Blood Labs – Q&A with Ben Oakley and Jonathan Sell
EMS EVOLUTION 2018 featured a lightning round presentation by Jonathan Sell of Booker EMS on blood labs for EMS. TEMSA recently sat down with Jonathan Sell and Ben Oakley of Blanco County EMS, who also has a blood lab, to discuss their experience with the service.
The following is the conversation.
TEMSA: When did EMS agencies start utilizing their own blood labs?
Jonathan Sell: Technically, every EMS that has a glucometer, which is also a lab, However, they are simply operating under a CLIA Certificate of Waiver (or they are breaking federal regulations if they don’t). As a result, most EMS agencies have a “lab,” so to speak. That said, what we are doing with a blood lab is taking that a few steps further. It’s important to define that what we are doing is point of care testing. We don’t have a lab back at the station that we take samples back to. Instead, the entire process is run though a simple portable device (ours is the Abbott iStat) on scene.
The iStat was developed for both civilian and military use back in the 1980s and 1990s. The company started in 1983, I believe, and the system was available and having studies published by 1994 and was bought by Abbott in 2003 for just under $400 million. It’s not particularly new technology, but the price point and the technical ability have now gotten to the point that we are seeing them a lot in health care settings.
Ben Oakley: As Jonathan mentioned, the utilization of laboratory data in the pre-hospital setting has been around a long time, as a result of the certificate of waiver requirement for fingerstick-based glucose assessment. With that being said, point of care testing is a newer concept, especially in the context in which we are utilizing it. There are a handful of systems around the country that do this, although the majority of these programs are typically air medical programs and/or hospital-based systems.
In our system, we utilize the epoc Blood Analysis System, which is a newer product than the iStat. The epoc is becoming increasingly popular in the hospital setting, but is not very common in EMS. In Texas, only our agency and one air medical program are currently using the device. The epoc Blood Analysis System was created by Epocal, Inc., a Canadian company, and the system first received 510(k) FDA clearance back around 2006. Subsequently, Epocal, Inc. was acquired by Alere beginning in 2009, and then it was acquired by Siemens Healthineers last year. Having now utilized both the iStat and the epoc, I can attest that both systems are fantastic systems, and our decision to move forward with epoc in 2016 was a tough decision. Ultimately, we chose to move forward with the Alere epoc Blood Analysis System as the price point was lower than iStat, better shelf life of the test cards, and the lack of any refrigeration requirements.
Jonathan Sell: I love where you guys are going with your lab program! I wasn’t aware that you had gone with the Epoc, and it’s great to hear you’re happy with it. Like you said, it won’t work for my program yet because the troponin is such a key component to us, but my hope is that as the Epoc grows and gets more recognition, the competition between it and the iStat will push them both to introduce even more POC lab tests that can expand our abilities even further.
TEMSA: What does it entail to create your own blood lab?
Jonathan Sell: We did ours as a three-step process. Step one was to choose a system and implement it under our certificate of waiver. We started that in 2013 when we purchased our iStats and started running only the waived Chem 8 cartridges.
Step two was to educate ourselves about the process to move our lab to a Moderately Complex level lab and also to perform internal testing of our iStat results. We did this by comparing our field results with the tests run at the hospital, preferably on the same blood we drew to use to compare results. The education was a steep curve for us. There are just a ton of things in the lab world that we don’t have to deal with or even think about in EMS. Dealing with federal level regulations can be a huge pain as well.
Step three was to move to a Moderate complex designation (we did this through accreditation rather than certification) and to fully implement the additional iStat cartridges we wanted, blood gases plus lactate, and troponin.
As far as training, not much is required. Each lab has to develop its own form of competency training and testing. As long as it meets the regulations, that and a high school diploma are all that are required to be a lab staff member. Now, key positions such as lab director, clinical consultant, and technical consultant have much higher requirements. In the EMS system, the medical director can serve in all three of these roles as long as they have some specific education. We paid for our medical director to go through about 20 hours of continuing medical education (CME) to meet the requirements. In retrospect, I would never recommend an agency medical director to serve as the technical consultant. There are plenty out there with whom to contract, and unless your medical director has a ton of very specific experience in lab operations, he or she will not be able to fill this role well.
Ben Oakley: Simply put … money, patience and a lot of education. In all seriousness, after we made the decision to move forward with our point of care testing program, it took us about 13 months to go “live” after we issued a purchase order, which excludes all the time we took planning, evaluating, and seeking the necessary funding, etc. Our decision to embark on this journey was ultimately a result of our sepsis program. We had already seen such tremendous success with lactic acid (lactate) monitoring through a cooperative agreement with one of our local hospitals, we quickly realized that there was a lot more diagnostic data out there that we were missing out on. With us, a routine transport to a comprehensive facility exceeds an hour, which is a lot of time for patients’ conditions to go untreated.
Once we made the decision to move forward and purchased the equipment, we began the process to become an accredited laboratory. For moderate-complexity testing, you have the option to either go with the certification route or the accreditation route. Like Jonathan, we chose the accreditation route based on feedback from other systems. Ultimately, we signed on with COLA, who turned out to be a huge resource in helping us through their accreditation process. Like Jonathan’s medical director, our medical director also completed 20 hours of laboratory-based CME to become qualified to be our laboratory director. Our device manufacturer developed an implementation schedule and got us connected with Technical Specialists and true experts in the field who helped us develop all of the materials needed to fulfill accreditation requirements. Ultimately, the accreditation book is several hundred pages of requirements you have to demonstrate compliance with, which was what we spent the bulk of our implementation time on. With accreditation requirements fulfilled and a qualified Laboratory Director (our Medical Director), we then focused on staff training. Our staff went through the necessary competency training, assessments and re-assessments, which ultimately focus on how to physically use the device, and perform testing in accordance with our accreditation requirements.
Our biggest mistake during our implementation was assuming that our providers felt comfortable with interpreting the laboratory values and modifying their treatment plans accordingly. We are fortunate to have a fantastic staff with mind-blowing clinical experience and backgrounds, including over half of our staff who are critical care paramedics, flight paramedics, etc. With that being said, upon implementation, it was a bit of information overload. We had to go back and work on getting our providers comfortable with all of the laboratory values which were now available to them in a matter of minutes.
Frankly, performing point of care lab testing is easy. However, interpreting laboratory values and incorporating those laboratory values into the clinical-decision making process can be quite challenging, especially on certain patients, but our providers have risen to the challenge and done amazing since implementation.
Jonathan Sell: I could not agree more with your last comment here. Running a Point of Care lab is incredibly easy. Interpreting it … that’s a whole different ball game! We learned in our process that most of what we got from the manufacturer as far as the implementation program was based in two areas: How to actually physically use the device and how to work within CLIA regulations. There really wasn’t much at all about interpretation, so we have had to be creative about bringing in educators who work with lab interpretations a lot, and try to incorporate their knowledge into our field of work. That’s been a challenge, but I think we are in a much better place on that now than we were a few years back. Like Ben, I also have a number of CC-C and FP-Cs on staff, so that helps as well. We are hoping to be 100 percent with those certs next year, not so much because of the certs themselves, but because of the validation it provides of the critical care education that we have been working on implementing within our EMS.
TEMSA: How have providers, such as hospitals and ER physicians, responded to your use of blood labs?
Jonathan Sell: We have had almost nothing but praise for our labs from other stakeholders. It’s now to the point that if we bring a critical patient in and don’t have labs, the emergency department staff is ribbing us asking why we didn’t get them done. We do go out of our way to educate our stakeholders that iStats, like any portable device, are not expected to have the precision that large lab devices in the facility have, but they are very good at what they do, and that our agency is very well trained and has a fantastic track record with them.
We share the results of our proficiency testing (a blind process that moderate complexity labs are required to participate in) showing that we are practically perfect with our results compared to all of the other testers. With those steps, we have had almost zero negative feedback.
Ben Oakley: Overall, the feedback we have received from our receiving facilities is overwhelmingly positive. I’ll tell you, nothing makes the receiving emergency department staff (nurses AND physicians) happier than when you walk in the door with labs in hands. They’re even happier when you walk in with initial labs in hand, explain your treatment plan, and follow-up labs showing improvement and/or complete resolution of the issue. It alleviates a lot of the workload, as the nursing staff isn’t scrambling to draw labs, and allows the staff to focus on a proper transfer of patient care. Our handoffs are a lot more similar to a handoff between the emergency department and admitting unit of the hospital, and we have time to give a detailed report and summary of interventions, working diagnoses, etc. When our crews are encoding a patient report and provide a critical lab value, many times the nurse taking the report will pause and ask, “Wait…is this a transfer?” as they assume that they misheard and the patient was coming from another facility, and our crews get to proudly tell them it is a scene call, which is typically followed up with a “radio high five.”
In the interest of full disclosure, I will admit that in all the years we’ve been doing this, I’ve heard of two instances where the receiving physician felt that doing labs on ambulances was “dumb.” In both cases, we were able to follow up with the facility, staff, and physician and ultimately determined they were isolated cases of someone having a bad day … which happens!
TEMSA: You are both smaller rural EMS agencies that have created your own blood labs. What types of agencies have developed their own blood labs?
Jonathan Sell: Honestly, I don’t see many out there. My understanding is that MedStar Mobile Intergrated Healthcare (Fort Worth), along with most of the community paramedic and mobile integrated health programs out there, use the iStat, but generally only under the waiver, so they don’t have all the options that we have, and they don’t have to deal with the regulatory issues we do. Also, they have a different process because generally the community paramedic is getting the lab data based on their hospital data/PCP orders and they report them back to the hospital/PCP as part of their report. Our process is unique because the medic makes the clinical decision to perform the labs they believe are clinically relevant. We have them all in protocol so they need no orders. They order the lab, obtain and process the lab, and then they also accept the results of the lab and interpret them and make clinical decisions as appropriate. When we transfer care to the ED staff we provide that data just like any other data we obtain in our assessment process. That requires a level of education, critical thinking, and CQI process on the labs that most places using this concept in their MIH programs don’t need in their processes.
I think the fact that North Blanco EMS and Booker EMS are both rural agencies actually lends towards why we think this way. We have to think about taking care of patients for hours, not minutes. If you work in an urban setting, you barely need all of the tools you have in a standard paramedic unit because we you will usually only have them for a few minutes. On the other hand, if you’re taking care of that same patient for a period of hours to get them to the care they need, you need every tool you can possibly get. That’s what labs are to me. A tool in the toolbox that a lot of my patients can benefit from – just like a 12-lead ECG or an IV line.
We started labs because we saw a problem we wanted to address. We were picking up cardiac patients who we felt certain were having an MI (myocardial infarction aka heart attack), but they had no ST elevation on the EKG, which is the definitive way to determine an MI based on an EKG alone. We would take them to the local ED where there would be a one- to two-hour delay while they did one key thing: assess for troponin. Troponin is a protein that is only created in the bloodstream when myocardial cells die. It is as definitive of a test for MI as is out there. The local emergency department would take 30 to 60 minutes to run it, and then do the rest of their protocol before starting the transfer process. The patient was getting delayed by 1 to 2 hours from getting to a cath lab for the care they needed.
Somewhere, I ran across a study showing that iStats could run a troponin in 10 minutes at bedside. We started investigating it, and eventually ended up with the three-step plan discussed earlier. Now, we have the ability to bypass local emergency department on a regular basis for positive troponin reading to instead go straight to a PCI. Even though that was the first reason why we had to go down this path, it’s not even the most common lab that we use now. We get a baseline hemoglobin on all trauma to establish a baseline, lactate on all sick calls to assess for sepsis; potassium on all cardiac patients, and all labs on cardiac arrest, etc. etc. Having labs has also completely eliminated us transporting cardiac arrest. We have effectively addressed all of the reversible causes of cardiac arrest that the emergency department can assess and/or treat, so we have eliminated the incredibly dangerous and unnecessary transport of cardiac arrest. We work them, and if we get ROSC (which we are now over 50 percent on compared to almost never before the whole process started) we then transport.
Ben Oakley: I answered this question a bit prematurely earlier, sorry about that! Everything Jonathan said was spot on. I’ll reiterate a few things, though. The sole act of performing point of care lab testing doesn’t really mean anything … it all comes down to what you do with the data. Like Jonathan’s providers, our providers are also using these laboratory values, interpreting them, and developing a treatment plan based on their clinical judgement, as independent providers. Occasionally, we get some lab values that just don’t make sense, and our providers may give one of our medical directors a quick consultation call to loop them in to our decision-making process. But for the most part, they are making these decisions on their own.
The beauty of point-of-care testing is your program truly is what you make of it. A good example is our system runs all of the tests possible on one card, but it does not do troponin. When we were evaluating systems, we moved forward without troponin, as our medical director was concerned that our providers might get too comfortable with a negative troponin result, and a single negative troponin is not sufficient (most of the time) to rule out cardiac. However, in Jonathan’s system, the utilization of a positive troponin value to bypass facilities to definitive care is a fantastic example of how he designed his system. In our system, given our geographical layout, all of our potential cardiac patients go to a PCI-capable facility, so we don’t have this challenge. If I were in Jonathan’s shoes, I absolutely wouldn’t have moved forward with a device without troponin … so it just goes to show how you have to design your program based on your community’s needs.
In our system, we run point-of-care laboratory testing on probably 50 percent of our calls, because it provides such important information. I’ll tell you one thing … prior to implementation of point-of-care testing, we had so many cases (both cardiac arrests and alive patients as well) where our medical director suspected hyperkalemia and we treated as such. I always joked with him about how much calcium we were going through, but then we started getting lab results after we implemented our system, and I’m truly blown away by the amount of patients with a K > 6, that are quite sick, but conscious, talking and a normal ECG. Point-of-care lab testing has really changed all of our provider’s suspicion index for many conditions, and they’re frequently right! I can’t begin to attest to how many lives have been saved with this tool, and can’t even begin to think how we survived without it. We get about 25 lab values with every test, and the information is a game-changer.
Jonathan Sell: I’m impressed your rate of usage is that high! Last time I checked we are at about a 26 percent usage on our calls. That number is probably higher if you eliminate the scene calls that end as refusals, and the transfers where baseline labs have been done and no problems are noted. On the troponin note, your medical director is exactly right about getting too much comfort from a negative troponin. We have discussed adding the CK-MB cartridge (shorter time to show change from MI than troponin) to our panel as well, but elected not to at this time. The other huge reason for us to have the troponin is the number of transfers that we take for cardiac patients who didn’t present to us initially, but instead self presented to the emergency department, or came via another EMS agency. We will follow the standard serialized troponin protocol as well, so at two hours and four hours (sometimes 6 hours, depending on the transferring physician) we will go ahead and run additional serial troponins to see what the trend looks like. Also, we don’t ever consider a negative troponin definitive, we just like a negative FAST exam in ultrasound, it really doesn’t mean anything, until you have it again several hours later, and combine those serial negatives with the patient’s presentation and other factors.