“Improving Safety and Efficiency in the IV Room” : thoughts on the ASHP webinar

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8 responses to ““Improving Safety and Efficiency in the IV Room” : thoughts on the ASHP webinar”

1. May 23, 2015

   Ray Vrabel, PharmD

   Jerry,

   I have to respond to your comment that the barcode, ingredient-checking feature of Epic and the other EHR companies who either have or will have this capability by the end of the year (i.e., MEDITECH, Cerner, and Allscripts) are an absolute bar minimum in terms of IV workflow management and safety.

   While the barcode checking of IV admixture ingredients don’t do much to increase the efficiency of the IV workflow process, they do “catch” the most common errors made by humans: choosing and using the wrong ingredients. Let’s face it, most of the vials look alike and the labeling becomes a blur at some point, regardless of focus. In addition, the wrong drug, wrong ingredient errors are the ones that have proven to produce the most significant, often lethal, medication errors. Therefore, I would conclude that the use of barcode ingredient-checking technology should be the Minimum Basic Requirement of any IV workflow process and that it should be used for the preparation of ALL IV admixtures.

   If barcode ingredient-checking is all a pharmacy can do, then they must still use the manual physical inspection of syringe contents and the final product. The latter, physical inspection, is ALWAYS required either directly by a pharmacist or remotely by a pharmacist using video or imaging technology. Whether gravimetics alone can be used for a proxy for the pharmacist inspection of the filled additive syringe is still question in my mind.

   I’m surprised that someone has not developed a system utilizing photo-recognition software to determine if a given syringe plunger has been pulled back to the correct point. Given how photo-recognition software can identity people and drugs, reading the line on a given syringe plunger should be a piece of cake. If a system had this type of technology, the remote pharmacist wouldn’t have to study these images to make sure that syringes are drawn-up correctly and it would make the remote pharmacist process much more efficient.

   Thanks for starting the dialog…
2. May 26, 2015

   Chuck DiTrapano, RPh

   I also participated in the ASHP webinar regarding Sterile Product compounding.

   I agree that is was a good overview given the time restrictions. I also agree with Ray Vrabel’s comment that, “the use of barcode ingredient-checking technology should be the Minimum Basic Requirement of any IV workflow process and that it should be used for the preparation of ALL IV admixtures.”

   But I was left with concerns over the direction my profession seems to be taking as it relates to sterile product compounding. There appears to be an over-reliance on the use of images for checking sterile product compounding. I was left wondering if it is truly best practice? It also concerns me that we appear to be willing to relegate the operational aspects of institution pharmacy and let someone else set the rules.

   There are four areas I think we must investigate further.

   1. Who is the person compounding the product? Usually, a Pharmacy Technician. In the vast majority of states, this is an individual who has had no formal education in pharmacy, no licensure, and no certification. In my opinion, they are the most underrated category of staff in healthcare and they deserve more recognition, more education, certification, and licensure. But currently, we allow these individuals to function in a clean room compounding products.
   In my state (PA), like most others, I could legally grab someone off the street and have them compound sterile products. I’m sure most of us have heard the statement, “My barber must have a license, but my pharmacy tech does not.”

   2. Should we be moving pharmacists out of the clean room or should we be getting more involved? When I ask the question of young pharmacy students and residents, “Who is going to do dispensing in institution pharmacy in the future?” I often hear the answer, “Pharmacy technicians and technology.” Technology, is evolving, making our jobs safer, more efficient, and most importantly saving lives! But I don’t believe that any product on the market today is a substitute for pharmacist engagement or involvement.
   We (licensed pharmacists) approve or disapprove compounded products based on barcode verification results and a view of images taken during various steps in the process. By doing so, we don’t observe the whole workflow, we don’t have a dialog with our staff, and we avoid constructive critique – a missed opportunity to educate.

   3. Who reviews sterile technique? USP 797 has changed our world for the better and we, as a profession, are focused on managing the potential for bacteriologic contamination. Looking at a photo, we do so, without observing the individual’s technique and process. I don’t know how a “remote pharmacist” cannot observe sterile technique. An image versus a real life observation, is it just as good? I have seen pictures of Italy and I have been to Italy; it is definitely not the same thing!

   4. Who’s responsible for determining best practice? Is it the pharmacy profession, ASHP, or some other group? Just because “they” say that best practice includes barcode scanning and images of process for sterile or non-sterile compounding, should we agree and stop there? If it’s not us (licensed pharmacists) making the rules, shouldn’t it be? Are there other technologies, ideas, or processes (like Ray mentions) that we can bring to the table to make compounding safer? Are we able to “fill in the gaps” left with the systems on the market today?
3. May 27, 2015

   Jerry Fahrni

   Hi Chuck-

   You bring up some great points. Definitely worthy of more dialogue.

   Not sure what you and Ray think you read, but my thoughts and opinions are inline with yours, i.e. the use of barcode-checking technology should be a minimum. I said as much…”[bar code verification of compounding components] are what I would consider an absolute bare minimum in terms of i.v. workflow management and safety”.

   In regards to using images for verification, I don’t have a problem with it. I think we could do better, and we shouldn’t settle for only using images, but it’s a far cry better than the “pull back method” that I still see used in cleanrooms today. Does a pharmacist have to sit there and watch a technician shoot ingredients into a bag? That seems rather silly to me. Check the volume prior to shooting ingredients into a bag? If you want. You can do this today with readily available technology.

   In regards to your four areas:
   1) Should technicians require licensure? Probably. I see both sides of the debate. Let me share what happened to me many years ago while working at a pediatric facility. We would go to the local university and hire science majors [chemistry, physics, biology] to work part time in our i.v. room. Some of the best technicians I ever worked with. Then people started screaming for licensure and credentials. We lost a lot of those smart, self-motivated, meticulous people. They were replaced with licensed technicians, many of whom were much less capable. Which is better, great technicians with no license or average technicians with one? I put the onus on the facilities to provide proper training and competencies. Does a license make you competent? Hardly. I’ve worked with licensed pharmacists that I wouldn’t let look at my dog.

   2) I agree with you that it’s not yet time for pharmacists to give up on operations. You can see my thoughts on the subject from this post in 2010 [http://jerryfahrni.com/2010/08/dont-dismiss-the-value-of-an-operational-sound-pharmacist/]. However, I do believe that we should be moving pharmacies out of the cleanroom. It’s such a waste. Do you really believe a pharmacist is better equipped to double check appropriate compounding simply because they have a Pharm.D. after their name? Does the degree make their eyes better? Why can’t technicians check technicians? I also believe that technology will eventually take care of most of this type of thing. Are we there yet? No, not yet.

   3) Hmm, this all boils down to training, testing, and competency. And to my point in #2 above, who says a pharmacist is required to evaluate aseptic technique? You have to be able to train your technicians and trust that they will do things correctly, i.e. use proper aseptic technique. If you can’t do that then you should re-evaluate your system, and your people.

   4) Good question. I don’t have an answer. Organizations like ASHP have historically been weak in developing best practice, although I must say that their guidelines for sterile compounding are very good. Unfortunately – and I’ve said this before – pharmacy won’t do the right thing until they’re forced to do the right thing. In other words, if it’s not “a law” a majority of pharmacy departments simply ignore it. I’ve seen it too many times. Should we (pharmacists) be making the rules? Probably, but it won’t happen. Why? History has shown that we’re not capable.

   Thanks for stopping by and for the thoughtful commentary, Chuck. Maybe someday you, me, and Ray should get together and discuss this in much greater breadth and depth.
4. May 29, 2015

   Ray Vrabel, PharmD

   I enjoyed the comments above. What scares me is that the three of us probably represent a small minority of the profession.

   Jerry, you stated that a product that only performs barcode checking of the ingredients is a 50% solution (i.e., “…you’re literally getting one half of the functionality necessary to ensure accurate compounding.”) That is only true if you have an IV room workflow process that does not rely on the pharmacist actually visually inspecting what a technician does. Granted, if you don’t have pharmacists properly supervising the work of the IV technician, then you definitely need something more than barcode scanning.

   What barcode scanning does is catch the “human error” of thinking one vial is something it is not (i.e., rocuronium versus fosphenytoin) and it does that very well. I would argue that this mistake (i.e., wrong vial and/or wrong bag) accounts for the vast majority of serious IV room medication errors. It’s the one medication error that I am still haunted by in my professional experience.

   The “human errors” that can be made during the actual preparation of an IV have much less consequence to a patient. Not that they are acceptable, but they are less harmful. The exact amount of an admixture may be wrong, but it probably won’t be wrong by much. If you start the IV admixture process with the right ingredients (i.e., the right vial for the right admixture), it’s hard to make a serious error.

   The issue with the Process Checking part of the IV admixture is that only a licensed pharmacist can have the responsibility for that part of the process if it is done in the pharmacy. A technician may be able to “do it”, under the supervision of a pharmacist, but there has to be supervision. Is looking at a still image “supervision”? It’s just a piece of data, showing the right amount of something was drawn up into a syringe. How do you know in an image-checking system if the drug was actually placed in the right bag or put in a bag at all? You don’t. Even the systems that have gravimetric checking, with or without imaging, cannot guarantee 100% accuracy. Instead, they will just warn you when something isn’t right.

   Even thought pharmacists may want to shirk their professional responsibility and let technicians perform tasks without proper supervision, they cannot legally do that. The surgeon can’t let his best surgical technician perform a procedure while looking at still images of the technician’s work remotely from outside the OR.

   It is my opinion that the barcode scanning of IV admixture ingredients in conjunction with online, real-time video streaming from the IV hood to the pharmacist outside the cleanroom is a better basic method. First of all, this allows the pharmacist to view the technician’s technique and their ability to follow IV hood procedures, something not captured with a still image. It also allows them to visually check intermediate steps (i.e., syringe pull-back with drug) as it is happening and the pharmacist could capture a still image when they do that for documentation purposes. The pharmacist would also have the opportunity to see the technician add the medication(s) to the bag (and observe their technique).

   Right now, the tale is wagging the dog. USP797 gave us standards to make sure our IV admixtures are near-perfect sterile, but they also helped drive the pharmacist out of the IV cleanroom. Then, vendors decided that still images were a “good enough” proxy for “technician supervision”, so that is now the de facto standard for hospital pharmacy.

   Let me predict that the direction we are going will “blow up” at some point in the future. A serious error is going to occur using one of our “remote control IV workflow systems” and someone is going to ask “who is actually supervising the work of these unlicensed pharmacy technicians?” Pharmacy either needs to “do it right”, not do it, or give it back to another licensed healthcare professional. The first option is the only one I would choose. Other than this, a decent pharmacy IV robot is the only technology that will provide the pharmacist with the freedom they want from this task in the future. They will still have to accept the responsibility for what the robot does, but they won’t have to deal with the uncertainty of human pharmacy technicians for such a critical task.
5. June 2, 2015

   Dennis Schneider

   (Full disclosure: I’m one of the original creators of DoseEdge)

   A few comments:

   1. First principal: there are no (exactly ZERO) human beings capable of consistently producing 100.0% perfect operations/inspections in repetitive process.

   A great process, great training, great oversight, great people, and diligent inspections can come close – but cannot get to “perfect”.

   Pick your own percentage of human error (the best data suggest 2%-3% error rates) and multiply that times the number of doses or operations or drugs picked – then add a another inspector and multiply the first one’s errors by your percentage… Hint: ZERO errors will not be a possible outcome of the exercise. (=Only a matter of time and the application of the Law of Large Numbers before a preventable ADE.)

   2. It’s asserted here (and elsewhere) that, if implemented properly, barcoding of ingredients can catch a significant portion of potential errors in sterile-to-sterile manual compounding. There is a giant body of statistical information (presented/published) that supports this assertion.

   In the spirit of “perfect” is the enemy of “good enough”: The “real” question is: “Where does ‘wrong ingredient that is caught by barcoding’ sit on the “Top 10 error sources list?” It is definitely “up there” – but there IS a LIST of significant error sources. There is little doubt that just automating the identification of right ingredients/electronically screening out the wrong ones IS of real value– but if you’re going to do the work, rework process, pay for IT implementation, build and diligently maintain ALL the barcode data, how will that investment’s ROI stack up against a more complete answer?

   More specifically: What is the impact on pharmacist time spent overseeing and inspecting compounding of JUST taking this step?

   3. The use of gravimetrics comes up a lot as “another automated check”/mechanism for avoiding those pesky “human beings are imperfect” errors. There is certainly a class of errors that can be reliably caught with correct implementation and use of gravimetric verification (easy example: volume errors of one or more orders of magnitude). This same class of errors is also reliably spotted by visual inspection. Of course, a 10x or 100x error might have come from an error made earlier in the order process – inspection by a knowledgeable pharmacist is still needed!

   I know there’s a giant cyclonic storm that will whip up when I say that basic realities of compounding don’t support catching small volume errors — syringe graduations are only 4%-5% accurate anyway. Key here is again, the ROI of the process cost. Digital scales take time to settle to a reliable measurement — and there will still need to be visual inspection. Time is money…

   Several IV workflow products support using scales… (my “ex-child” included)

   I’ve not seen anything published that suggests that a well designed and implemented use of IV workflow automation WITH gravimetrics produces a better result than one without.

   4. The idea of using image analysis to verify volume using a syringe image was raised.

   Suffice to say that this isn’t a new thought. Having a system that could reliably screen images for syringes, ID the syringe geometry, measure the plunger distance from “0” might make a lot of staring at pictures more productive and — if fast enough – could catch errors during compounding. Assume that it IS possible/feasible AND it will not be free — takes memory and a pile of “right now” computes. Add another $700 PC for each camera? Push your vendors.

   FInally: If the common enemy is “Errors in Compounding”, does everyone have their Top 10 list of error sources and SOME game plan for error reduction? Outside the world of pharmacy compounding, EVERY decent manufacturing process will have a clear answer for this one.

   Sorry if I intruded or rambled..

   Best

   Dennis Schneider
6. June 3, 2015

   Ray Vrabel, PharmD

   Dennis, Thanks for providing your non-pharmacist, more technological view regarding this discussion. Pharmacists come to problem solving with their own biases and input from a variety of disciplines is what is needed. The following are my thoughts regarding your comments:

   (1) Human Error: Your first principal, that the best humans all have some level of error rate, when combined with the fact that many vials look alike, support the requirement that the barcode scanning of IV admixture ingredients should be a required Minimum Requirement for all pharmacy-prepared IV admixtures regardless of type.

   (2) Barcode Checking: The purpose of the barcode ingredient-checking step is not intended to save the pharmacist time. It is solely to minimize and eliminate the possibility of a “human slip” during the selection and use of the IV admixture components. Another issue is that as you increase the complexity of a process (e.g., taking multiple images during a simple IV admixture process), the greater the chance that pharmacy management is going to limit the use of the more advanced work-process IV admixture technology (e.g., imaging, gravimetrics) to just certain types of admixtures (e.g., high-risk drugs, chemotherapy). Unfortunately, this leaves lower risk IV admixtures (e.g., a fosphenytoin drip) to be done without any IV Work Process checking automation (i.e., ingredient barcode scanning). The lethal medication error that occurred this past December in Bend, Oregon has proven the fallacy associated with that approach.

   (3) Gravimetrics: I think your comments about gravimetrics are valid. Gravimetrics are a tool that “can” be used to further enhance the accuracy and safety of a Workflow Process. An attentive pharmacist directly involved in the IV admixture process (i.e., in the cleanroom, checking the work of a qualified technician directly) would probably produce similar outcomes. The difference is that gravimetrics might catch any “human slip” actions introduced into the process. On the other hand, there is a lot of work that must take place with gravimetrics (i.e., before and after vial and bag measurements) and the question has to be asked whether or not this additional work will provide additional value (i.e., ROI), given the types of errors that gravimetrics might catch, that would not have already been caught with proper barcode scanning of the ingredients.

   Another factor is that gravimetrics just introduces more low value, repetitive work into the process for a technician and gives them a false sense of security, possibly allowing them to create other types of errors (i.e., unintended consequences).

   (4) Syringe Imaging: If you weigh the time spent by pharmacists looking at pictures of syringes with their plungers pulled back and then add to that the inaccuracy of this process secondary to “image fatigue”, I think the ROI for the additional costs of this option would be fairly quick.

   (5) Game Plan: Clearly, it would be valuable to have individuals trained in work processes to carefully examine, dissect, and evaluate the sources of error associated with pharmacy IV room work processes and develop a game plan.

   Thanks for joining the conversation. Keep in up…
7. February 8, 2017

   Jay Osty

   Hi,

   Can anyone tell me where the EMR companies like Epic, Cerner and Meditech are in being able to do IVWF? I have heard that this was a possibility, but not sure to what extent. Thanks, Jay
8. February 8, 2017

   Jerry Fahrni

   Hi Jay – All 3 companies are working on solutions. To what extent? Well, that’s super top secret.

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