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Press Start: Lead an Empowered Life as a Clinical Laboratorian

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, LabLeaders.com.


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


He continued, "LabLeaders.com 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!

Miss America and Nurses and Medical Lab Scientists
September 19, 2015 3:29 PM by Glen McDaniel

A few days ago during the Miss America televised pageant one of the contestants, Kelley Johnson representing Colorado, presented a somewhat unique “talent.” Instead of singing or dancing or twirling a baton, Johnson, a registered nurse, came on stage in scrubs, a stethoscope slung around  her neck and proceeded to highlight the value of nursing by reading aloud emails from one of her patients with Alzheimers.


The hosts of the daytime chat-show the View  then poked fun at the selection of this “talent” and even questioned the use of a stethoscope as a prop.


This criticism quickly elicited pushback from nurses, nursing organizations, and other individuals. Such was the negative reaction that The View went overboard to highlight nursing through tributes, guests and mea culpas for several days.


Advertisers also reacted, hitting ABC in the pocket book. Industry giant Johnson and Johnson, an avid supporter of nursing over the years pulled their ads from the shows; as did Eggland’s Best.


Other networks quickly picked up the story and interviewed not just nurses, but others with sympathetic views toward the nursing profession.  Many detailed  first-hand experiences of the dedication and skill they had observed  in their interaction with nurses.


This morning on MSNBC an author, Alexandra Robbins, appeared as a guest to talk about her admiration for nurses gained from following several nurses around for a couple years in preparation for writing her book The Nurses - which she just happened to be promoting.


I do not want to play the “me too” game, or feed the “poor me” we-get-no-respect philosophy that many in our profession subscribe to. However I have to question the odds of  a laboratorian highlighting the profession given such a public stage. Just follow this to its logical  conclusion: if  the MLS profession received public criticism (as happened recently in a newspaper article), how many of us would push back so publicly and vigorously? Which of our vendors  (commercial laboratory giants) would pull their ads and go to bat  for us?


I wondered: would anyone follow a laboratorian around and detail the skill, knowledge and critical thinking demonstrated on a daily basis? Would they find it "sexy" to highlight the diagnoses made or lives saved through information provided by a medical laboratorian? Maybe they could start with the patient, follow the specimen through the laboratory and then loop back to see how MLS influences diagnosis, treatment, monitoring and eventual clinical outcome.


I made that suggestion to Ms Robbins. She did not make a commitment but at least she retweeted my tweet to her. She may be reached through her website at http://www.alexandrarobbins.com/  and her Twitter handle at @AlexndraRobbins 


I bet that  book would be a great read!

Has Theranos Passed the Sniff Test?
September 12, 2015 3:10 PM by Glen McDaniel

Just a few short years ago healthcare technology company Theranos burst on the scene. This company founded by a non-scientist college dropout Elizabeth Holmes is now a billion-dollar success story.


Holmes’ differentiating edge is to make lab tests available easier, faster, cheaper and using micro samples instead of the traditional multi-tubes of blood.


She believes that the healthcare consumer should direct their healthcare. Part of the Theranos gospel is the belief that if testing were more widely available (faster, cheaper, easier, a less painful collection) then many diseases could be diagnosed earlier and more effectively treated-or even avoided completely. So far Theranos has partnered with Walgreen pharmacy to offer the in-pharmacy collection of micro samples which are then sent to Theranos labs for analysis where the results are then turned around rapidly.


Cost is also a differentiator. As an example, Theranos charges around three dollars for a typical cholesterol test, while the traditional lab might charge around fifty dollars.


In the interest of direct access testing (DAT) and a more empowered patient (not to mention creating a huge market for itself) Theranos aggresively backed a new law in Arizona that gives the public wide latitude in ordering their own lab tests.


Scientists, being conservative and suspicious by nature, have looked askance at Theranos. Where are the peer-reviewed studies showing the science behind microanalysis? How is it possible to offer such large panels from a single fingerstick? With the collection piece performed by individuals with a variety of training, and done in a variety of settings, how do they guarantee the integrity of the specimens? Where are the comparative studies and correlations?


Theranos  has been largely silent and has not even responded to critics convincingly. However several of their tests are FDA approved. Recently the FDA also cleared the use of the Theranos nanotainer tubes and the proprietary Theranos analytical software. In that same clearance the FDA cleared an HSV-1 test that Theranos had correlated using blood collected in their nanotainers and run on Theranos systems against traditional venous draws analyzed by an FDA cleared commercially available reference method.


The mystery has not been completely solved. The suspicion is still there. But this is a step in the right direction.


Holmes' goal of a financially successful company offering a wide variety of lab tests directly to patients using microsamples collected at convenient sites and tested on robust equipment, delivering accurate results with a short turnaround time, sounds too good to be true.  Is it?
Are You Ready for ICD-10?
September 7, 2015 4:07 PM by Glen McDaniel

Come October 1st, 2015 Medicare will only accept claims (with a date of service on or after October 1, 2015) if they have a valid ICD-10 code. Is your lab ready to meet that directive?


Clinical laboratories are required to submit accurate and complete diagnosis codes in electronic and paper claims to third party payers. ICD-10 introduces more than 100, 000 new diagnostic and procedure codes that will impact diagnostic description and ultimately reimbursement. With ICD-10 comes greater specificity, including age and gender related codes. Claims with insufficient diagnosis coding can trigger denials, requiring both the lab and the provider to invest labor and time to resolve and, very often, creating inconvenience for the patient. It is imperative that the most specific ICD-10 code is provided to avoid these scenarios.


What has your lab done so far to prepare for ICD-10? Many organiazations have mounted massive education campaigns for staff using material developed inhouse, or by third parties including CMS itself (www.cms.gov/ICD10)


However, even labs that are very aggressive have to ensure that testing and care are nor delayed by assuming too aggressive a stance in terms of not performing testing until ICD-10 code has been attached to a test request. Some labs have developed a crosswalk to more easily “translate” an ICD-9 code into the most appropriate ICD-10 code as a last resort.  This is a strategy specifically recommended by American Clinical Laboratory Association (ACLA).


I  am interested in  hearing out your opinions of how laboratories will be affected by ICD-10, your readiness and strategies that your lab is using to meet this mandate. 

Why are Pharmacists Practicing Medicine?
August 30, 2015 6:31 PM by Glen McDaniel

A few days ago I was speaking to a physician, an ID specialist, who shared how frustrated he was with, as he put it,  “pharmacists telling us how to practice medicine.” He is a member of a healthcare organization which, like many today, has a fairly specific formulary. Physicians are restricted as to the medications available for routine use. All off-formulary orders must be justified to various degrees.


Pharmacists have done a phenomenal job in driving better medication utilization. They serve powerful roles on pharmaceutical and therapeutics (P&T) committees where they not only offer guidance, but also critique on medication use. They have procedures and protocols meant to effect more efficacious use while controlling cost.


In many organizations clinical pharmacists guide anticoagulation therapy and direct therapeutic drug monitoring (TDM). In states like Georgia pharmacists order and and in some cases even perform some laboratory tests. Lately pharmacists have taken to administering common vaccines as well. Again in Georgia state law has been modified to increase the scope of pharmacists who have a strong lobby (including pharmacy-legislators).


I understood the frustration of my physician friend who, as he explained, was recently constrained form ordering the expensive Zyvox for a patient with several gram positive organisms showing resistance to the on-formulary medications. His latest outburst was prompted by a block from ordering Synercid for another patient.


My thought immediately went from empathy for the ID doctor to a comparison of how far away from controlling utilization the laboratory profession is right now. We do have small utilization projects from time to time, but generally we are far from being able to dictate laboratory test selection and interpretation. I have long advocated a laboratory formulary.


This doctor probably had reason to be frustrated, but for the most part pharmacy expansion of scope of practice has been accepted (and even welcomed) by the medical profession and by administration.


Medicine is a team sport and we all have to work together. That should mean drawing on the expertise of each professional role. We have different bodies of knowledge and add value to the patient in a different way. Exerting influence should not mean overstepping your expertise, but it also should not mean a physician with little a laboratory training, overwhelmed by data dictating medical laboratory utilization.

AACC Issues Position Statement on Personalized Medicine
August 8, 2015 10:14 PM by Glen McDaniel

The AACC recently issued a position statement on personalized medicine(PM). Much has been written about the emergence of a more individualized approach to medicine.  Patients often present with a variety of symptoms for the same disease and react differently to the same treatment.


The laboratory will play an increasingly important role in personalized medicine.


The exciting thing for Medical Laboratory Science is that there is a scientific (usually genetic or genomic) explanation for how patients react to various medications. The presence or absence of  a gene often influences  metabolism or overall sensitivity. Types and dosages of several medications are often customized for patients with diabetes, cancer, coagulopathies and the like. In other cases, a gene could indicate a predisposition for developing a certain disease and so on.


Since MLS plays such a pivotal role in personalized medicine, AACC put forward certain positions in its statement. For one it suggests Congress should increase funding for more research in PM tests. They also urged the FDA not to adopt policies that would, in effect, stifle test innovation.


Reimbursement from Medicare, Medicaid and private payers  should cover PM tests adequately under the Coverage with Evidence Development program. This is especially important since the increasing concentration on cost savings does not provide an incentive to adequately cover conditions that may affect only a relatively small subset of the patient population.


Another position is that laboratorians must assume the role of educating clinicians on the availability, advantages, limitations and interpretation of PM tests. Drawing from areas like clinical pharmacy the laboratory should work jointly to provide guidelines and algorithms for testing. They should consider producing reports with more interpretive guidelines.


As medicine advances, and as payers  increasingly concentrate on outcomes and evidence-based practice, I think we will find that laboratorians will have more opportunities. It is up to us to assume a more expanded role as these opportunities present themselves.



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