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CLIA Labs and Credentials  

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Nate W.
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January 3, 2017 7:27 am  

Dear Forum,

I wondering your thoughts on this debate (see link below). There are several CLIA labs located near me. However, these labs will not hire a skilled scientist from a non-CLIA lab unless they are licensed by the state. This requires that the scientist attend a CLIA certified program (for 1 year at 10-30K) regardless of degree or skill level. CA programs requires an additional 1 year apprenticeship on your dime. As you can assume, this eliminates many well qualified individuals from the basic research ranks. Further, I have to question the motivation behind the author's position because he runs a CLIA certifying program at a TX college. It should also be noted that many of these CLIA programs have been eliminated due to the lack of funding by the state and CA has the most restrictive programs in the country. Often there is no reciprocity for licensure between states. CA rarely accepts any licensure from another state. Personally, I find this ironic because the scientists who often develop this assays or work for the diagnostics companies are not CLIA certified scientists but they aren't qualified to run these assays using patients samples.

While in academia, I ran high complexity assays in support of clinical trials even though I wasn't CLIA certified. The department had a CLIA certification. Yet nobody was certified except maybe the PI.

Has anyone with significant experience in basic research went back to get a ASCP CLIA licensure?

Was the cost of the program worth the career outcome?

Is this merely an effort to sell more educational credentials and coursework by legislation?

Is there any exemption that will allow one to sit for the ASCP exams w/o attending a CLIA program? I think there is and I am going to try to lobby the ASCP for an exemption.

https://www.elsevier.com/connect/almost ... -wait-what


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PG
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January 3, 2017 11:12 am  

I have not attended this type of training so I dont have any experience from a personal career perspective. I have however collaborated with a lot of CLIA laboratories around the US and also in California. Finding and hiring licensed staff is a major problem for many of these laboratories and especially in California. This is leading to higher salary costs and relatively low competition for positions which should be beneficial for applicants. If this is sufficient to offset the costs and time needed for training I dont know.

You can see the same problem at lab director level. It is becoming more common that a single certified lab director is head of several laboratories sometimes very far apart geographically and the main driver for this is the problem with finding staff that are actually allowed to take this type of position.


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RGM
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January 4, 2017 1:19 am  

Nate- You'll find at least 2 general view points IMO on CLIA

1. Necessary to make sure valid lab results are produced by qualified, ie credentialed, people.

2. It's a money making scheme.

I think there are some examples where number 1 is valid. However for many positions it is number 2, ie such credentials aren't needed.

I always felt CLIA should be included in PhD level training to allow for greater job flexibility for job seekers.

I'm not aware of any of my PhD friends who went back to obtain this certification. Nothing would surprise me however.

On the flip side, science is science, and generally speaking no credentials should be necessary such as this IMO, simply the degree and the experience, ie knowledge.

"Some men see things as they are and say why, I dream things that never were and say why not"
"If you think research is expensive, try disease." - Mary Lasker


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Nate W.
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January 4, 2017 8:45 pm  

There maybe a loophole around the CLIA program requirement. Here are the guidelines for MB(ASCP):

Route 3: Baccalaureate degree from a regionally accredited college/university, with a major in biological science or chemistry, or baccalaureate degree from a regionally accredited college/university with a combination of 30 semester hours (45 quarter hours) of biology, chemistry and/or medical sciences, AND one year full time acceptable experience (clinical, veterinary, industry or research) in a molecular biology laboratory* in the U.S., Canada or an accredited laboratory** within the last five years.

Route 4: Graduate level degree (Master’s or Doctorate) in molecular biology, chemistry, biology, immunology, microbiology, allied health, clinical laboratory sciences, or an appropriately related field from a regionally accredited college/university, AND six months full time acceptable experience (clinical, veterinary, industry or research) in a molecular biology laboratory* in the U.S., Canada or an accredited laboratory** within the last five years.

*A molecular biology laboratory is defined as one capable of providing individuals with knowledge and practical experience in all aspects of molecular methods including, but not limited to, nucleic acid isolation, amplification, detection, sequencing, hybridization techniques, and data analysis.
**CMS CLIA certificate of registration, compliance, accreditation; OR
  JCI accreditation; OR
  Accreditation under ISO 15189.
To fulfill the experience requirement for the Technologist in Molecular Biology examination, you must have laboratory experience within the timeframe required in one of the following areas:
Genetics/Genomics (e.g., genotyping, gene disorders, pharmocogenomics)
Oncology (e.g., hematologic lymphoid neoplasms/neoplasia, solid tumor gene markers)
Histocompatibility (DNA-based)
Infectious Disease ( molecular microbiology/virology)
Molecular Identity Testing (e.g., bone marrow engraftment, paternity, forensic

So, I am wondering how they would define molecular biology lab. Does it have to be a CLIA certified lab? Can you lobby the ASCP with a recommendation letter from a pathologist or scientist saying a basic scientist in academia has this training so they can just sit for the exam?


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Nate W.
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January 4, 2017 9:03 pm  

RGM,

I agree with you on this. I have to really question their motivation behind why they make the qualification so strict, especially when you might already have the experimental training from a basic research lab. A doubt the CLIA training programs at these smaller or community colleges have the resources to adequately train their graduates to perform and troubleshoot some of these complex diagnostics, like NGS. I question even if they have some of the needed instrumentation. They have gone overboard with the requirements and alienated potential candidates to the profession. Other professional exams aren't so onerous (see examples below).

I wrote this professor an email and urged him to contribute to the discussion.

Some of my comments in the email:

"However, individuals, like myself, from basic research can’t easily work in a high complexity clinical laboratory even though they are better trained in basic molecular techniques and experimental skills than most medical technologists. When I read the article, the irony that I saw in the proposal was that it would be saying to the most qualified that you can develop the assays used in a CLIA laboratory but you just can’t test patient samples with the assay you just invented. Who better to run the assays than the guys who invented or understand the principles behind the assays?"

"These scientists from the basic research ranks would be ideal candidates for clinical medical laboratories and I think would consider the field. However, the reason they don’t is because the licensure process is a hindrance. Why would one spend tens of thousands of dollars on a 1-2 year CLIA certification program after a PhD or MS and many years of training in academia or even industry (i.e. relearn what they already know through experience)? Also, their experience in a non-CLIA basic research wouldn’t be consider part of the licensure process and would have to be repeated. For example, one could be trained in NGS at an excellent academic or industry laboratory but would have to repeat that training in a CLIA laboratory with NGS in order to get a license."

"CA also has the problem of the required apprenticeship in a CLIA laboratory or training facility. I tried to call several of these CA facilities. Many of these programs are so poorly funded that they only accept a handful of students (less than 5) when possibly more than 100 apply. More than half of those that I called either terminated operations due to a lack of funding or they didn’t have the resources to accept any students this year. Plus, these programs don’t provide a stipend and require their students to take out more debt to finance their living expenses."

" Most programs are found at smaller four year and community colleges where they just don’t have the right resources and equipment to train their graduates in cutting edge technologies found in only a few select laboratories located at mostly major medical schools and private companies. If the concern is about quality laboratory results, why not try to make it easier, not more difficult for those scientists who are truly qualified for these jobs?"

" So, I would propose the following. Allow scientists trained in a basic research environment who have significant experimental experience (or advanced degrees) in the life sciences to take the ASCP or accreditation agency exams for their licensure. The agency can review their experience and transcripts to ensure they have the proper background. However, I would not make it a requirement that they have to complete a CLIA certification program and/or an apprenticeship in order to receive their license. Essentially, they would only be required to take the exam and have their background reviewed by the agency. This approach is not unique. Scientists can take the patent bar exam after the USPTO reviews a candidate’s scientific credentials. If one wants to a financial planner, investment banker, or stock broker, FINRA reviews a candidate’s educational background then allows one to take the Series 7 and licensure exams. The same is true for a CPA examination. In all of these situations, a candidate is not required to graduate from a specialized program and/or gain experience in an accredited work environment, possibly learning skills they already know; they are only required to have their background reviewed for the basics and then pass an examination on their own time with minimal financial or professional burden."


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RGM
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January 4, 2017 10:05 pm  

Nate-

Let me know the response, if you even get one. Most people, sadly, don't take the time to read a letter that long. Trust me, I've written shorter letters in the corporate world, and people ask me "what/who", and the info I anticipated they'd ask is in the original email!!

I agree with what you wrote from my perspective.

The only part that is not always true is this

"Who better to run the assays than the guys who invented or understand the principles behind the assays?"

While one might think that is true, often times a product is created and the company sees the product being used a different way in the lab etc, might be an exception to the rule, my comment that is.

Regardless, I'd like to know what the response is you get!!

"Some men see things as they are and say why, I dream things that never were and say why not"
"If you think research is expensive, try disease." - Mary Lasker


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Nate W.
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January 6, 2017 4:01 am  

RGM,

He did respond and I'll get his approval first before posting his comments. I am surprised that his comments were not dismissive and he understood my criticism.

Any thoughts on my other post about routes 3 and 4 for the MB ASCP?

Some of my comments back to him were:

" My argument is that most of these techniques are molecular in nature and the biochemical principles are universal whether they are being used for a clinical diagnosis or asking a basic fundamental question in a clinical specialty. Sometimes a clinical background is helpful in interpreting the results but not necessarily required to perform the assay. Also, there are candidates who graduate from basic research programs who do get the clinical exposure while doing their dissertation in a translational biomedical research laboratory. For example, a MS or PhD graduate who did a SNP analysis of patients with NASH and characterized a genetic variant. Of note, they work on patient samples and their results influence clinical decisions by the PI, a MD. There are students doing that work at UT Southwestern who work in a non-CLIA basic biomedical research lab. There are other examples."

I'll talk with him soon. Will update the post.


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Nate W.
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January 15, 2017 10:03 pm  

RGM and Others:

Here is his reply:

HI Nate,
I’m crazy busy preparing for the spring semester start as well as juggling some grants and manuscript deadlines. I really need some time to answer your questions completely (and probably to your satisfaction). In a nutshell, you are confusing CLIA and NAACLS. There is no CLIA certification education program that one goes to in an academic setting to become a MLS. These programs are NAACLS based and accredited by NAACLS. CLIA is a federal mandate for the “lab itself” not the personnel working in the lab.

ASCP allows one to obtain the certification (in those states without personnel licensure) via different routes. There is no exemption. I obtained my credentials in this way. So, I totally understand where you come from…truly. However, I have been in a MLS (CLS) university-based, NAACLS approved program for 15 years now. I fully support this non-exemption. Our MLS education is Soooooo unlike the other biological science degrees, including all of the clinical education (internship required hours in a clinical setting). Remember, I can speak to this b/c I didn’t go that route originally. I did it the hard way by working route and higher degrees. So, I and my colleagues fully support the mandate that one must document “medical laboratory working experience” in ALL areas of the lab (for the MLS generalist credential or MLT associates generalist credential)…or, in the particular category they wish to obtain a credential for (e.g. M for microbiology only).

Believe me, I understand your argument about “developing” and creating laboratory assays, etc. etc… I did that myself at the TX DSHS labs and CDC. I was on the cutting edge of molecular tech in the 90’s as I was working there…BUT, many of those technologies are not used in hospital labs….and, while some “skills” transfer well, it’s the theory of the 1000’s of hospital panel tests, the abnormal ranges, the understanding of the biological false pos/neg in relation to incorrect specimen collection, etc. etc. that is NOT obtained in the environment you speak to below. Again, I Am not Doubting the amazing skill and brain power you and others like you possess….it’s just one doesn’t know, what one doesn’t know about the clinical/medical testing environment…especially as a generalist across all areas. Immunohematology for example (Blood banking) is a crazy, deep, and complex process that one can literally kill a patient with if they don’t understand the nuances via theory AND clinical experience…

Again….I totally respect your comments and I really do need to work on some crazy deadlines I have this week and next….but, perhaps, we can talk by phone sometime….I have answered these types of questions many times and it can take hours of time trying to work through all of the complex issues…..

THANK YOU for caring….and, I am not dismissing any of your comments….perhaps we can talk again later….or one of my coauthors on that article can assist you sooner…

Happy New Year…
Doc R

PS. I will save this and check out your online discussion, etc. as I have time

RGM I think he is saying that he supports the requirement that one should have to graduate from a NAACLS program and then do an unpaid internship. If so, I think that is boloney and makes me question the motive behind the requirement. This is why sometimes academia and the policy makers within science policy do the profession of science a disservice by pretending to be equalitarian but by making unreasonable and obtuse policies meant to deliberately exclude qualified candidates in order to generate money for an under enrolled academic program or further their own career.

This is why he never followed up with me and he didn't care to do so because he couldn't defend his actions.

I urge people interested in this field from the basic biomedical sciences labs to apply anyway through this possible loophole. There are some good labs in the diagnostics field. Try to apply to the ASCP through the 3/4 route with a good letter from your PI and then study for the exam on your own. Also, write a letter to your state congressional leaders to prevent Dr. R and others like him from enacting his policies and his viewpoints. There are other valid opinions on this topic.

This is the same BS that is going on with PhD teaching in public high schools and certification. Frankly, I would gladly debate these unreasonable administrators because they only care about themselves than the profession and can't see things in gray.


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LMN
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June 23, 2017 7:25 pm  

Adding to what Doc R alluded to, inventing a technique, developing a technique and even validating it is a very different skill than to routinely run clinical samples and release results to providers and trouble shoot those results. A medtech's main skill is in following a protocol to the T and ensuring that all the work is traceable and ready for inspection. I don't think you understand that distinction.
You don't need too much instrumentation or scientific skills to run most routine clinical samples. Many of them are black boxes that your scientific skill may not be useful for anyways. But you do need to know the quality system surrounding clinical testing and your responsibilities to patients and regulatory agencies if you deviate from protocol. There are many things you have to do to ensure quality least of which is your scientific knowledge. These are not small potatoes that a smart inventor/scientist can jump in and do it right with minimal training.
The key distinction between research setting and clinical lab setting is that in clinical lab you get 1 shot at a patient sample and then you need to ensure that the next time the same patient comes in and if the patient has no clinical changes, that your result should be very close. If there is a clinical change, you need to demonstrate that your assay has not changed and that the clinical change is real. This requires understanding of the quality system and your responsibility in the role. How to accomplish this through longitudinal quality control is what a medtech learns that a hot shot scientist is not trained on without going through additional training. You cannot achieve this training on the job because you are not allowed to kill patients while trying to learn this. Do not think that just because you know how to operate an instrument or develop a test method that you are ready to report patient results. It is frustrating that the docs clear explanation was lost on you because you continue to think that this is a conspiracy to get your money. It is not evident from the docs letter. I don't think you are ready for patient care.


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Nate W.
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June 24, 2017 1:54 am  

Adding to what Doc R alluded to, inventing a technique, developing a technique and even validating it is a very different skill than to routinely run clinical samples and release results to providers and trouble shoot those results. A medtech's main skill is in following a protocol to the T and ensuring that all the work is traceable and ready for inspection. I don't think you understand that distinction.
You don't need too much instrumentation or scientific skills to run most routine clinical samples. Many of them are black boxes that your scientific skill may not be useful for anyways. But you do need to know the quality system surrounding clinical testing and your responsibilities to patients and regulatory agencies if you deviate from protocol. There are many things you have to do to ensure quality least of which is your scientific knowledge. These are not small potatoes that a smart inventor/scientist can jump in and do it right with minimal training.
The key distinction between research setting and clinical lab setting is that in clinical lab you get 1 shot at a patient sample and then you need to ensure that the next time the same patient comes in and if the patient has no clinical changes, that your result should be very close. If there is a clinical change, you need to demonstrate that your assay has not changed and that the clinical change is real. This requires understanding of the quality system and your responsibility in the role. How to accomplish this through longitudinal quality control is what a medtech learns that a hot shot scientist is not trained on without going through additional training. You cannot achieve this training on the job because you are not allowed to kill patients while trying to learn this. Do not think that just because you know how to operate an instrument or develop a test method that you are ready to report patient results. It is frustrating that the docs clear explanation was lost on you because you continue to think that this is a conspiracy to get your money. It is not evident from the docs letter. I don't think you are ready for patient care.

I respect your opinion but I have to disagree. It is all about excluding others from the profession to protect the jobs of people already in the field. Don't you think experienced research scientists do these items you suggest are important in a clinical lab on a daily basis to ensure the quality of their results. Plus, the research scientist has been trained in the theory behind the assays which makes troubleshooting easier if there is an abnormal result or something goes wrong. MedTech don't get this training. Plus, most of these assays are already validated and automated. I have worked in a ASCP lab that tested patient samples in support of clinical trails and that also had a basic research component. However, I was not required to be certified. My supervisor was a GI doctor; the onus was on him to make sure the results were correctly interpreted, not the Medtech or the scientist doing the assays. There was enough serum collected to make sure the assays could be run multiple times and within the normal ranges for that assays (+/- SEM). Likewise, the same is true for a clinical lab at Duke and UT Southwestern, who often ran our patient samples as a check sometimes. The pathologist in charge interpreted the results, wrote patient reports, and conferred with the doctors ordering the test. The Medtech never did this; the onus was on the pathologist and prescribing physician for patient care. The doctor's inability to order the correct assays and understand the results jeopardizes a patient's health.

The Theranos scandal only makes my point. They employed mostly Medtechs and engineers and they couldn't validate their technology and reproducibility run these assays on the Edison machine. Why? Because the Medtech didn't have the ability to troubleshoot and validate the assays since they weren't trained in the theory behind the assays. A well trained scientist from the research ranks is trained quite well to validate and perform these assays reproducibly (whether the sample was from a patient, mouse, rat, or cells, etc.).

It is my position that basic researchers with a graduate degree and experience should be able to sit for the exam w/o attending a MT program and be required to do a short paid internship at a diagnostics lab to be certified. They could easily master these skills you referred to in a short internship.

PS: In CA, they have practically eliminated all these training programs. Even if you wanted a license in CA, it is very difficult to get because of this. That's why you have Doc R's program as a cash cow and why he wants stricter regs; patient safety boloney.


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LMN
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June 24, 2017 5:37 am  

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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Nate W.
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June 24, 2017 9:08 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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LMN
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June 26, 2017 6:32 pm  

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."


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Nate W.
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June 26, 2017 11:17 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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LMN
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June 26, 2017 11:27 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.


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