Each year, up to 49 million people are affected by sepsis worldwide.1 Behind every diagnosis is a patient and physician in need of answers, which is why Beckman Coulter is committed to replacing the burden of wait and worry with the ability to know and act.
Watch Dr. Tobin Efferen and Hunter Bowen’s presentation on sepsis diagnosis and management highlighting the use of standardized laboratory and clinical operations in the context of one patient’s journey from initial assessment in the Emergency Department through treatment in the Intensive Care Unit (ICU) to eventual discharge.
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|Hunter Bowen||Welcome everyone and thank you for joining. My name is Hunter Bowen and with me, I have the pleasure to have Dr. Tobin Efferen. Our goal today is to introduce a new concept, which is disease state management, using a term we at Beckman Coulter have coined as total process control.
I think we all know that the laboratory has long remained the unsung heroes of healthcare. We are offering physicians vital results that give them the ability with confidence to help treat their patients timely. And this happens throughout the patient’s journey.
We at Beckman Coulter live that same mission, which is why, during today’s topic, we are going to discuss sepsis. What can we as healthcare providers be doing differently to help manage the treatment pathway that causes so many of our patients to, unfortunately, pass each year? What are the processes, informatics rules, reflex testing that, when working in harmony with the instrumentation and your technologists, can help physicians proactively diagnose and manage these very critical patients?
So, to do that, I’ll turn it over to Dr. Efferen to introduce our patient and the case study that we are going to be working from.
|Dr. Tobin Efferen||We will track our patient through not only the care she receives in the Emergency Department, but also through her time in the Intensive Care Unit (ICU), the general medical floor, and then of course when she is ultimately discharged. Too often in the laboratory, we do not see the long-term journey of a patient because we are focused on one tube at a time. We want to explore a different narrative today.
We start with a young woman, only 39 years old, entering the Emergency Department (ED). She has a history of pyelonephritis and ovarian cysts. Her chief complaint is right-sided flank pain. Her vital signs in triage around 40 minutes later are fairly normal with a slight elevation in pulse and lower blood pressure. These vital signs are not low enough for her to meet the SIRS criteria that would begin the sepsis bundle.
After these initial triage results, standard lab work would be collected and sent to the laboratory. In this case, a “rainbow” of blood tubes was drawn, and the patient was able to provide a urine sample.
I’ll transition back to you, Hunter, to dive into the laboratory’s handling and analysis of our patient’s precious samples.
|Hunter Bowen||Upon those tubes arriving at the lab, we want to be able to highlight the lab’s usefulness in supporting the management of the sepsis pathway. Standard emergency room orders for a patient generally consist of a CMP (Comprehensive Metabolic Panel), CBC (complete blood count), and some type of urinalysis. Using our DxA automation system and its sophisticated preanalytical functionality, we want and advise our customers to place as many of those samples on the automation so that it can receive all samples on the LIS; it can do all of those preanalytical process steps, and then run those tests that have been ordered. And then once completed, store those, even those “extra tubes” we see from the ED.
As you will notice through our animations you will load the green top to be sent to the AU for the CMP, the lavender top to be sent to the DxH 900 hematology analyzer for the CBC, which as we are going to discuss in greater detail also includes MDW (Monocyte Distribution Width) hematological biomarker, the UA (Urinalysis) yellow top tube so that DxA can receive it and then place it in an analyzer specific rack, which is what we call personality racks, making it easily transferred from the DxA automation to the DxU instrument for the Urinalysis and microscopic.
You will notice that the remaining tubes, so those remaining “rainbow” tubes that we get from the ER (Emergency Room): the blue, gold, and grey top, and even the urine culture tube are sent to our ECSD, or our environmentally controlled storage device or storage module to be housed and managed by the DxA, reducing a ton of that pre- and post-analytical energy that our techs are currently spending.
|Hunter Bowen||As the chemistry and hematology samples are ran, the medical technologist will remove the analyzer-ready rack with the Urinalysis sample and move it to the DxU Iris urinalysis solution. With the DxU Iris, we have an average run time of 5 minutes, and at least a 96% automatic analyzer review rate, so we can ensure a rapid urinalysis result with few of our urinalysis requiring microscopic results or microscopic review.
In this patient’s case, there is an elevated WBC (white blood count), we have a normal epithelial cell count, and a positive bacteria result from the microscopic portion of the instrument. As we can guess that normal epithelial concentration is going to help ease our reservations that this particular sample is contaminated, and the positive bacteria and WBC lead us to believe that there could be an infection or UTI (urinary tract infection). These results meet the criteria created by that hospital’s pathology team to reflex a urine culture test.
|Hunter Bowen||What laboratories need to be thoughtful of us is using their automation to process and automate how that urine culture tube is going to be handled. We want to move beyond what traditional core laboratories have been doing. The customer’s DxA, fortunately, can house these urine culture tubes within the storage module, and upon those positive UA, results force those results into the middleware, REMISOL, and reflex a urine culture test. And so, what DxA will do is automate that process by going and picking up that urine culture tube and bringing it to a microbiology-specific portion in the output.
Rather than your microbiology techs being forced to store, hunt, and search for these urine culture tubes, we are automating this process with DxA to simply provide the urine culture tube to a designated area so that the microbiology techs can pick them up in a timely manner and take them to be smeared.
|Hunter Bowen||While the DxA is managing the urine culture process, we are going to subsequently see the CMP and CBC results be resulted in parallel. From the CMP, we see an elevated creatinine level, and in the CBC we see an elevated WBC and MDW result.
To provide some context, we wanted to be able to demonstrate some expected turnaround time results from our DxAs in the field. We accumulated a huge data set from all of our DxAs installations nationally. So, across 26 installations, we see an average turnaround time for CMP of roughly 28.6 minutes. This is received to result. The same is true for CBCs we can look at a turnaround time across those installations with our DxAs from receive to result approximately around 12.6 minutes you would expect a CBC result and also included an MDW result.
I know MDW might not be a term everyone is familiar with so I’m going to turn over to Dr. Efferen to discuss in more granular detail why MDW is important for this particular case.
|Dr. Tobin Efferen||MDW is a proprietary, FDA-cleared hematology biomarker that is unique to Beckman Coulter. DxH analyzers can measure monocyte distribution width, which is a pattern of response monocytes have to pathogens. Changes in these monocyte populations help to establish risk of sepsis in adult patients in the ED.
What makes MDW a game-changer is that it is the only marker approved for this use, it is available early in the patient encounter, and it comes with every CBC that has an ED location tied to it. When we use MDW in conjunction with an elevated WBC, the sensitivity is at its greatest. Even as a single parameter, MDW has a greater sensitivity than WBC at identifying a likelihood of infection.
Back to you Hunter to discuss more of the laboratory's operations.
|Hunter Bowen||Because of the elevated MDW and WBC results, there is now a strong suspicion of infection, and this is an opportunity for the hospital to ask the question if the focus should be on the cost per test or the cost per treatment.
And so using those two hematology values as a reflex rule for lactic acid, we are going to reflex the running of a lactic acid. We can do so quickly and in an automated fashion, meaning that no medical technologist intervention is required, we create these sophisticated rules to retrieve and run that extra grey top, a lactic acid result, which is within that Sepsis bundle parameter first lactic acid within the sepsis bundle and we can provide some exceptional value to our physicians quickly.
As many of us know lactic acid is an important parameter and an important metric that physicians are going to track as they are trying to look at patient prognosis when sepsis is suspected. A lactic acid level that is above 4 mmol/L is associated with a 27% mortality rate, and as that level decreases so does the mortality rate. Lactic acid is going to be used as a guide for determining the severity of the patient’s illness and the effectiveness of the treatment we are providing.
|Hunter Bowen||By reflexing that first lactic acid result from within the sepsis bundle, we are able to operationally impact the ability to meet and thus be compliant with the CMS Sep-1 bundle. A recent study amongst a large cohort of physicians coming from a wide variety of medical institutions – well-known and prestigious institutions, such Harvard affiliates like Massachusetts General and Duke University Health System. They outlined the most common reasons for hospitals failing the Sepsis Bundle.
Thus, this brings us to a very important question; by building these sophisticated decision rules within our middleware and automatically reflexing that first lactic acid result, can we an impact the reasons for the failures of that Sep-1 bundle? This study determined that nearly 20% of all bundle failures were because hospitals were missing the collection and thus running that first lactic acid result in a timely manner. Using DxA and since we automate that process based on hematology results especially now that we have MDW that correlates so well with a high probability of infection and thus sepsis, can we now mitigate that 20% of Sep-1 failures?
During this time, our patient’s clinical pathway has progressed and so I am going to turn it back over to Dr. Efferen to discuss that.
|Dr. Tobin Efferen||All of these events have occurred in the first hour and a half of the patient’s time in the ED. All of those processes have been automated by the Beckman Coulter all-encompassing solution. We pivot back to the patient, who has taken a turn for the worse in the ED.
Her temperature and heart rate have spiked, while her blood pressure has plummeted. The time is 9:49, 1 hr and 12 minutes since she arrived in the ED. She now meets SIRS criteria and is in septic shock. Fortunately, the lactic acid has reflexed and is ready at 10:04 to further support the diagnosis of septic shock.
Rapid treatment is of utmost importance. The remainder of the bundle is triggered. As the pathogen has not yet been identified, ceftriaxone, a broad-spectrum antibiotic is given.
Blood cultures are collected, a fluid bolus is given, and lastly, additional testing will be ordered to better determine the nature and severity of the patient’s illness. Commonly ordered tests are CRP (C-reactive Protein) and PCT (Procalcitonin).
Back to you Hunter to discuss how laboratories retrieve samples for add-on test orders.
|Hunter Bowen||It is fortunate that again with the additional ordering of tests, we can now automatically, using DxA, and without technologist intervention, ensure that we are performing these add-on tests quickly and without the potential for clerical error. With DxA we have a guaranteed retrieval time of 90 seconds from the stockyard or ECSD, which is the fastest in the industry. You can expect us to pull the tube from the stockyard in 90 seconds. Thus, we are able to run these assays and provide it back to the physician, and truly differentiate these time-sensitive samples more efficiently and offer some greater operational efficiencies.
Back to you Dr Efferen to discuss our patients and how they are progressing.
|Dr. Tobin Efferen||As we continue to follow the patient, a more complete radiographic workup confirms what is causing her condition. A CT of the abdomen and pelvis demonstrates a 6 mm obstructing stone lodged in the right ureter where it meets the kidney. This obstruction has caused inflammation and has led to the development of a complicated urinary tract infection.
At this time an ICU bed becomes available, and we will see the transfer of the remaining sepsis bundle items move to the ICU staff. These include physician reassessment, the monitoring of vasopressors, and urologic consult.
Lastly, knowing that this patient will be an inpatient for several days, standing orders will be entered. I don’t think any of these tests will come as any surprise to those in the room.
Hunter will now walk through the value we hope to show in terms of supporting a patient.
|Hunter Bowen||What we have tried to do is demonstrate a holistic view of the value the laboratory is providing physicians for each one of their patients. So just to quickly break down this visual, we have the assays physicians would order for this disease state, and then the frequency they expect those lab tests to get completed and from that we are able to gather how many samples are headed to the laboratory for this particular patient.
If we subtract the number of ABGs, because we assume those are going to be done by respiratory via a point of care test, after just four (4) days, the laboratory would have received 53 samples for this one patient. This, of course, does not count the hundreds of patients you are treating.
|Hunter Bowen||During that four-day period, we would have started to see some microbiology results as well. Using the DxM Microscan WalkAway ID/AST System, the laboratory is able to identify that the pathogen responsible for this woman’s illness is E. coli, and it is also confirmed using this system to be producing ESBL, and once we have that identification, we can now isolate that organism and perform susceptibility testing to find antibiotics that are going to be able to target that bacteria more effectively. You’ll notice that the susceptibility produces two that are going to be highly targeted or more effective at removing or treating that bacteria. You’ll notice that the antibiotic that the patient received in the ER is actually only intermediate in its result in being able to combat that particular bug. So, if we are able now to switch our patient to a more effective treatment, we now would hope and expect a quicker recovery.
To talk about this process of moving the patient from the ICU to that non-critical care area I’m going to turn it over to Dr. Efferen.
|Dr. Tobin Efferen||Once we see some key changes in the patient’s health status she will be downgraded from the ICU to the general medical floor. Transfer from the ICU differs from one institution to another. However, patients, in general, need to have an O2 sat greater than 90% on room air and need to be off of vasopressors. The patient’s renal function tests will continue to be monitored.
Her stay on the general medical floor will be short, and since she has improved, the standing orders will be reduced
As her condition stabilizes and improves, she will be transitioned from IV antibiotics and discharged home on oral therapy with trimethoprim-sulfamethoxazole.
Back to you Hunter to summarize how the laboratory supported our patient’s journey
|Hunter Bowen||What few administrators and directors monitor is the true value the laboratory is bringing to each and every patient. When we tally the number of samples we would expect to run on a sepsis patient of this nature – that’s when they arrive in the ER, their ICU stay, non-critical care, then subsequently discharge – what is the total number of samples that we are collecting and running for this patient? The laboratory in this patient’s case efficiently ran 68 different samples to provide some results for their providers.
Another question to consider is how does automating laboratory operations effectively support these resource-heavy disease states. This doesn’t just impact sepsis. What does this mean for the cardiac disease/damage, strokes, etc.?
|Hunter Bowen||To summarize this patient’s particular hospital stay or her journey, she was in the hospital for 6 days, and thankfully she is going to be discharged only going home with oral antibiotics, after having had a positive response to targeted antibiotic treatment to the ESBL – E. coli.
When we look at the course of the patient’s treatment, one major component stayed the same, the laboratory. The lab remains the only hospital discipline that continually touched and provided result after results that led to a lifesaving cure for every single patient.
As we have walked through this case, we also think it is important to really describe what the Beckman Coulter difference would be. What did Beckman Coulter provide the patient in this case that you might not have been able to have with another potential partner? And we want to summarize that impact so we have bucketed those into clinical and operational benefits so that you can see what you can expect from a Beckman Coulter solution.
|Hunter Bowen||First, we’ll take it from an operational perspective because we were able to automate the running of that first lactic acid, and by implementing MDW, the only Food and Drug Administration (FDA) approved hematology parameter to identify the severity of infection, we can help you manage and thus increase compliance with the Sep-1 Bundle. You will remember that statistic where 19.7% of bundle failure due to not being able to collect that lactic acid timely. We are potentially mitigating all those failures.
Secondly, I hope it was obvious that having and implementing a solution that is harmonized across all disciplines, one that feeds and has access to information from other disciplines, the sophistication, and the decision rules we are able to create helps increase the efficiency that you’re providing to your physicians in a dramatic way. So how quickly and how proactively are we providing results that our physicians need.
And lastly, using the DxM Bruker MALDI and LabPro software combination, your laboratory can provide physicians rapid bacterial ID and AST testing from a single platform so that targeted treatment pathways can be implemented quickly so that you are able to see some marked improvement with your patients.
|Hunter Bowen||Next, let’s talk about how we are going to gain some clinical efficiencies.
Using decision rules, automated add-ons, etc. ensures we remove potential delays in providing physician results by eliminating potential clerical errors and the potential for results and/or orders to be in an unnecessary waiting period.
Also, by using MDW in triage, you can help enhance the odds of infection detection substantially. And as we all know, the sooner we are able to suspect sepsis or infection, the lower the risk of mortality.
And finally, the gold standard MIC (Minimum Inhibitory Concentration) reporting in antibiotic sensitivity testing is with the Beckman Coulter microbiology solution.
|Hunter Bowen||Another key differentiator is that all of the instrumentation, decision rules, automation, that we’ve discussed today is no longer just for big hospitals. Beckman Coulter is uniquely positioned to be able to provide any sized lab the same key benefits. You as an administrator or lab director can now ensure the same standardized and innovative treatment paths for all of your hospitals. By doing such you are able to make sure patient care is maintained and the same efficiencies remain for all laboratories and thus all of your patients. DxA , DxC, DxH, DxM, etc. are all consistent no matter the series number.|
|Hunter Bowen||Now more than ever, in order to rise to the occasion to help heal patients, we as healthcare providers have to relentlessly reimagine how we offer healthcare, and we have to do it a single diagnosis at a time, it just so happened that this time we talked about sepsis. We have to be thinking about this across all our disease states.
With that, we thank you for your time.
Request more information to learn about our total laboratory solution in patient care for sepsis diagnostic solution here.