disclosed the jagged hump to a single person, unless that person has gone to the lab and demanded to see the records.
At least one jury has agreed with us, as attorney Jeffrey Oswald obtained an acquittal in a jagged hump case.
Defense lawyers should demand the disclosure of lab records, including the chromatograms of a client’s tests, as well as all other chromatograms in the batch.