Q&A with Scott Soefje, PharmD, MBA, BCOP, FCCP
This is part 1 of a two-part series on IV workflow management. Part 1 discusses increasing safety in IV compounding, while part 2, which will appear in a future issue of Pharmacy Purchasing & Products, will address overcoming challenges in IV workflow software implementation.
Pharmacy Purchasing & Products: What are the potential error points in a manual IV preparation process?
Scott Soefje: Sterile IV compounding has become an increasingly complex pursuit for hospital pharmacies. When the United States Pharmacopeia (USP) released the first iteration of Chapter <797> defining sterile IV compounding, many institutions had to significantly redesign their IV compounding processes to ensure compliance. Prior to compounding high-risk drugs in cleanrooms, the components could be set up by the technician and the pharmacist could easily check the product before the mixture was compounded. However, USP <797> introduced important safety measures into the process. The pharmacist must now perform hand hygiene and don personal protective equipment (PPE) to accomplish the same task. While USP <797>-compliant IV compounding is undoubtedly safer, compliance with the chapter has increased compounding complexity.
Although many methods have been devised to decrease the time required for the pharmacist to check sterile compounds in a USP <797>-compliant environment, each is fraught with potential errors. Some institutions place a pharmacist in the cleanroom to check IVs; however, this may be an inefficient use of time, as the pharmacist cannot complete other tasks if they must remain inside the cleanroom. A common method used to prevent pharmacists from having to enter the cleanroom to verify compounded sterile preparations (CSPs) is the syringe pull-back method, wherein the technician compounds the product, pulls back the syringe to show what was injected, and places the syringe, the vial, and the finished bag in an area for the pharmacist to check. Another method is having the technician place the IV vial next to the compounded bag and note on the label, or on a compounding form, how much was injected in the bag.
All of these methods can introduce the possibility of error. The technician could mix up the vials and/or amounts, resulting in an incorrect dose; this becomes increasingly possible when the same drug is used for multiple compounds, but with different doses. Relying on human skill and memory to ensure accuracy simply invites risk for mistakes to occur.
PP&P: How should an organization identify potential error points in its IV process?
Soefje: Each institution must perform a self-assessment of its workflow to determine possible error points in the sterile compounding process. At the University Medical Center Brackenridge, we developed a process map and then examined the error points based on best practice recommendations. Our goal was to increase compounding safety and eliminate the syringe pull-back method for checking sterile compounds while minimizing the impact on pharmacist and technician workflow. Potential error points included:
- The syringe pull-back method was used to check the IV compounding
- The pharmacist verified chemotherapy prior to injection, but had to scrub-in to the cleanroom every time. This was a significant time waster and pharmacist dissatisfier
- IV workflow was impacted by D/C orders. If the IV batch had printed, the pharmacist had to physically pull the printed label to prevent it from being made
- We were not efficient in recycling returned IV products that were still within the beyond-use dating time
There are several effective ways to undertake a self-assessment. Checklists can be helpful, and the process is well suited to conducting a failure modes and effects analysis (FMEA), which The Joint Commission recommends as an effective tool for identifying weaknesses in the IV compounding process.
PP&P: What best practice recommendations should organizations take into account when automating the IV workflow process?
Soefje: In 2016, the Institute for Safe Medication Practices (ISMP) announced a best-practice guideline that states, “When compounding sterile preparations, perform an independent verification to ensure that the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container.”1 In this guideline, ISMP reports continuing compounding errors, involving wrong concentrations or amounts, when performing manual IV compounding. One of the best practice recommendations is to “Use technology to assist in the verification process (eg, bar code scanning verification of ingredients, gravimetric verification, robotics, IV workflow software) to augment the manual processes. It is important that processes are in place to ensure the technology is maintained, the software is updated, and that the technology is always used in a manner that maximizes the medication safety features of these systems.”1
ISMP recommends the elimination of all proxy methods wherever IVs are compounded. Given this best-practice guideline, organizations should seriously consider implementing IV workflow technology to identify possible compounding errors.
PP&P: How should an organization approach choosing an IV workflow software system?
Soefje: These systems are challenging to evaluate, because they require an electronic medical record (EMR) interface to use, making it nearly impossible to pilot and/or test multiple systems. Thus, pharmacy must identify which features are required, and which are desired, but not mandatory, when choosing a system.
Identify the systems that provide the required features and invite the vendors of those systems to present their products at the hospital. Be sure each vendor provides a comprehensive overview of the entire compounding process utilizing the software. Develop a list of questions for each vendor to make an informed comparison. It is vital to keep the current IV compounding workflow in mind when envisioning the new system. No IV workflow software system will meet all of an organization’s needs, so it is necessary to identify which best supports the ideal workflow, compromising on certain features when necessary.
PP&P: Can you describe the typical dispensing process using IV workflow software?
Soefje: The IV workflow software system, which is interfaced with the EMR, receives the order following pharmacist verification. Some systems utilize an electronic queue, while others rely on the printed IV label as the trigger for the technician to begin compounding. The technician assembles the drug and the supplies needed, and selects the compound they are making on the computer screen. The software guides the technician through the steps of the compounding process.
All IV workflow systems require bar code scanning of the drug and will take multiple photographs of the preparation process to allow the pharmacist to visually check the completed CSP. Gravimetric weighing of the syringe, the IV bag, and the final product is available on some systems. When using gravimetric verification, consider that some drugs may lack densities; thus, accommodations must be made for drugs that are measured in units or in volume.
Design the workflow verification process so that the pharmacist has sufficient data to verify the accuracy of the compound. Once the technician completes the CSP, the pharmacist views the photographs and the related information about the preparation, and can then approve or reject the preparation from a computer terminal anywhere within the health system.
With an IV workflow software system, pharmacist verification occurs more quickly than compounding manually. In addition, the pharmacist can be offsite and still review and approve compounded IVs, provided your state board of pharmacy allows such a process.
PP&P: What IV workflow automation training is required for pharmacists and technicians?
Soefje: IV workflow systems are intuitive to use, but training is required. Pharmacy technicians who will compound medications using the technology require the most training. Technicians at University Medical Center Brackenridge were quick to adjust to incorporating the bar coding and photography requirements of IV workflow software. It took some time and practice for technicians to learn how to properly position large IV bags and their tubing on the scale to be weighed. After we mastered this task, it was incorporated into training for every new technician.
Little training is typically required for pharmacists. While it was somewhat challenging for pharmacists to learn to manipulate the photographs and zoom in and out to enable visual confirmation, most pharmacists adopted this skill quickly. The most challenging process was loading the drug database into the IV workflow software, as detailed information is required and sufficient time must be set aside to complete this task. It is important to create a standardized process to load the data. This process takes time to master, and if not used for a period of time, may have to be relearned.
PP&P: Are there any capabilities you wish the software offered that it currently does not?
Soefje: There are a few capabilities that would significantly improve our system.
- Two-Way Interface with the EMR. Currently, most IV workflow systems, including ours, utilize a one-way interface with the EMR. A two-way interface, which would enable the IV workflow system to send information back to the EMR, would be ideal. For example, two-way communication would allow documentation of the exact NDC number used in the preparation or the waste of single-dose vials.
- Automated Bar Code Sharing. Bar code maintenance is often a significant challenge in hospitals. Our organization utilizes four systems that use bar codes, and none of these systems exchange data. Therefore, maintaining bar codes will remain a manual process for the near future. Ideally, the IV workflow system should be able to pull the drug data, including the bar code, from the EMR or the inventory management software.
- Mobile Capability. Some IV workflow systems are cloud-based or have mobile capability. Our current system does not have a mobile app to allow access from a tablet or smart phone. This would be an extremely beneficial feature.
- Improved Access to Drug Densities. Gravimetric weighing creates a final layer of confidence that the product was added to the IV bag. However, the drug densities are difficult to find for every product and can differ by vendor. The process would be simpler if pharmaceutical companies published this information.
- ISMP 2016-2017 Targeted Medication Safety Best Practices for Hospitals. http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf Accessed January 29, 2017.
Scott Soefje, PharmD, MBA, BCOP, FCCP, is the director of pharmacy at the Dell Seton Medical Center at The University of Texas at Austin. He is the immediate past-president of the Hematology/Oncology Pharmacy Association (HOPA). Scott earned his Bachelors Degree in pharmacy from The University of Texas at Austin and his PharmD from the combined program at The University of Texas Health Sciences Center at San Antonio and The University of Texas at Austin. He is board-certified in oncology pharmacy and recently earned an MBA from George Washington University.
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