generalist – Page 27

Can I Use This Figure in My Talk?

Ever found that perfect figure that beautifully illustrates a point you’re trying to make? Ever wonder if it’s okay to use that perfect figure in your presentation? Are you infringing on someone’s copyright when you do? I attended a nice session on copyright the other day and I learned a few things I thought I’d share.

The first thing I learned is that when you create something, a text, a picture, a figure, a song, it is automatically copyrighted. You don’t have to apply for a copyright, nor put the little copyright designation on it (c inside a circle). It’s belongs to you unless you sign away your copyright to someone else.

The next thing I learned is that in general, use of a single figure from something does not constitute copyright infringement, especially if you attribute it to the source. It is considered “fair use” of that figure. That may not be true in some circumstances however, depending on other factors. There are basically four factors that are considered when it comes to the courts deciding on copyright infringement versus fair use. Put very, very simply (and from what I consider most important to least important), the four factors are:

If your use of another person’s (or company’s) work will affect their bottom line, then you are infringing on their copyright.
Is it transformative use or derivative? Are you using the figure or text in the same way that it was originally used, or are you using it for a different purpose entirely? For example a figure from a published paper, with a clear attribution allowing anyone to find the original, used in an educational lecture is fair use.
If you copy an entire textbook and pass it to your students, that’s copyright infringement, and also goes to the fact that you’re eating into the publisher’s bottom line since now your students don’t have to buy the textbook. In general if you use less than 10% of a published work, you’re still in the fair use ballpark. Again, bottom line money can affect this.
Facts and ideas cannot be copyrighted. Expression of facts or ideas, or fixing them into a written work or figure, is copyrighted.

Another thing I learned is that Google images is probably not your best place to find images to use, especially if you want an image in something that you plan to publish. They are all copyrighted, and you will need to track them to their source and get permission to use them. However, for an occasional image in an educational powerpoint, including the attribution (usually in a link) is probably sufficient.

Of course, being a legal thing, copyright and fair use can be much more complicated than this, and lawyers and courts make their living making those decisions. I would say in general though, for a few random images in your powerpoint presentation, you are not breaking any copyright laws.

-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

Food and Drug Administration and Next Generation Sequencing

As readers of this blog are probably aware, The Food and Drug Administration (FDA) is currently considering how to tailor its oversight of Next Generation Sequencing (NGS), methodologies that can produce extremely high quantities of genetic sequences. In turn, these sequences can be used to identify thousands of genetic variants carried by a particular patient. NGS will usher in an age of truly personalized medicine in terms of patient risk assessment, diagnostics, and personal treatment plans.

Currently, the FDA approves all in vitro diagnostic (IVD) tests with the exception of laboratory defined tests (LDTs). These tests are used in clinical laboratories and typically detect one substance or analyte in a patient sample, and this result is used to diagnose a limited number of conditions. (One example would be a cholesterol test; every manufacturer that makes the analyzer and reagents to detect cholesterol in a blood samples has to get their methodology approved.) However, NGSs have the potential to detect billions of base pairs in the human genome, and therefore the potential exists to diagnose or discover thousands of diseases and risk factors for disease. Also, many NGS tests are developed by individual laboratories, not big companies, and so would be considered an LDT.

The FDA has opened a public docket to invite comments on this topic. American Society for Clinical Pathology, as well as other professional societies—American Association of Clinical Chemistry and Association for Molecular Pathology among them—has publically commented on the FDA preliminary discussion paper “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” In its comments to the draft paper, ASCP stated that the “CLIA framework offers a more logical model for providing federal regulatory oversight of LDTs.” Similar points were made by AACC and AMP. The associations also agree that any regulations should not interfere with the practice of medicine.

What do you think? How involved should the FDA be in genomic testing in the clinical setting?

Further reading:

AMP comments

AACC comments

But How does it Work?

There’s an old saying that goes like this: if you understand it, it’s obsolete. Sadly, in this day and age of rapidly advancing technology, this saying is truer than ever. I say “sadly” because what this means for us in the laboratory is that we are becoming less and less likely to be able to troubleshoot and repair our own instruments. This is another thing I sometimes miss about bygone laboratory medicine. Taking instruments apart used to be fun.

Many instruments now are considered “black boxes” by clinical laboratory scientists. They may not understand the principles behind how the instrument works, and even if they do know, they are not inclined or encouraged to attempt to fix it if it stops working. In the early days of laboratory medicine, we could repair most of the instruments we used in the laboratory. Now we can repair almost none of them. Instruments have become so sophisticated, with so many bells, whistles and extras, that even if you know the basics of how the instrument works, being able to fix it when it goes down is no longer a possibility.

For example, most big main chemistry analyzers work on the basis of two principles: some type of photometry and ion-selective electrodes (ISE). Knowing that information used to make it possible to troubleshoot and do some repairs on the photometer system, as well as replace ISEs. Troubleshooting and repair was a matter of checking the functioning of your optics and cleaning as necessary, replacing tubing and replacing electrodes and fluids for the ISE part. Medical technologists were much more likely to repair systems themselves than to call Service in. That ability is rapidly becoming a lost art however.

Modern instruments are much more than a photometer and a set of ISEs. The sheer volume of working parts in current instrumentation is orders of magnitude higher than in old instruments, and most of those parts are robotics in the instrument rather than analytical components. With more sophistication and technical abilities though, come more things that can go wrong. And these are things that cannot be fixed by the clinical laboratory scientist working the instrument.

Of course, for every lost ability is a gained ability. While local troubleshooting may not be possible, many of these major instruments are now connected to the internet. Troubleshooting can be done remotely by the people who do have the knowledge to service them. Honestly, I probably do not want to return to the days of fixing my own instruments in the case of the big chemistry analyzers, but I still do enjoy troubleshooting my mass spectrometers. And it was nice to know I could fix things.

Are We Creating Wisdom After Y2K?

We all remember the panic and drama over the centennial turn of the century? Well, here we are in the middle of the second month of the fifteenth year of this “new millennium.” Who could imagine we’d be this far into the future this fast?

As the world turns, we balance on the precipice of our “seasoned and experienced” laboratory professionals reinventing, repurposing, redefining their careers, or just moving on to enjoy life after laboratory service—and leaving the bench at a rate that looks like a diabetic insulin spike. We are also experiencing a surge of new laboratory interest, (thanks, CSI!) and it’s refreshing to see students eager to learn and practice in our labs and specialty departments. But there is a “gap” in the middle, a desert of years when schools closed, students went into nursing or pharmacy or radiology instead of laboratory science, and we didn’t “feel” it because we were in the prime years of our careers. This “gap” is very soon going to appear on the horizon and it’s looking a bit like the Olduvai Gorge…deep and wide with not too many ways to cross unscathed.

It is with urgency that those of us still active in the field begin to engage, mentor, sponsor and grow new laboratory professionals around the world. Seek out that student you don’t know yet, take that youngest tech to lunch, make friends with a student/young tech from another country, take a turn at teaching and training (yep, without the stipend or salary bonus—just do it because someone did it for you a long time ago, and I’m guessing they weren’t compensated either…) I’d like to challenge everyone to leave some knowledge behind as you take the next step on life’s path. There are so many ways to do it, find a way to give a little bit back, help complete the circle.

Just remember…the next generation of medical technologists and laboratory scientists are going to be performing tests and releasing results for us one of these days. Wouldn’t it be great if they were as good as I want them to be when they’re doing my CBC and chemistries, and cross matching that unit I hope I don’t need during surgery? I’ll be crossing my fingers, and counting on the fact that YOU were one of their mentors!

Here’s to the next 15 years in our Y2K world! Cheers!

–Beverly Sumwalt, MA, DLM, CLS, MT(ASCP) is an ASCP Global Outreach Volunteer Consultant.

Something for Nothing

I’m probably going to be a little bit on a soap box with this post, but this is something that is bothering me. It’s about the society we live in and how it’s becoming more and more of a “something for nothing” society. We expect to get things without having to pay for them. In fact we’re so used to it that we even get angry when someone asks for payment. Let me give you some examples:

How many times have you gone to Wikipedia to look for an answer to a question? Or any other site on the Internet for that matter? And how many times have you donated any funds at all to the upkeep and maintenance of that site? Guess what. It costs money to maintain a website.

How many times have you downloaded a song off the Internet without paying for it in any way? People spend money to record songs and money to make movies. Where does the money come from to allow them to continue doing those things if nobody pays for the ones already made?

The reason this is bothering me is in relation to our professional associations. Even here, people want to receive benefits without paying for a membership – something for nothing. Our professional associations are worth supporting. They offer us educational opportunities, networking opportunities and a host of other benefits. All of these things cost our associations money to produce and provide. And even big associations cannot afford to continue eating the costs without eventually being financially unable to continue. You might be surprised to know how much of any given board meeting for your association is spent discussing staying financially viable.

Nobody, including your professional associations, can stay in business if they cannot make enough of a profit margin to survive, basically if they give away too much for free. I think it’s time for us to stop expecting everything to be handed to us without needing to give anything in return. So go for it. Donate to Wikipedia, buy your CDs, blue-rays and downloads, and join your professional societies. You will not regret it.

CLSI Publishes New Guide for Laboratory-Developed Tests

From the press release:

“The Clinical and Laboratory Standards Institute (CLSI) has published Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.This guide converts the requirement complexities of US Food and Drug Administration (FDA) regulations into plain language, offering intuitive assistance on how to conform to the Quality System Regulation (QSReg), 21 CFR 820, when creating laboratory-developed tests (LDTs). This CLSI practical guide can help laboratorians learn how to address the new demands, beyond the Clinical Laboratory Improvement Amendments (CLIA) regulations, within their unique laboratory settings.

“LDTs are in vitro diagnostic devices that are intended for clinical use and are designed, manufactured, and used within a single laboratory. This practical guide is intended to clarify how to implement the QSReg that may be required for some classifications of LDTs. On October 3, 2014, the FDA issued draft guidance for regulating LDTs that includes notification or registration of LDTs with the FDA, reporting adverse events, and other requirements. This document only addresses the QSReg that is currently applicable to manufacturers and is expected to become applicable for some classifications of LDTs when the final guidance is published.”

To purchase this guide for your laboratory, visit the CLSI website.

How to Say “No”

Saying “no” to things is a learned skill that takes continuous practice, and a good amount of balance. The balance is because when you’re starting out in your career, I firmly believe that it’s important for you to agree to requests and to take on new tasks. It gets you out there, introduces you to new people and new skill sets, and teaches you so much you might not learn just performing your regular job. But then we get into a habit of saying ‘yes”, and we all know how hard habits are to break. We think things like, “if I don’t do it, no one will” or “if I do it, it will be done correctly.” Or more than just those things, we all like to please people, especially our friends and colleagues. So when a friend asks you to take on another research project or review a paper or look over some data or run a test or cover their call, we all readily agree to taking on just one more task.

As with every other aspect of life though, there is such a thing as too much of a good thing. Saying “no” occasionally is good for your overall health and sanity. It’s entirely possible to reach a stage where you’re so over-whelmed that you cannot do a good job at any of the tasks you have undertaken. Thus learning the art of saying “no” is also important, and is something I myself am just still struggling to learn.

Here are some points to remember that may help you when you need to say “no:”

Don’t give an immediate response, especially if you have any concerns about having time for this new task. Tell the person you will get back to them after some thought, and tell them when you will reply to them.
Give yourself time to consider whether the new task can be accommodated in your current workload, or whether you will have to short something else to accommodate it.
Be firm once you’ve decided. Don’t use phrases like “I don’t think I can.” Say “I cannot. ” And be persistent because you may have to turn down this opportunity more than once.
Always remember, you are turning down a request, not a person. It is especially hard when the request comes from a friend, but sometimes it is necessary.
Accepting a task that you don’t have time for is not doing any favors for yourself or the person asking. If the requestor has to then become a nagger to get you to complete their task, they will not thank you for it.

In conclusion, it’s important to maintain a balance at work without overloading yourself with too many tasks to allow you to accomplish any of them well. Learning to say no to requests is an important part of keeping that balance.

Test Turnover

What’s your lab’s procedure for getting rid of an obsolete test, or bringing in a new one? Any change to the test menu has some level of difficulty associated with it, however my opinion is that replacing a test with a new method that gives different results is the easiest to accomplish, followed by introducing a completely new test, and lastly removing an obsolete test. In that last case I’m specifically talking about removal of a test that is no longer the best way to diagnose a disease or monitor treatment.

In any of these cases, does your lab use the “rip the band aid off” method? For example, do you send a succinct notification that as of the first of the month this test will no longer be available in your lab, or this test will have results 33% higher than the doctors have been previously seeing? Or do you use a more gentle method, such as offering to run the old and new method together for 2-6 months to let the doctors get used to the new values? Or in the case of removing a test, do offer to try to find them an alternative lab which is still running the old test? Or do you simply leave the old test in place and hope it eventually dies a natural death from lack of use? Unfortunately, some tests never seem to die – like CKMB and bleeding time.

A lot of the difficulty, both in getting rid of old tests and in bringing in completely new ones, can probably be laid on the doorstep of human nature. Just like other humans, doctors like what they’re used to and don’t like changing their routine. Even when overwhelming evidence suggested that a new test is better (troponin), they want to use what they have always used to diagnose and treat their patients (CKMB). When the evidence for a test’s utility is not so clear cut, it’s even more difficult to introduce a new test. Examples of this include Cystatin C and fructosamine. Cystatin C is becoming more widely used and will no doubt survive as a test, but fructosamine? Part of the issue with fructosamine may have been the silly name they gave it. Fructosamine? Really? If they had called it glycated proteins/albumin it may have fared better. Fructosamine sounds too much like a fruit drink.

Maintaining a test menu that is appropriate for your population and that doesn’t include unnecessary or obsolete tests is an interesting balancing act. It definitely requires having a good rapport with your clinicians and getting their input along the way.

Season of Greetings

It’s amazing the year is nearly over, the halls are decked, candles lit, celebrations scheduled. Friends and families gather, eat too much, hug and kiss, pass around gifts and graciousness…and microbes.

Laboratory professionals know all too well that “Seasons Greetings” are just the thing for passing along your favorite virus or enteric pathogen. This year, we are especially conscious of the contagious nature in the world of unseen assailants. Global health has faced the disastrous affects of improper hand washing and challenging sanitation conditions; and not just with the Ebola crisis, but in refugee camps and among those facing the strife of war.

Laboratories don’t close for holiday celebrations…and laboratory professionals don’t always get the days and times off that would make them happy around the holidays. But this year I challenge us with two things:

Remember to offer “Seasons Greetings” with best practices and don’t take any of your laboratory favorites along to the parties and gatherings!
If you’re working that extra shift, or one that is encroaching on your family and personal time—remind yourself that there are so many in the world who would rejoice in the opportunity to be working, to be healthy enough to be working and free of disease, strife and conflict, and could watch their children and families smile, eat too much, hug and kiss and pass along “Seasons Greetings”.

My best to you for this holiday season, whatever ways you celebrate, and ‘tis the season to remember our colleagues globally and do something to make the world a little better place locally! Happy Holidays!

–Beverly Sumwalt, MA, DLM, CLS, MT(ASCP) is an ASCP Global Outreach Volunteer Consultant.

The Future Cost of Antimicrobial Resistance

Over on Superbug, Maryn McKenna (are you following her yet? No? If you’re into infectious disease, you should) discusses a recent report on the global ramifications of antimicrobial resistance. In it, the authors project by 2050, 10 million deaths a year will be attributed to infections caused by six resistant organisms. (Those are: Klebsiella pneumoniae, E. coli, MRSA; HIV, TB and malaria.) These deaths will cause an estimated loss of 100 trillion dollars of lost gross national product.

So what can laboratory professionals and pathologists do to help stop these predictions from coming true? For starters:

Advocate for and implement antibiotic stewardship programs.
Educate the public about proper antibiotic use.
Practice good laboratory safety practices.

What else can labs, microbiologists, and pathologists do to stem the tide of antibiotic resistance?

–Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.