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Press Start: Lead an Empowered Life as a Clinical Laboratorian

New USB Stick Measures HIV
November 18, 2016 4:10 PM by Glen McDaniel

Science never stands still. I am particularly interested in the merging of technologies in the new era of the logarithmic growth of technology. For many decades science was fairly plodding and sometimes even static as research followed certain set rules and required a certain rigor to be considered credible and acceptable.

Scientists, engineers and even social scientists are joining forces to advance human knowledge. I love to read about those joint projects. Recent developments often involve the use of micro samples and use of cutting-edge technology originally developed for other areas such as communications.

One recent development that caught my attention is a USB stick that is able to detect HIV particles. This takes "lab on a chip" or "black box laboratory" to a new level. As someone who speaks a fair deal, I cannot live without my memory stick. I load my presentation, and bring them everywhere.

 A UK Biotechnology company called DNA Technology joined forces with bio-scientists at the University of London to develop a USB stick that acts a small HIV lab.

A single drop of blood is added to the stick, the pH is adjusted and an electrical signal is generated depending on the viral load detected in the sample. The signal can then be read and displayed on a computer or similar device. Analysis takes about 20 minutes.

Initially it is perceived that the application will be mostly for patients who are known to be HIV positive. This device will essentially indicate a viral load and suggest whether treatment needs to be adjusted or clinical intervention needs to be changed by an increasing viral load. At this point it is not intended as a screen for HIV. This detects viral particles and not HIV antibodies.

Conceivably patients could be in a clinic or even at home, rather than making a visit to the doctor or going to the laboratory and waiting several days for a result.

There are already biological sensors for glucose and other "simple" analytes. However this technology opens the door to auto-monitoring of many other diseases.  I am all in favor of self-monitoring or expanding access to those who might not otherwise be able to take advantage of traditional medical care.

Work Smarter Not Harder or Longer
August 29, 2016 2:10 PM by Glen McDaniel

 There is always so much to be done. Today's society is so fast-moving that it’s hard to accomplish every single thing on a day’s agenda. Working in the laboratory, we know that emergencies happen, stats keep coming in, instruments act up, and colleagues call out. It’s agreed we are expected to do more and more with less and less.


One of my jobs outside the laboratory was as the COO of a hospital. We were evaluated on several formal metrics but one informal metric for COOs was always how much time we spent in our respective hospitals. We were not only expected to be visible but to come in early and leave late. Consistently. Because it was such an expectation, peer pressure also cemented this practice. COOs actually fell into the trap of judging each other's work ethic by hours worked.


One of the most popular phrases (almost a boast) is that we are multitasking. Recent studies have shown however that multitasking is not only exhausting mentally, but might make us less productive than we have been led to believe.  Paul Atchley, PhD, Associate Professor of Cognitive Psychology at University of Kansas has studied this issue extensively.

His research finds that when you multitask you are less productive, accomplish less and are more likely to miss vital information. He found it takes an average of 15 minutes to reorient to a primary task after being involved with a secondary (possibly less important) task. Think of the implications of that finding for a science as critical and exact as laboratory science.


Several authorities and studies not only argue against multitasking, but go further to stress the importance of what some call “single tasking."

Then there is the whole idea of working longer hours either to make more money or to accomplish all we have on our plate. However work-life balance is important.  Both work and social/family life suffer from working too many hours.


My friends in Europe who routinely receive 6 weeks’ vacation and multiple holidays and casual days off cannot understand the American penchant for working so much.


Studies at various universities have demonstrated that routinely working more than 40 hours a week is counterproductive. The individual who makes that a way of life can become chronically tired and is, in fact,  accomplishing much less (quality) work than they think.


Having work-life balance is important for employees of any age but a recent study has even found that the ideal work week for those over 40 is actually (wait for it…) 3 days.


We know that in a clinical laboratory we cannot work in a merely linear fashion. Life happens. Several priorities present them selves at once. However we can learn to work smarter. We should prioritize work; use technological tools available and organize work teams where we share tasks instead of one person assuming all steps of a particular function.


We need to refresh and take more frequent breaks, even for a few minutes throughout the day. Stand up, stretch, go to the breakroom, look out the window, and even go outdoors, if you can. This needs to be the standard rather than the exception. Rather than making you less productive, such “recesses” will refresh you, cause you to refocus and cause your productivity to skyrocket.


As the profession ages, we might be able to retain- or attract back into part time work- those of retirement age. However they will not be interested in working 40 hour plus work weeks.


We do ourselves, our employers, our patients and our families a disservice by multitasking and chronically working long hours and too many hours per week.

CMS Says Nurses Can Perform High Complexity Tests
July 31, 2016 4:38 PM by Glen McDaniel
The Centers for Medicare and Medicaid Services (CMS) recently published a memo that it sent to CLIA inspectors on how to interpret educational requirements. CLIA had always specified the minimum educational requirements for individuals performing laboratory tests. 


In recent years there has been quite a  strong lobby from nursing to recognize a nursing degree as a biological science degree, having the requisite credit hours of biology, chemistry etc. Those of us with oversight for point of care testing (POCT) had also been unsure as to whether nurses could perform non-waived tests and maybe even fully manage a POCT program where non-waived tests were utilized.


Now CMS has weighed in definitively by saying that, yes, a nursing degree is a science degree making nurses qualified to perform non-waived tests. A careful reading of the CLIA regulations would suggest that if that is true, then nurses may in fact be allowed to even direct laboratory testing.


In my view, this is an encroachment on our scope of practice that also potentially endangers the patient health.  POCT and some other laboratory tests are seen as merely “recipes” by some inside and outside the profession. But we know that laboratory testing requires critical thinking skills way beyond the memory and motor skills required to add 1 drop of this, 2 drops of that and time for 5 minutes to see if a blue line appears or not.


The CMS guidance to its CLIA inspectors directs them to accept a bachelor’s degree in nursing as a biological science degree qualifying the  holder to perform even high complexity testing, and that an associates in nursing qualifies the holder to perform moderate complexity testing. Yes!


Lest you think this is something that no serious employer will follow, bear in mind that this came after lobbying from nurses who wanted to perform and supervise laboratory testing. They had a definite goal in mind and will certainly take advantage of this new development.


Not wasting much time the Veterans Administration  (VA) has already jumped on the band wagon.

 In a recent letter to its members ASCLS said the following regarding the VA decision:


"The Department of Veterans Affairs (VA) has published Proposed Rule that would expand the authority of Advanced Practice Registered Nurses (APRNs) beyond ordering and interpreting lab tests, as they can now, to supervising and performing laboratory testing. If adopted, an APRN could supervise and direct a clinical laboratory.

"In proposed § 17.415(d)(1)(i), a CNP would have full practice authority to provide the following services: Comprehensive histories, physical examinations and other health assessment and screening activities; diagnose, treat, and manage patients with acute and chronic illnesses and diseases; order, perform, supervise, and interpret laboratory and imaging studies; prescribe medication and durable medical equipment and; make appropriate referrals for patients and families; and aid in health promotion, disease prevention, health education, and counseling as well as the diagnosis and management of acute and chronic diseases."


This is setting a dangerous precedent. Nurses are valuable members of the healthcare team but they have a body of knowledge and a scope of practice different from those of medical laboratory practitioners.


This is not about competition and “staying in ones lane.” It is about a real risk to the public health. I can no more practice nursing from reading a package insert and following schematic workflows than a nurse can (safely and effectively) practice medical lab science.

What We Could Learn from Pharmacists
June 25, 2016 8:34 PM by Glen McDaniel

I know our profession is unique and cannot be identically modeled off any other profession. However in both my personal and professional lives I often try to learn lessons and draw parallels from observations around me.


I have been in this profession for more years than many of my readers have been alive. I have practiced in several countries. Although there are differences, some nagging challenges are universal and also have persisted for years. One such bugaboo is the dissatisfaction with how we are perceived, given our education, training and abilities. We also compare unfavorably with others in the healthcare fields who have somehow managed to overcome barriers similar to those we cannot seem to overcome.


So that’s where the comparison with pharmacists comes in.  They did not like the name “druggist” so they universally adopted the more professionals sounding moniker  of “pharmacist.”  Yet, we still struggle as to whether we are “just technicians,” “medical technologists,”  “medical lab scientists”  - or something else. We argue among ourselves as to even whether choosing a descriptive name is mere elitism and fanciful thinking.


Pharmacists decided to limit entry to the profession. They control their own profession,  have a rigorous entry exam, and allow only a certain number of entrants per year. That practice creates demand from employers and also helps to select the best candidates.


They have crafted  their program specifically to fit their body of knowledge. They won’t accept a bachelor's in basket weaving, plus 2 years’ experience working in a pharmacy as an acceptable pathway to enter the profession. Biology and chemistry are essential foundational sciences, but they are distinct from pharmacy.They are not substitutes for a degree in pharmacy. The training is also standardized. I certainly do not want to disenfranchise any current laboratory practitioners, but we ought to have a cutoff date after which we offer (and accept) only a very specific entry level degree. Every one practicing the profession should possess a medical laboratory science degree.


Then there is the hot button issue of licensure. Seen by some as just another fee to pay, or a devious plot by government to take more money from the working citizen, it is also one way in which the public health is protected. Each hard-working practitioner is also protected because they cannot be legally displaced in the workplace by anyone who is not similarly educated, certified and licensed. What about the need for a separate licensure examination in each state?  Professions like law and nursing have licensure compacts where licenses are essentially transferable from state to state. Once you licensed, there is no need to sit a different licensure exam if you relocate. Accepting national certification for licensure is also not without precedence. So that barrier is very easy to leap.


In recent years pharmacists have deliberately crafted practice routes for themselves without waiting for others to offer them, and without asking for permission to do so. There are clinical pharmacists who make patient rounds and order labs, they manage therapeutic drugs from antibiotics to anticoagulants, they adjust dosages; and they create algorithms and develop best practices. Now it is common for pharmacists to administer immunizations and vaccinations and manage diabetes. They are also the specialialists for medication administration and storage wherever such functions occur in the institution.


Pharmacists have gradually (without disrupting the status quo) made the PharmD the entry level professional degree and thereby greatly enhanced their image, demand and earning capacity. Those practicing pharmacists with other degrees were offered creative routes to the PharmD so no one was disenfranchised. See any parallels there?


In many states like Georgia, pharmacists have crafted and carefully developed political power as well. Through colleagues in public office and lobbyists they ensure laws are not just pharmacist-friendly, but constantly expand their scope of practice. They can perform some lab tests,  and directly order several tests. They ensure physicians use certain secure mechanisms for writing prescriptions; without which they do not have to fill those prescriptions. All those requirements are prescribed by laws pharmacists helped to create.


It’s easy to say we are different. But it is worth drawing parallels and learning from others as well. I think we have a real viable model here.

Representing all laboratorians as “lab techs” hurts the profession
May 30, 2016 9:13 PM by Glen McDaniel

A few months ago I went to the doctor with a friend.  The nice young lady taking my friend’s vitals and medical history introduced herself as “Dr. O’s nurse”. I noticed her name badge read “RMA”- registered medical assistant. She was professional, competent and very friendly, but I wondered why she would represent herself as a nurse, when she clearly was not. 

Just last week a nurse manager enquired why the “lab techs” in one particular clinic did not perform tests while others in the multi-facility organization did. Most of the clinics that she was familiar with had  laboratories with medical technologists/medical lab scientists. The smaller clinics, like the one she mentioned, were staffed with phlebotomists who collected samples and shipped them off to the laboratory for testing.  The phlebotomists she questioned explained that they were “not allowed” to perform testing; without explaining the difference in competency and scope of practice between a phlebotomist and an MLS. To the nurse, they were all  the lab or “lab techs.”

In the laboratory, the individual the customer (patient, public, doctor, nurse)sees most often -or speaks to first on the phone- is not a medical laboratory scientist (MLS) or CLT, but a phlebotomist or customer service representative. I have overheard such individuals overtly misrepresent themselves as  “lab technicians”, or at least not correct others who assume they are clinical laboratorians. 

It does a dis-service to the profession and the customer if those we serve receive or act on incorrect or incomplete information from someone they presume to be an MLS. I think it also damages our image as a profession long-term when we let others in the health care assume everyone who is associated with medical lab science is a “lab tech” or can be accurately lumped together under the generic term “the lab”.

In some states at least it is illegal for a non-nurse to represent him or herself as a nurse. In most settings, registered nurses insist on making clear the difference in expertise, education and scope between registered nurses (RNs) and licensed practical nurses (LPNs). While there might appear to be a degree of elitism in that move, it is a very legitimate distinction that can only help patients, doctors and the profession itself.

 I think the same distinction about scope and levels of practice should be clearly articulated to our customers.  For one it would avoid lots of frustration and  unrealistic expectations from those we serve.

Happy Medical Laboratory Professionals Week 2016
April 24, 2016 3:42 PM by Glen McDaniel

It's that time of year again, when we celebrate and acknowledge Medical Laboratory Professionals (technicians, scientists, specialists, pathologists and others).

I receive a lot of email and read several misleading posts about "Lab Week." So I am essentially reprinting a primer to share with colleagues. 

The American Society for Clinical Laboratory Science (ASCLS) website has a very concise  history of this celebration which, like the profession it highlights, has experienced many changes. It was started in 1975 as National Medical Laboratory Week under the auspices of American Society for Medical Technology (ASMT) which later became ASCLS.

Over the years several other laboratory organizations signed on as co-sponsors. For example, this year there are 14 organizations cooperating in the effort  to salute the nation's estimated 300, 000 medical laboratorians.

In 2005 advocates from ASCLS spearheaded a change to rename it NMLP Week, with the "P" standing for Professionals. This was a deliberate attempt to emphasize that the celebration was for actual, real, live,  talented, educated, hard-working professionals and not simply a room (the lab).  This change was small but very significant and evocative.

Traditionally, each year a group of professionals selected a catchy slogan as that year's theme;  often a catchy double entendre. In 2010 it was decided to brand the celebration with a permanent recurrent theme, "Laboratory Professionals Get Results."

Then in 2012, the word "national" was dropped from the name to make the title less unwieldy. So here we are many years later celebrating the latest iteration: MLPW.

For 2016, ASCLS has issued a 30 day challenge urging laboratorians to write (each day in April) a short synopsis of another aspect of their life and experiences  in the medical laboratory. They suggest use of the hashtags #labweek and #lab4life.

Much has changed over these 40 years. We have seen regulatory changes, emergence of disruptive technology, nanotechnology and healthcare reform. But one thing has not changed: the skill, knowledge, competence and dedication of a cadre of medical laboratory professionals who work diligently, often behind the scenes, to advance the health of this nation.

To all my colleagues, I say: take a bow. You deserve it. Happy MLPW!

New Laboratorian Excited About Profession
March 26, 2016 5:09 PM by Glen McDaniel
As our profession ages and many of us lumber towards retirement, it is often hard to be optimistic. Many are burnt out and never miss an opportunity to tell those just entering the profession what a mistake they are making.

I monitor social media quite a bit, partially to feel the pulse of fellow professionals. I am especially interested in, and curious about, what young professionals like and dislike.  When they compare themselves to friends, family and classmates who took a different career route, are they satisfied or dissatisfied with their choice? Do they believe the naysayers who say this is a dying profession where its members are underpaid and under-appreciated?

With that background, I was reading posts on a medical laboratory site on Facebook a week or so back and came up on a post by a young MLS professional; in fact she is still a student.

This is what student Amber Hill wrote on her timeline:

Today was the day that I knew undoubtedly that I have made the right career choice.
I am currently a student and I will graduate next year. I work at a local family owned grocery store part time. There were some bad storms today and the entire town is out of power but my store has a generator (pretty much the only place in town that is open).

The wife of one of the doctors from my local office walks in the front door with a rack of blood and a centrifuge. She asked if she could borrow our power to spin down some blood so that it could be sent off to the lab. I of course jumped at the opportunity to help! (She couldn't even figure out how to open it, let alone balance the thing).

 I was ridiculously excited for an entire hour and all I was doing was spinning down blood!
If something as simple as centrifuging blood puts a smile on my face, everything else is icing on the cake.

Within 72 hours Amber’s post had got  received 339 “Likes.”  That made me very happy.

We are members of a very noble profession. But it’s easy to forget why we chose this vocation. It’s easy to get sucked into all the negativity. Here is a young student recognizing she could use her knowledge to be of service, to contribute (even anonymously) to patient care; and she got excited about doing it. She felt a sense of pride.

Sometimes it takes the simple things to remind us to check our own attitudes. If we have more Ambers out there, this profession will be in very good hands for years to come.

Laboratorians DO Influence How We are Perceived
March 20, 2016 7:19 PM by Glen McDaniel

A few months ago the physician group American Osteopathic Association (AOA) which represents osteopathic physicians (they use the credential DO instead of MD) embarked on a branding campaign for their profession.

Some clever marketer decided to use the physician credential and title the campaign “Doctors that DO.” What could possibly be wrong with that? Well, the idea was to use a series of videos and posters emphasizing that osteopathic doctors look at the whole person, they care about the entire patient  - as opposed to a body part. Patients are more than numbers. So far so good.

However in tooting their own horns they managed to insult and minimize others in the medical profession, and most of all medical laboratorians. Slogans like “A chart doesn’t empathize. I DO” and “Machines don’t  listen. I DO” are both clever and effective. However when they went down the path of “Lab Tests don’t listen, we DO” and worse slogans they started hitting dangerously close to home.

I, along with several other laboratorians, contacted AOA to share our concern.

The response was a dismissive: “Sorry you feel that way; that was not our intent.” Further emails and tweets to the organization only caused them to double down and respond in totally tone-deaf and condescending ways by admitting that indeed, “lab technicians are important.” While some felt that nothing ever changes and our voice never means anything, enough people were incensed to keep writing and discussing this issue publicly.

At some point ASCP got wind of the campaign and the significant offense that laboratorians felt. Well AOA finally backtracked after discussions with ASCP. They have agreed to suspend the campaign after March, to review the entire campaign in May, and to work with laboratory organizations like ASCP to advance common goals of patient care.

Who says your voice doesn’t count? Who says no one ever listens? They DO listen. Osteopathic doctors care about patients, but laboratorians DO as well. DOs educate others about what they do, but so can we if we just speak up, instead of accepting the status quo.

Do We Practice What We Preach? Part 2.
February 21, 2016 4:00 PM by Glen McDaniel

Clinical laboratorians sometimes complain, “Well, they didn’t ask the lab!”  As someone who has held administrative positions outside the laboratory, I noticed very quickly that the lab was not present at the table for many decisions.  Having come from the lab, I was not totally surprised.

What really shocked me, however,  was the claim from other stakeholders that the lab seemed disinterested and did not volunteer even when asked.  I was able to validate that reality when I personally asked the lab for input, asked lab representatives to join hospital-wide teams, to offer suggestions and to weigh in on decisions affecting them.  The response was often lukewarm at best.

The other responsibility of wanting to be taken seriously and to make decisions regarding our practice is that we have to be believable and put our money where our mouth is. 

If we are to be credible experts, then we must be certified and maintain current competency through continuing education.  It is irresponsible to support the contention that passing one examination 15 or 20 years ago affords anyone current competence. The vast amount of recently discovered knowledge and technological advances require much more currency than that. Ongoing education is essential to offer yourself up as an expert with any degree of confidence and credibility.  

Anything less is dishonest and unfair to those we serve. Another aspect of being the expert is being willing to put your foot down and call the shots when necessary in the interest of patient care, safety or ethics. When clinical lab services are being inappropriately used or prudent practices are not being followed, you should be willing to audit, document,  educate-and even report- rather than simply grumble or concede.


Another area of dissension between the laboratory and other departments, as well as among laboratorians is that we do not get the praise or recognition we deserve. Are you one of those individuals guilty of doing just the bare minimum required to get by, or do you go the extra mile? Health care workers, including laboratorians, are notorious for cannibalizing each other; often with biting criticism or setting up a hostile work environment.

Those of us who manage others should be aware of the effect of the feedback we give subordinates. Managers I speak with are often surprised that their staff feels unappreciated and demoralized and blame their managers for these feelings. When I speak with the staff, they complain of getting mixed messages, inequitable treatment, harsh criticism, negative feedback and little support.  Sometimes they feel they were never prepared for they job they are expected to perform-efficiently and error-free.

Equally surprising is how often such managers naively think the culture can be turned around and perceptions reversed simply by the odd pep talk or (mandatory) viewing of a trendy video with crashing waves, inspirational words, music and maybe a dove or two! Again, what a “disconnect.” This is schizophrenia, not inspiration; insincerity, not leadership.

We must do what we say we do, we must do the work it takes to be knowledgeable professionals, we must step out of the lab and inter-act with others, we must treat our colleagues with the respect we expect-and they deserve. 

Remember, habitual actions always speak louder than mere words.



Do We Practice What We Preach? Part 1.
January 31, 2016 4:11 PM by Glen McDaniel

Well today is my birthday and it's making me a little retrospective. As you all know I am not about making big resolutions based on the day or date; such as New Year's. However I did think back over my professional life today: what I have done, what impact I have made on the profession and what I would do differently, given a second chance. Then an unrelated conversation with a friend who is a pastor and counselor got me thinking more deeply about us in the medical laboratory science profession as a group.

We often say so many things, we are often so critical of others and we regularly bemoan how badly we are treated. That got me thinking about how much we do (or do not) always practice what we preach. Do we do what we demand of others? Do we exude a degree of professionalism commands respect?

Just look around and you will find many examples where actions speak louder than words.” For example, we constantly say how valuable and important we are as a profession. Then why is it that some of us are too complacent or busy to serve on hospital committees or performance improvement teams? How do we add value to providers and patients if all we do is follow orders and provide numbers?


We tend to be passive recipients of actions taken by others. Instead we should be bulldozing our way into every meeting where pivotal decisions are made that might impact the future of the lab or the delivery of laboratory services to the patient. Too many of us forfeit our hand in the game and unhappily settle for unwanted results.

The term “professional” is bandied about so much that its meaning has become unclear to most of us. Often we say we are not being treated as professionals, meaning we are not given the recognition usually afforded well-educated individuals with a unique, complex body of knowledge. Then why do we not belong to our professional organizations in larger numbers, or why do some willingly choose to be less than full members of any professional organization?

Why is our scope of practice (and the public) not protected by licensure in more states?  If our claim of professionalism is to be more than empty platitudes we need to act more consistently professional in dress and actions, conducting ourselves with dignity, confidence and resolve.

I would love to hear your thoughts on this subject. While there are many reasons for the state of affairs, I am more interested in solutions, rather than explanations for why things are bad and about to get worse.

I await your responses and will continue this conversation in my next blog with Part 2 of the discussion. 

What's Your One Word Resolution for the New Year?
December 31, 2015 6:13 PM by Glen McDaniel

It's that time of year again. I could hardly believe it when I was leaving work today and someone made the inevitable never-stale comment, "Well, I wont see you until next year." Today is really the last day of a very interesting  and eventful year.

Starting today and into the next few days, many will be laboring over New Year's Resolutions. They will pledge to lose weight, be more tolerant, be more assertive, work more, play more, and on and on.

As I have written before very few resolutions come to fruition. The sad reality is that many are discarded to the dustbin of time within days of being dutifully constructed and sworn to. The fact is many resolutions are just unrealistic. Others are made in a vacuum, with no plan as to how to achieve them. In any event most are made under pressure-from society, or friends or oneself.

For years, I have myself adopted - and recommend to others as well - a different approach. If you have identified a goal you would like to achieve, make it a SMART goal (specific, measurable, achievable, realistic and time-limited). You can set this goal at any time (not just the start of a new calendar year). Depending on what is, you may choose to keep it secret (it's no body's business after all) or you may share it so you have one or more accountability partners that will hold you accountable and help to keep you on track.

My other suggestion is to brain-storm by yourself. Yes, it's possible to sit by yourself with pad and paper and just write down what's important to you and what you'd like to achieve. Don't judge or censure; let the thoughts flow. Leave it for a while, put the pad down, sleep on it and then revisit your list. Is there a pattern? Is there one word or phrase that embodies and encapsulates  your goal (s)? 

Ok. Then write that one word down. That is the "resolution" that will govern you for the new year. We are teleological goal-seeking organisms. If we concentrate on a concept, look at it frequently, and absorb it, it is remarkable how we move towards that goal; sometimes automatically. We will meet people and "accidentally" find information or people that help us.

Faced with decisions in the new year, look at the choices through the lenses of your one-word resolution. What option would move you towards your goal and what actions would divert you, or prolong the attainment of your goal? 

So what's your vision for 2016? What one word describes the ideal state you'd like to achieve this next year. 

Write it down, look at it, digest it. I support you in your vision.

Here's to your best year yet!! 

Theranos Under Regulatory Microscope
December 22, 2015 8:04 PM by Glen McDaniel

Theranos has been in the news and has garnered both bouquets and brickbats because of its proprietary technology as well as its business model.

This company started by wunderkind Elizabeth Holmes and valued in the billions uses small samples of blood (often from a fingerstick) and runs tests on its own proprietary instrument. The value proposition is that  they are able to obtain small samples, less painfully, and then turn out tests (including full panels) in less time and at far less cost than traditional labs.

Theranos is not without political clout as well. They were able to get the FDA to fast track approval of several of their tests. They also mounted  a powerful lobby in  Arizona to shove through a bill allowing direct access testing (DAT) whereby patients can order their own tests. There is a huge market for DAT.

Traditional medical laboratory scientists have long been suspicious of the claims made by Theranos. Very few have seen the wizard behind the curtain. Little or no data have been peer-reviewed and published.  There have been reports of titular directors with doctoral degrees who are not medical laboratorians with the requisite knowledge and experience.

It was only a matter of time before employees or ex-employees blew the whistle. Largely as  a result of complaints from 2 former employees, both the FDA and CMS are taking a closer look at Theranos. Of particular interest is the fact that the company was told to discontinue use of their miracle nanocontainers. Employees indicate that the Edison, the magic proprietary instrument at the very heart of Theranos, is in fact only used to run a handful of tests; most tests are run on traditional instruments. How do these instruments accommodate the tiny volumes that Theranos collects? The reports are that specimens are simply diluted to volume and then a dilution factor is applied (even for normal specimens.)

Then there is the little matter of supposedly flawed and manipulated data from study protocols. Proficiency tests are performed differently than patient specimens. The list goes on and on.

I love advancement in technology, including in the field of  MLS. I embrace it. However if information is incorrect, or if data are being manipulated it is only ethical and just that such shenanigans be exposed. 

What's the case with Theranos? We'll see. 

French Hospitals Respond to Terrorist Attack
November 16, 2015 9:16 PM by Glen McDaniel

Through a friend in Paris, I was able to speak briefly with a medical lab scientist at the American Hospital of Paris. I was interested in getting an overview of how the hospital, particularly the lab, responded in the hours directly after the massacre and perhaps see if their protocols were similar in any way to what we are used to in the United States.

Yes, hospitals do have mock codes and disaster drills as we do.  About 22 30h (10:30p) on Friday the government declared a Plan Blanc (Code White) which immediately put all hospitals on alert and informing them to prepare for dealing with a mass casualty. Unlike our individual hospital plans here in the US,  in France Plan Blanc is a city-wide (sometimes nation-wide) plan where all hospitals prepare jointly, share resources and share communication in an emergency.

Phillipe (who unfortunately does not want to be identified by name since he was speaking off the record) said it started as a pretty routine shift for him. The Plan Blanc was announced about an hour after the shooting but he  actually heard about the attack shortly before the Plan Blanc. Immediately hospital staff: administrators, laboratorians, nurses and others opened floors, mobilized additional beds, readied operating rooms, mobilized ambulances, inventoried the blood bank and pharmacy and called in additional staff.

Because the metro was slowly being shut down, ambulances had to transport staff from their homes and sometimes moved staff among 7 hospitals in the same vicinity. No staff member was allowed to leave and many worked until Saturday around noon, sleeping when they could.

The terrorist attack coincided with a planned strike by unionized doctors and nurses (this is France, after all). Luckily the doctors called off the strike and decided to work.

Because of the fluid situation, most patients were transported to the hospital in contradiction of the French tradition of treating patients as much as possible at the scene of the accident. This time even the walking wounded were all brought to the hospital for security. Needless to say there was severe overcrowding and confusion.

By Saturday, communication went out that 53 patients had been treated and discharged but another 400 or so were hospitalized (at the various hospitals) with 200 classified as critical or serious. 

The most common tests requested were  basic metabolic profile and  a hemogram. Several patients were given type-specific uncrossmatched blood. They did as many immediate spin crossmatches . It was not clear from the conversation which was their protocol in emergencies.

By noon on Saturday, thousands of Parisians were standing in line to replenish the blood bank supply.

In a tragic twist, Phillipe found out on Sunday that a friend of his was killed in the attack on Le Stade de France. Another colleague had been brought in to his  hospital but he was not aware at the time, since many were identified initially by arm bands with colors and numbers. He ruminated about the possibility he might  have performed tests on his friend's sample.

It is interesting and heartening that wherever you are in the world, healthcare providers including medical laboratorians run towards the injured, and often place their own physical and psychological needs second while they save lives. 

Ours is a noble profession and we should never forget it. 

Labs Have a Role in Fighting Diagnostic Error
November 14, 2015 10:58 AM by Glen McDaniel

In 1999  the Institute of Medicine (IOM) published that seminal report, To Err is Human: Building a Safer Health System.

We can all recite the much-quoted statistics that medical errors result in between 44,000 and 98,000 deaths in this country each and every year. The report rated medical errors as the 8th leading cause of death.


It is a reasonable expectation that this stark reality, together with the adoption of best practices, and the advancement of medical technology would have improved that situation quite a bit in the ensuing years. But has it?


I just finished reading James Lieber’s  book, Killer Care:How Medical error Became America’s Third Largest Cause of Death.  His book paints a grim picture, as he summarizes studies and research over the years. He often refers to the cost of medical errors by using terms like potentially compensable events (PCE), adverse events and performing human factor analysis after an error. He also gives his prescription for tackling this huge problem.


An often overlooked cause of medical error is misdiagnosis.Because  the laboratory produces the majority of objective information used in medical decision making, the lab obviously plays  a pivotal role in diagnosis. In fact a  recent report from IOM estimates that misdiagnosis contributes significantly to at least 10 percent of patient deaths. 


Medical laboratorians working with other healthcare professionals  like physicians, nurses and pharmacists- as a team- could reduce this number. More than that, they have  a responsibility to decrease misdiagnoses and medical-error deaths.


AACC president David Koch, PhD supports this idea and points out that laboratory medicine professionals have a wealth of knowledge, a unique body of knowledge, that if properly tapped would go a long way towards better patient care. “If involved in day-to-day consulting (laboratorians) can provide vital insight to find better, faster and more precise answers to challenging health care problems” Koch states.


What has your organization, or you personally, done to contribute MLS  knowledge to improving the efficiency and accuracy of diagnoses? Do you ever intervene or go beyond the “well, he/she is the doctor” hands-off approach? I would love to hear from you.

Roche Launches Website for Lab Leaders
October 31, 2015 10:17 PM by Glen McDaniel


Like other professionals and interest groups medical laboratorians like to network and share challenges and wisdom with their colleagues. Social media has made sharing easier by developing professional websites and discussion groups.


Very often the emphasis is on the “how” and “why” of clinical skills. Sometimes there is a management aspect, but generally that does not take priority. Recently Roche Diagnostics launched a website for lab leaders and it’s named, very appropriately,


According to Roche President and CEO, Jack Phillips, was designed as a forum to bring together nationally recognized experts in fields like informatics, quality, pathology, operations, finance, leadership and more.


He continued, " lets you share game-changing insight on how you can re-imagine the critical role of the laboratory during a critical juncture in healthcare.”


The 5 target areas of the website are listed as leadership, financial, operational, and clinical and market forces.


This site looks promising, and sites like these always benefit not just from traffic, but the interaction of the target audience: you!



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