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CLIA Labs and Credentials

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Re: CLIA Labs and Credentials

Postby LMN » Fri Jun 23, 2017 9:37 pm

Theranos does not make your point. Theranos makes my point. They did not have a board certified lab director instead they had an engineer (with credentials such as you mention) masquerading as CLIA lab director. Board certified medtechs don't make policy; they perform protocols to the T. CLIA lab director sets the policies. You are demonstrating the quintessential fishbowl model; looking at a different world from your view. Inspite of the doc and myself clearly explaining the difference between a biotech scientist and medtech you are not finding the missing link. MedTechs have a different skill set than a scientist. knowledge of technology and assay invention is not the requisite experience for a medtech. I will not hire a scientist for a medtechs job and vice versa and it is not because I have monetary incentive.
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Re: CLIA Labs and Credentials

Postby Nate W. » Sat Jun 24, 2017 1:08 pm

Go back and read the CMS report. The CMS cited Theranos mainly for not having with the right expertise and technical ability as well as issues of poor quality control. Most of the employees performing (and troubleshooting) these assays for Theranos were MedTechs. As you said and I agree with you, MedTechs are trained as technicians, merely to carry out a protocol; perform a test exactly as written and in a automated format.

When you are trained in a good basic research environment, you are taught the theory of the technique or assays, the importance of controls, how to troubleshoot an assay, why certain reagents are used in the assay, alternative approaches to yield the same answer, and how to interpret the data collected. This training provides one with a far more in-depth understanding of the science than merely being able to perform the assays according to a script. Thus, these individuals who receive this training can perform assays in clinical labs at a greater (or equal) level of proficiency and skill than a MedTech, especially when dealing with high complexity assays and lab developed tests.

It is my contention that if the MedTechs at Theranos had this level of skill and training, Theranos would have avoided much of their problems. MedTechs do not receive this level of training at most MT programs found at community colleges. However, this type of training is found in the research ranks. Many high complexity assays now used in clinical labs require a sophisticated level of understanding in order to just perform the assay; let alone be able to troubleshoot the assays if something goes wrong. Examples of such high complexity assays include Mass Spec, Real Time PCR, and NGS sequencing. You are not going to get exposure to these assays in a MT program but they are commonly found in the basic research environment and routinely performed by non-MT scientists.

Why make the requirements more demanding for well trained scientists when there is a demand for scientists in the clinical labs? It is my contention that this is done for entirely selfish reasons. Suppose the ASCP made an exemption for basic scientists to get their license; you would probably be opposed to this exemption. Why? Because you had to jump through this hoop and they didn't. I promise you wouldn't say: I am happy for them and we can use all the help in the clinical labs.

We differ in our position that basic scientists can easily learn these skills you alluded to w/o much additional training. Yes, they can overcome this easily due to their level of training and in-depth understanding of the science. Plus, they can help avoid the issues raised by Theranos scandal due to their level of skill. Of note, many PhD and MS level scientists are the ones who develop these assays run in a clinical lab. Yet, you don't believe they can perform the same assays when it involves a patient sample.

I have done it for a physician and know many other scientists in academia who have also; their data influence physician diagnosis and decisions.

I also agree with you that Theranos never should have appointed an engineer as a lab director. The lab director should had been a board certified pathologist.

CMS Report:

https://techcrunch.com/2016/04/25/thera ... ents-show/
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Re: CLIA Labs and Credentials

Postby LMN » Mon Jun 26, 2017 10:32 am

I have read the CMS report. Medtechs are not to be blamed for Theranos issues; the problem is much bigger than a few medtechs not performing experiments correctly. It is like blaming bank cashiers for wall street problems.
The missing link here is that you content that because a person has the expertise to develop assays, the person can with minimal training perform routine production to CLIA specifications. No. CLIA specifications need to be learnt through dedicated training. Running clinical trial samples is not the same as running routine patient samples - from the point of view of quality assurance. A person who develops assays could find routine running of samples mundane and boring and may not naturally tend to pay attention to all the pieces of information that a Med Tech is taught during the dedicated training. I have developed many clinical assays personally but I would need a lot more training and focus to step into a clinical lab and start running patient samples. As a lab director I will not let an untrained hot shot scientist touch my patient samples. If the person has been trained in handling patient samples form the point of view of safety, traceability, SOP training, documentation etc then I would be fine. You are not considering safety, traceability, continuous training etc as necessity for clinical lab because you are not exposed to it. No, running a set of clinical trial samples that are well characterized and planned before it ever reaches the lab, is not sufficient for you to enter a clinical lab and start running patient samples. All Medtech need to do is to merely perform the tests but with the well defined and complex set of regulations. What you consider proficiency needs in clinical lab is wrong assumption and unnecessary (although beneficial): "When you are trained in a good basic research environment, you are taught the theory of the technique or assays, the importance of controls, how to troubleshoot an assay, why certain reagents are used in the assay, alternative approaches to yield the same answer, and how to interpret the data collected. This training provides one with a far more in-depth understanding of the science than merely being able to perform the assays according to a script."
Last edited by LMN on Mon Jun 26, 2017 4:04 pm, edited 1 time in total.
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Re: CLIA Labs and Credentials

Postby Nate W. » Mon Jun 26, 2017 3:17 pm

LMN, Your thinking is flawed. You said "If the person has been trained in handling patient samples form the point of view of safety, traceability, SOP training, documentation etc then I would be fine. You are not considering safety, traceability, continuous training etc as necessity for clinical lab because you are not exposed to it. No, running a set of clinical trial samples that are well characterized and planned before it ever reaches the lab, is not sufficient for you to enter a clinical lab and start running patient samples": should someone with a PhD or MS with significant experience be required to go back to school for two years at an expense of 20-40K to learn these skills?

You are sorely mistaken if you think the clinical lab has a monopoly on these skills and issues of safety and documentation. You are just lacking in your understanding of academic research and other area of biomedical research and drug development including clinical trials, CROs, and IRB documentation.

It is my contention that a well trained scientist can learn these skills quite easily through self-study and a brief training period. Why make a huge fuss over skills that are insignificant to one's ability to perform and troubleshoot various assays. You think the handling of patient sample is such a significant factor that only MedTechs know how to handle those samples correctly. Scientists in academia and other venues have those skills as well. If the MedTechs at Theranos knew about this critical skill of handling patient samples correctly, why then didn't they figure out that blood samples fromn finger pricks contained contaminating substances from the skin cells that inferred with many of these assays and/or that all blood samples have to be clotted, spun down, and serum removed at 4C before the sample could be tested?

These are skills that can be easily learned by someone well trained in the lab from the basic research ranks. We routinely test clinical samples in academia and we don't get MedTechs to do this work. See the enclosed publication:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1764809/

By your thinking, only MedTech's could have performed these SNP analysis on patient samples? Trust me when I have to perform an analysis on patient samples in academia, I had to draft IRB protocols and there were strict regulations on SOPs and documentation. The technical skills or techniques to perform these assays don't magically change because one's is handling a patient's blood versus samples from an another animal.

You act like ignorance is bliss for MedTechs in assessing their ability to test patient samples. The scientists that I know would think that the more you know about the science (and the items I referred to before) behind the assays and your proficiency with your hands ("lab technique") is a good thing. You are saying it is not and that these other skills (i.e. " handling patient samples form the point of view of safety, traceability, SOP training, documentation etc") are more critical in one's ability to perform and troubleshoot an assay or group of assays. Maybe if we were talking about a series of bilirubin assays that have been automated. These non-scientific skills you alluded to can be learned on the job or through a probationary period.

What does a MedTech do when something goes wrong with an experimental technique and they get no result? I am sure this happens in a clinical lab. Forget to add a regents or set up a control. If you have the right scientific training simply beyond just being able to run the assays, you can figure out whether it is a problem with the experimenters' technique, the patient's sample, a reagent, or a significant problem with the patient. Let me give you a simple problem to solve:

You are performing a PCR on a patient sample. You run out the PCR reaction on an agarose gel and you see no amplified product. What is the most likely cause of this problem?

<Hint> It is not the patient's sample or the patient.

If you don't want MedTechs to have this level of knowledge and it is these other non-scientific skills that determine one's proficiency in performing clinical assays, what about performing high complexity tests like NGS, Mass Spec. (MALDI-TOF), and real time PCR ? Are you going to get a MedTech to perform Mass Spec on patients samples if he has the experience " handling patient samples form the point of view of safety, traceability, SOP training, documentation etc" when he lacks significant scientific experience performing Mass Spec and understanding its principles? What about other high complexity assays, like real time PCR?

Curious, what high complexity test was performed in that paper?

I strongly believe that basic research scientists can add significantly to the diagnostics industry from the perspective of better results, better quality control, new innovative tests, more integration of high complexity tests, and better troubleshooting of assays.

Avoiding much of the problems that occurred at Theranos and the numerous small labs that are cited yearly by CMS for poor QC. However, people like DocR and LMN want to protect their turf and/or increase program enrollment in the so called name of "patient safety."

Please feel free to have the last word because I don't think we will ever agree and you can't prove to me (or this audience) that you don't have a bias against well trained scientists entering the diagnostics rather than offering up silly concerns about patient safety when there is actually a need for good scientists in the industry.
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Re: CLIA Labs and Credentials

Postby LMN » Mon Jun 26, 2017 3:27 pm

We are not on the same page but I think both of us have said everything we needed to. I thank you for taking time to explore the question.

"Should someone with a PhD or MS with significant experience be required to go back to school for two years at an expense of 20-40K to learn these skills?"

No, PhD does not prepare you for specific CLIA lab work of GLP. It prepares you to think. Just like PhD does not prepare you to balance your checkbook, PhD doesn't teach you how to do a specific task in a specific way. In fact, a PhD would be a misfit as a lab technologist.

Trouble shooting will be directed by the labs technical director who is likely a PhD and a board certified lab director. In clinical lab decision making has to be centralized; Director/manager troubleshoots with data produced by Med Tech. Med Tech's primary function is to meet the TAT and ensure that all samples are run and reported; not perform random, free lance, eureka experiments like in academia. That is a huge difference between the two disciplines.
Last edited by LMN on Mon Jun 26, 2017 4:03 pm, edited 1 time in total.
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Re: CLIA Labs and Credentials

Postby Nate W. » Mon Jun 26, 2017 3:57 pm

LMN, you posted your comments before I was finished editing my thoughts. I appreciated your thoughts and the exchange.

It seems to me that better quality control and patient safety is directly related to one's level of scientific expertise and technical ability to perform at the bench, not anything else.

Don't fool yourself getting a PhD and publishing is all about technical skills, designing experiments, and performing those experiments, less about critical thinking skills.

You say no to the training but that is what DocR is advocating and what ASAP is requiring of PhD and MS scientists to be hired in a clinical lab. That should be changed.

I get the sense from you that you think basic scientists are overqualified to work as a MedTech or testing patient samples in a clinical lab.
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Re: CLIA Labs and Credentials

Postby LMN » Mon Jun 26, 2017 4:12 pm

Let me try a different way. I am not about to give up on you yet.:)

The goal and training of a med tech is production of patient sample results. (this mandates that the med tech focus on achieving production goals while a technical expert troubleshoots the problem. The director may have to review the raw data and sign off on it but med tech is not tasked with that function).
The goal and training of an academic scientist is to build institutional knowledge.

I hire med techs to perform production and PhDs to build tools. I don't mix up the two unless there is a true overlap. There usually is no overlap because the two tasks require different mind sets. Trying to force one to do the other is detrimental to both and patients.
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