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  • Stephen Biss

Stop, Document, and Report


Purpose:

To educate the Court about good laboratory practice.

To obtain an admission from the CFS scientist, that good laboratory practice requires contemporaneous documentation.

To obtain an admission from the CFS scientist that good laboratory practice requires that a technician stop, document, and report whenever an anomaly occurs.

To apply good laboratory practice to breath testing for a forensic purpose.

Q. All right. Paragraph 4.9.1 of I-S-O-17-0-2-5. A. Page?

Q. On page 7.

A. Page 7, yes.

Q. The first item that’s listed there, is that when there is non-conforming testing and or calibration work there needs to be a policy specifically, in paragraph (a) of something called, “Including halting of work and withholding of test reports and calibration certificates.” A. As it applies to a forensic yes. Q. That’s good lab practice.

A. Yes.

Q. But you’re not aware of any rule that

requires that the police do something similar when they have non-conforming work. A. That would be part of the quality assurance program for that police service, what they do when they have issues. Q. And that’s why you have recommendations in the Intoxilyzer 8000C training aid that say when you have a diagnostic fail you start the instrument again after you do a cold reboot of the instrument, let it start again, and if it is taken out of – if it is – fails the diagnostic again, if you get two diagnostic fails in a row then there’s a question of do you take it out of service or not. Right? A. That sounds like almost a direct quote from the Intoxilyzer 8000C Training Aid. That is just one possible solution for troubleshooting a problem, right? In the past, we have said that the instrument should be turned off and rebooted but sometimes the simplest solution is just to leave the instrument alone and let it warm up a little bit longer. So, when you have a temperature regulation test fail, right, the problem is, is that the instrument has detected something wrong with itself. So, it self-diagnosed that one of the temperatures is not up to proper operating temperature. It’s outside the parameters, right, for either the sample chamber or the breath hose, and so by detecting this, it’s letting the operator know that there’s a problem. So, it’s working properly. And sometimes the simplest solution, rather than shutting it off is to just let it warm up for another period of time because if you shut off the instrument, as we’ve said in the past, as you’ve just quoted, that – then all of a sudden the heaters turn off, and then they have to heat up again. And so, that could delay the tests actually being done, because of course, now it’s taking longer for the

instrument to warm up to proper operating specs. Q. Is that true with respect to all kinds of failures in diagnostics, like a general diagnostic fail? A. Well, with a general diagnostic – you don’t know which one failed until you actually see the test record card because it’s not – it’s not recorded in the Cobra data. Q. So, you need to document the failure. You need to report it. You need to troubleshoot it. A. Well, the – the – the diagnostic that failed would be printed on the test record card. That’s the purpose of the test record cards. It tells you what happened and what diagnostic failed or what occurred during that breath test, whether it was an ambient fail, whether it was R-F-I detect, invalid sample, indicating mouth alcohol or any other number of messages. Q. But you would expect that a qualified technician, if the instrument generates one of these failures, makes notes about what happened. A. That's correct. But it’s an issue of what happened and what did they do to rectify the problem. So, the example of the temperature regulation test fail that I gave... Q. Yes. A. ...would not be something that is an active participation of the qualified technician. They simply sat back and let it heat up for another five minutes. Q. So, it’s done.... A. It’s not necessarily noteworthy, right? We don’t tell police services what their technicians should put in what particular manual or in their notebooks, because if they physically have to do something, that’s different than if they just simply let the instrument warm up. Right? Q. I see. And what if the general diagnostic

fail is being caused by the instrument detecting drift? Then is it – doesn’t it make sense from a procedural – and I’m talking about drift over a matter of a couple of seconds. A. Well, what the instrument monitors is, it looks at the two wavelengths that it’s using to determine the alcohol concentration. Q. Yes. A. And what it does is, it checks to make sure that it’s stable with respect to it not either increasing or decreasing or both. Q. And if.... A. Outside.... Q. And if that stability, that problem with stability, generates a general diagnostic fail, then doesn’t it make sense to follow strict procedures in stopping, documenting, reporting, and then follow whatever it says, in the Intoxilyzer 8000C Training Aid as to how you rectify the situation. A. The Intoxilyzer 8000C Training Aid is just general recommendations for troubleshooting. There could be more than one possible way to troubleshoot a problem. We can’t obviously write them all down and put them in – include them in the manual because every single issue that happens is going to be possibly unique for that operator at that time for that instrument. So, it’s not possible to cover all that off, and so we have general recommendations, and of course on the course, verbally we teach police officers that, you know what, when you have an ambient fail message, sometimes the simplest solution is to move the breath hose away from the accused, because that’s more likely what’s caused the ambient fail message, as opposed to, maybe removing them from the room, turning on a fan, because that would be more intrusive and

require more time compared to simply moving the hose away from the individual. The instrument will recheck the air and if it passes then the problem is solved. Q. And of course, in a laboratory you’d follow what it says in I-S-O-17-0-2-5 and your laboratory would have a specific policy and procedures of how to handle those situations and the individuals who detected that kind of nonconforming work would make notes, would report it, would document it, so everybody else involved in the forensic science of your lab would have that information available to them. Right? A. Yes, to the extent that we do it, yes. It’s not often that we have controls that fail. Q. That’s page 8 of I-S-O-17-0-2-5. A. What?

Q. In terms of corrective action. A. Oh, okay. Q. It looks like 1-1 is the paragraph. Do you see that there under 4.11? A. Oh, sorry. Yes. Q. And under 4.11.2 is you have an investigation to determine the root cause of the problem. A. That’s what that says, yes. Q. All right. A. For the purposes, again, for a forensic laboratory.

Comment:

Note the definition of "laboratory" in this footnote 23 at page 180 of Motherisk:

Here is a confidential example (please do not share it) of an excerpt from a corrective action report in the US:

Quaere: Why aren't police required to stop, document, and report? Why are there no audits of police compliance with their SOPs?

#crossex

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Intoxilyzer®  is a registered trademark of CMI, Inc. The Intoxilyzer® 5000C is an "approved instrument" in Canada.
Breathalyzer® is a registered trademark of Draeger Safety, Inc., Breathalyzer Division. The owner of the trademark is Robert F. Borkenstein and Draeger Safety, Inc. has leased the exclusive rights of use from him. The Breathalyzer® 900 and Breathalyzer® 900A were "approved instruments" in Canada.
DrugTest® 5000 is also a registered trademark of Draeger Safety, Inc.. DrugTest® 5000 is "approved drug screening equipment" in Canada.
Alcotest® is a registered trademark of Draeger Safety, Inc. The Alcotest® 7410 GLC and 6810 are each an "approved screening device" in Canada.
Datamaster®  is a registered trademark of National Patent Analytical Systems, Inc.  The BAC Datamaster® C  is an "approved instrument" in Canada.