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Press Start: Lead an Empowered Life as a Clinical Laboratorian

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.

Take Yourself to Summer School
August 2, 2015 7:09 PM by Glen McDaniel

I was speaking to a friend who was complaining about how busy and tired she was this summer. In addition to working full time on the evening shift she has been shuttling kids to activities and summer camp. She has a seriously packed schedule which starts early in the morning and goes all day..


“I can’t wait for the kids to go back to school,” she bemoaned. "The kids are out of school, but it's like I am in summer school."


Her schedule is such that  sometimes it’s not worth her while to go all the home between “pick ups” and “drop offs.”


Having had a long commute years ago where I worked 140 miles from home and only made it home on weekends, I developed ways of occupying myself during the drive. I listened to books on tape, MBA audio lectures and even studied lines for whatever community theater play I happened to be in at the time.


The bigger point is that down times, long commutes, or those annoying wait times can be turned into opportunities for acquiring new knowledge and skills.


If you have been placed on the night shift and have downtimes  when you twiddle your thumbs, that’s a great opportunity to study for an online degree or learn some new skill in another laboratory department. If you work on weekends and have odd weekdays off, those are the best days to pamper yourself, have alone time and run errands when most of the world is at work.


But back to my friend shuttling the kids. She found a park close to the center where her daughter does dance; so she often takes the opportunity to walk and get some exercise in. For some reason she never learned to ride a bike really well, and has now made friends with a lady who is teaching her to ride a bike, while her new friend’s teenage son is teaching her to skateboard (!) in exchange for English lessons. It’s like she is now in her own Summer school-and enjoying every minute of it. How cool is that?


Those are pretty simple examples. But you can always use inconvenient times to your benefit. Just look around and see how you can fill those moments not simply with with busy-work, but with something worthwhile; something that will add value to your own life.


Try it and see the difference it makes.

Celebrating Differences
July 26, 2015 3:56 PM by Glen McDaniel

There are differences all around us: at work, in society, and even in our own family or circle of friends. We tend to focus on the differences a lot. Just look at the news and see how all of societal ills are being blamed on those who are different from us.


This weekend I have been catching up on my reading. I just read several Facebook posts on MLS-related pages where several posts are recounting negative interactions with nurses and doctors. As a profession we tend to make sport of the “stupid things” nurses and doctors say and highlight how they think differently from us. It’s always “us versus them.”


Psychologists describe how individuals develop and act on biases based on the concept of the “in group” (those like us) and the “out group” (those who are not like us). We construct in/out groups for individuals, cliques, communities, organizations, races and entire countries. Think of some countries which are like America. Now think of countries which are unlike America. Then ascribe negative and positive qualities (actions, expectations, morals, values) to each. See how we place higher values on countries which are more like ours?


The same thing happens in professions of course. It is especially tempting to make fun of, and demonize, professions that we think exert some imbalance of power against us.


I just happen to be reading a book called “Us Plus Them” written by Professor Todd Pittinsky. In fact, going back and forth between Facebook and this book is what prompted me to write this blog. Pittinsky explains in convincing, if obvious, terms why differences and diversity should be valued. We can capitalize on differences to make interactions more effective. When individuals with varying points of views, or representatives of different professions, serve on a team (in a lab, in an organization, for example) we can draw on the strengths afforded by the diversity.


One reviewer has this to say about Pittinsky’s book, “Us Plus Them upends the way we look at relationships. No more zero-sum games; no more clever nuancing around human differences. A key challenge of leadership is harvesting the gains that arise from the basic incongruities of our collective humanity. Pittinsky’s original perspective is destined to create healthy controversy and healthier organizations.”


I continue to suggest that we draw in multi-disciplinary teams whenever we can, whenever we want to get ideas or make changes. This way we build relationships, build up relationship-capital for later, get different perspectives and ultimately arrive at better outcomes. This is especially important in healthcare. where patients are the ultimate beneficiaries.


Each nurse-doctor/lab interaction which now forms the basis of a new joke and ridicule on Facebook can become a teachable moment. It’s a natural side benefit that we learn and become better human beings as well, whenever we teach or listen.
Is Proficiency Testing Enough to Prove Accuracy?
July 4, 2015 6:07 PM by Glen McDaniel

 Proficiency Testing (PT) is just part of life for most laboratories. Laboratories are sent challenges (unknown samples) which they test like patient samples and then submit their results. An agency like CAP then grades the result against those submitted by peers using the same test system. Your lab is considered as doing a good job if your results are close to those of the peer group.


Statistics like standard deviation and SDI give the impression the results generated are being checked for degree of accuracy. But are they? Well not really, the mean is used as a surrogate for the correct value and the variation from that mean is then regarded as the degree of inaccuracy (bias).


But PT materials are not patient samples and often additional material is added to preserve and stabilize the samples. How do these additives change how samples react? To assume that closeness-to-peer indicates “correct” accurate results is to be overly optimistic-and wrong.


Additives - and even shipping and storage conditions-  introduce matrix  and other effects meaning the PT sample used to give you that “atta boy” is in fact not directly comparable or commutable to a fresh sample from your patient.


So what if we just made allowance for that knowledge, knowing PT is not perfect but it’s the best we can do right now?  However that assumption raises another issue. How can we be completely sure that our test system (say an analyzer with a certain reagent) is in fact producing accurate patient results. Calibrators and quality control material often have matrix effects as well. Then there is the additional issue of comparability among various test systems.


Suppose research shows that a clinical condition has certain cut points or diagnostic targets. Given the degree of uncertaintity and variation how can a clinician be confident making clinical decisions based on such results? We are already familiar with harmonization for cholesterol and with the use of INR (versus PT)  to guide warfarin anticoagulation. In both cases there is much less inter-laboratory variation than there used to be.


That brings us to the areas of accuracy and harmonization. Accuracy is “trueness of result” while harmonization is a system of ensuring results for an analyte are truly comparable; even performed by different methods, at different sites, on different platforms.


CAP has recently introduced Accuracy-Based Surveys for various analytes like lipids, Vitamin D, Creatinine, testosterone and Hemoglobin A1C.


Participation is a totally voluntary process and laboratories might not want to subject themselves to extra scrutiny and the possibility of “failing” even if results are within the peer group. One advantage of the Accuracy Based Program (ABP) is that manufacturers can re-evaluate their products (reagents and test system) and even revisit their calibration traceability.


Wouldn’t it be wonderful if your PT results indicated how you were doing in an absolute sense, and not simply compared to your peer group who may have the same bias? Wouldn’t it be great to have tests systems giving equivalent results across platforms and laboratorians and clinicians having the confidence that their “numbers” are both accurate and comparable and can be used to confidently guide patient care decisions?


What’s Your Style?
June 28, 2015 4:44 PM by Glen McDaniel

Have you ever found someone very difficult to work with no matter how you try? On the other hand you find others who consistently seem to adjust, cooperate and understand even if things don’t go as planned.


We all have different personalities and behavioral styles so it is probably unrealistic to expect all personalities to mesh. However in our increasingly diverse workplace it is important to at least learn how to have a collegial working relationship with a wide variety of individuals-with many different personalities.


There are various psychological tools for determining personality styles. One very popular one that has been around for quite sometime  is the Myers Briggs Type Indicator (MBTI)  Test.  Another is the DISC Personality style test . DISC stands for Dominance, Influence, Steadiness and Conscientiousness.


In any communication it is important to recognize your own style:  how do you perceive the world, where do you get energy, how do you relax, what pushes your buttons, what do you consider important, what do you require from colleagues and bosses?


Then the next step is recognizing the personality types of others you interact with on a regular basis. Like a lock-and-key you then adjust your actions and emphasize certain behaviors while minimizing others.  In that way you can indeed work with a variety of personality types and have a harmonious, productive working relationship, even if you are not personal buddies.


Let’s look at the DISC personality style more closely, as an example of leveraging personality types.


D (Dominance) is typical of a go-getter who relishes fast-paced activities and is task oriented.


With that type of person you want to engage them by being more fast paced (matching their style) and direct. They might not want to chit-chat about personal events in your life. They are the “just the facts” types and like executive summaries with the bottom line clearly stated. They eagerly take on challenges. They want deadlines and respect those who set and stick to deadlines.


I (Influence). This is also called the Promoter type. They like a fast pace but are very people-oriented. They like working in teams and will probably preface each interaction by discussing their family or asking about yours. Relationships are important to them. They enjoy a compliment or a good joke and will react favorably to either. While deadlines are important they will understand if a family emergency impacts a project temporarily.  The Influencer employee craves recognition.


S (Steadiness). This type, also called the Nurturer, tends to operate at a slower, more deliberate pace and is very people oriented  This is the typical laid back, congenial individual who will seek input, try to get consensus and consider the impact of change on all stakeholders. Consistency, dependability, honesty and incremental change are important to them.


C (Conscientiousness) or Examiner type enjoys a slow pace and is task oriented. This person is likely to create lists and pore through data. They will analyze before they come to a well-reasoned conclusion. You impress this type most by proving competency, discussing statistics, data, trends and research. If you direct this person you might have to rein them in, because they will tend to research and re-analyze all the way up to the deadline.


If you work in a team (and everyone does to a degree) it can be useful to know the various personality types on that team.  Depending on the task at hand it might even be useful to select certain personality types for a particular project. The good colleague or manager plays to the type of the other individual in order to have a more effective, productive  and harmonious relationship.


It is important to remember that this is not about being fake or changing your natural personality. Rather it is learning a valuable skill that will pay off  handsomely both in your professional and your personal life.

Who Inspects the Lab Inspectors?
June 13, 2015 9:02 PM by Glen McDaniel

Labs are used to being regulated. It seems they are always preparing for inspection by the state, CLIA or some accreditation agency-or two. Very often laboratories think inspectors are being too hard, or picky, or even plain wrong in the way they interpret the standards and grade the laboratories.


My last blog discussed a very harsh critique of the laboratory profession written by a journalist. One of her claims was that not only was it near impossible to get access to specific accreditation records, but the accreditation process itself may be flawed. In that regard some laboratorians might agree with her.


I have been a member of several laboratory inspection teams and I observed  several differences in approaches, thoroughness and (yes) even interpretation of the standards. One big area of difference is the subjectivity of determining whether certain documentation does indeed prove adherence to, or fulfilment, of a certain standard.


Part of the reason for the difference as I have also discussed previously is the fact that agencies like the Joint Commission and COLA use professional inspectors while CAP uses volunteer peer-professional inspectors. It’s logical to think the use of part-time volunteers might increase variation between visits -and even during a single accreditation visit.


While accreditation is voluntary, licensure and certification are mandatory. Under CLIA, CMS has granted most accreditation agencies deemed status which essentially means CMS will accept the accreditation visit/finding in lieu of conducting its own visit. State agencies will often perform the role of CLIA inspector.


So how can a laboratory be sure that its accreditation agency is being not just fair, but accurate as well? CMS does routine validation of a subset of inspections. CAP indicates that CMS will routinely re-inspect about 80-120 CAP-accredited labs per year. They then look for differences in findings. Such differences are called disparities or misses.


So how much of a difference is considered acceptable? In the last round of summary reports produced by CMS they found a variation of about 17 percent for CAP-accredited laboratories. A disparity level of 20 percent is the benchmark at which CMS takes a closer look and reconsiders its deemed status. In fact they perform a “deeming status review.”


So are validation visits more likely to find “something missed by CAP or another inspection agency,” or are they more likely to overturn an adverse finding? Details are hard to come by, but it appears the former is more common.


Are discrepancies more likely to show up in some standards than others? Yes, it seems the following 5 areas are the primary source of disparities: test validation, proficiency testing, competency, personnel records and responsibility of the medical director. Given this knowledge and the fact that a validation is more likely to mark you “down” these should be considered areas of high concentration for your lab.

More Negative Press for the Laboratory
May 17, 2015 1:58 PM by Glen McDaniel

 A little while ago I wrote a blog in which I referred to a great, balanced, intelligent article written about the medical laboratory  and printed in The US News and World Report. That article was remarkable by its rarity. I asked my readers to respond directly to the writer, thanking her for a positive article. Many of you contacted the journalist by email and Twitter, much to her delight.

This morning, another article crossed my desk. This one is a hatchet job written by a journalist for the Journal Sentinel. It is an indictment of the laboratory written using sources who have been harmed from inaccurate results generated by laboratories. Everyone from accreditors to MLSs/MLTs are assigned blame. Reference is made to shoddy habits like the use of expired reagents and mixing up samples.

To read this article it seems like there is no standardization, there is no quality assurance, and every lab test has the potential of leaving ruined lives in its wake.

Some of the "experts" who commented for the article are laboratorians and I would like to think they were misquoted or their words were taken out  of context. It's disheartening to think fellow laboratorians would allow such a biased and unbalanced piece to see the light of day.

There is a lot of buzz on social media about this article: mostly hurt feelings and righteous indignation. But as I pointed out on Facebook, commiserating among ourselves is not going to educate the journalist or the public; and will not change anything.

I strongly suggest you read the article and weigh in here. Feel as indignant as you want to, but , more importantly, respond by contacting the journalist ( reached at egabler@journalsentinel.com or (414) 224-2071) and her editor.

Five Tips for More Productive Meetings
May 16, 2015 4:56 PM by Glen McDaniel

Sometimes it seems like those of us in healthcare just love to hold meetings. We seem to even hold meetings simply to figure out how to plan more meetings. Not surprisingly, as busy professionals, always on some sort of deadline we hate attending meetings as much as some people love holding meetings.


One reason that meetings are so dreaded, other than the sheer volume of them, is that they are often not very productive.  Since some meetings are in fact necessary, it’s important to know a view hints that can make your meeting more productive-and less dreaded.


Get clear about the reason for a meeting.  This seems like a no-brainer, but too often we think about the reason to meet in vague terms or try to squeeze too many subjects into one meeting, “While I have everyone together” is a common justification. Big mistake. Some attendees will be totally disconnected and the presenter will be less focused if the agenda is too loaded.


 State the purpose of the meeting simply and clearly in the invitations. That way invitees can start thinking about the subject. Their contribution is likely to be more considered and thoughtful that way.


Set a time.  I mean set a time literally and figuratively. Yahoo’s CEO Melissa Mayer is known for holding 10 minute meetings. Some studies show that 15 minutes is the ideal time for a meeting if the goal is to be focused and productive.


I have found that even for a staff meeting where you might discuss several items and solicit feedback from various individuals, a 1-hour time frame is the maximum. In any event set a timer and wrap up quickly (no matter where you are on your discussion list) as soon as the timer goes off. Meetings are not the time and place to do research and in-depth thinking.


Assign extra detailed work to a subgroup. If discussions are running too long, schedule another meeting later on. You will get more accomplished in four15 minute meetings than you will in a rambling  1-hour session. Say goodbye permanently to long drawn out gatherings unless the goal is to leave everyone feeling numb, uncommitted and frustrated.


Ban phones. This seems to be a no-brainer but we all know how distracting it is when someone’s cell phone goes off, they break the mood, apologize and turn it off. Then it happens to someone else.  Some of us “live” on our smart phones so it becomes a habit for many  to constantly check their phones even during a meeting.


Have a basket or bucket to “check” phones that made it to the meeting. It is not enough to just ask that they be silenced. The tradeoff for a long meeting is a much more focused meeting while actually engaging all the stake-holders' undivided attention.


Assign A Directly Responsibility Individual.  If a task has to be followed up on, assign the responsible individual publicly in the meeting.  The DRI (another trendy term) should know exactly what to do and be given a deadline for getting it done. Don’t be vague and don’t assign to an entire group (unless it’s for the group to meet and work out details).


Don’t abandon tips that have worked up till now. It is still good practice to have an agenda, send out the agenda before the meeting, send out a draft of the minutes and ask for corrections before distributing the final copy of the minutes, use email rather than distributing hard copies if at all possible.  All those habits still make sense.


The big danger with unfocused untimed meetings is that any activity tends to expand to fill the time allotted. If there is no drop-dead time, discussion just goes on much longer than necessary. If you can make just one of the changes above in the short term, I suggest setting a time-limit and sticking to it. Over time your attendees will learn to come prepared to work and get out. Your staff will be grateful and you will surprise yourself at how much more productive your meetings are.



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