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CLIA Labs and Credentials

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CLIA Labs and Credentials

Postby Nate W. » Tue Jan 03, 2017 1:27 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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Re: CLIA Labs and Credentials

Postby PG » Tue Jan 03, 2017 5:12 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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Re: CLIA Labs and Credentials

Postby RGM » Tue Jan 03, 2017 7:19 pm

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.
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Re: CLIA Labs and Credentials

Postby Nate W. » Wed Jan 04, 2017 2:45 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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Re: CLIA Labs and Credentials

Postby Nate W. » Wed Jan 04, 2017 3:03 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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Re: CLIA Labs and Credentials

Postby RGM » Wed Jan 04, 2017 4:05 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!!
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Re: CLIA Labs and Credentials

Postby Nate W. » Thu Jan 05, 2017 10:01 pm

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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Re: CLIA Labs and Credentials----Dr R's Reply

Postby Nate W. » Sun Jan 15, 2017 4:03 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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Re: CLIA Labs and Credentials

Postby LMN » Fri Jun 23, 2017 11:25 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.
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Re: CLIA Labs and Credentials

Postby Nate W. » Fri Jun 23, 2017 5:54 pm

LMN wrote: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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