A laboratory developed test (LDT) is any test that has been developed by an individual laboratory, often using instruments and/or reagents that have not been approved by the FDA for use as/in an in vitro diagnostic test. For example, measuring pH using a pH meter and pH calibrators from a scientific supply company is an LDT. So is performing a spun hematocrit, measuring acylcarnitines by tandem mass spectrometry, or performing newborn screening on dried blood spots. Even using an FDA-approved assay for samples or in a manner not specified by the manufacturer makes that assay an LDT. If you look around your lab, you may find that you’re performing an LDT without really thinking about it.
Who regulates these tests? The FDA regulates in vitro diagnostic testing, and LDTs fall under their purview. Until recently the FDA has used “enforcement discretion” and has essentially allowed CLIA regulations and CLIA oversight to ensure proper validation and monitoring of LDTs. CLIA regulation Subpart K, Section 493.1253 gives the specific parameters that must be properly validated in any non-FDA-approved assay. CLIA also regulates the proper usage and control of LDTs, just like any test performed in the laboratory. Is it necessary for LDTs to be regulated more highly than this?
In June of 2010 the FDA announced its intention of taking a more active role in LDT regulation in the future. They also held a public meeting to discuss their increased oversight. All laboratories which perform LDTs will do well to monitor developments in this newly intended enforcement of the FDA’s role, and keep abreast of changes coming out in the regulatory environment for these tests.
Anyone who has worked in a laboratory for any length of time knows that animosity can exist between health care providers and laboratory staff. Dennis Ernst, MT(ASCP), Executive Director of the Center for Phlebotomy Education, recently spoke with Lab Medicine about this “wall” and how laboratory professionals can break it.
Listen to the podcast here.
As a Global Health Outreach volunteer working to strengthen and build capacity for laboratories around the world, I travel to many strange, new and wonderful regions. When people learn about my travels, they ask such questions as “Where are you going? Where is that exactly? What are you doing there? Isn’t it dangerous? Who’s going with you? Will you get to see any exotic animals/historical sites/seven wonders while you’re on vacation? Don’t you need shots or something to go there? Wait, don’t they eat monkey brains/fried grasshoppers/fermented worms there? Eeewwww!” Their curiosity and awe serve as a reminder that little is known about global healthcare outreach. While many people think working internationally sounds glamorous, they don’t know what this work involves.
To tell you what volunteer work in international health is all about, let me first tell you what it ISN’T.
- It’s not a vacation. Volunteer and staff teams are expected to present, teach and train, tour and assess laboratories, mentor improvement projects, teach phlebotomy (sometimes by collecting samples on themselves to demonstrate technique), meet with leaders of that nation’s healthcare system and participate in the country’s goals, agendas and plans for laboratory operational improvement. And, oh by the way, get up early and work late to accomplish all that in very short periods of time, without regard for jet lag or any other travel inconveniences like lost luggage. A leisurely iced tea by the pool, reading a novel, or sightseeing just isn’t going to happen (except perhaps on the 1000 km drive through the desolate, hot, deserted two lane road from point A to B…now and again you spot a warthog!). The food can be challenging, the bathrooms are a chapter all by themselves, and accommodations can be shared with insect species you can’t identify.
- It’s not a chance to beef up your resume. Our government, our professional societies, and the nations who invite us are all expecting a very high level expertise. It’s necessary to have a lot of experience in order to establish credibility, and to have real experiences to share when the tough questions or collegial discussions come up—and believe me, they will come up! Before you consider volunteering, have some years in the trenches in bench laboratory operations and in manager/supervisor/director level positions.
- It’s not “lucrative”. Often, quite a bit of time is spent before ever leaving the U.S. preparing presentations, learning about the people and country, challenging yourself with knowing polite language and greetings, and researching. Conference calls, early morning and late evening debriefs, all are very exciting and fun—and unpaid time. It can be challenging squeezing all that around your “real job” and family commitments, etc.
Given all that, who in their right mind would want to do this? To answer that, I’ll tell you what Global Outreach in laboratory medicine IS.
- It’s the chance to be part of something bigger thanyourself. You’ll be reminded that health systems we have in our country are so much more robust than what exists globally, and we should not take our laboratories for granted.
- It’s an opportunity to learn how to build a better mousetrap. Many times, international laboratories find solutions to problems that are less complicated or use fewer resources than we would use in the states. These ideas can be brought home and used in our labs. I’ve never yet worked on an international project where I haven’t brought back several ideas for improvements!
- It’s humbling. I’ve worked with so many extraordinary people who have strong skills, knowledge, education and training. They have great understanding of concepts but lack resources. It’s about resource management and using what you have in the safest way possible to provide quality for patients. We can learn a lot from a resource-restricted environment—and we can share a lot on how to incorporate safety and quality metrics in that environment. The knowledge exchange, the relationships with international colleagues, the dedication and commitment of volunteer teammates, the results of seeing and being part of change that improves safety and patient care are rewards beyond amazing.
If you have a passion for making the laboratory world a better place, and think you have the “right stuff”, there are ways to be involved. Consider volunteer work with a local “underserved” clinic in your own community; no muss, no fuss, no immunizations, and no food challenges. See if the rewards of volunteering ring your bell. Tap into your professional societies (ASCP as #1 of course!) and explore international volunteering, help prepare training materials,and meet others who have done this kind of work. Or, even support another volunteer (work an extra shift while he/she goes…that’s unsung hero-ship at its most altruistic!) The glamour of traveling to a project is part of it, but it takes a whole society of people in lots of roles to create positive outcomes—and together, we ALL can reach out and make a difference!
Next time….let’s talk a little bit about the history of global healthcare outreach. How did we get to where we are today?
And, oh yes, if you’re ever at the Jannat Hotel in Bishkek, Kyrgyzstan, be sure to have the Greek Salad. It’s amazing! If you can’t make it there in person, I have the chef’s recipe hand-written on a cocktail napkin in Kyrgyz, in milliliters and grams. If you’d like a copy, feel free to email me at: email@example.com .
A colleague, upon checking her lab test results after an annual physical, was horrified to discover a flagged eGFR result of 57 ml/min/1.73 m2; even more so after her research indicated this result could mean she had stage 3 chronic kidney disease. She immediately called her primary care physician, who informed her that since her creatinine value hadn’t changed in more than 25 years (it had been 0.9 at 29 years of age and again at 59 years of age), he ignored the eGFR as useless. So what’s the purpose of an eGFR? If physicians are ignoring it, is it necessary and important to report it with every creatinine value?
Chronic kidney disease is an increasingly huge problem facing the American population. According to the the National Kidney Foundation (NKF) Kidney Disease Outcome Quality Initiative (KDOQI) Guidelines more than 4% of the American population suffers from stage 3 chronic kidney disease, with another 3% in stage 2 and 3% in stage 1. It’s well known that renal function decreases with age, and recent estimates suggest that roughly half the US population is over the age of 50. Although creatinine is the most commonly used marker of renal function, it is a remarkably insensitive marker of renal function loss, and new markers are just being discovered and validated. Glomerular Filtration Rate (GFR) is considered the best estimate of kidney function; however it’s not simple to measure. eGFR is an estimated GFR, calculated from the creatinine the age, gender and race of the patient. It is a way of assisting in the early diagnosis of kidney disease. To help make this diagnosis, urine albumin is an important test to use along with eGFR. In addition, both should be abnormal for >3 months in order to make the diagnosis. Early diagnosis can help prevent progression to renal failure.
The equations for calculating eGFR have evolved and improved, from the early 6-parameter formula which came out of the Modification of Diet in Renal Disease (MDRD) study, to the most recent 4-parameter CKD-EPI formula. For adults, the CKD-EPI formula is increasingly being considered the most useful of these formulas. Formulas are also available for children, and online calculators are easy to find.
When a physician describes what they do they will often say, “I practice medicine.” The reason for this is because each patient, even if they are in similar disease states, usually requires a somewhat unique treatment regimen. The same can be said of leadership. We as leaders are constantly refining our leadership styles, and to a degree practicing what we learn and observe. Just like the patients, each employee we lead is slightly different and it is up to us to adjust to them and not vice-versa. I have been a leader for three short years but my leadership style has already gone through many changes and modifications as I learn and interact with my employees.
I have also been confronted with the challenge of the leader versus manager mentality. The natural tendency when an employee is struggling is to jump in and save the day. However, did you really help them? Perhaps the better approach is to discuss the problem with the employee, give them the tools they need, whether it be knowledge or physical items, and then observe the employee working out the problem themselves. This is the tightrope leaders walk, and it can sometimes feel like the most daunting of tasks.
I start this blog with the hopes of putting together the leadership puzzle by first analyzing the pieces and then taking a step back and viewing the big picture. I just finished my 6th year as a laboratory professional and celebrated by re-certifying with ASCP. I gain my experience through being a blood bank supervisor as well as a general supervisor in a mid-sized community hospital that is part of the larger conglomerate Cleveland Clinic. Working here has given me insight into the entire gambit of the lab as well as how we interact with the rest of the medical profession. I will often refer back to issues and how they relate “outside the four walls.” This is especially important to leadership and how we keep our employees engaged.
Just like in any profession, laboratory medicine faces challenges that are universal to any almost any lab, anywhere. Those familiar with laboratory medicine will recognize these challenges: inadequate resources in labs and in medical technology schools; communication difficulties between lab staff, clinicians and others; patient education; and personnel shortages.
Those who practice laboratory medicine in the developing world know these challenges and more. Poor or non-existent electricity supplies mean that automated machines are not an option, temperature regulation of samples is unreliable, and working conditions are excessively hot. Lack of quality roads and transportation options make specimen or patient transport difficult and supplies hard to obtain. Few educational opportunities mean that lab workers do not receive adequate training or opportunities to practice hands-on skills before working in a lab. Current laboratory employees have few resources with which to improve and refine their skills and learn about the latest research and technology.
The Center for Global Health at ASCP has been working to improve medical laboratories in the developing world since 2004. By providing continuing education training to professionals, assisting schools with the revision of their curriculum, and purchasing needed laboratory supplies the Center for Global Health has touched thousands of individuals and labs around the world. You can read more about their work and find additional stories here.
Every month on this blog, I’ll explore the world of laboratory medicine in the developing world. I’ll also discuss topics such as equipment maintenance (how do different climates affect equipment functionality?), development aid (how do non-profits and other forms of aid impact changes in the lab?), and communication with the clinician (how does this work in a non-digital world?), among others. I hope to provide a few interviews of those working on the ground in the developing world and am open to your questions to guide our blog ‘conversation’.
If you’re reading this, you’ve stumbled onto the inaugural post for the Lablogatory–the blog for medical laboratory professionals. It’s dedicated to helping phlebotomists, clinical laboratory scientists, pathology residents, and pathologists perform their jobs better. We’ll have information on new technologies, posts by lab professionals working in the field, and polls to gauge your opinion on various topics. We may also have the occasional comic-relief post.
Actually, this blog is edited by a laboratory professional. Comic relief comes with the territory.
Come in, look around, and see if you like what we’ve done with the place. We’ll post new content often, so be sure to check back. And don’t be shy about using the comments! We hope you enjoy your time at Lablogatory.
–Kelly Swails, MT(ASCP), web editor, Lab Medicine