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Floyd Landis, WADA, LNDD, Chain of Custody and Poor Lab Procedures

By Roberta
[Tuesday, June 26, 2007]

One month ago the closing arguments in drug doping hearings for 2006 Tour de France winner Floyd Landis concluded. During the Landis' Hearings we did two "heat of the moment" write ups on the science issues surrounding this case. Afterwords, the folks at Trust but Verify, which is the unoffical clearinghouse for everything related to this case, suggested we do a follow up on "chain of custody" to help those who may not be familiar with chain of custody understand it better, and we thought this would be a great idea (although it took more research than we expected, you try digging through 1800 pages of hearing transcripts for what is most important).

The key acronyms

  • WADA – World Anti-Doping Administration: they are chartered by the International Olympic Committee with overseeing anti-doping efforts for many Olympic associated sporting federations including cycling.
  • USADA – United States Anti-Doping Administration: The U.S. national anti-doping affiliate which is prosecuting the Floyd Landis case for WADA.
  • LNDD - Laboratoire National de Dépistage du Dopage: the French drug testing laboratory responsible for carrying out the drug tests on Floyd Landis' samples from the 2006 Tour de France.

Chain of Custody explained

Chain of Custody, the documentation of the movement and handling of chemicals and drug testing samples is standard procedure through out many different industries. The chain of custody includes a form that accompanies the material in question from the "cradle to the grave." That is to say from the time the material in question enters a process requiring tracking (in the case of drug samples that would be the time the sample is collected) to the time the material is disposed of. It typically requires an unbroken trail of information including numbered seals, time and date of any observations of changes in seals or damage to seals, new numbers of and new seal applied, every change of custodianship, type of handling (tests and procedures), purpose of handling, dates and times of each handling procedure. Even when a sample is in storage, the individual who put it in storage is still the custodian and is responsible for the sample until the chain of custody is signed over to another custodian. For the chain of custody to be valid, every moment that the sample is in custody must be accounted for or the sample is not valid.

Definition of Custody

While each agency has its own wording for the definition of custody, they are all basically the same. The National Enforcement Investigations Center of EPA defines custody of a sample in the following ways(1):

  • It is in your actual possession, or
  • It is in your view, after being in your physical possession, or
  • It was in your possession and then you locked or sealed it up to prevent tampering, or
  • It is in a secure area.

Rules of the Game for WADA drug testing

WADA specifies that there must be two documents: the external record that is initiated at the testing site and ensures that the results generated by the laboratory can be unequivocally linked to the athlete being tested; the second document is generated by the testing laboratory. The second document, called the Laboratory Internal Chain of Custody is kept within the laboratory to record the testing process and location of the particular sample during testing. In other words, with these two documents, there should not be a question of where the sample was, or what process was taking place at any time while it is in the custody of the laboratory personnel. While a separate form is not required, the standard laboratory worksheets, logbooks, forms, etc. must provide information concerning the movement of the samples and sample aliquots during the analysis. The records must show a continuous record of the individuals in possession of the samples or sample aliquots. When the sample is not in an individual's immediate possession, records should document that the sample or sample aliquot is in a "controlled zone" per International Standards for Laboratories (5.4.3.2)(2). However, whenever the sample is in an uncontrolled or unsecured area of the laboratory, it must be in an individual's possession, and the chain of custody must be completed whenever the possession changes. The laboratory Internal Chain of Custody must include the name or initials of the individual, the date and the purpose of the transfer (a complete signature/name must appear in document at least one time)(2).

Note that this information is required for both samples A and B and every aliquot that is prepared for a testing procedure. All movement from the time it is received by the laboratory through storage, sampling, and disposal must be recorded. Records for aliquots should include all movement from preparation through analysis(2).

Whenever a forensic correction is made to the document, it should be done with a single line through the change. The change must be initialed and dated by the individual making the change. Erasures or whiteouts that obliterate the original entry are not permitted(2).

How the Game Was Actually Played

Note that according to the official WADA rules(2):

The records must show a continuous record of the individuals in possession of the samples or sample aliquots. When the sample is not in an individual's immediate possession, records should document that the sample or sample aliquot is in a "controlled zone" per International Standards for Laboratories (5.4.3.2)(2).

The rules seem to have been broken as soon as sample B was received by the laboratory. Note the following testimony of technician Claire Frelat (reporter page 686 line 23 through reporter page 690 line 1 / PDF pages 539-542 of hearing transcripts)(3),

Q [Floyd Landis Attorney Mr. Suh]. Now, looking at this form, which is 24 USADA 254, show me on the form where it shows that you received -- excuse me. Let me reask that question. Show me on the form where it records the transfer of the sample to you.

A [Claire Frelat]. The transfer is not written, but it is written that at 11:03 I received the bottle.

Q. Well, the form reads, if I'm not mistaken, that at 11:03, the aliquot occurred, correct?

A. In order to do the aliquot, I have to have the bottle in my hand.

Q. Certainly. But where does it show the time or how that you received the bottle, the transfer? In other words, not that you did the process, but where does the form show that the transfer occurred from operator 18 to you?

THE INTERPRETER: Operator 18?

Q. Yes.

MR. DUNN [USADA attorney]: May I interpose an objection. The witness just stated that in order to do the function she already said she did, she had to have received the bottle. So you have asked it answered -- you've asked it, and she has answered.

MR. SUH: It's actually not right.

Q. The question was, where on the form does it show the time or how or any other data about the intra- -- intralaboratory transfer? How it go from 18 to 26? Not that she had it at 11:03 and did the aliquot. Of course, she had to have it. But the chain of custody is from -- is the process she -- by which the sample moves through the laboratory. We know that -- that the form here records where and when certain things were done to the sample; but where does the form record how the bottle moved through the laboratory through each of those steps?

A. The transfer is not recorded, is not written.

Q. And why don't you now look through what is Exhibit -- Exhibit 25 and find for me any document that shows, once again, the intralaboratory transfer in this process, any document. Exhibit 25 is the lab pack for the B sample.

THE REPORTER: For the what?

MR. SUH: B sample.

MR. DUNN: I'm sorry. Could you repeat that for me? I didn't catch it.

MR. SUH: Why -- can we have the question read back?

(Reporter complies.)

MR. DUNN: I guess I -- my -- my request would be that when you say "the process," you'd be more specific, because there are a number of processes involved.

Q. The process by which the sample moved through the intralaboratory transfers from stage to stage, which is listed out here in the 1, 2, 3 operations that are set there. Find for me a document that shows how the sample moved through the laboratory in each of these tests.

A. There is no -- there is no registration or entry with respect to how the sample is transferred. There are entries which pertain to who received the bottle at what time, and when, and where.

Q. In other words, information, just like the information we have up here, which is the operator, the time and date in which an operation was performed, and what operation it was, correct?

A. Yes.

Q. But nothing else?

A. No.

From the moment that the chain of custody was broken, the integrity of sample B was in question. If the integrity of the sample cannot be guaranteed, then how can it be used for determining whether or not Landis had tested positive for a banned substance?

While the initial lapse in the chain of custody should have been sufficient to question the validity of sample B, that event was only the first of many irregularities in the chain of custody. There seem to be more than seven hours that have been unaccounted for during the testing of sample A. There is neither a written record of the events that happened during the unaccounted for hours, nor could the technician who was allegedly in custody of the samples able to recall what had happened to the samples during the missing hours (3,4).

Note that USADA insisted, prior to the hearings, that there had been no lapse in the chain of custody(5). However, they were overlooking an important purpose of the documentation. An unbroken chain requires more than just a note that someone had the sample. It requires an indication of who delivered the sample to whom, at what time and date . The standard format involves a date / time signature of the receiving party. More than that, a chain of custody goes hand in hand with procedures. It is important to know exactly what happened to a sample. Was there any deviation from standard procedure (corrections, retesting, diluting, etc)? What happened to a sample between tests if there was a lag time between procedures. Did the custodian go on break any time while the sample was being tested? If so, what was the status of the sample. USADA does not address any of these issues.

Another thing that is really troubling is the number of times that the "standard procedure" was violated during the testing of sample A because technician Cynthia Mongongu realized that she had "forgotten to complete" a specific procedure. Note that in addition to being the technician who performed the tests for sample A, Cynthia Mongongu had also trained Claire Frelat who performed the tests on sample B (for full testimony of Ms. Frelat's training see reporter page 535 line 20 through reporter page 685 line 20 / PDF pages 535 – 538 of transcripts, for testimony of Ms. Mongongu's training see reporter page 507 line 13 through reporter page 530 line 18 / PDF pages 376 - 397) (3).

Example 1 (reporter page 599 line 21 through reporter page 604 line 17 / PDF pages 460-464)(3)

One would have expected Ms. Mongongu's laboratory procedures above reproach. But here's what happened:

Q [Landis' lead attorney Mr. Suh]. Okay. Now, I'm going to go to the last mix cal acetate. That is -- you see the mix cal acetate 001 A2, right?

MR. YOUNG [USADA lead attorney]: Again, could we have the page?

MR. SUH: Sorry. USADA 183.

Q. And look at the acquisition time here. It's 20:39, right?

A [Ms. Mongongu]. Yes.

Q. And the current time is 14:24:44. Now, the reason I want to show this to you, and the reason it's important, is when I put these two side by side, this is the last sample fraction, right? This one right here, that's the last sample fraction, right?

A. Yes.

Q. And this one is the last mix cal acetate, right?

A. Yes.

Q. How much time separated the last mix cal acetate from the running of the last sample, if you can calculate that for me, please?

A. About five hours.

Q. About five hours, right?

A. Yes.

Q. So, in any case, this last mix cal acetate was not run immediately after this one, right? It was run about five hours later, right?

A. Yes.

Q. And there's no record here of what happened in those five hours, now, is there?

A. No.

Q. This is the sequence that was supposed to run automatically, correct?

A. Yes.

Q. Does the sequence automatically pause every time for five hours between the last sample and the mix cal acetate?

A. No.

Q. What happened in this five-hour time gap?

A. If the mix cal acetate was injected at 20:31 -- what was it, 20:31.

Q. 20:39?

THE INTERPRETER: 20:39, sorry.

A. It's because it's on the level of the sequence. I must have added it at that time.

Q. On the level of the sequence, you must have added it at that time?

A. Yes, because I remember that there was some -- there was a problem. And when I went to look to see that the whole sequence had run properly, I must have noticed that the mix cal acetate had not been injected, and so I corrected the error by placing it at the end of the sequence.

Q. Did you make any notes contemporaneously of the fact that you forgot to somehow add the mix cal acetate at the end?

A. No.

Q. Now, you testified before that when you did the sample, you didn't know it was Floyd Landis' sample, correct?

A. No.

Q. And this occurred -- the testing occurred on this date, July 23rd of 2006, right?

A. Yes.

Q. And your testimony is now, sitting here, you remember way back then that there was a problem that you had forgotten at that time to add the mix cal acetate. That's your testimony?

A. What I'm saying is that if it was injected at 20:39, is that it was because, at that time, I asked for the acquisition of the mix cal acetate.

Q. Do you recall earlier on today when you testified that you could not remember anything about the times you had called or serviced on the IsoPrime instrument when it had a problem?

A. No, I didn't remember the exact number, right.

Q. You couldn't remember the exact number or the dates or times or anything, correct?

A. That's correct.

Q. But you remember this one IRMS test that occurred in July of 2006 which explains this one time gap. That's your testimony; is that right?

A. Well, what I'm saying is that there's a sequence and that it was injected at 20:39, so that is then the time at which -- that the mix cal acetate was injected. That's what I'm saying.

Q. Well, everybody knows it was injected about five hours later now. The question is, why did you do it that way? Your testimony is you now have a present-time recollection of what occurred --

THE INTERPRETER: Wait a moment.

Q. -- in July of 2006, without ever knowing at that time that this was an unusual IRMS test in any way. That's your testimony?

THE INTERPRETER: I need to have it read back to -- to interpret it.

Q. Let's have it read back.

(Reporter complies.)

A. I said the mix cal acetate -- I said that was when -- that particular time was when the mix cal acetate was injected, that I can see that from the sheet, from the paper, that it was done at 20:39. That's what I'm saying.

Q. This test -- just to be clear, this test only takes about 45 minutes or so to do, as you previously testified, right?

A. Yes.

Q. And the time gap between this and this is about five hours, correct?

A. Yes.

Example 2 (reporter page 708 line 25 through reporter page 711 line 21 / PDF pages 559-561)(3):

Q [Landis attorney Mr. Suh]. Okay. I'd like to turn your attention now, to Page 1069, GDC 1069. And Todd, if you could blow up the beginning at 8:45:20 all the way down to, say, 8:59:20. Okay. Looking at the top there, it says -- at 8:45:31, it says Starting Acquisition, and the data was saved to the 2104stabilite1.raw, and then going down to 1, 2, 3, 4 lines, Starting Acquisition again data saved to again 2104stabilitie1.raw. And then 1, 2, 3, 4, Starting Acquisition again, data saved to stabilitie1.raw?

A [Ms. Frelat]. I see that.

Q. And the data that was saved to the file stabilitie1.raw, on the top two lines there, 2104stabilitie1.raw, and the second one, when you resaved the data with the same file name, the information in that data no longer -- in that file no longer exists?

A. Yes.

THE WITNESS: Can I explain?

A. May I explain?

Q. Sure.

A. So in order to prepare the IRMS, in the morning, we fill a liquid nitrogen Dewar -- D-E-W-A-R -- and then, after that, we verified the peak center, and when it is good, when it is ready, then we launch, or we start, the stabilization. I had forgotten to verify the peak center. When I noticed that, I then verified the peak center and then when -- in order to verify the peak center --

THE INTERPRETER: Is it peak center or center peak --

A. In order to verify the peak center or the center peak --

DR. BOTRÉ [Director of the Rome WADA Laboratory and USADA witness]: Peak center.

THE INTERPRETER: Okay. The peak center.

A. -- the peak center, you have to open up the 22 CO2.

DR. BOTRÉ: It's -- let's call it the valve.

THE INTERPRETER: Oh, the valve.

A. Okay. The valve, the CO2 valve. In order to -- in order to do the peak center, and then you have to close the valve. And I had forgotten to do that on the second one, which means that I then closed the valve, and then I performed my stabilization.

Q. And why didn't you do this process when you changed the nitrogen earlier?

THE INTERPRETER: When you changed?

Q. The nitrogen earlier? Where you added nitrogen earlier?

A. Because I forgot.

Q. Okay. And you remember now here today that you forgot.

A. Yes, because it caused me to lose time, to waste time.

Q. And the time that it caused you to lose was about beginning at 8:45:31 to about 8:48:55. So you remember this day because it caused you to lose three minutes on April 21, correct?

A. Well, I'm not sure I like the way you put it.

Q. I've never heard that before.

Example 3 (reporter page 713 line 14 through reporter page 715 line 24 / PDF pages563-565)(3):

Q [Landis attorney Mr. Suh]. Now, do you recall -- and, of course, the data from the first three cal mix -- MixCalIRMS 1, 2, 3, whatever those results were, are gone, right?

A [Ms. Frelat]. They -- they don't exist anymore because they did not correspond -- because they were not mix cal IRMSs, it wasn't what was -- I'm going to start again. I remembered that morning, because there was a lot of wasted time, not just three minutes, but more. When I put the mix cal IRMS into the auto sampler, I did not place it in the correct place, area, and I only discovered that when the third injection was performed. So then I had to correct -- oh, I corrected the position -- and then I started my mix cal, cal mix IRMS again.

Q. So, just to make sure I understand, you began the automatic sequence, and as the automatic sequence is running from the mix cal IRMS 1, 2, 3, you didn't realize until the end of mix cal IRMS 3 that they were in the wrong place, correct? Correct?

A. Yes.

Q. And then you went back, stopped this process, correct?

A. Well, it stopped by itself.

Q. Okay. And then you went back and put three new mix cal IRMSs in the right place?

A. The injection of the mix cal IRMS is performed, is done from one vial only, from only one vial.

Q. So you put another vial in the right place and ran it again?

A. Yes. I replaced the vial into the correct position.

Q. And why didn't you, at that point, simply save it to a different file name, so everyone would know what happened?

A. Well, that's the way I did it.

Q. And absent your testimony here today, that's the only way we would know, from your perspective, what happened here, correct?

A. From my point of view?

Q. Yes. I mean, without your explanation, there's nothing else that shows what happened to this rerunning, correct?

A. Yes.

Q. And, in other words, if someone were to say, well, the reason why these mix cal IRMS and the log files are shown --

THE INTERPRETER: Counsel, can you start that again.

Q. If someone were to say that the reason why the mix cal IRMS and other samples are rerun and saved with the same file name was because you saw results you did not like and resaved over it. The only way we would know that that didn't happen is your memory of what occurred on that day; is that right?

A. Yes.

Note that in this one test run there were at least three major procedural errors each of which seems to have been compounded by attempts to correct the errors.

Multiple procedural errors alone were pretty serious, but there is no reference to procedural errors in the logs. In fact, rather than striking through results of errors with one line as required, the technician consistently saved new results in place of the originals. There is no way of knowing what really happened or what results were obtained on previous runs.

Example 1: Let's look again at the previous testimony in Example 3 above:

Q [Mr. Suh]. And why didn't you, at that point, simply save it to a different file name, so everyone would know what happened?

A [Ms. Frelat]. Well, that's the way I did it.

Q. And absent your testimony here today, that's the only way we would know, from your perspective, what happened here, correct?

A. From my point of view?

Q. Yes. I mean, without your explanation, there's nothing else that shows what happened to this rerunning, correct?

A. Yes.

Q. If someone were to say that the reason why the mix cal IRMS and other samples are rerun and saved with the same file name was because you saw results you did not like and resaved over it. The only way we would know that that didn't happen is your memory of what occurred on that day; is that right?

A. Yes.

Example 2 (reporter page 589 line 15 through reporter page 591 line 6 / PDF pages 451-452)(3)

Q [Mr. Suh]. Going down the page a little further, you'll see an entry number -- a time entry at 11:26:19. It indicates, that time entry, Commencing analysis of 2004MixCalAcetate01? And do you see, three lines later, that there is a file saved to 2004MixCalAcetate01? And then 1, 2, 3, 4, 5, 6 lines below that, at 12:22:45, once again, Commencing analysis of 2004MixCalAcetate01. Do you see that?

A [Ms. Mongongu]. Yes.

Q. And on the next page at 1069, the data run at -- the very top line, 13:06:48, MixCalAcetate01, correct? 13:06:48, the very first entry. Todd, we're going to have to switch back and forth between those two pages. And of course, when the cal mix acetate was rerun and saved to the same file name, the first file -- the data of the first file is deleted and no longer part of the record, correct?

A. Yes.

Q. And why did you run mix cal acetate again here?

A. Because the first mix cal acetate was undoubtedly not correct.

Q. And did you take any contemporaneous notes of the first mix cal acetate being not correct?

A. No.

Q. So the record of the first mix cal acetate that was not correct no longer exists, right?

A. No.

Q. And you remember that the first mix cal acetate was not correct from your memory alone, right?

A. If I did a second mix cal acetate, it's because -- it was because the first one was not correct.

As a result of failure of the testing laboratory to insure anonymity of the sample donor, both Cynthia Mongongu and Claire Frelat were aware that they were testing the Floyd Landis sample B (reporter page 718 line 25 through reporter page 719 line 3 / PDF page 568)(3) .

Q [Mr. Suh]. So you're saying that when you did this test, you knew that the IRMS test that was being done on this sample was Floyd Landis'?

A [Ms. Frelat]. Yes, the B; yes, I did know that.

It is also important to remember that in addition to knowing that the sample B being tested belonged to Floyd Landis, Clair Frelat, who ran the test for sample B, had been trained by her supervisor, Cynthia Mongongu who had tested sample A. In other words, Frelat was in the position of having to verify her supervisor. She knew that Mongongu had reported a positive test for sample A. If the test had not been reported as positive, sample B would not have been run. In most cases the B sample is analyzed in the same lab where Sample A was tested. Anonymity is of utmost importance, however, in this case, the lab technician knew that she was testing Floyd Landis’ sample B, and that she was validating her supervisor’s work.

When I was an individual who worked under a random drug testing policy for 14 years, I would have been very concerned if the individual testing sample B knew the sample belonged to me and that she was verifying work that her supervisor had done -- especially if the supervisor knew which subordinate was verifying her work. This just creates too much potential for the subordinate to feel compelled to simply validate the original test rather than critically verify the testing. At the very least it should always be the supervisor who verifies the work of a subordinate or an equal level employee verifying the work.

If the evidence presented thus far does not convince you that the testing procedures used to evaluate the Floyd Landis' urine samples were so seriously flawed that they should be excluded as evidence, read further. The testimony by Dr. Davis, a PhD in mass spectrometry, who was instrumental in designing the IsoPrime mass spectrometer being used in these tests and author of the users' manual for the instrument, should put the final nail in the coffin. Quite simply, there was nobody at the hearings who knew the IsoPrime mass spectrometer, which was used to test Landis' samples, better than Dr. Davis (Dr. Davis' background can be found at reporter page 1730 line 1 through reporter page 1740 line 24 / PDF pages 1483 – 1492; his background as an engineer with MicroMass and being a development project leader for the IsoPrime begins on PDF page 1484; discussion of the IsoPrime user manual which he helped write begins at the bottom of PDF page 1522). To summarize Dr. Davis' testimony, the installation of the mass spectrometer was improper and the technicians didn't know how to run the equipment. As a result, the accuracy of the instrument was suspect from the beginning of operation.

Testimony (reporter page 1775 line 3 through reporter page 1784 line 7 / PDF pages 1524-1532)(3):

Q [Mr. Suh]. And when you were actually at LNDD, did you have a conversation with Dr. de Ceaurriz and Mrs. Buisson [LNDD supervisor of Ms. Mongongu and USADA witness]?

A [Dr. Davis]. Dr. Buisson, yes. I have been continued -- the IsoPrime is not a particularly linear instrument. It has problems. And from the first moment I entered into the laboratory, I requested to see linearities and was told I could not see them. I then had further discussions with Mr. Dunn, and Mr. Aguilera -- Dr. Aguilera [Author of key papers on CIR applied to doping control], who was there -- requested that we could see linearities, one on each day of the analysis. I was told yes. And then the two gentlemen I just mentioned consulted the laboratory staff who, much to my utter astonishment, said they only did one linearity per month, and we have evidence that they don't even do that. And that linearity had, again, much to my surprise, had only been done the day prior to us arriving at the laboratory. And I requested -- I spoke to Dr. Aguilera, and I said, "Do you feel it's unreasonable for me to request the linearity runs?" And he went quiet and eventually said, "No comment." As far as Dr. Buisson went, I was talking to her later on in that day, and she stated quite clearly that -- that at the extreme ranges -- I presume she's talking down towards the lower or the upper ranges -- she said they did have problems with linearity on the IsoPrime. And as we saw later when getting some of the -- eventually getting some of the linearity results, we noted that had they did not change the reference gas process down to the lower end and the upper extremes of the range required. They truncated it somewhat.

Q. Let me show you what is marked LNDD 547. Do you recognize what LNDD 547 is?

A. Is this their SOP?

Q. Yes.

A. Yeah.

MR. SUH: And perhaps, Mr. Chair, since it is in French, and we are no longer with the benefit of our French/English interpreter, you might be able to interpret the highlighted section?

MR. BRUNET [Chair of the three person arbitration panel]: This test is to be run at least once per month. It consists to verify, and that's a technical translation, so I'll try my best -- it consists to verify the -- the scope of the linearity field of the instrument. It's the best I can do.

MR. SUH: But the first sentence is, it should be done at least once per month.

MR. BRUNET: That's what it says.

Q. All right. I'd like to show you some documents, Dr. Davis, beginning with LNDD 313. Have you seen this before?

A. I have, yes.

Q. And what is it?

A. This is a printout from the JA 10 series IsoPrime, the one used to analyze the Stage 17 samples.

Q. And, Dr. Davis, just for -- for ease of sake, why don't we say that the Stage 17 IsoPrime is -- we'll call it the IsoPrime 1.

A. Okay.

Q. And the --

A. I see it is labeled, yes.

Q. And the other IsoPrime as the IsoPrime 2?

A. Okay. This is a printout of a linearity -- a linearity test performed on IsoPrime 1.

MR. JACOBS [Landis' attorney]: And the page?

MR. SUH: It's LNDD 313.

Q. And then turning to LNDD 315 --

MR. WEISS [Landis' attorney]: The exhibit number, for clarification, is Exhibit 26.

MR. BRUNET: I'm sorry?

MR. WEISS: Exhibit 26.

MR. BRUNET: Oh.

Q. And I'm sorry. Before I go off of this, when was this linearity run performed?

A. The acquisition date was the 26-06-05.

Q. So --

A. I'm sorry. I apologize.

Q. -- June 26th of 2006?

A. Yes.

MR. CAMPBELL [arbiter]: Can we get that reference page? The Bates number again?

MR. SUH: Yes. LNDD 313.

Q. Okay. And then, Dr. Davis --

MR. BRUNET: I'm sorry, Mr. Suh, going back to what I was translating before. What was that reference? Was it once a month? MR. SUH: It was once a month or at least once a month. It was LNDD 547.

MR. WEISS: Which is Exhibit 112. 112.

Q. (By Mr. Suh) And then just to show you LNDD 313 -- 315, do you recognize what 315 is?

A. Yes. It's another linearity run, yes.

Q. Linearity runs are done in triplicate; is that right?

A. The stability is done in triplicate. I believe the linearity runs are also done in triplicate. I'm not sure the SOP refers -- actually states that. I could be -- I could be incorrect, though.

Q. But this is -- this is the second linearity run on the same --

A. Yeah, I think it's perfectly reasonable, yeah.

MR. CAMPBELL: We're still trying to locate one, please, Mr. Suh.

MR. SUH: I'll hold.

MR. CAMPBELL: Do you have any 2 times?

MR. SUH: I don't have times.

MR. CAMPBELL: Okay.

MR. WEISS: Here's the single page.

MR. CAMPBELL: We're trying to find it in your books.

MR. WEISS: It's 547 in Exhibit 112.

MR. SUH: Just -- just so the Panel knows, I'm just showing each one of the pages for the linearity runs for each. These are -- the 315 -- 313, 315 and 317 are just the linearity runs, three done on June 26th of 2006.

MR. BARNETT: And, Mr. Campbell, to clear up the mystery, the binder that says it has Exhibit 110, exhibits were brought with us and added to that, so it actually should have the rest behind that.

MR. CAMPBELL: Okay. Thank you.

MR. BARNETT: Sorry for the confusion.

Q. (By Mr. Suh) Dr. Davis, looking up at LNDD 317, was this linearity done on June 26th, 2006?

A. That's what the printout says.

Q. Okay. And then now turning to LNDD 320, when was this linearity run done?

A. The 31st of the 7th, '06.

Q. It would be July 31, '06?

A. Yeah. Sorry.

Q. And when was this one done?

A. The same day as the previous sample.

Q. And when was this one done?

A. The same day as the previous sample.

Q. And turning to the last set -- when was this one done?

A. The 25th of the 9th, '06.

Q. And how about LNDD 329?

MR. BRUNET: Which one's that one?

MR. SUH: LND- -- this was LNDD 327, which is the September 25 linearity run.

MR. WEISS: And now we're on Exhibit 26.

Q. Turning to LNDD 329, when was that linearity run done?

A. The 25th of the 9th, '06.

Q. And the next one, Page LNDD 331? Again, was the third one done at the same time?

A. Same as the previous one, yes.

Q. Okay. So based upon the records and the documents you've seen, did LNDD perform linearity tests pursuant to its own SOP? A. Nope. They -- even with the one or two, they kept missing out the occasional -- the occasional month.

Q. Based upon what you've seen in the records and your visual -- and your inspection of LNDD and discussions with LNDD personnel, do you have an opinion as to whether or not the IsoPrime 1 instrument was linear?

A. I think it drifted in and out of linearity, and I think there was also a degree of uncertainty as to how unlinear it was, because they did not do the tests properly over the full range. And let me just -- to instruct you, let me just emphasize how important linearity is. If you have a peak -- if your system is nonlinear, the isotope number will change dependent solely on the peak heights. If you have a big peak and a small peak, there'll be a shift in that isotopic number reported, irrespective of the composition of that compound. And in the context of GC/C-IRMS in doping control, we have quite a big range in peak heights, so the system has to be linear. This is a very demanding isotope application. Your system has to be working properly.

Q. And if it is not, what happens to the final values?

A. They're wrong.

Testimony (reporter page 1784 line 8 through reporter page 1787 line 4 / PDF pages 1532-1535)(3) :

Q [Mr. Suh]. All right. Let me ask you -- turning to another subject now -- as for -- these are all a number of different subjects. Did you, when you were at LNDD, have an opportunity to take a look at the IsoPrime 2?

A [Dr. Davis]. I did, yes.

Q. It is GDC 734.2?

A. Yes.

Q. Is that a picture of it?

A. That's a picture of the IsoPrime 2 at LNDD, yes.

Q. And how did you get a picture of it?

A. I used my mobile phone.

Q. And do you recognize this as an IsoPrime instrument that you are familiar with?

A. Yes.

Q. And can you tell the Panel what these things are? Do you know what these are?

A. It's either a Mickey Mouse head or they've left the magnet lifting rings on.

Q. What are -- what are the magnet lifting rings?

A. The magnet is a very, very precisely engineered piece of metal. It's also very heavy. So, therefore, to pick it off the ground and put it on the machine, you have to use a very thick steel bar which is passed through those two removable rings, and two people can then lift the magnets up and place it on top of the mass spectrometer in a position for operation.

Q. You mean, there's a magnet in this instrument?

A. Yes, there's a magnet. This is the magnet here. Thus being, this is what we refer to as the analyzer. It's called the analyzer because it's probably the most important part of the mass spectrometer. You get that wrong, your mass spectrometer doesn't work. Simple as that.

Q. Okay. Let me show you your diagram again. Where does that magnet sit?

A. That's this portion here -- this blue outline.

Q. That's what spins your --

A. That's what causes the ions to rotate and to cause the separation of the carbon 13, the carbon 12, and every other ion that should pass through it.

Q. Now, is the magnet function an important function for this process?

A. As I just stated, it is the most crucial function. You can have faults with your source; you can have faults with your detectors; you can get around those, but if your magnet is not right, you're dead in the water.

Q. Okay. So going back to this picture, did it shock you to see that there were these rings?

A. I was astounded.

Q. What does it matter that there are rings on the instrument?

A. Well, as I think I mentioned, the magnets produced to, within my review of the drawings, .01 of a millimeter precision, and they're produced to that kind of -- they're manufactured to that kind of a precision because they're produced to a very precise magnetic field, and if that magnetic field is not correct, the ions will go all over the place. And at the end of the day, the ions are the important stuff; that's what you are trying to count.

Now it should be noted that the IsoPrime 2 that had the "Mickey Mouse ears" was NOT the machine being used to test Landis' samples, but this is not the point. The following cross examination testimony makes this clear:

Testimony (reporter page 1888 line 14 through reporter page 1889 line 19 / PDF pages 1626-1627)(3)

Q. [USADA lead attorney Mr. Young] Okay. When you talked about this picture of the magnet with the handles, you said something about putting your hand over your heart and not being able to say that that affected the results?

A [Dr. Davis]. I don't know if I said exactly that. I said I couldn't say what the effect would be, and I stand by that.

Q. What results are you talking about?

A. Any results that were produced on that machine.

Q. Okay.

A. This machine was not -- I think your point would probably be -- this machine was not the machine used for the Stage 17 Sample under which Mr. Floyd -- Mr. Landis is accused of taking drugs. But my point is not so much this would have changed the results of Mr. Landis' case, but it shows a complete lack of understanding of the instrument to allow those to still be there.

Q. And what I wanted to make clear, because it wasn't clear from what you said yesterday, is, this has nothing to do with the IsoPrime 1 that the Stage 17 results were analyzed on.

A. It has nothing physically to do with it, but it does have implications as to the knowledge and understanding of LNDD staff as to the processes of the isotope machine and the application and use of the isotope machine.

Testimony (reporter page 1787 line 18 through reporter page 1790 line 6 / PDF pages 1535-1537)(3):

Q [Mr. Suh]. All right. Again, in no particular relation to the magnet issue, I'd like to show you the USADA brief, Page 62. Have you had a chance to read the highlighted portion before?

A [Dr. Davis]. This is where they refer to the server control, the lights showing that they haven't got a leak. Yes.

Q. This deals with the issue, in their brief, they're dealing with an issue of whether or not the IsoPrime was being run at the proper pressure, which we'll get to in a moment.

A. Okay.

Q. And in response to this concern, do you see where it says, "The instrument has a built-in operating light which establishes that the instrument is operating within the correct pressure range. When the instrument is operating properly, a green light is displayed on the instrument. If the operating pressure becomes too high, the light turns yellow as a warning followed by red and instrument shutdown." Exhibit 32 is three, color photographs of the LNDD IsoPrime instrument operating at a pressure of 5E-6 millibars with the green light display.

A. Yes.

photo of part of the instriment showing the green light.Q. Okay. And then turning to those pictures, do you see -- have you seen this picture before?

A. Yes, I have.

Q. Now, you're familiar with this instrument.

A. I am.

Q. Now, what do you think about the argument that this green light, right here, is a warning light, which -- I'm quoting the brief -- that if the operating procedure gets too high, the light turns yellow, as a warning, followed by red, and instrument shutdown. What do you think of that?

A. It shows a complete lack of understanding of that instrument. That -- first of all, that light does not change color. It's either green or off. That light -- well, first of all, that unit is a control unit, a control unit which switches on and switches off the pumps which are used to create a vacuum. That green light refers to the speed at which the pumps are working, and it comes on when the pumps are operating at the correct speed. Now, if there's a huge leak, the pumps will not be able to maintain the speed, and the green light will go out. But that will be a leak so large you can hear it. And we're talking about leaks of -- of atoms here. We're not talking about of a gas flow; we're talking about very minor leaks. That has nothing to do with pressure.

Q. And does this light turn -- change color?

A. As I have just said, it does not. It either goes on or it goes off.

Testimony (reporter page 1790 line 11 through reporter page 1792 line 8 / PDF pages 1537-1539)(3):

Q [Mr. Suh]. All right. Let's turn to another issue. I'd like to turn to Page 9 of a discovery response from LNDD. Do we have this marked as an exhibit in discovery responses? For the record, they're just discovery responses. We don't believe they're marked as an exhibit. The discovery response says, "LNDD has no manual specifically for the IsoPrime."

A [Dr. Davis]. I did ask for -- to see the manual, and Mr. Dunn said I was not allowed to whilst I was there. So I couldn't say whether it existed or not for the simple reason I was not allowed to see it. I did not see any signs of it whilst I was there.

Q. Now, having been in charge of installing and working with these instruments, do you think it's important to have the actual operating manual for it?

A. It's essential. You wouldn't buy a car without a manual. You certainly wouldn't buy a mass spectrometer without one.

Q. But why would you need it?

A. Because mass spectrometers are not washing machines. They're very complex pieces of -- of a manufacturing kit, and there's no way that you can keep that knowledge in your mind. Each one of these mass spectrometers is many, many decades of work that's gone into developing them, and that knowledge has to be passed on. And the best way to do that is in a written -- a written or electronic document. And most individuals who buy these mass spectrometers are people who specialize in applications. They're not mass spectrometrists by their nature; they're biologists, they're doping control experts, they're interested in global greenhouse warming. They're not -- they don't spend their whole lives playing with mass spectrometers. They want a nice, simple instrument they can go in and use, and that requires instructions and procedures and laid-down processes which they have to follow to ensure the machine is working correctly, properly, it's maintained in a manner which is necessary for good analytical results.

In short, the instrument had not been properly installed to begin with, periodic tests were not conducted as required, the technicians had no understanding of the operation of the mass spectrometer. In fact, they didn’t even know what the green light on the IsoPrime indicated, and had no access to the users' manual, a book that is required for day to day operation information. Had they used a check-list that had been developed based on the users’ manual every time they ran the experiment, steps would not been missed and many corrections could have been eliminated. Even as a commercial Hazardous Waste driver I was required to follow a check list to inspect a vehicle every time I drove it. Why should a lab technician not also follow a checklist when running drug testing procedures to prevent mistakes?

The Prosecution's take on CoC and procedural concerns

Some may observe that almost all of the testimony referenced so far was the result of questioning by Landis' attorneys and in only one instance questioning by USADA attorneys was referenced. This was because USADA attorneys choose to mostly ignore the chain of custody and procedural issues raised. The following statement from lead USADA attorney Mr. Young closing arguments sums up their position on this very succinctly (reporter page 2004 lines 7-24 / PDF page 1731)(3):

When they're [Landis' attorneys] making an attack, it's not directed to a violation of the International Standard. It's directed to what they view as not as good laboratory practices as they would like to see. Except that it's not the Panel's job to cast -- to make a decision on whether the Paris laboratory should be accredited or whether they generally do their work well or even whether they generally do their work well for IRMS. There's an accreditation body whose job it is to make that decision. That accreditation body is the ISO agency that inspects and accredits them, and that's what happened.

Excuse me? Just because they have an accredited lab that supposedly gets inspected every now and then, the arbitration panel should not consider laboratory practices at LNDD? Let us look at WADA's chain of custody standard, which WADA labs are supposed to be held accountable to (reporter page 843 line 11 through reporter page 844 line / PDF pages 679-680)(3):

Q [Landis' attorney Mr. Jacobs]. You would agree, would you not, that you can't do chain of custody by memory. It has to be documented?

A [USADA witness Dr. Ayotte, Head of the Montreal WADA lab]. Of course.

Q. So, it's not sufficient to come into an arbitration like this and simply say, I remember that at such and such a time the bottle was in such and such a location. That has to be documented, correct?

A. Well, if you go to the definition of the chain of custody in the document, it is said that the chain of custody is composed of documents and records and testimony.

Q. So it would be okay for gaps in chain of custody to be filled by someone's memory from what would now be nine or ten months ago?

A. According to the technical document, yes.

Q. As long as that person has a really good memory, right?

A. Yes.

Q. It's better to have it documented, isn't it?

A. Yes.

We have two issues with the preceding testimony. First, have you ever tried to remember what you did six to ten months ago. Ms. Mongongu certainly had problems at times remembering what did or did not transpire. Our second issue is that Dr. Ayotte's understanding of the WADA definition of the chain of custody is wrong. The document states(2):

The chain of custody, along with relevant testimony from individuals documented on the chain of custody documents, should provide a complete record of the Sample or Aliquote location.

Read that again very carefully, the testimony must be documented on the chain of custody documents. Thus testimony from memory in a hearing such as this CAN NOT be used to fill in the gaps.

Another criticism Mr. Young made during his closing statements was that none of Landis' witnesses were ISO accredited. For the most part the only people who would be ISO accredited as Mr. Young was referring to would be working at a WADA accredited lab. As came out during the hearings, individuals who work at WADA accredited labs are not allowed to testify for or assist athletes during their defense. To Mr. Young's statements on this issue, Mr. Campbell, who is one of the three arbiters hearing this case asked the following line of questioning (reporter page 2022 line 3 through reporter page 2024 line 23 / PDF pages 1748-1749)(3):

MR. CAMPBELL: Mr. Young, I've got a question I want to ask you.

MR. YOUNG: Yeah.

MR. CAMPBELL: I think you'll agree with me that this doping system that we have is supposed to be in place to protect the interests of athletes. And when I look at that issue -- just athletes in general, not in particular an athlete -- and you've got a code of ethics of laboratory directors that essentially states that they can't point out the mistakes of the lab, how is that -- how does that protect the interests of athletes when they may be the only ones, given their expertise, that really knows when there's a problem?

MR. YOUNG: There's -- Mr. Campbell, there's -- first of all, that code of ethics doesn't require people like Don Catlin, Christiane Ayotte, Willie Schänzer, to come forward and support a result in a case. These are not the kind of people that would put their reputation on the line in support of some other laboratory's result unless they really believed it. Second, as we have heard from Dr. Catlin, this is no monolith. I mean, Dr. Catlin has testified against the findings of other laboratories. And third --

MR. CAMPBELL: And he's received criticism.

MR. YOUNG: Yeah. But he did it. And it's pretty clear that he'd do it again. He would have done it yesterday. He would do it tomorrow. Because these are people that say what they believe, as scientists. And finally --

MR. CAMPBELL: Well, if you had a code of ethics that was a code of ethics, why wouldn't it say, you have an obligation to point out if there's a problem as opposed to say -- say, you have an obligation, really, not to.

MR. YOUNG: It could say that. It certainly could say that.

MR. CAMPBELL: Well, I think it should.

This exchange between Mr. Campbell and Mr. Young was precipitated by the following earlier testimony (reporter page 1204 line 5 through reporter page 1208 line19 / PDF pages 1007-1011)(3):

Q. And what does it mean to become a --to be "a good citizen of the WADA world of accredited labs"?

A. Get the right answers.

Q. And what else?

A. Don't testify against your neighbor.

Q. And testifying against your neighbor would be your other WADA labs?

A. Yes.

Q. So in order to maintain your WADA accreditation, you must make sure that you do not testify against other WADA-accredited labs, correct?

A. Well --

Q. Isn't that what you just said, sir?

A. Well --

MR. YOUNG: May the witness finish his answer? Ruling from the chair, please?

MR. BRUNET: Let the witness answer.

A. Sorry. It -- it is what I said. I would like to clarify that I don't know exactly what words they use, but it's very clear that it's not, you know, permitted to go out and testify against other labs.

Q. Are you familiar with the laboratory code of ethics?

A. Yes. I wrote it.

Q. You wrote it? How opportune.

A. I wrote the first version of it.

Q. Okay. I would like to show you -- you must recognize it -- annex B, the laboratory code of ethics?

A. Yes.

Q. Okay. And I'd like you to turn to section 3.4. Do you see that?

A. Yes. I do.

MR. CAMPBELL: Can I have reference for that in the exhibits, Mr. Suh?

MR. SUH: Mr. Campbell, I'm sorry. Exhibit 8. Okay?

Q. Can you take a moment to read it?

A. Do you want me to read it out loud?

Q. No, just read it to yourself, just to refresh your recollection.

A. (Witness complies.)

Q. Do you see where -- I'm going to highlight sections of it. "The laboratory should not provide testing services in defense of an athlete in a doping control adjudication." Did you write that?

A. No. Actually, this document appears to have changed quite a bit from what I wrote some ten years or so ago.

Q. And then on the next page, the highlighted section: "The laboratory personnel shall not engage in conduct or activities that undermine or are detrimental to the anti-doping program of WADA, an international federation, a national anti-doping organization, a national Olympic Committee, a major event organization committee, or the International Olympic Committee. Such conduct could include, but it is not limited to, conviction for fraud, embezzlement, perjury, et cetera, that would cast doubt on the integrity of the anti-doping program." Do you see that?

A. I do.

Q. Okay. Does this mean -- is this a description of what you'd said earlier about being a good citizen of WADA?

A. Yeah, that means being a good citizen of WADA --

Q. And --

A. -- and not misbehaving.

Q. Have you ever testified -- in all the many times you've testified in an anti-doping trial -- have you ever testified in defense of an athlete?

A. Well, there was one case with Mr. Jacobs that might be classified as that. There was -- I'm not sure, but there was another case a year or two ago having to do with a hair loss product where I testified on behalf of an athlete and got beat up kind of badly.

Q. The case with Mr. Jacobs, was that the Zach Lund case? The Zach Lund case.

A. Actually, I think Mr. Jacobs was involved with the two cases: The Zach Lund case and another one.

Q. The Zach Lund case, though, you were testifying on -- on behalf of USADA; is that correct?

A. That's right.

Q. And in the other case, which is the Kicker Vencill case --

A. Yes.

Q. -- that was a civil trial --

A. Yes.

Q. -- not one of these kinds of the anti-doping cases?

A. No.

Mr. Young's criticism that none of Landis' witnesses is hypocritical because WADA has basically locked up all of the ISO/WADA accredited labs via WADA's code of ethics, which is basically an omerta. Furthermore, this ignores the fact that one of Landis' witnesses had been recently solicited by the WADA accredited UCLA laboratory to apply to be the director of the UCLA lab (reporter page 1096 line 23 / PDF page 910).

Summary

It is apparent that the discrepancies that occurred in the Landis sample testing at LNDD were not simply an isolated case, but rather examples of systemic testing errors related to poor laboratory techniques, insufficient training, and improperly installed instruments. One must question whether ANY drug test samples that have been processed through LNDD should be accepted as accurate. How many people have been falsely accused because poor laboratory practices at LNDD? Poor practices, that have been consistently overlooked, covered up or excused away by a code of silence, and system that places the objective of convicting athletes of doping ahead of due process, sound laboratory practices, and a search for the truth.

Make no mistake about it, drug cheats need to be excluded from athletic competitions; however, this goal can not be achieved if testing labs and WADA are not held to the highest standards themselves. The evidence is overwhelming that the testing done by LNDD was systematically flawed and seriously unreliable. If the goal is to search out the truth, serve justice and further the cause of fair play, then Floyd Landis must be exonerated. LNDD must also be shut down until which time its staff has been properly trained and/or replace, with properly trained individuals. Finally, WADA must be overhauled such that athletes have real due process protections to ensure no innocent athlete ever becomes a victim of the system.

Mr. Suh summed up our feelings in the opening of his closing statement when he said (reporter page 2027 lines 4-13 / PDF pages 1751-1752)(3):

In case there's any question about what we stand for, let us tell you: We believe in clean sport. We believe in clean athletes. We believe in real science. We don't believe in incompetent laboratories, cherry-picked data and unreliable and inaccurate results. It hurts us all, all of us that are part of this system, and it hurts the sport if we were to rely and accept incompetent laboratories, cherry-picked data, and unreliable, inaccurate results.

We would only add that bad laboratories also hurt the cause of science.

Related Articles

Footnotes

  1. Chain of Custody Procedures for samples and Data; US EPA; http://www.epa.gov/apti/coc/; Last accessed 6/23/07
  2. International Standards for Laboratories (5.4.3.2); Last accessed 6/23/07, referenced in: http://www.wada-ama.org
    /rtecontent/document/chain_custody_1_2.pdf
    (PDF); last accessed 6/26/2007
  3. TRANSCRIPT OF PROCEEDINGS, May 14, 2007; UNITED STATES ANTI-DOPING AGENCY, Claimant, vs. FLOYD LANDIS, Respondent. Available online at USOC PressBox, Transcript.pdf (PDF, 2.3mb, 1808 pages); last accessed 6/26/2007
  4. Data processing results for Mix Cal Acetate 001A-2; available on line at USOC PressBox USADA_183.pdf (PDF); Last Accessed 6/23/07.
  5. USADA position on COC issues in regards to the Landis case; available on line at: USOC Pressbox 032A.PDF (PDF); last accesses 6/24/07

Additional reference sources at Trust but Verify

38 comments:

NOTICE: Comments are user generated feedback and do not represent the views and/or opinions of EnvironmentalChemistry.com.

Ken (EnvironmentalChemistry.com) said...

Some may wonder why a website that focuses on environmental and chemistry related issues and has much bigger wind mills to tilt would take such an interest in the Floyd Landis hearings as to research and write four articles on the subject totaling around 40,000 words of text including quoted testimony. The answer is we also care about good science and due process. We started following this story out of personal curiosity. What we saw exposed during the hearings in May troubled us greatly and drove us into action because we felt the mainstream media was not doing as good of a job as they should have covering this story.

I would like to thank David Bower with Trust but Verify for reading a rough draft of this article and providing a very helpful critique. I hope we covered the aspects of this issue Dave felt needed further exploring. I'd also like to thank my mother Roberta for being the lead writer on this article and my wife Julia for once again copy editing our work. Roberta took countless hours out of her very busy schedule this past month to research and write this article. Julia's copy editing skills were absolutely critical for the completion of this article. Without Julia's copy editing skills, I know I would be getting a lot more complaints from the grammar cops out there.

Illinoisfrank said...

Wow! Great article. Well written. Your summary alone should be required reading for anyone with an interest in professional cycling and/or Floyd Landis.

Ken (EnvironmentalChemistry.com) said...

Illinoisfrank, thank you for the kind comment. It was greatly appreciated. :-)

To all readers:
If you found this article particularly good or good reading for those who are sitting on the fence of this issue, I will ask that you spread word of this article far and wide (e.g. email links to friends, link to it, etc). Normally our articles get picked up by Google News, but this time this article did not make it into Google News for an unknown reason. As such those who may be most interested in reading this article might not be seeing it. Any help spreading the word about this article will be most greatly appreciated.

Roberta and myself spent an extreme amount of time researching this article at it is kind of disappointing for it to have been overlooked by Google News when our other articles make it in on a regular basis.

Apex DBS said...

Ken

Awesome, awesome article. It's long, but it's thorough.

Getting much riding in these days?

David

Ken (EnvironmentalChemistry.com) said...

Thanks Apex DBS, yes it is long, but we wanted to be extremely thorough such that we made our case to the best of our abilities.

I'm afraid I don't do much bike riding. :-(

Ken (EnvironmentalChemistry.com) said...

Arnie Baker MD and the Wiki Defense Team have released an ebook, which is the science compliment to Floyd Landis' book "Positively False". The book is over 300 pages long and laid out with a very good table of contents for easy browsing. I received a complementary copy of it last night and have only had time to browse some sections, but what I have looked at are very concise and very easy to understand. For those researching this issue, especially reporters, this a very important reference source. The ebook costs $22.95 and can be purchased and downloaded from Arnie Baker Cycling's Wiki Defense page.

pem said...

Ken, Roberta and Julia:

Excellent article. I only hope the arbitrators read it before they release their decisions.

Peter.

Ken (EnvironmentalChemistry.com) said...

Peter, thank you for the complement. In regards to the arbitrators, I think everyone should agree that the arbiters should base their decisions the evidence, testimony, etc presented as part of the official records. I don't think any of us would ever want to see a judge or jury in any case allow their decision to be tainted by what they saw on CNN, Fox News, etc. The same goes here, I think it might even be an ethical lap on the part of the arbiters if they allowed unofficial commentary, like this, to sway their opinion.

We did, however, intentionally try to stick to official hearing testimony and documents when laying out our case as this is what Landis has to be judged on; so Landis' defense team could if the dreamed appropriate use the research presented here to aid in writing their final written arguments. For instance they could decide to juxtapose Dr. Ayotte's testimony that I quoted against the actual WADA CoC rules as I did to refute her testimony and help argue the CoC aspects of this case.

I will remind folks that Landis' team consists of highly talented professionals and I'm certain they have spent way more time than any of us weighing these issues. The real purpose of this paper was to help argue Floyd's case in the court of public opinion because the public debate has been long on accusations and short on science and procedures. People really must be made aware that CoC and procedural issues are not minor technicalities. These are very fundamental issues and no laboratory's results should be trusted if they can't get these basic fundamentals of science and testing right.

Anonymous said...

I am working my way through this detailed and thoughtful article. I have a number of questions, many of which may be VERY fundamental and basic questions. I won't ask them all at once.

What, exactly, does the question of "chain of custody" have to do with whether Floyd Landis cheated or did not cheat?

Let me try to be a bit more precise here. Let's say that the French lab failed to properly document chain of title. How would this affect the lab results?

Is the concern that without a good chain of custody, someone could have intentionally interfered with Floyd's urine sample? Say, the sample could have been switched with someone else's sample, or spiked with a foreign substance? If that's the concern, then doesn't the same concern exist even if you have a good chain of custody? It's possible to spike a urine sample in a split second, when the lab technician's back is turned. (I don't see how the chain of custody could protect us against the lab technician being the person who spiked the lab sample -- there's no comfort there if we know that the technician was continually in possession of the sample!)

Is the concern that the sample might accidentally and unintentionally become contaminated if not handled correctly? As an example (probably not a real world example), maybe the urine sample needs to be continually refrigerated, and can only survive uncontaminated outside of the refrigerator for up to 15 minutes at a time. If that was the case, you'd certainly want documentation of when the urine sample was removed from and returned to the refrigerator. But I don't understand that there's any concern resembling this one in the Landis case.

Or is this the case that chain of custody problems would probably have no effect on the test results per se, but instead are evidence of sloppy lab practices -- in which case, we're concerned about OTHER lab practices that could have affected the Landis results?

Ken (EnvironmentalChemistry.com) said...

@Anonymous 7/02/2007 05:24:00 PM,

The reason the chain of custody is of a concern in ANY situation is for all three reasons you listed.

A highly detailed chain of custody significantly reduces the risk of the intentional sabotage of a testing sample. A proper CoC also significantly increases the probability that tampering with a sample would be detected. The risk of tampering is significantly reduced with a proper CoC because it significantly reduces the number of people who have the ability to tamper with a sample, there by virtually eliminating any opportunity for tampering by anyone not connected with the actual testing of the sample. It also helps ensure that if someone connected with the sample tampers with it they will be caught.

Even if there are no malicious intents, a poorly maintained chain of custody greatly increases the potential for samples to accidentally get switched and/or contaminated. It also increases the concern of spoilage because of undocumented improper storage. If there is a proper chain of custody there is no question about the condition of the sample when it was tested.

A very badly broken chain of custody as we saw with LNDD's handling of Landis' samples is indicative of very bad lab procedures in general. A proper chain of custody is a very fundamental part of any laboratory testing procedure. If a lab does not maintain a proper chain of custody, it is almost a certainty that their other laboratory procedures are very suspect as well. In this case the testimony of lab personnel under cross examination bared this out and there is plenty of evidence of very bad lab procedures in general.

As Roberta pointed out in our article above, lab personnel made repeated admissions of having forgotten to do critical steps in the testing process; having improperly deleted data; failed to properly document their work; and not having a basic understanding of the machine they were using. For instance, they had a completely wrong understanding what the green LED on the pump indicated. We also saw in the testimony that lab personnel did NOT have a proper users' manual for the mass spectrometer they were using to test Floyd's samples and that the mass spectrometers were improperly set up. In the testimony it was also reveled that the lab personnel had an almost caviler attitude towards manipulating data and there were multiple instances of manually "adjusting" the data, rerunning tests and deleting of initial data if the desired results were not returned. This is not testing, this is fraud.

There are countless instances of CoC and procedural issues as well as violations of WADA's testing rules that independently should be enough to raise enough doubt about the validity of the test results as to completely dismiss the charges against Landis. When combined together, these issues not only completely invalidate the tests but raise to the level of scientific fraud on the part of the laboratory. Quite simply there is absolutely no scientifically valid evidence that Floyd Landis cheated. Not only should Floyd Landis be completely exonerated with a strongly worded 3-0 decision, but criminal investigations should be opened against LNDD by the French authorities.

Anonymous said...

Ken -

Thanks for your detailed and thoughtful reply. I'm going to ask a few follow-up questions that will help clarify things, at least for me.

1. Let me try to summarize the essence of your post on chain of custody: Chain of custody is important because it reduces (but does not elimiate) the risk of sample switching, tampering, contamination and spoilage (whether intentional or unintentional). Also: good labs produce good chain of custody documentation -- if the French lab failed to produce good chain of custody documentation in the Landis case, then on this fact alone, the Landis lab results are suspect. Is this a fair summary?

2. Do you see any evidence in the Landis case that samples were switched, tampered with, contaminated or spoiled, apart from the evidence that the lab failed to produce a good chain of title?

3. Looking solely at the issue of the potential impact of chain of custody on the Landis lab results, is it fair to say that this potential impact is reduced where the lab procedures are witnessed by third parties (for example, members of the Landis legal team)?

I DO want to ask some questions about the requirements for a good chain of custody, but I think it would be helpful to try and nail down the connection between chain of custody and the accuracy of the lab results.

Thanks for your patience.

Larry

Ken (EnvironmentalChemistry.com) said...

Larry,

In response to your latest questions:

1) Your summary is close but understated. A proper CoC doesn't just reduce the chance of tampering or mistakes, but virtually eliminates the potential for these risks. When such events do happen a good CoC will immediately reveal any mistakes to the next individual in the CoC. Should said events not be immediately detected a good CoC will allow a subsequent investigation to pin point where the corruption of the sample took place and who was culpable.

2) There is no way of knowing what happened to Floyd Landis samples during the gaps in the chain of custody. You can't find tampering, mistakes, contamination or spoilage if the CoC is broken as it was in this case because there is no evidence to support or deny the integrity of the samples. As such if the CoC is broken, especially if it is broken as badly as it was in Floyd's case, the sample MUST be assumed to have been tampered with and invalid. The overall problem with your question is that you are looking for proof of corruption of samples by some means. How CoC is supposed to work is to prove that there WAS NOT a corruption of the samples. If it can not be proven that the CoC is continuous and proper then the samples must be considered contaminated.

3) No this is not a fair assumption; the witnesses were observers only and only saw some of the testing. Their being there did not prevent breaks in the chain of custody, nor did it prevent procedural errors, all it did was give us first hand witnesses to those issues. Landis' observers did report and document very significant problems, which included bad laboratory practices, improperly set up equipment, no users' manual and repeated rerunning of samples with original data being deleted and the fudging of numbers. The witnesses even had to show the techs how to use some of the software used during the testing.

The connection between a good CoC and the accuracy of the lab results is that if the CoC is broken then the lab results are invalid because the sample is invalid.

In the Landis case don't become too focused on the CoC issue. This is only one small part of the problems with the testing done by LNDD. There are mountains of evidence showing: improper lab procedures beyond the CoC issues; incorrect analysis of data (which was improperly collected to begin with); incorrectly set up equipment; improperly trained personnel; etc.

There are actually other parts of the case that provide stronger evidence that the lab results were not what LNDD and WADA claimed, however, these get into aspects of the science that is beyond our ability to analyze and discuss in an authoritative manner. We focused on the CoC issues because we felt that the CoC issues were an understated portion of the case and that the issues with the CoC was more than enough to proved that Landis should be exonerated. We also focused on the CoC issues because we felt we could successfully help the average layperson better understand these issues and better appreciate why an improper CoC is a very serious concern.

The point being we don't want people to think that if Floyd Landis is exonerated because of the CoC and procedural issues that he got off on a "technicality". Instead we want people to understand just how serious these issues are.

Anonymous said...

Ken -

You ask me not to become too focused on the chain of custody issue. Fair enough! But you also express concern that, if Landis is found innocent because of chain of custody concerns, people will think that he got off on a technicality. That's a very real concern, in my opinion.

You might hope that, if Landis is found innocent, the arbitrators will do so based on the entirety of the procedures utilized (or mis-utilized) by LNDD. You might hope that the arbitrators would use the occasion to blast the LNDD and the entire system of drug testing. You might hope for this, but it's not a likely scenario. The more likely scenario is, assuming that Landis is found innocent, the arbitrators will search for the simplest and most narrow available rationale -- a "technicality", in your words. Why would they do this?

There are a bunch of reasons why.

1. Judges want their decisions to stand up on appeal. They do not want their decisions to be reversed. Narrow decisions are easier to defend on appeal than broad decisions.

2. In an ideal world, the arbitrators should want to do only what is fair and right in the case before them. But we don't live in an ideal world. It is natural to expect the arbitrators to ask, what effect will our decision have on the international system of drug testing? I think that nearly everyone wants to have such a system in place, and for the system to work effectively and fairly. The arbitrators might hope that their decision would "prod" WADA and LNDD to do a better job, but I don't think they'd want to devastate the existing system, even in the hope that such devestation would result in the design and construction of a better system.

If the arbitrators' decision is a sweeping condemnation of the existing system, the results could be chaotic: it could throw every test conducted by the LNDD (both in the past and in the future, including all of the testing for this year's Tour de France) into question. If such a state of events came to pass, you or I might blame the LNDD, but a lot of people would blame the arbitrators. The arbitrators will face enough heat if they find for Landis; they probably have no appetite for the additional criticism they would face if their decision destroys the LNDD and cripples the drug testing program at this year's Tour.

On the other hand ... if the arbitrators decide to side with Landis, they could avoid a certain amount of criticism if they do so on narrow technical grounds. They can say, for example, that the WADA rules require chain of custody to be documented in a certain way, and that LNDD did not do the required documentation, so Landis cannot be found guilty. WADA will express dismay and outrage, the pundits will roll their eyes, and most people will still consider Landis to be guilty. But he will be the 2006 Tour de France champion, and LNDD will survive to conduct their drug testing.

LNDD can then assure everyone that they'll do the necessary paperwork going forward. No one will doubt that LNDD is capable of cleaning up its paperwork. We might doubt after the Landis case whether the LNDD is capable of doing better lab technical work, but we'd probably be willing to assume that the lab is capable of filling out a new form or two.

You and I might question whether such an outcome represents true justice. But understand, judges and arbitrators have limited powers. They can't act directly to clean up the system. They can only decide a case involving a single athlete.

3. Ken, guys like you may "get" the science, but most of the rest of us never will. The Landis case (when it wasn't distracted by side shows, like the Lemond testimony) was mostly about the science. Landis put up his experts, USADA put up their experts, and the experts disagreed. The battle of the experts happens in nearly every case like this one.

You might hope that the arbitrators would carefully evaluate the science presented by each expert, but that is probably not going to happen. Judges respect the expertise of the experts, and are loathe to question whether Expert A is right and Expert B is wrong. To do so, the judges would have to consider themselves to be smarter than the experts.

(An aside: this is why the Landis team made such a big deal about the presence of the electromagnet on the LNDD testing equipment. You don't have to be an expert to question why there's a magnet on a sensitive piece of equipment!)

So, in most cases like this, the experts on one side neutralize the experts on the other side, and the "battle of the experts" is declared a draw.

There are exceptions to this rule, of course: one side's experts might have credentials that are clearly superior to the other side's experts (Expert A went to MIT, Expert B went to art school). Or one side's experts may present critical evidence that is not contradicted or disputed by the other side's experts. Or one side may have a ton of experts, and the other side only one. Or in some cases, a judge may simply decide that a particular expert is not believable -- not based on a scientific analysis, but on the factors a judge would use to measure the credibility of any witness (demeanor, confidence, lack of bias, lack of internal contradictions, etc.).

This is not a hard and fast rule, I'll admit. But in the Landis case, the arbitrators' decision is probably not going to state that they believed Expert A and did not believe Expert B. It's too easy to shoot down such a decision.

Now ... you've read the case transcripts carefully. I know you see major problems in the procedures utilized by LNDD. However, I think that USADA managed to come up with expert testimony supporting all of these procedures. You may not believe the USADA experts, you may think that the Landis team produced better experts, and I might agree with you. However, so long as the scientific issues are all disputed by the experts on both sides, I think that the arbitrators will struggle to find for Landis based on the science.

But the "technicality" issues are a different matter. When it comes to a question like, did the labs do the paperwork required by the WADA rules, the arbitrators do not have to defer to the experts.

For all of these reasons: if the arbitrators decide for Landis, they'll almost certainly do so based on a "technicality" like chain of custody. For this reason, chain of custody may become the most important issue to understand in the Landis case.

So ... I think it would be valuable for us to continue this conversation, focusing only on chain of custody. I don't know if you have the strength or stomach to do so. ;^) I don't entirely buy everything you've said so far about the importance of chain of custody, but I think we'd be better served if I shift focus, and start asking questions about what is required to produce a good chain of custody. Once I have a clearer picture of what a good chain of custody looks like, we can better examine the importance of having the chain of custody in place.

If you're up for this, let me know. Even if you'd rather not continue this back-and-forth, I'd like to thank you for your patience and for all of the terrific information you've provided here.

Larry

Ken (EnvironmentalChemistry.com) said...

Larry, I'm very happy to focus our discussion on the CoC issues if you would like. I just wanted to make sure that it was understood that there were lots of other issues with LNDD's testing and that the CoC issues are only one aspect of the bigger picture. I can not fully answer your questions this evening due to time constraints, but I have asked others to chime in on your questions to help provide a broader range of prospectives. Hopefully as a collective we will be able to fully explore this issue over the coming days.

Anonymous said...

Ken -

Let’s try to clarify what is required to produce a “good” chain of custody, focusing on the WADA requirements. Rather than asking questions this time, I’m just going to give you my interpretation of the requirements and my reading of the facts of the case as cited in your article. Please understand that I acknowledge your expertise, and that I’m not trying to set myself up as someone with comparable knowledge to yours. I just think that the best way to set up this dialog is to try and interpret the rules and your article as best as I can, and allow you to clarify and provide your own take.

Let’s start with … what events must actually be documented in the chain of custody?

According to the WADA Technical Document, the chain of custody is supposed to document the “movement” of samples. The requirement to document movement appears to be twofold.

(1) You need to document each change in the individual possessing a sample.

(2) You also need to document each change in the procedure being performed on a sample.

Let’s start with requirement (1). It appears to be relatively clear-cut. The WADA rules require that (a) the chain of custody must show “a continuous record” of the individuals in possession of the sample, and (b) when the sample is not in an individual’s immediate possession, records should document that the sample is in a “controlled zone”. So, let’s say that (i) lab technician A picks up a sample from the refrigerator, (ii) lab technician A hands the sample off to lab technician B, and (iii) lab technician B returns the sample to the refrigerator. It appears to me that step (ii) must be documented in the chain of custody, since step (ii) involves a change in the individual in possession of the sample. It also appears that step (iii) must be documented in the chain of custody, since this is the step where the sample moves outside of the personal possession of anyone in the lab and into the controlled zone. It does not appear to me that step (i) must be documented, or at most, the documentation could state simply that lab technician A took possession of the sample at such and such a time. Agreed?

Requirement (2) is more complicated. The WADA document states that chain of custody for a sample “should record all movement from receipt in the Laboratory through storage and sampling to disposal”, and that chain of custody for an aliquot “should record all movement from preparation through analysis.” I say that the second requirement is unclear, because it seems to confuse the concept of “movement” – relocation of a sample from one place to another – with the procedures being performed on a sample, which may or may not require the sample to be moved from one location to the other. However, it’s at least clear that chain of custody should document something with respect to a change in the procedures performed on a sample.

The tough question is, what procedures need to be documented in the chain of custody? There appears to be great latitude given to the labs in terms of defining what constitutes a change in procedure.

Since I don’t understand drug testing all that well, let’s say that I need to document a chain of custody at a car wash. What constitutes a change of procedure in a car wash? You could say that there’s one procedure: wash the car. Or three procedures: vacuum the interior, run the car through the wash, and dry the car. Or many more procedures: take the order from the customer, vacuum the car, take payment from the customer, drive the car to the wash, run water on the car, optional wax, and so forth. How should I define what constitutes a change of procedure at the car wash? It’s a judgment call.

In your article, you suggest that “changes in procedure” must be documented at a great level of detail: not only the procedures performed, but also deviations from standard procedure and so-called “procedural errors.” This might be good lab practice (not the errors of course, but the documentation of the errors), but it’s not at all clear to me that WADA requires such detailed reporting in the chain of custody. Remember, the WADA Technical Document uses relatively broad words to describe the procedures that should be documented: words like “storage”, “sampling”, “preparation”, “analysis” and so forth. There’s nothing in the WADA Technical Document to suggest that labs need to document procedures with a fine level of detail.

Similarly, you suggest that the chain of custody should not contain long time gaps between entries. However, long time gaps do not appear to me to be a violation of the WADA rules, so long as all of the relevant changes are covered by log entries. The article refers to 7 hours during the testing of sample A that are not accounted for. This may be bad practice, but it does not appear to be proof of a violation of the rules governing chain of custody. So long as a single lab technician was in continuous possession of the sample and performing a single procedure during the 7 hours in question, there would seem to be no requirement to make entries in the chain of custody during this 7-hour period.

So … from the above, I only see one potential violation of chain of custody documented in your article, the one involving Claire Frelat’s receipt of the B sample at 11:03. If she received the bottle from another person, the chain of custody should have indicated the identity of the transferor. If, however, Ms. Frelat was the first person to take possession of the bottle that day, then I don’t see how Ms. Frelat violated the WADA Technical Document by merely noting her receipt of the bottle at 11:03.

You point to other potential violations of the rules governing chain of custody – unexplained time gaps, failures to document deviations from standard procedure, failures to document procedural errors – but as I noted above, it’s not at all clear that these time gaps and failures violate the WADA rules.

I look forward to seeing where you agree with what I’ve written, and where you think I’ve got it wrong.

Larry

Anonymous said...

From The Wiki Defense, by Arnie Baker MD. Posted by Arnie Baker.
arniebakercycling.com

***3A. Chain of Custody
ISL Violation

ISL 5.2.2.2:
“The Laboratory shall have Laboratory Internal Chain of Custody procedures to maintain control of and accountability for Samples from receipt through final disposition of the Samples. The procedures must incorporate the concepts presented in the WADA Technical Document for Laboratory Internal Chain of Custody.”

TD2003LCOC:
1. “The entry into the Laboratory Internal Chain of Custody should be completed at the time that any change of possession occurs.”
2. “In the case of Samples, the Laboratory Internal Chain of Custody should record all movement from receipt in that Laboratory through storage and sampling to disposal.”
3. “The Laboratory Internal Chain of Custody shall be a continuous record of individuals in possession of the samples or Sample Aliquots.” [Emphasis added.]
4. “When not in an individual’s possession, it should be documented that the Sample or Aliquot is within a controlled zone.”

As we will see, the LNDD has failed to provide adequate chain of custody documentation.


Chain of Custody Flawed
The chain of custody and work-flow documents are incomplete, contradictory, erroneous, and unreliable.
Egregious and systematic breaks in the chain of custody in the handling of Sample 995474 in both the A and B sample bottles while at the LNDD undercuts the reliability of the LNDD’s findings and are fatal to the reliability of their test results.

Need for Impeccable Chain of Custody
In a 1994 report to the International Amateur Athletic Federation regarding laboratory procedures, Professor Manfred Donike, the father of the anti-doping movement, stated: “The chain of custody… must be impeccable before a positive finding can lead to sanctions.”

WADA Lab Directors Note Requirements
WADA laboratory directors and experts including Don Catlin and Manfred Donike note:
1. An impeccable chain of custody is necessary “To ensure that the urine tested suffered no contamination, tampering, or mislabeling…”
2. “The chain of custody begins at the collection site and ends with the final report.”
3. “Each transfer must be documented, including within-laboratory transfers.”
4. “The laboratory must be able to give exact documentation on such details as where a certain sample was located at a given time and the identity of the person handling the sample at the time in question.”


LNDD’s Documentation
The LNDD documents its “chain of custody” at USADA0253 though USADA0257.
The material on these pages repeats material from the ‘A’ sample found on USADA0010 though USADA0012.
Although not part of this “chain of custody” record per se, we have created a timeline, and noted selected features of workflow.
The timeline is found on page 43.

Not a True Chain of Custody
USADAA0253 to USADA0257. USADA0200.
LNDD’s documentation at USADA0253 through USADA0257 is merely a summary sheet of aliquoting and procedures performed of sample bottles and aliquots. It is inadequate as a chain of custody document. It was constructed after the analyses.
It is not a contemporaneous record.
It does not record movement of the sample.
These pages document custody at a point in time while in each operator’s possession, not continuously during that possession.
Inadequacy is immediately apparent. For this reason, these pages are referred to in quotation marks as a “chain of custody.”
Consider the ‘A’ sample bottle on July 22, 2006 at 11:25 AM.


Figure 8. USADA0253. Where was the ‘A’ sample bottle at 11:25 AM?


The document at USADA0253 shows that operator 49, Cynthia Mongongu, had the sample bottle at 11:20 AM and that she took an aliquot for IRMS testing. It shows that operator 18, Esther Cerpolini, returned the bottle to storage at 12:45 PM.
The question arises: Where exactly, and under whose custody, was the bottle at 11:25 AM? At 11:30 AM? At 11:35 AM?
In testimony, Ms. Mongongu stated that she had a clear recollection, a specific picture in her memory, that Ms. Cerpolini had possession of the bottle at 11:25 AM in order to perform specific gravity and pH testing. (See page 288 for her exact testimony.)
However, USADA0200 documents that Ms. Cerpolini performed specific gravity and pH testing at 10:50 AM.



Figure 9. USADA0200. Operator 18, Esther Cerpolini is documented as having performed the pH test (value = 5.22) and specific gravity test (value = 1.025) at 10:50 on July 22, 2006.

It therefore remains unknown where, and in whose custody, the bottle was at 11:25 AM.
During the May 2006 arbitration, Montreal Laboratory Director Christiane Ayotte said that testimony is acceptable as method of documenting chain of custody.


Arnie’s comment
Dr. Ayotte is correct in quoting the technical document: however, this document should be rewritten. Testimony as a method of documenting custody is absurd. What happens in the event of a witness’s memory failure or death?
Chain of custody documents must be complete, and stand on their own without the need for testimony.
This particular problem also shows the folly in accepting WADA rules and regulations without considering world-wide laboratory practices and common sense.
Moreover, in this case, testimony is documented to be flawed.


Failure to Record Intra-Laboratory Transfers
LNDD systematically failed to record intra-laboratory transfers of the ‘A’ and ‘B’ sample bottles and aliquots.
Operator-to-Operator Transfers
‘A’ Sample
1. On July 21, 2006, LNDD failed to record how the ‘A’ sample bottle was transferred from Martin in Salle [room] 107 to Garcia in Salle 106, when the sample was transferred, and where it was transferred.
2. On July 22, 2006, LNDD failed to record how the ‘A’ sample bottle was transferred from Cerpolini in Salle 103 to Mongongu in Salle 104, which occurred sometime between 10:50 to 11:20, where it was transferred, and when it was transferred.
3. On July 22, 2006, LNDD failed to record how the ‘A’ sample bottle was transferred from Mongongu in Salle 104 to Cerpolini which occurred sometime between 11:20 and 12:45, where the transfer occurred, and when it was transferred.

‘B’ Sample
1. On July 28, 2006, LNDD failed to record who removed the ‘B’ sample bottle from the freezer, and where this transfer occurred.
2. On August 3, 2006, LNDD failed to record how, where, and when the ‘B’ sample was removed from the freezer. And, LNDD failed to record the transfers of how, when, and where the B sample bottle was transferred from Cerpolini in an unknown location to Frelat in Salle 004, which occurred somewhere between 9:12 and 11:03.
3. On August 3, 2006, LNDD failed to record the transfer of the ‘B’ sample bottle from Frelat in Salle 004 to Barlagne in Salle 103.

LNDD’s systematic failure to record intra-laboratory transfers is apparent when compared to the method of documenting intra-laboratory transfers at the UCLA and Montreal laboratories. (See Figure 10.)
Exhibit GDC0030-0031 is a chain of custody document from the Montreal laboratory. This chain of custody document establishes the time, date, and person or place who had the sample bottle; and the person or place to whom the sample bottle was given. This is in direct contrast to LNDD, which simply records information in only one-half of the intra-laboratory transfer, i.e., information about one aspect of the work the person who received the sample bottle performed, and not the person who provided the bottle.
LNDD’s “chain of custody” documents are also in stark contrast to the UCLA laboratory’s chain of custody documents.
Exhibit GDC0032-0033, contains two chain of custody documents from the UCLA laboratory. Similar to the Montreal laboratory, the UCLA laboratory records both parties to the intra-laboratory transfer, which, unlike LNDD, creates a continuous chain of custody.



Figure 10. Both UCLA (left) and Montreal (right) WADA-accredited laboratories document intra-laboratory transfers—including receipt and delivery of samples and aliquots—to machines, to storage, and to individuals.


Chain of Custody/Workflow Mismatch
USADA0057. USADA0058.
Rescreening (second screening of the ‘A’ sample) was performed on July 25, 2006.
USADA0057 reflects an ‘A’ sample screening performed or interpreted by operators (analysts) 45, 35, and 10. Operator 10 clearly appears in the top right-hand corner of this document. Perhaps operator 10 only reviewed the results.
There is no corresponding record of this work in the “chain of custody” documents.
If the person who transferred the aliquot or performed this work was an analyst who would later perform any of the ‘B’ sample analysis, then the whole report is unacceptable and the case should be dismissed—according to CAS Landaluce 2006.

USADA0256.
There is no “chain of custody” record documenting the unhydrolyzed ‘B’ sample GC/MS.
This is different from the “chain of custody” at LNDD for the ‘A’ sample where aliquoting of the unhydrolyzed ‘A’ sample is recorded.

USADA0309.
This and other pages show that work was performed on August 4, 2006.
There is a “chain of custody” record mismatch. This event is recorded as occurring on August 3, 2006 on the chain of custody page.
There is no corresponding record of this work in the “chain of custody” documents.


Dubious Handling
Due to the well-appreciated problem of degradation (spoilage), the sample bottle should not sit needlessly around the laboratory at room temperature. Operators should promptly return sample bottles to refrigeration.
USADA0253.
On July 21, 2006, the ‘A’ sample bottle was removed from the refrigerator at 7:25 AM and was not returned until 9:25 AM, two hours later. During those two hours, the only documented task completed was the creation of aliquots, which takes just a few minutes.

USADA0119, USADA0120, USADA0200.
On July 22, 2006, the ‘A’ sample bottle was removed from storage at 9:05 AM and not returned until 12:45 AM, over three and a half hours later. During these three and a half hours that the ‘A’ sample bottle was removed from storage, the operators who purportedly had possession of the ‘A’ bottle were conducting chemistry for both the T/E and IRMS tests.

USADA0079, USADA0253, USADA0256.
On July 23, 2006, the ‘A’ sample bottle was removed from the refrigerator at 2:20 PM and not returned until 5:00 PM, over two-and-a-half hours later. The aliquoting for the second confirmation T/E test, which was the only reason for removing the bottle from storage, was completed at 3:00 PM; yet, the bottle was not replaced until two hours later.


Sample Number Errors
Sample number errors are present throughout the document package. Of course, if one is examining the wrong sample, the chain of custody is broken.
These are discussed in more detail on page 56. One example:
USADA0024. USADA0229.
There is a question as to whether Floyd’s sample/sample number is properly recorded as having been transported. It is a question of handwriting legibility: a ‘6’ vs. a ‘4.’

Other Chain of Custody Issues
USADA0023.
The chain of custody documentation of the handoff of the samples from the doping control officer to the courier is inadequate.

USADA0022. USADA0023.
The chain of custody documentation of the handoff of the samples from the courier to the LNDD is contradictory or uncertain. It is unclear whether Molina or Rahali received the sample.

Ken (EnvironmentalChemistry.com) said...

For the record, I did confirm via email that the last comment above was posted by Arnie Baker MD, who is the author of the ebook "The Wiki Defense" which can be purchased and downloaded at http://www.arniebakercycling.com/books/wiki.htm for $22.95. This book is intended to be a companion book to Floyd Landis' book "Positively False". I have been reading Arnie Baker's book myself and I'd highly recommend that anyone who is seriously interested in the Floyd Landis drug testing issue also read it.

Ken (EnvironmentalChemistry.com) said...

I do disagree with Dr. Arnie Baker on one point above and that is on his analysis of Dr. Ayotte's testimony and WADA rules on one point. He stated that:

Dr. Ayotte is correct in quoting the technical document: however, this document should be rewritten. Testimony as a method of documenting custody is absurd. What happens in the event of a witness’s memory failure or death?

HOWEVER, as we pointed out in our main article above the rules actually states (see International Standards for Laboratories (5.4.3.2) PDF): The chain of custody, along with relevant testimony from individuals documented on the chain of custody documents, should provide a complete record of the Sample or Aliquote location.

Notice the key statement testimony from individuals DOCUMENTED ON THE CHAIN OF CUSTODY DOCUMENTS. The testimony MUST be documented ON the chain of custody and thus Cynthia Mongongu testimony in the hearings as to the bottle's location is not acceptable for chain of custody requirements by WADA's own rules as it wasn't written down on the chain of custody documents.

Legal eagles normally pounce on the slightest word in a rule or law and argue the meaning of what the meaning of "is" is to the bitter end. I'm very surprised that Floyd's lawyers weren't picking up on the phrase "documented ON the chain of custody" and beating it to death in this instance. It would have gone a long way towards discrediting Dr Ayotte's testimony in regards to her understanding of the CoC rules and would have helped invalidate Ms. Mongongu's CoC testimony in the hearings.

Anonymous said...

Ken –

I plan to review today the material you posted from the Wiki Defense. I want to carefully analyze whether the material you posted changes my summary of the WADA requirements for a good chain of custody. I also want to examine the specific incidents described in the posted materials to see which of these incidents violate the WADA requirements. This will take some time.

But in the meantime … let’s take a look at the role that “testimony” can play in creating a chain of custody. I agree with you, Dr. Baker does not correctly understand the WADA rule regarding “testimony”, but I think that your understanding is also incorrect.

I’ll start with a warning: I’m a lawyer (maybe not a “legal eagle” but I’m some form of legal animal!), so what follows is the kind of close reading that can drive non-lawyers batty. I promise I won’t go off on the meaning of the word “is”, but I AM going to look a the meaning of the words in the WADA rules.

The main document containing the WADA rules on chain of custody is, I think, the WADA Technical Document at http://www.wada-ama.org/rtecontent/document/chain_custody_1_2.pdf. This document contains the general requirement that chain of custody “is documentation (worksheets, logbooks, forms, etc.)”. But it also contains the language about “testimony” referred to by Dr. Baker. This language is as follows:

The chain of custody, along with relevant testimony from individuals documented on the chain of custody documents, should provide a complete record of the Sample or Aliquot location.

Dr. Baker misreads this provision if he thinks WADA permits “testimony” to be included as part of the chain of custody. That’s NOT what the provision states. The provision states that the chain of custody plus “testimony” must be sufficient to determine the LOCATION of a sample or aliquot.

Of course, chain of custody must do much more than merely indicate the location of a sample at a given time. Per our analysis, chain of custody records changes in possession, and changes in procedure. There’s nothing in the WADA document to indicate that “testimony” can be used to provide the required record of changes in possession and procedure. The WADA document simply adds the requirement that the chain of custody should also document the location of a sample, and permits “testimony” to be used in addition to the chain of custody for the purpose of determining location only.

So, to sum up our reading (so far), we could say that the WADA document requires the following:

(1) the written chain of custody (i.e., the “documentation” referred to in the WADA rules) must document changes in possession;

(2) the written chain of custody must document changes in procedures;

(3) the written chain of custody plus “testimony” must document the location of the sample or aliquot.

OK so far? I think at this point you and I are probably in complete agreement. Let’s proceed to where I disagree with your reading of the WADA requirements.

You read the WADA rules to require that “testimony” can be included as part of the chain of custody only if the testimony is documented in the chain of custody documents. Go back and read the rule carefully. There’s an ambiguity in the language of the rule that you’re failing to catch: it might be that (a) the testimony needs to be documented in the records, or (b) the individual giving the testimony needs to be documented in the records. Under reading (b), if the written records document that Mr. X had possession of the sample, then Mr. X might provide oral or written testimony at a later point to indicate where the sample was located when he was in possession of the sample.

You seem to interpret this requirement in accordance with reading (a) above, so let’s examine that interpretation first. You’re saying that the “testimony” must be documented in the chain of custody documents. If so, then why wouldn’t WADA have written the requirement to state simply that “the chain of custody should provide a complete record of the Sample or Aliquote location”? By adding the language about “testimony”, WADA is saying that the chain of custody plus something else must provide the complete record.

Also, consider why WADA included the phrase “from individuals” in this requirement. If WADA intended to require that the testimony be documented, there would be no reason to include the phrase “from individuals” in this requirement. Saying that the testimony need be “from individuals” adds nothing to the meaning of the requirement – of course the testimony is going to be from an individual! But there would be reason to include the phrase “from individuals” in the requirement if WADA intended to limit oral chain of custody testimony to individuals that are identified in the written record.

I understand your reluctance to consider oral testimony given after the fact in a case like the Landis case. I agree, you cannot trust oral testimony made months after the events in question, given by people with a significant vested interest in being proven right. But I can’t base my interpretation of this provision solely on how I think the requirement should work. I have to think first and foremost about what the requirement actually says. Also, the requirement limits the use of “testimony” to identification of the location of the sample. You could not use “testimony” to satisfy any other WADA requirement concerning chain of custody. So this at least limits the problems we both see in the use of oral testimony given after the fact.

So … let’s modify our rule (3) stated above:

(3) the written chain of custody plus “testimony” must document the location of the sample or aliquot. This “testimony” need not be included as part of the written chain of custody, so long as the testimony is given by the person identified in the written chain of custody as being in possession of the sample or aliquot in question at the time relevant to the determination of the location of the sample or aliquot.

Agree? Disagree? Am I missing something relevant?

Larry

Ken (EnvironmentalChemistry.com) said...

Larry, to give you a heads up, we are trying to make contact with individuals who are involved with similar lab testing procedures for their take you your questions. Given that this is a holiday it might take some time to make these contacts.

Following your suggestion, I reread the last paragraph with your alternative interpretation of the meaning in mind. I will say I could see the alternative argument of the intention of the wording. I will also say that this ambiguity makes for a very poorly worded document. I would argue that since WADA writes the rules, prosecutes the cases and decides who can judge the cases, that any ambiguity should be interpreted in favor of the "defendant". After all, WADA has an obligation to provide athletes with clearly written rules.

As you say you are a lawyer, would you not agree that WADA's rules should be written in as unambiguous of a manner as is humanly possible? In a way, one could argue that the cited rule is just another example of where the rules have been written ambiguously to allow WADA (who acts as prosecutor, judge and jury) to reinterpret rules as they need to suit their needs.

If we are going to consider the more lax interpretation of these rules then we must look at the reliability of the witness who frequently used phrases like "I forgot" and "I don't remember". Even if her oral testimony is accepted, there are still many hours unaccounted for which samples are out of the refrigerator with the seals having been broken.

You asked earlier how does these breaks in CoC affect the accuracy of the tests and I will ask you this question. If you were being tested for say malignant testicular cancer or your loved one was having a biopsy being tested for breast cancer, would you trust the test results from a lab that had similar CoC and/or procedural issues that we saw with LNDD?

Throwing a case out on the grounds of a broken CoC is not a dismissal on a "technicality". It is about due process and the "prosecution" being required to prove their case based irrefutable test results generated by using proper lab procedures and maintaining a proper CoC.

Anonymous said...

Ken -

Writing this from my perspective as a lawyer ...

At some level, all law is ambiguous and must be interpreted in light of the surrounding language, the evident purpose of the law, precedent and the like.

Yes, lawyers are trained to write rules in the clearest possible language, but often other considerations get in the way: the need to reach compromises, to get agreement from all relevant parties, and so forth. So as a lawyer, I am often called upon to interpret rules and laws that are ambiguous on their face, or ambiguous as applied to a given set of facts. It's simply not an unusual occurrence.

As to whether the WADA rules are well written or badly written as compared to other similar sets of rules ... that's a judgment call. My own opinion is that as a general matter, the WADA rules are poorly drafted. Look at how much work you and I are putting in just to determine what's required for a "good" chain of custody under the WADA rules! And we haven't even reached some of the more difficult questions yet. However, there are many badly drafted contracts and sets of laws in the world, and we have to do our best to work with the rules and laws we've been given.

As to whether WADA intentionally drafted an ambiguous set of rules to serve their own purposes? I doubt that was their intent. My experience is, when a party to a contract has the power to control the language of the contract, that party tries its hardest to craft contract language that unambiguously serves the party's interests.

You are quite correct, there is a doctrine to the effect that an ambiguity in the language of a contract should be interpreted against the draftor of the contract. However, you generally do not reach this doctrine unless you've exhausted other possible ways to resolve the ambiguity. To be sure, it's not as simple as saying, "I found an ambiguity, so WADA loses"!

I don't think my interpretation of the WADA rules is "lax". It limits the use of testimony to determining the location of a sample, while requiring the written record to stand alone as documentation of the movement of the sample through the lab. And you're quite correct, there's nothing in the rule requiring us to accept unreliable testimony.

As for your question about whether *I* would trust LNDD in a personal matter? That question takes me WELL outside any qualifications I might possess. But you asked. So I'll answer: no, I would not trust LNDD to evaluate a critical test result for a family member, or even a routine test result for a family pet.

In any event ... I'd prefer to focus on nailing down exactly what the WADA rules require on chain of custody. I think it's important to be as clear as we can on this ... especially if you'd like the rest of us to see chain of custody as something other than a "technicality".

By the way ... someone should give Dr. Baker a "heads up" that he's reading the WADA rule regarding "testimony" in a way that's unfavorable to Mr. Landis. I hope that the Landis legal team is interpreting this rule in a manner closer to your interpretation, or to mine.

Larry

Anonymous said...

Ken -

I've looked through the Wiki Defense material that you've posted here. I wanted to see, first, whether this material contains any WADA requirements for a "good" chain of custody that differ from or add to the three requirements we've noted above. So far, I think that our three requirements do a pretty good job of summarizing the WADA rules as Dr. Baker understands them.

The Wiki Defense materials DO point out that LNDD is required to have Internal Chain of Custody Procedures that incorporate concepts from the WADA Technical Document. I don't remember seeing any discussion of these LNDD Procedures in the arbitration, and I wonder why not. I won't question the strategy of the Landis legal team -- that's one of the best team of lawyers I've ever seen assembled. But I would have thought that all questioning on chain of custody would begin with the LNDD's own chain of custody procedures: what ARE these procedures, do they incorporate concepts from the WADA technical document, were the lab technicians aware of these procedures, and were they followed in the Landis case?

Oh well. Maybe these procedures WERE examined as part of the arbitration process at some point, or maybe they're not really as important as they seem to me.

I've also taken a look at the facts you've posted from the Wiki Defense showing possible breaks in chain of custody. It's a little bit difficult following this description ... but if Dr. Baker has accurately summarized LNDD's chain of custody in this case, then yes, there appear to be significant gaps in the reported chain of custody.

I've also tried to examine some of the underlying documents presented by USADA to prove chain of custody. I can read a little bit of French, so the language is not a huge barrier ... but these documents are NOT set up the way I'd expect! They are very hard to follow. So far, I can't verify Dr. Baker's analysis, because I can't derive anything like a chain of custody from a quick review of the documents.

Sigh. Guess I'll have to shell out the $25 and read the Wiki Defense.

In the meantime, Ken ... have you examined any of the documents presented by USADA to demonstrate chain of custody? If so ... putting aside the substantive issue of whether LNDD can demonstrate chain of custody in this case ... are these documents set up, filled out and organized in a way you'd expect as an expert in lab procedures?

Larry

Ken (EnvironmentalChemistry.com) said...

Larry,

First a point of clarification. Dr. Baker actually posted the CoC excerpts from his ebook himself. I did not make that post. He had contacted me previously when he first released his book to let me know about it (we are cited in the the section titled "Book 3: Selected Press Coverage"). When you started asking your questions I sent him an email asking him if he would be willing to comment on your questions. That is why he posted the excerpts from his book here.

The ebook has a very detailed section on CoC including a carefully documented timeline. I think you will find Dr. Baker's book to be exceedingly well laid out and documented. It also has a very well structured set of bookmarks/table of contents that allows you to quickly get to just that part of the book you are interested in.

In regards to your questions about our review of the documents, none of us can read French, so when we were writing the article above we relied on transcripts of oral testimony and those written documents that had been admitted as evidence for the hearings that were in English. The an important thing about the testimony is that the key LNDD witnesses did not deny that there were gaps in the written CoC and logs, they simply felt such documentation was unimportant because THEY knew what was where. It was a caviler "we are professionals so we know what we are doing and besides who's going to question us" attitude. Remember the Landis hearings were the first time that such a case was ever made public and lab practices were opened up to public scrutiny. If you read the complete cross examination of Ms. Mongongu and Ms. Frelat you will see what I mean. Their testimony under cross examination was quite stunning. Ms. Frelat's testimony was actually pretty frank and almost had a "they can't fire me so what do I care" quality to it in my opinion.

In regards to the legal teams, I think anyone who followed the hearings via the commentary of Trust but Verify would agree that the lawyers on both sides were very good. The hearings were absolutely fascinating to follow. I do think, however, that WADA foist a stinker of a case onto USADA and their lawyers basically had to dress their case the best they could.

There is no doubt in my mind that if left to their own devices, USADA would have never let such a bad case get past the testing phase before being quietly dumped. Actually I don't think we would ever see such a bad set of testing come out of U.S. or Canadian WADA accredited labs. I can not help but wonder if the other WADA labs are really embarrassed by LNDD and none to happy to have their reputations soiled by the lab practices exposed at LNDD. I also can not help but wonder that if it were not for the written down code of silence in the WADA "code of ethics" that some of the other testing labs would have publicly turned against LNDD in an effort to distance themselves from such bad lab practices.

Larry, just so you know, Roberta, who actually wrote the article above is working on reading through these comments and will hopefully be posting a reply shortly. It is just that she is very busy and can not drop things the way I can to reply in a timely fashion. Her researching and writing this article in the first place took an incredible amount of her already limited time.

Anonymous said...

Ken -

I appreciate the time you all have put into this discussion. Many of my posts (and the analysis behind them) also take a good deal of time to prepare, but hey! I'm the one asking the questions! (for the most part)

You raised the issue of the tone of some of the testimony by the French lab technicians. I blame some of that on interpretation. It's difficult enough to get your tone right in your own language.

But to some extent, I think the stance taken by the USADA witnesses regarding chain of custody reflects a problem in WADA's procedural rules. Per these rules (at least by my reading):

1. LNDD is presumed to have followed the International Standard for lab analysis (including, I would guess, standards governing chain of custody). It's up to the Landis team to prove a violation of the standard by LNDD.

2. If the Landis team is able to prove a violation of the lab standard, then it falls to USADA to prove that the violation did not cause the adverse finding against Landis.

Now, you might hope that the arbitration hearing would consider each of these questions separately -- you'd have a hearing on whether there was a violation of the International Standard, then the arbitrators would rule on whether a violation occurred, then (if the violation was proven), the parties would argue about whether the violation caused the adverse finding. But obviously, that's not the way it worked here! We had only one arbitration hearing and no rulings so far by the arbitrators.

So, USADA is actually in a difficult position: it has to argue that there were no violations of the international standard, AND it has to argue that any violations had no effect on the adverse finding. That's a tricky stance to take (and maintain) during a two-week arbitration. How do you argue that the violations did not affect the finding, without effectively admitting that there was a violation? But if you fail to address the effect of a violation, and the arbitrators FIND a violation, THEN where are you?

It's sort of a "when did you stop beating your spouse" kind of a problem -- you can't say when you stopped, and you can't say you never did stop. You can argue that you always stopped, but it sounds strange.

The awkwardness of this stance might push USADA into maintaining a "who cares" kind of tone when it comes to chain of custody. You say something like, "the facts alleged by the Landis team don't amount to anything, we were careful, we knew whose urine we were analyzing, and our care and attention is shown in the documentation." Then the arbitrators can interpret the USADA argument to mean either that there was no violation or that the violation did not affect the results.

Of course, USADA ran the risk of coming across like the French lab technicians: arrogant and snarky.

One other thing: USADA did not act during the hearing like they'd been pushed into prosecuting a case that they would prefer to have dropped. USADA ran a nasty prosecution, with a large measure of personal attack. They went after Landis' credibility and his character. Not very nice.

As for the other WADA labs represented at the hearing, particularly UCLA ... these labs DID testify in favor of USADA and against Landis. Agreed, they were not exactly praising LNDD to the skies! But they supported the LNDD finding. I think that under the code of honor, they could have refused to testify, or testified only as to specific practices and areas of the science. I think they could have said, we did not perform the tests and cannot comment on the result. Ken, you're a lab expert -- couldn't you have found words of art that would have justfied your keeping silent?

Larry

Ken (EnvironmentalChemistry.com) said...

Larry,

In regards to the interpretation,of the French witnesses, I should note that my wife is an interpreter (English/Russian) and the original interpreter was incompetent. For starters they were speaking in third person when an interpreter is supposed to speak in first person. They then seemed to have a poor grasp of basic French. I'm not sure where that first interpreter came from, but it was USADA's responsibility to provide interpreters as needed for the hearings. Not having a competent interpreter from the beginning was really sloppy on USADA's part. The second interpreter was much better. In regards to the tone of the testimony, I wasn't referring to how it was said as much as what was said as I was going on Written transcripts.

When I referred to USADA being dragged into this case, I wasn't referring to how they prosecuted it, rather that it would not have been a case we would have seen initiated by USADA on their own. Of course the other labs probably do a much better job and have much more rigorous lab procedures so it is highly unlikely that the other labs would cause such a bad case to be initiated in the first place. Always keep in mind that LNDD has an adverse analytical finding rate that is 300% greater than other labs and they train their techs in only a fraction of the time of other labs.

Overall I think the USADA lawyers fought this case as hard as they could as was their obligation to do, but I am not convinced that the USADA lawyers (who were outside "hired guns") where really convinced of the science of the case. This is why I think we saw them going after character and credibility and avoided the science aspects. If the science was good enough to convict Floyd there would have been no need to attack his character, they could have stuck to the science and came out of the hearings looking like the good guys.

While yes people from other labs did testify for USADA, as you say they weren't exactly overwhelming in their support of LNDD findings and they were never asked tough science questions by USADA. To me their testimony seemed more like them accepting LNDDs findings at face value. Under cross examination these witnesses seemed to really hedge their statements. Politically, I'm not so sure that the other labs could have really refused to testify on USADA's behalf or they may have agreed to testify based on what they saw in LNDD's final findings without knowing the extent of the procedural issues at LNDD. I mean who in their right mind would have expected a lab to have such sloppy work?

Larry, I really wouldn't call myself a lab expert. In fact this is why I had someone else write the article above in the first place. I am primarily a web publisher who through a really weird twist of fate runs a science site. Most hard science articles on this site are written by scientists I recruited to write articles for me.

I come from a family of scientists and I have been subjected to random drug testing protocols in the past due to employment at various times in my life. My lab experience, however, is limited to my university studies. This is why I'm trying to find an actual lab tech who can answer some of your questions rather than answering them myself. I'm also hoping that Roberta will be able to answer your questions but she is really busy so I don't know how long it will be before she can respond.

My primary background with this case is that I have read the vast majority of the oral testimony and have sifted through as much of the surrounding documents and analysis of the case as I could. Like you I wanted to have as full of an understanding of the issues as possible. We started writing our series of blog articles on the Landis case because we wanted to share with others what we saw to the best of our abilities.

Roberta, who wrote the article above and is my mother, was particularly appalled by what she saw with the CoC at LNDD and their general disregard for sound lab procedures. At one time in her life she was a fleet manager for a hazardous waste company that held DEA contracts and as such her and her drivers were subjected to random drug testing. When she started reading the testimony in regards to CoC issues, she was horrified to think that there was even a remote possibility she had subjected her drivers to the mercy of sloppy testing procedures. She had always assumed (like many of us) that testing labs could be just trusted on blind faith. After what she has seen with LNDD she isn't so sure she could ever trust testing labs the same way again.

If you haven't done so already, I'd recommend reading Roberta's first blog on LNDD's CoC issues, which was written while the hearings were taking place.

Anonymous said...

Ken -

Wanted to let you know that yes, I've read Roberta's posts. They're very good.

Based on my review of the WADA rules, if Landis is acquitted on the basis of chain of custody, you'd say: the lab violated international rules in how it conducted its tests, and WADA presumes that this violation affected the lab results.

You could also say that the lab was unable to prove that its violation did not affect the lab results ... but this is at least a "double negative" (maybe a triple negative, if you count the word "violation" as a separate negative). I try to avoid multiple negatives when I discuss a rule of law -- they tend to confuse people.

In any event ... I think such a description would make it clear that a chain of custody violation is not a "technicality". Agreed?

Larry

Ken (EnvironmentalChemistry.com) said...

Larry,

You are essentially correct from a CoC perspective, although I would have preferred if you had not used the word "you" as this could refer to me specifically or it could be a generalization.

The arbiters could say that based on WADA's rules LNDD violated international rules in regards lab procedures and CoC and that this violation affected the lab results.

One could also say that there is no way to prove that the lab results were unaffected by these violations and that in all probability the poor lab procedures did adversely affect the integrity of the reported findings.

While I would agree that these descriptions would help make it clear that a CoC violation is not a technicality, I would hope rulings on this case would go further than just being based on CoC violations. Such a ruling would satisfy no one and would not settle anything in the court of public opinion.

The arbiters' ruling really needs to address the broken CoC, bad lab procedures, incompetent testing, and the deletion of data in violation of WADA's own rules. Said ruling needs to show that there are multiple reasons why said testing was invalid and does not constitute any evidence that Landis cheated. The best thing the arbiters could do is use the CoC and procedural errors as additional reasons why they found in Landis' favor. Their primary reasons for exonerating Landis should be that LNDD used bad peaks and incorrectly interpreted the results, which resulted in an incorrect analysis of the results and thus the lab did not actually find what they think they found. In this way there would be several layers of reasons why Landis was found to be innocent thus making it harder for WADA to justify appealing this case on.

Earlier you mentioned that in a normal case judges like to draft narrow rulings such that their ruling is less likely to be overturned upon appeal. In this case, however, the rules are completely different. If this case is appealed the new hearing will start all over from the beginning and the case would have to be argued all over again. Thus the new hearing would not be focused on the findings of the initial hearings. Remember we are dealing with some really goofy WADA rules in regards to how these cases are "prosecuted" and appealed. We had be really happy that our normal legal system does not function the way WADA does.

The ruling needs to be so well written that it shows that there is absolutely no doubt that any one of the individual reasons given for exonerating Landis is enough to invalidate LNDD's claims on their own. It must be absolutely clear that LNDD is a rogue lab

In fact, taking LNDD down as a rogue lab may be the best way for the powers to be at USADA, WADA and the Tour de France to "save face". LNDD could be forced to take the fall with WADA stripping them of their accreditation. Christian Prudhomme, the head of the TDF, could claim that the system worked, in the end an innocent athlete was exonerated and that the whole misunderstanding was the result of a rogue lab that was beyond the control of the TDF. This would allow the TDF to put the past year behind them, remove a serious cloud from their records and restore some credibility to the TDF.

Of course I suspect this is all wishful thinking and I seriously doubt that Dick Pound would stand for WADA cutting its losses and abandoning LNDD to the wolves. After all, he is convinced that all cyclists dope and he is very pleased with the fact that LNDD has 300% more adverse analytical findings than any other lab.

Anonymous said...

Ken -

Sorry about use of the word "you". Earlier you'd written that "we don't want people to think that if Floyd Landis is exonerated because of the CoC and procedural issues that he got off on a 'technicality'". In the context, your "we" did not include me, so I thought it was OK for me to respond to your "we" with my "you". I did not mean to get too personal.

Regarding possible grounds for acquittal, the odds of acquittal on ANY grounds are small. USADA has never lost a case.

Regarding a possible finding on misidentification of peaks in the analysis, the material I've read about the peak analysis is inconclusive. There's a long back and forth on this topic in The Daily Peleton between people more knowledgeable than I'm ever going to be, and they could not agree. http://www.dailypelotonforums.com/main/index.php?s=cc06eccbf1f8e9f1fd8a82a7283ad135&showtopic=4861 I drew from this discussion that it's at least possible for knowledgeable people (like OMJ in the cited discussion) to conclude that the evidence supports the LNDD finding.

Finally, regarding the 300% statistic, I think it's a meaningless statistic without more information about the population being tested. I participated in a discussion in Trust But Verify on this ... as you may remember, since you participated in this discussion also. http://trustbut.blogspot.com/2007/05/look-at-lab-stats.html

Finally, as to the appeal. Yes, the appeal is technically a new trial, and not a review of the facts found in the existing trial. However, it's hard for me to believe that the two sides would start from square one in any such appeal. Both sides spent a lot of money in the arbitration, and I doubt that either side wants to go through that process a second time. I'm not an expert on sports arbitration, but my guess is that the USADA findings will be given considerable weight if the case is appealed.

Larry

Anonymous said...

Dear Ken:

Your interpretation of the WADA chain of custody rules concerning testimony from individuals seems to have been made with a bias to what you think it should be, rather than what it actually states.

The statement, as I would interpret it, implies that additional testimony “ from individuals documented on the chain of custody documents” should provide a complete record of the Sample or Aliquote location. The verb documented refers to individuals NOT to testimony.

The statement clearly is meant to identify those who may offer additional testimony that might be deemed relevant. By definition, a completed chain of custody document is the testimony (firsthand authentication of a fact) of those individuals identified by their signature and date on that document. Your interpretation therefore would represent an unnecessary redundancy.

I believe such a statement suggests that additional oral or written testimony could be offered by those identified on the chain of custody as having possession of samples. I also have no problem with such a statement; however one must be careful of the term “relevant”. After a significant passage of time, testimony to minute details of fact, without the aid of contemporaneously written notes or documents should and was effectively challenged by Landis’ lawyers as not reliable and therefore not relevant.

- Dave H.

Ken (EnvironmentalChemistry.com) said...

Dave H., as you'll note above, we have been discussing the issue of how to interpret this WADA rule. Quite extensively. If, however, your interpretation is correct, then it is one more example of how WADA deviates from "industry standards" for such issues for their own convenience and sacrifice due process to ensure convictions regardless of how poor the case. Under no other chain of custody regime, whether it be medical testing, drug testing or hazardous waste disposal would oral testimony be allowed to fill in the blanks of a written CoC. To even suggest that such testimony should be considered to reinforce a CoC would get ridiculed and totally dismissed under any other setting. A CoC is the contemporaneous documentation of the what, where, when and why at the time the event happened. Anything else is suspect. A lab tech could have (and in this case did) totally screw up and then try to cover up their failures after the fact during a hearing if oral testimony was allowed to support a CoC. This is the way any CoC must be handled for the CoC to be trustworthy.

If it is not written down and documented when it happened, it can not be validated. I learned this long ago whether it was dealing with accounting issues, maintaining my logs as a commercial driver, inspecting my vehicles before trips, or documenting events as a volunteer EMT/Firefighter/HazMat Tech. If as a commercial driver I had been pulled over and my log book didn't have the proper documentation that I had done what I was supposed to have done to my vehicle prior to driving out of they yard a police officer could have cited me and put me out of service. To accept anything less from WADA is ludicrous.

Our opinion about CoC rules are not biased because I am a fan of Floyd Landis. Prior to the 2006 TDF I had never really heard of Floyd Landis. I was, however, a fan of Jan Ullrich, Ivan Basso, Tyler Hamilton and others over time and have not rushed to defend them because I was a fan of theirs. Our bias if there is any on this issue is based on the idea of fair play and due process, which requires that testing labs and WADA be held to the highest of standards. Our bias also comes from the fact that both Roberta (who wrote the article above) and myself were subjected to random drug testing protocols as commercial drivers and as such our reputations and livelihoods absolutely depended upon the drug testing labs following proper protocols and procedures as well as maintaining a proper CoC.

Allowing oral testimony at a hearing fill in the gaps in CoC documentation makes a mockery of justice. There is no other way to put it.

As I have asked others, would you want to subject the fate of your life or the life of those you love to the sloppy testing we saw with LNDD?

Anonymous said...

Dave, I agree that "documented" should be interpreted to refer to "individuals" and not to "testimony".

But I disagree that the rule permits testimony to be used to supplement the CofC. Look carefully at the entire rule (http://www.wada-ama.org/rtecontent/document/chain_custody_1_2.pdf). The rule states that chain of custody “is documentation (worksheets, logbooks, forms, etc.)”. It also states that "[t]he chain of custody, along with relevant testimony from individuals documented on the chain of custody documents, should provide a complete record of the Sample or Aliquot location."

Tell me if you think I'm wrong ... but the rule does NOT state that testimony can be a component of the CofC. It says that you can use testimony together with the CofC to determine the location of a sample. (In fact, it seems to require that the CofC along with testimony be sufficient to determine sample location.)

Ken, I agree with you: if the WADA rules allowed testimony to be used to fill gaps in the CofC, that would be truly unfortunate. I just don't read the WADA rules to allow testimony to be used in such a way.

Larry

Ken (EnvironmentalChemistry.com) said...

Thank you Larry for keeping up with the comments in this post. Your thoughts are greatly appreciated.

Here is a link to the WADA CoC rule that Larry provided an address to above.

By the way, I'm afraid I didn't have much luck with making contact with someone who works in a testing lab. We gave it a good try but my contacts in that direction are limited.

Anonymous said...

Ken -

Thanks for making the forum available for this discussion, as well as for the terrific work you and your Mom have done here.

Larry

Anonymous said...

Larry:

I believe the reference "along with testimony from individuals documented on the chain of custody" is simply meant to suggest that the individuals listed as having custody of samples are the ones who are responsible for answering any special questions, or requests for further details and discussion regarding issues which might later be deemed relevant to the custody, condition, or integrity of the samples or the testing protocols applied during the time that the samples were in their possession.

To clarify the original intent of my comments; I was attempting to point out what I considered to be an incorrect reading of the text presented in this blog as the WADA rule on chain of custody, right or wrong, (italicized on Ken's blog from 07/04/2007 11:40 AM). It was not my intention to suggest that the written documentation should not be thorough and complete with regards to who had custody of a sample, the location of the sample, and the purpose for taking custody of any sample(s).

I've worked in the field of analytical chemistry services for well over 20 years and tend to be a stickler when it comes to wording in SOPs, contract protocols, and business contracts, however sometimes it is necessary include the use of one's professional judgment recognizing the context and original intent of the document.


- Dave H.

Ken (EnvironmentalChemistry.com) said...

Dave H., I could concur with your interpretation with your reading of CoC rules in regards to oral testimony. Unfortunately, this was not the argument put forth by USADA via their witnesses. They claimed that oral testimony could be used in the absence of written documentation. In other words, the lab techs weren't explaining documented notes in the CoC, they were using oral testimony to fill in major time gaps in the written documentation. At the same time the lab techs in question, used phrases like "I forgot" or "I don't remember" frequently in other aspects of their testimony.

We could probably all agree that the WADA CoC rules need to be rewritten to more forcefully require thorough and complete written documentation for the CoC. I'd even suggest striking the oral testimony comment all together to eliminate the ability to use this clause as a fall back for sloppy documentation.

Anonymous said...

Dave -

I appreciate the fact that you are a professional in the field of chemistry. I am not. I'm just using my lawyer skills to give you a close reading of the WADA rules.

You and I both agree that an individual must be named in the CofC in order for that individual to give "testimony" under the WADA rule. The remaining question is, what information can be provided by means of this testimony? I'm suggesting that testimony can only be used where necessary to determine the location of a sample or aliquot.

You seem to be suggesting that testimony might be used for a broader purpose. You said that you're a "stickler" when it comes to legal language, and so am I. However, rules governing the practice of professionals should be interpreted in light of prevailing professional standards (at least in the absence of an intent in the rules to deviate from that practice).

I would think that the prevailing industry standard here would be to document CofC with contemporaneous written records. But you (and Ken) would know better. Your opinion here as to prevailing professioal standards would be valuable in helping me understand this rule.

Larry

Carolyn said...

Does anyone know if this article has been translated into French? Or if there exists any other article in French that provides a solid scientific critique of the Floyd Landis case?

Anonymous said...

Some of you may remember reports of the French antidoping lab, the LNDD, being hacked. This happened in November 2006, not long after Flandis began his public relations campaign. Someone took info discovered in the lab hacking, inserted it messages with mangled French and badly forged e-mail headers to make it look like official lab correspondence. Then these fake e-mails were sent to various WADA labs and press members to make it look like the LNDD was up to no good.

It turns out that the source of the fake e-mails was none other than Arnie Baker, Floyd's long time mentor and coach. Baker paid a French hacker 2,000 euros for the information. This same hacker was also found to have hacked into Greenpeace computers, supposedly for a French energy company. The exact relationship between the hacker and Baker is unclear but it just adds another layer to the bumbling, low level criminality of the Landis defense.

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