Category: management/administration

Microfluidics + Consumer Electronics = The Future of Point of Care Testing?

In a paper published yesterday in Science Translational Medicine, researchers tested a low-cost smartphone attachment (a “dongle”) that detects the presence of HIV and syphilis antibodies using ELIZA technology. While the research took place in Rwanda and highlights the usefulness of such technology in low-resource settings, the implications are potentially far-reaching in terms of point-of-care and direct-to-consumer testing.

What do you think? Do you think using smartphone attachments could replace full laboratories in the not-so-distant future?

Swails

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

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 On October 3, 2014, the FDA issued draft guidance for regulating LDTs that includes notification or registration of LDTs with the FDA, reporting adverse events, and other requirements.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.

-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.

Letters of Recommendation

Have you ever been asked to write a letter of recommendation? One of my favorite tasks is to write such a letter for someone who I believe is totally worthy of the honor for which he/she is being considered, or completely suited to the position or new career for which they are headed. Conversely, one of my least favorite tasks is to write such a letter for someone I’m unconvinced fits either of those categories.

Writing a letter of recommendation for someone you know well and believe in is a joy. It’s easy to write, easy to find examples, easy to express concepts. It almost writes itself. Writing a letter for someone you don’t know well, or aren’t sure fits the reason for the recommendation, can be a painful, tedious project.

A colleague once told me that if I can’t write a glowing recommendation for someone, I should decline to write one at all. That’s good advice because the recipient of the letter can often tell when you’re enthusiastic, and when you’re not. I have also received letters of recommendation for applicants from people who actually write a bad recommendation – why not to hire the person or admit him/her to the program. I’m appalled that people would agree to write a letter if they are going to write a bad recommendation. Yes, it is hard to say no to someone who comes asking, but it is far better to say no than to write a bad letter of recommendation.

Occasionally you may not have any options, and may need to write a letter of recommendation. For example a person may need a letter from their boss and have only worked in the job they currently have. Or they need a letter from their most recent instructor, and that’s you! These are especially hard to write because you may feel obligated to write a reference, but not have enough personal experience with the person to write a glowing one. In these cases, all you can do is write about as many positive aspects of the person as you are aware of and leave it at that. Sometimes I have talked to the person’s immediate supervisor or work colleagues to gain some insight before writing the letter.

I have declined to write a letter of recommendation on occasion. In general, I decline because I have not had enough direct contact with the individual asking me to provide them with a good recommendation. Once in a while I decline because I truly can’t recommend the person.

From the opposite perspective, when asking someone to write a letter of recommendation for you, always ask for a GOOD recommendation. Also, try to always ask people who know you well and know your work and work ethic well. You’ll be doing both them and yourself a favor.

-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.

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.

 

-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.

Management and Administration Housekeeping Items

A few items relevant to your interests have crossed the editor’s desk over the past few days.

1. As we mentioned several months ago, laboratories need to provide lab results to patients (or their representative) when requested to do so. The Privacy Rule amendments went into effect on October 6, 2014. Is your lab compliant? Read the regulations to be sure.

2. The Draft Guidance for the FDA regulation of LDTs has been published. You can read them here and here. The FDA will accept comments about the draft for the next 110 days.

 

 

 

Steady the Ship

The relationships you have as a supervisor with the people you lead (notice I did not say “manage”) are important when it comes to day to day operations. They become especially important is when you have to guide them through change or conflict. I won’t even comment on the appropriateness of intimate relationships except to say if you engage in one then you are taking your career into your own hands and don’t plan on it lasting long. Beyond that, the lines are blurred and you may be engaging in an inappropriate relationship that won’t get you in trouble with management but will with the people you lead.

I am 31 years old and the majority of the people I lead are double my age so I have a unique (but becoming a bit more common) relationship with them. With many reaching retirement age in the near future the younger generation is taking the responsibility of leading and it creates unique issues. Do I sometimes feel awkward discussing a behavioral incident with someone who could be my grandmother? Absolutely, but my approach is what makes it a successful or unsuccessful discussion. I have learned that a “by the book” or “letter of the law” approach is not always successful. This is where emotional intelligence comes into play. As a leader you need to identify the needs of the people you lead, both as a group and individuals. It is very important to distinguish between the two because the needs of the group may be vastly different than as individuals. Once you do this it is easier to lead them because you know what they need to be successful and what you need to avoid, staving off failures. If you can successfully identify the needs of the group and individuals you can have relationships that grow and the people you lead will have confidence in you to lead them.

One issue that gets supervisor/managers into trouble is favoritism. It doesn’t even have to be true; perception in any workplace is often seen as fact. If one employee thinks that you favor another employee over them you will instantly lose their respect (not to mention a certain amount of work ethic). This can be especially difficult if you have worked with a group for an amount of time as coworkers and then you are promoted to supervisor. You will already have developed relationships and more than likely friendships with them so some of the perceptions may start with the start of your new role. If this is the case it may be a good idea to have a discussion with the group once the new role is assumed.

I have had the experience of taking over for someone that had their responsibilities taken away so I had some hard feelings to deal with when I took over. It was very difficult but I learned that if I took it day by day and worked with each individual they eventually came around and understood I was only there to help. There are all different kinds of situations that pop up as we lead our teams. We fight fires and make sure we don’t take on too much water that we cannot float. If you do not address these issues when they present themselves you may wait too long and not be able to steady the ship.

 

Herasuta

–Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

 

Perfection

When I was in school I learned a lot about science and the laboratory science body of knowledge. The one thing that was emphasized over and over was accuracy and precision. It wasn’t until I secured my first position and started training did I realize just how important those two words were. Not only are we counted on for our accuracy, we are counted on for the repeated accuracy of everything we report to physicians. I have heard some statistics reported that up to 80% of physician decisions on courses of treatment are based on lab results. I really do not get caught up in that number because if you think about it every single value we report is going into a patient’s clinical picture and can affect a decision on a treatment one way or another. So the question always comes up, how do we deal with errors? This question is multifaceted and as a supervisor/administrator we are responsible for much more than just the correction of the error.

I wrote this in my 5 year progress report article but I think it deserves repeating. Everyone makes mistakes, but, it is how you recover and learn from your mistake that is most important. Everyone has had that sinking feeling in their stomach when they learned they have either reported out an incorrect result or have mislabeled a specimen. As a laboratory professional it is our biggest fear and each and every day we sit down at the bench and are expected to be absolutely perfect. Zero errors are a standard that not even the most efficient manufacturers know is possible yet we are expected to perform on this level each and every day. Errors happen to everyone, and when they do it is what happens afterwards that is key to inhibiting that error to occur again. Especially with newer technologists it is important to teach them so that they are able to recover and not make the mistakes again.

The first thing I do when an error is discovered is address it with the technologist. Ask them, “do you remember this sample or this patient? Do you remember what you were doing at the time this error happened?” One thing to watch is how much the technologist can remember. If they cannot remember too many details, were they trying to do too much at once? If they mislabeled did they have a pile of tube and labels while also trying to result specimens? With mislabels I found it helpful for myself to read the name in my head as I was labeling the tube. That way if what I was reading in my head did not match the label underneath I would stop to look. If it is a procedural error why did the technologist deviate from the actual process? Did they learn a shortcut but that shortcut actually increases the chances of error? Going over this with the technologist also will help them with their problem solving skills. Especially with new technologists building problem solving skills is vital to the success or failure of a young technologist. We know humans are not perfect, but when you work in an industry that accepts nothing less, each error made is amplified but also that much more important.

 

Herasuta

–Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

Enterovirus D68

Over the past few weeks, hospitals around the country have seen a sharp uptick in cases of respiratory distress in children. The majority of patients test positive for Enterovirus D68, and most seem to have a history of asthma.

Only select laboratories test for this strain of enterovirus. If a suspected case comes to your facility, contact the CDC or your local health department for information about specimen collection and shipping.