For several years now there has been talk
about a doctorate in Medical Laboratory Science (DCLS). This idea was advanced
by ASCLS to support the idea that medical laboratory science has a unique,
distinct, significant body of knowledge that MLS practitioners should be able to practice independently as do
other professionals with similar education and training.
developed and published a substantial toolkit which
serves as a reference for educators wanting to craft and offer a DCLS program.
Professional groups worked with NAACLS, the agency that accredits MLS programs,
to develop standards and guidelines for accreditation of DCLS programs
recent years many professions that contribute significantly to patient care
have asserted their right to have their own doctorate, with pharmacists being
the most well-known non-medical “doctor” in the healthcare setting. Others like
physical therapy have also advanced the idea of a doctorate as an entry level
the hard work that has gone into floating the idea of a DCLS, very few schools
have made the leap to actually offering such a degree and enrolling students. I suspect it might even be difficult to convince universities to authorize a new program without a clear return on investment for the university.
think there are several reasons for this lackluster response to the DCLS:
MLS practitioners still think of themselves as “only techs” and do not believe
there is a viable option for advanced practice or a more significant role in
health care for “lab techs.”
contents and goal of a DCLS curriculum are not clear. Even those who support
the idea of a DCLS describe the ideal program in several very different ways. Will a
DCLS focus on clinical research, advanced practice, clinical consultation,
directorship of a medical laboratory? All of the above? Will there be the
option to specialize in one area, as pharmacists often do, for example?
no clear or reasonable assurance of a niche in healthcare, few want to expend
the time and finances involved in completing a doctoral program
healthcare administrators nor pathologists are advocates of the DCLS role.
Healthcare administrators are concerned about increased labor cost, while
pathologists might fear competition and usurpation of their role as “the lab
requirements for DCLS programs seem very rigid. One program says “Only those
with an MLS(ASCP) will be admitted.” A
successful program, especially one that is largely experimental should be more
flexible, offering online options, allowing specializations and so on. This can
be done while maintaining academic rigor. Just look at the flexibility of many advanced
practice nursing programs.
I continue to be an advocate of the DCLS idea, I feel more needs to be done to
clarify the role, to market the benefit to employers and regulatory agencies, and
to make the degree more attainable.
is unlikely that the DCLS will catch on as a first professional degree (as the
MD or PharmD) needed to enter the profession.
If folks balk at the idea of professional licensure (for professionals
who already meet the requirements for licensure) they are unlikely to go for a
higher entry-level degree.
DCLS is much more likely to be an advanced practice degree, gained after a
first degree (and some experience) where the practitioners assume roles over
and above that of the “typical” bench MLS/MLT. The question remains “What
The DCLS is unlikely to gain popularity until that question is answered satisfactorily and all the players (MLS practitioners, clinicians, employers, regulatory agencies
and even the public) can see some benefit for themselves.
In casual conversation we use the terms cost, price
and value almost interchangeably. That might seem to be just semantics, but I
think we send mixed messages or act inappropriately when we start believing these
concepts are identical.
Anyone who has a teenager probably knows all too well how they
are guided by peer pressure. All the girls tend to wear the same fashion. Young people of
both genders hanker for the latest “trendy” shoes, gadget or new toy. To many
the cost does not matter and the sellers (knowing the demand) over-charge accordingly.
A friend of mine told me his son who is unemployed
borrowed $200 to acquire a pair of sneakers because they were the “it” shoes of
his generation. I have driven a luxury car for the past few years but as it
aged the repairs became never-ending and very expensive. So I traded it in for
a sturdy, dependable Japanese car and am shocked at the many comments I have
received. You would think condolences are in order because I have been “reduced”
to a non-luxury car with much less status.
OK, so that gets me back to the various terms I
started this blog with. I am writing this not only because of recent experiences, but because I believe they have
significance to all our personal lives and also our professional lives. How do
you value yourself, your colleagues and your profession?
Let’s just define those key terms simply, instead of using the formal economic definitions.
whatever is spent to produce goods and services. So it might be what Toyota spends
to make a car, how much Apple pays a worker in Asia to make an i-phone, or how
much your employer is out of pocket to have you work for them (recruitment,
salary, benefits etc).
Price: is the what is charged
or received by a seller. Again, using the car/employer analogy, it’s what someone
pays the dealer for a Camry, or what your employer pays you to do a job as a
phlebotomist, MLT or MLS for them.
is whatever the customer believes a certain good
or service is worth. Value is a much more subjective quality, but it is what
really drives the price. The perceived value of "it" sneakers or an I-phone have very little to do with their respective cost of production. You can look at various professionals and realize that pay
is not commensurate with education, work ethic, competence, service provided and so on.
neighbor was willing to go into debt and pay hundreds of dollars for a pair of
sneakers because of the value he assigned to those shoes. Employers will pay certain employees more because of their perceived value in the organization.
We tend to regard anything with a high price tag as
being valuable, or more significant and important. The converse is also true:
if we can convince a customer or employer that we are valuable, important,
critical, crucial to their success, then our value increases.
These might appear to be subtle differences, but not
knowing the difference often results in being undervalued and underpaid.
Here’s to recognizing and explaining your value (and
fetching an appropriate price) as you move into the New Year
Think about the people you know professionally; and
most likely the majority are also laboratorians. That seems logical because you
interact with colleagues at work. Maybe you belong to a local professional
group or even a national membership organization. You might even know the
majority of medical laboratorians in your city. That makes sense.
But think for a minute about the many professionals you
know who may help in your career or who you can use as a resource from time to time.
Research conducted by Ronald Burt at the University
of Chicago School of Business finds that our personal and professional lives
are richer and more productive if we build bridges with others who are
different and with whom we would not normally interact. This is called bridging
Certain individuals and groups seem naturally connected to
certain others; often comparing similarities and exchanging thoughts, ideas and even
Burt says social capital, on the other hand, is created by brokering
connections by otherwise disconnected segments. All parties benefit from this symbiotic structure.
By the way, this is not the same as networking which is a
deliberate strategy of expanding your list of contacts so that you can call on them
periodically if needed.
You can deliberately bridge structural holes by
creating associations outside of the laboratory: in your organization, at
church, in a volunteer organization and even online. Sometimes
it takes someone with different experiences and frames of references to
bring a new perspective. They can identify strengths, weaknesses and even holes
in your logic that you cannot see. In return you can garner support and even borrow ideas of how to
solve a problem you are grappling with.
The great thing about bridging structural holes is
that it is mutually beneficial. Many processes or lines of thought which are traditionally
connected with scientists can be beneficial to those in business, social
science and other areas. The reverse is also true. I cannot count the many times I have been complimented on my ability to analyze complex material or my keen attention to detail. These traits come naturally to scientists, but not necessarily to my friends in business, some clinical disciplines or even journalism.
When you adopt (or adapt) someone’s ideas you don’t even
have to tell them, and you can avoid the sense of obligation of having to constantly
ask for favors.
Here's the take-away. Deliberately court relationships with others “not
like you” and observe how they think, the logic they use, they tools they have,
the resources they draw on. Learn from them as they learn from you.
Chances are you will find something useful that will
benefit you in your personal or professional life.
year is winding down and it is traditional to start looking forward to the next
year. This is the time of year when we traditionally start thinking about what
changes we will make in the New Year.
have already started penning their New Year's Resolutions. May I suggest that
before you jump into crafting the year ahead, you review the current year. Get
pen and paper and be brutally honest. It might take several sessions. If necessary,
leave your list and come back to it after some hours (or a few days) of
contemplation and memory recall. Analysis of personal and professional
successes and challenges often come up with similar issues; a theme if you
worked well? What did not? What issues kept popping up? What challenges were
there? Those should be the areas on which you focus your attention. Is there a theme? You might
find, for example that both personally and professionally time management or
life balance were challenging. If so, how can you commit to doing things
differently in 2015?
am not a big advocate of lists or promise-to-do resolutions. I have blogged
about those previously.
Since areas that we want to
work on or goals we want to achieve tend to have a theme, I suggest (as I did
that we concentrate on a vision for the new year.
Holding that one grand idea helps to focus attention and keeps you in check as
you measure significant actions against
that vision, “Will this action (move,
job, school, relationship, expenditure etc.) move me closer towards my grand goal
I received scores of emails from individuals who have
found this concept useful, so I submit it to you as well.
Here’s wishing you a very happy, prosperous and
successful 2015, and please share your insights and successes with us!
As we come towards the end of the year several publications generate lists, perform annual reviews and select the most newsworthy items for that year. One eagerly anticipated “contest” every year is the Time Magazine Person of the Year (POTY).
This year Time chose “The Ebola Fighters” as their POTY. “They risked and persisted, sacrificed and saved,” says the preamble to the declaration. They even waxed poetic by adding, "Not the glittering weapon fights the fight, says the proverb, but rather the hero's heart."
I totally understand this choice given the focus on Ebola this year, and the fact that for the first time in the history of the disease Americans were affected in a real way. It is human nature to attach more importance to matters that affect us than those that occur far away.
However, if the POTY needs not be one individual, and if the honor is to recognize those who have made a real impact on the world, then I nominate (and select) the Medical Laboratory Professional.
These professionals-scientist, technician, specialist, pathologist-work tirelessly all year to be medical detectives, ferreting out the cause of disease, monitoring the effectiveness of treatment and helping to maintain health. This might not be a showy endeavor that makes the news, or even attracts the attention of patients and other healthcare providers, but it is vitally important work. In fact it is essential.
I suggest that the real heroes are those who not only perform yeoman duty every day, but continue to do so despite the lack of public recognition or even compensation commensurate with the value they contribute to the public’s health. It is not the "glittering weapons” of analyzers and “toys” in the laboratory, but the talent, competence and heart of the laboratorian that really make the difference.
Like everyone else I read the annual lists and honors, but I choose to salute you, my fellow laboratorians, individually and collectively, as The Person of the Year!
Bigger is not always better, it turns out. It seems our appliances, gadgets and instruments are getting smaller; or at least coming in smaller versions, even as they have more capability.
I was watching an old crime movie this past weekend and burst out laughing when a detective pulled out a cell phone the size and shape of a brick. That was state of the art technology in communications back then. Over the years cell phones have gotten smaller even as their sophistication has increased. The typical smart phone is not just slim, but has the memory and capability of a full size computer. In fact the cell phone in your pocket most likely has more computing power than the computers that first put man on the moon.
The entire Point of Care Testing (POCT) arena has been growing by leaps and bounds as many tests traditionally performed in the laboratory on large, complex instruments can now be done on small black boxes or test kits close to the patient.
One new development in the news is that of what has been dubbed by some the Theranos Miracle. California-based startup company Theranos under founder Elizabeth Holmes is threatening to revolutionize the field of medical laboratory testing. Theranos has developed a proprietary phlebotomy process that is self-described as “a painless micro-needle that draws a few drops of blood, enough to perform 70 assays per sample.”
The company is now offering blood draws in Walgreen pharmacies, offering not just convenience, but patient comfort and fast turnaround time. But lest you think this is just a small niche market, or that the claims of revolution are hype, look at the following
- The Theranos lab in Palo Alto is CLIA certified
-They are highly capitalized with millions of venture capitalist dollars
-They intend to expand nationwide
- They want to act as a reference lab for smaller labs and even larger hospitals by being competitively priced, offering a large menu, small sample size and rapid TAT
-They use cutting edge testing technology like ELISA and nucleic acid amplification
-They are in the process of obtaining FDA clearance for all of their tests
-They are highly computerized, so there is positive identification and specimen tracking from collection all the way back to the ordering provider
Laboratorians traditionally love technology. But here is a development that could revolutionalize the way we practice-and even who performs testing. How do you feel about this sort of new development? We have seen that technology tends to grow exponentially rather than incrementally so ventures like Theranos are likely to become more common with more bells and whistles pretty fast. Technology tends to be exponential, even as organizations change more slowly or logarithmically. Will your organization be ready to capitalize on this sort of modified lab-on-a-chip?
Do you feel threatened in your role as a traditional laboratorian and how do you think these changes will affect the profession as a whole?
In a few days the country will be celebrating Thanksgiving,but this festive holiday means different things to different people. To many it will be a day off from work, a time to spend with family, to over-eat and drink too much. It will be a time when family members get to show off their favorite recipes, critically assess relatives they haven't seen all year and, if lucky, enjoy a long weekend. To others it signals the start of the Christmas shopping season and an opportunity to start eagerly stimulating the econmy!
It is pretty easy to forget how Thanksgiving started as a celebration of a successful harvest by the Pilgrims, that over the years there have been different days of thanksgiving based on historical milestones, or that the day itself was not always a permanent national holiday.
Many incorrectly think of Thanksgiving as a uniquely American holiday. I once mentioned to a colleague that I was headed to Toronto to celebrate Canadian Thanksgiving with family and friends. I told him the celebration was on the 2nd Monday in October. He replied in utter consternation, "Why do Canadians celebrate Thanksgiving? What are they grateful for and why are they celebrating on the wrong day?"
So the idea of giving thanks on a particular day has a checkered history; but reduced to its basics, it is a time to be grateful for all the blessings we have individually, as a nation, as a family, and as a profession. It is formal recognition of the gratitude we should feel all year long.
As a profession we should be grateful for the opportunity to serve, the ability to make such a valuable contribution to the health of this great country. We have a long way to go in terms of recognition (pay, independent practice and licensure, for example) but we have also come a very long way, especially technologically.
While many can kick back and enjoy a long weekend of feasting, fellowship and foootball, many of you, my colleagues, will be away from family and friends; working as you do all year long. You will be supporting the health of the country. For that, I am personally grateful. You will be using your expertise, competence, knowledge and critical thinking skills to make crucial decisions that often mean life or death. For that, I am immensely grateful.
Whatever you are doing this Thanksgiving and however you choose to celebrate it, enjoy it and be safe. And, please take a moment to acknowledge those achievements, qualities, individuals and blessings for which YOU are grateful.
Just a few short weeks ago, Ebola was the talk of the
town. Both the lay public and healthcare professionals seemed consumed with the
topic. Entire cottage industries were born to supply Ebola-proof personal
protective equipment (PPE) and to teach Ebola safety.
There was a CDC conference call almost daily to
update (and modify) guidelines. Hospitals diverted lots of resources to train
their staff and to provide PPE in emergency departments and many patient care
areas. The nation’s largest airports started screening visitors originating in Western
Several very enterprising merchants ramped up
production of Tyvek-looking full body suits in time for Halloween.
Now, Ebola is rarely even mentioned-at least on the online
sites that I visit and the healthcare organizations that I work with. So what
First, the cases in the USA seem to have got less
and those being treated in the US (except in one Texas hospital) have all had favorable outcomes. They were all
released, essentially cured.
Conversely, why the earlier panic? Again it’s conjecture
but there are several possibilities:
-This decades-old disease was now infecting Americans
so it suddenly became new, serious, significant and important to Americans
- The media pushed the fact that it was largely
fatal, and as much as they explained how it was spread through intimate contact with body fluids, the public chose to
concentrate on the fatality rate and the fact that PPE use as described by the CDC might not be 100% fool-proof
-There was an election looming and this was too
tempting a drama not to exploit for political purposes. Who would be best at coping with this “foreign
disease?” How tough should sanctions be: travel bans? Quarantine? What would
each candidate do to protect you?
Now the election is over, the US has an Ebola-czar
and there are currently no patients being treated for Ebola in the USA. So
Americans have tended to turn away as if bored with a prime time melodrama and its drawn-out plot.
But the battle continues elsewhere. According to the
World Health Organization (WHO) more than 14,000 have become infected and over
5,000 have died since the 2014 Ebola outbreak in March.
One doctor infected in Sierra Leone is on his way to
be treated at the Nebraska Medical Center’s Biocontainment Unit, which like
Emory University in Atlanta and National Institutes of Health have a perfect record of treating patients using
appropriate infection control protocols and targeted treatment by dedicated
medical lab scientists, doctors and nurses.
There are 3 principles that come to mind. In healthcare,
actions should always be based on science. We should be concerned about
healthcare issues regardless of who is affected. Finally, healthcare delivery should
not be politicized or overdramatized for political reasons. The Ebola scare is
instructive because the public reaction violated all 3 rules.
This is a shame.
My dad was so proud of the fact that he worked for the
same employer for 40+ years. He was never late, was rarely sick and sometimes
went to work despite the fact he was under the weather. He thought he was
indispensable and that his employer really valued him. To him loyalty to one
employer was huge.
He received a small pension - not even the metaphorical gold watch, or a cake and punch party - when
he retired riddled with aches and pains.
How things have changed. It is now very clear that employers
have no loyalty to employees who are typically viewed as “elements of
production” and therefore costly and replaceable.
Several years ago, the American Management
Association (AMA) conducted a survey of 6,000 participants across the United
States. The survey asked employees 2 questions:
1) Do you get enough recognition at work?
2) Would you do a better job if you got more recognition?
There was no equivocation in the answers. Over 97%
of the respondents said "no" they didn't get enough recognition at
work, and 98% replied "yes" they would do a better job if they
received more recognition. This means that employees think recognition is very
important, but that they don’t receive nearly enough from employers.
The typical employee (inside or outside of
healthcare) will have several jobs in their lifetime, sometimes even changing
professions. Laboratorians are no
exception and have come to realize that employers have no loyalty to them, and
will gladly cut an employee loose for a variety of reasons including preserving the
That does not mean that the employee-employer
relationship has to be adversarial. However it is important to realize that you
work for yourself first and foremost. In
every job you should learn as much as you can, develop new transferable skills
and keep your resume current. Consider a reasonable work-life balance.
A flexible, nimble employee is a good
employer of him or herself. To be a good self-employer, you should be open to
change, cross training, taking on new projects and practicing constant networking.
Learn as much as you can, and acquire skills that no one can take from you.
Position yourself as a valuable individual professional, not merely as an
employee of ABC Laboratory. It is easy
to get comfortable in a job, but at least once a year, update your resume with any
new skills you have acquired. Look at job ads and decide, in an ideal world, which
one would you go for. Practice writing a cover letter. List the professional colleagues
you would like to act as your professional reference if necessary.
This exercise is as much a matter of
psychology as practical preparation. If you suddenly have to make a change
(voluntary or not) you will have a leg up if you are prepared, sale-able and have
a current resume. Faced with change, you
will then have real options to make the move that is right for YOU. Your employer
will be OK and will move on without you. Trust me.
It seems that experiences always occur in groups. Recently I had 3 separate but similar experiences that made me decide to write this blog.
Laboratorians on an online forum were discussing recent issues that their particular labs faced with nursing, such as specimen draws above an IV, many hemolyzed specimens, abuse of stat; the usual. In each instance several respondents said, “Tell the pathologist.” The same sentiment was echoed for a physician over-ordering uncrossmatched O negative blood.
The discussion continued with each example apparently designed to show an even more ridiculous "pathologist issue" that laboratorians are confronted with.
“One so called doctor wanted to know which hepatitis B test to order. Another genius asked me what was the difference between a PT and anti Xa test”
“What do you do when a doc insists on ordering a bleeding time for his pre-op patients?”
"Check this out, one doctor asked how could the current b-HCG be less than the prior result when the patient is still pregnant as confirmed by ultrasound."
Some questions were tricky. But there was also a fair amount of agreement that even the most casual question regarding selection, use or interpretation of a test should be referred to a pathologist.
“I am just a tech.” said one comment. “The pathologist gets the big bucks,” said another. “I did not go to medical school,” said a third.
This discussion made me think about a coupleother recent experiences I had regarding essentially the same issue. About a week ago, an MLS around my own age was opining to me how lax and unsupportive pathologists are these days. I asked her for more details. She gave me a list of annoyances, mostly breaches of common laboratory practices, such as frequency of ordering the same test, ordering boutique tests from private laboratories and insisting they be sent out, or demanding that specimens be retrieved from storage for add-on tests long past the recommended time period. One physician realized that specimens were discarded after 5 days and now demanded that “his specimens” be maintained for 7 days for add-ons.
"In the old days, a pathologist would just call and set them straight," she says. "Not these young guys who just want to do quick biopsies, a little histology and nothing else. They are friends with the doctors and don't care about the lab."
That piqued my interest so I asked for more specifics. “I have told our pathologist about these problems and he does nothing,” she said. Have you talked to the physicians yourself and pointed out that these are violations of laboratory policy? Have you had your technical manager attend a medical staff meeting and educated doctors? Have you shared your Test Utilization Policy? Have you involved Quality Assurance or Risk Management? No, no, no she said.
“Have you told the pathologist the extent of the problem?” She admitted she had talked to him once, giving him examples and she expected him to act if he really cared. It is not really within the purview of a laboratorian to talk directly to a physician, she said.
The other example I was told about was even more baffling. In a community hospital a group of MLS/MLTs were assigned to review procedures that were long overdue for review. Their review policy called for a biennial review but some had not been looked at in close to 5 years. They wanted to do the right thing. They went the extra mile of verifying best practices with local sister hospitals, checked with specialists in the hospital about cut points for troponin, use of glucose tolerance test for gestational diabetes and updating the glucose range from 70-110 mg/dl which is what the current procedure listed. They also developed a list of critical test ranges based on physician input.
A new pathologist on staff objected to any change in procedures despite the fact the change would reflect current best practices. They provided justification, but he would not budge. It was unclear why he was resistant to changes that were clearly justified, but he made it clear he had the final say.
I cannot fault anyone mentioned in any of the examples above for consulting their pathologist in his/her role as medical laboratory director. However, does every annoyance, breach of policy or question about laboratory practice have to be referred to a pathologist? As professionals is there a point we can decide it’s within our scope (and body of knowledge) to answer questions or resolve problems. It should not be difficult to re-state what current policy is or to explain the principle of a test or give guidance on selection of a test.
A couple of months ago, I wrote two blogs: What do doctors want from the laboratory? Parts 1 and 2
discussing a major study which found that clinicians really do want more from the laboratory. Furthermore providers think we are more than prepared (educationally and intellectually) to provide answers and give guidance but we hesitate to do so.
The pathologist certainly is one tool in our arsenal, but should not be used as an excuse for not stepping up and offering answers or resolutions to problems that are fully within our capability.
It is extremely important to get back to basics in whatever
we do. This simple edict is so often ignored because- well, because it is so
basic. We tend to go for the complicated and glitzy. I thought about this
truism when the CDC issued its new
more rigorous guidelines this past Monday.
There is nothing really complicated about the guidelines at
all. What is remarkable is that these guidelines have been used with thousands
of Ebola patients for years in Africa. The group Médecins Sans Frontières (MSF) or
Doctors Without Borders has treated hundreds of Ebola patients under
horrendously primitive conditions for years with very few cases of
provider-infection by using very basic guidelines similar to these finally
adopted by the CDC.
We like to think we have the best healthcare system in the
world, the most sophisticated equipment,
and the most knowledge. We are reluctant to modify our more high-tech rituals;
we certainly do not like to borrow ideas from less developed countries. CDC
first issued Ebola guidelines in 2008 and again as recently as August of this
year. But we have a situation where 2
American nurses using CDC guidelines became infected on American soil. The CDC
admits they have not been able to identify any specific breach in protocol
so it’s possible the problem was the ineffectiveness of the protocol itself.
According to CDC Director Dr. Thomas Frieden, the new,
MSF-type guidelines are based on 3 principles:
-healthcare workers should be rigorously trained in both
donning and doffing PPE
-there should be no skin exposure at all
-each episode of donning and doffing should be supervised by
a trained monitor
Looking at the protocol in more detail, consider how basic
certain steps and concepts are
1. Full coverage
of the body, no neck or face exposed as in previous guidelines
2. Use of face
shields versus goggles that leave skin exposed, fog up, and may be adjusted
inadvertently with contaminated hands
gloved hands and soiled PPE with a
virucide during and after removal
4. Use extra
covering such as aprons if the patient is producing excessive body fluids like
vomiting and diarrhea
5. Use a “buddy”
monitor to observe, coach, and correct in both the donning and doffing of PPE
to ensure there are no shortcuts or violations of protocol
6. Hand washing,
hand washing, hand washing
7. Staff should be
trained, practice and be familiar with the protocol before they have to
actually use it
It is worth noting that as scientists with highly
sophisticated instrumentation at our disposal, specimen processors, auto
verification and the like we sometimes give up autonomy and abandon critical
thinking. Nothing is a substitute for ensuring the right specimen is collected
from the right patient, the right test is performed, the result makes sense,
and the correct result gets back to the right decision maker in a timely
No matter what our
instruments say, we can over-ride technology and should still go with the
basics whenever there is doubt. Or if there is a problem of any sort. Or as
part of troubleshooting. Or if we have a gut feeling.
Technology and established protocols are great helpmates.
But I cannot think of one instance in which going back to the basics is not a
sound principle by which to operate.
Just a few short months ago Ebola was a disease in a far away continent. The greatest fear was that with our internationally mobile population a case or two might slip into the USA. Then 2 Americans in Liberia contracted the disease and were flown back amongst great fanfare to Atlanta's Emory Hospital where they were treated for several weeks, during which they obtained various experimental treatment. They both recovered and were discharged from the hospital.
But then there was another case in the US, and then another. The CDC has also been receiving calls from emergency rooms all over the country. Epidemiologists and health scientists assess symptoms on the phone and advise whether patients should be hospitalized and isolated, hospitalized and treated supportively, or treated and sent home. Sometimes specimens are drawn and tested for the Ebola virus, sometimes not.
A man who traveled from Liberia to Texas, presented to the emergency room with flu-like symptoms. He was misdiagnosed and sent home. A few days later he returned to the hospital, was admitted and died of Ebola several days later.
The World Health Organization (WHO) estimates there have been over 4,000 deaths from the current Ebola epidemic, and has called this the biggest epidemiological challenge since AIDS .
Several countries including the US have started assessing travelers at the larger airports and denying them travel if they appear to have been exposed to Ebola (or have flu-like symptoms and are traveling from certain areas).
The US hospitals that have treated Ebola patients tend to have entire isolation suites, often with a dedicated care team. In one hospital I know of, specimens were handled exclusively in a point of care lab, samples for further testing were specially bagged and sent off to the CDC. Equipment was sterilized and samples were incinerated or specially disposed of. That is great for a couple of patients, but how will the typical hospital handle suspected Ebola cases coming through their emergency rooms? It is conceivable to have more than one patient at a time.
Laboratories need to know what tests to perform for diagnosis and retrospectively on someone who might have died suspiciously.
Infection control practitioners and risk managers might be building protocols right now, but is the lab involved in the planning? How would your lab handle the sample of a suspected Ebola patient sent for a CBC and electrolytes and crossmatch, for example?
I would like to hear how you personally feel as a scientist in terms of your own comfort level and how well prepared do you think your lab is to handle your first case of Ebola?
Why do we run quality control in the laboratory? The simple, obvious answer is to ensure that the entire test system working together is able to produce reliable results. The rub lies in the concept of reliability. So we run QC based on manufacturer’s directives. But how does the manufacturer come up with its recommendations for a kit, set of reagents or an analyzer?
Then we also run some QC based on regulatory requirements (accrediting agency, CLIA, best practices, state) or based on our organization’s policy. The mandate is to go with the most stringent requirement in each case, but all with the notion of ensuring that the results we produce are reliable.
So if we run quality control for an entire chemistry profile on analyzer ABC once per shift, how sure are we that every patient result generated for the next eight hours is reliable? Some of our confidence comes from studies done on that instrument, using those reagents. We know that statistically, even with the best instrumentation, we cannot absolutely guarantee 100% accuracy 100% of the time.
Over the years several advancements have been made that have helped to increase our confidence that our results are accurate, precise and reflect medically significant values. Technology has become more robust, with more internal checks and balances, reagents have increased sensitivity and specificity. The analytical measurement ranges (AMR) of most tests have increased; as has precision. Once again these factors help to make us more confident that time after time the result we receive is pretty close to the real thing.
It is because of all this progress that CLIA is introducing new QC standards using a protocol called the Individualized Quality Control Plan (IQCP). Why do we have to blindly follow the old 2 levels of controls with every run or every 8 hours if the state of the art is such that our systems have been proven over time to produce reliable results? Available as a voluntary option under CLIA, IQCP is designed to give labs greater flexibility in customizing their own QC program based on their particular environment.
The rub is that you cannot simply decide to move to IQCP, a system some might see as less demanding and less expensive. Your lab must do a risk assessment evaluation to study what QC regimen you can “get away with” under CMS regulations.
IQCP was launched in January of this year and labs that choose that option have been given 2 years to make the transition to IQCP and verify how their lab is operating under that option. IQCP applies to all non-waived testing, except Pathology. Labs will need to provide sufficient data to show a credible analysis/assessment was done.
Has your lab been contemplating IQCP? What have they done so far? How do you personally feel about IQCP?
The concept of Pay for performance (P4P) is based on the use of
incentives to encourage and reinforce the delivery of evidence-based clinical
practices in health care; with the goal of better outcomes.
As the cost of healthcare has skyrocketed, major payers have
adopted P4P as a way of curtailing costs while improving quality of care. The
theory is that if providers all adopt proven standardized methods of care,
patients will have better outcomes at overall reduced cost to the payers. As an
incentive, adherents of the P4P are paid more, while non-adherents are paid
Not only Medicare, but some commercial managed care plans as well,
now pay based on performance or outcomes. More commonly payers penalize providers
(usually through reduced payments) for not meeting certain set treatment guidelines. The
P4P movement is not new, but the Affordable Care Act (ACA) has a significant
pay for performance component as well.
Each year, Medicare looks at its total payment to providers
(doctors, hospitals, laboratories, for example) and tries to tweak their
payment schedule to reduce total cost to Medicare. The rate of hospital readmission is a target indicator
that is used to indicate suboptimal treatment or clinical relapse. Readmissions
are expensive so Medicare pays reduced reimbursement for readmitted patients.
Laboratory testing will continue to play a significant role in “proving”
whether a provider should be paid the full reimbursement, a bonus or be
penalized in some way. For 2015 there will be reduced payment for certain hospital
acquired conditions. Central line associated blood stream infections and
catheter-associated urinary tract infections will prompt reduced payment for
providers. In 2017 Methicillin Resistant Staphylococcus Aureus (MRSA) infection
and Clostridium difficile infections will be added as criteria of performance.
Medicare also penalizes healthcare organizations that do not
report indicators like infections, falls,
pressure ulcers and the like in a timely fashion.
Many chronic conditions like diabetes, obesity, hyperlipidemia,
hypertension and others will also incorporate regular laboratory tests as best
practices for their diagnosis and management. Not performing the correct tests, not testing
with the right frequency, or obtaining results that suggest non-adherence to
treatment will result in reduced payment.
While the laboratory might not be directly involved in selecting
these tests, it is important to know why they are being ordered. It is also
important to stand ready to manage utilization (over testing is costly and may
not be reimbursed) and the interpretation of test results.
to a recent press release, American Medical Technologists (AMT) has partnered with the American Kidney Fund (AKF) to foster and
promote collaborative work focusing on the role of allied health professionals
in the prevention and treatment of chronic kidney disease and end-stage renal
“Throughout the partnership, AMT will help raise awareness
of kidney disease through professional and public education and communications.
AMT will also raise funds to support the American Kidney Fund’s programs and
services” the statement reads. I hope other professional MLS organizations will
also get onboard.
is very good news and a logical partnership. Medical laboratory science plays a pivotal
role in the diagnosis and monitoring of renal disease, from impaired function to
chronic renal failure (CRF). Laboratory tests guide clinical decisions from pre to post renal transplant assessment
and monitoring. As professionals we ought to take a more active role in disease
prevention, management and education of the public.
requests to AMT to elaborate on the role they will play and specifically how
they will include/co-opt medical laboratorians have gone unanswered. However, according
to the press release AMT will play at least 2 roles-education and fund raising.
urge you to join this and similar efforts to contribute to the nation’s health
in a more public way while showcasing the expertise and social conscience of