Given the critical nature of accurately compounding IV medications, improving safety in the IV preparation process is a goal of every hospital. The University of Texas MD Anderson Cancer Center, one of the largest cancer centers in the world, is devoted exclusively to cancer care, research, education, and prevention, and is ranked the top hospital for cancer care in the US.1 The cancer center’s division of pharmacy prepares all sterile compounds, including chemotherapy infusions, for our unique patient population.
Given our high-risk patient population and our routine preparation of narrow therapeutic index drugs, the pharmacy historically utilized a gravimetric verification check in our manual IV preparation process to ensure accuracy and safety. Gravimetric preparation—the process by which a volume of a drug ingredient is weighed on an electronic balance and validated for accuracy based on the measured weight and the density of the substance—has been utilized in the IV preparation process in all of our pharmacies for over 20 years.
Considerations for Automating IV Preparation
As the devastating repercussions of IV compounding errors became increasingly visible across the nation in recent years, and as IV preparation technology options increased in the marketplace, MD Anderson began to explore the possibilities of adding additional safety features to our existing manual gravimetric process. However, prior to implementing additional safety measures, including evaluating and implementing an IV workflow software technology solution, an accurate assessment of our pre-implementation workflow was critical.
Failure Modes and Effects Analysis
A failure modes and effects analysis (FMEA) was conducted to identify potential areas of weakness in our process (see TABLE 1).2 Pharmacy management, pharmacists, and pharmacy technicians from all outpatient pharmacy areas participated in the FMEA, which was led by one of our health care systems engineers. The IV preparation process steps were mapped out and the group identified potential failure modes at each step. Among the potential errors documented were selection of wrong drug or vehicle, calculation errors, and incorrect labeling of a bag due to the printing of multiple patient labels prior to dose preparation. The effects of these potential failures were identified and assigned a severity level. The FMEA group investigated current controls in the process and assigned scores based on the effectiveness of those controls to detect errors.
To ensure safety at these critical points in the IV preparation process, the group recommended implementing IV workflow software, which could have a significant impact on reducing the risk of more than half of the failure modes identified in the FMEA. An IV workflow software product was chosen that offered bar code scanning, gravimetric workflow, and electronic documentation; another important requirement was an HL7 interface to the pharmacy order entry system with the ability to receive order updates and dose changes as needed.
IV Workflow Software Implementation
The implementation phase comprised several steps, including hardware setup, interface development, database build, software testing, and staff training. A 1-year pilot of the technology in one outpatient infusion pharmacy was key to evaluate the impact of the software on IV safety and cost savings prior to implementation into the remaining seven outpatient infusion pharmacies located throughout the health system. In order to install a touchscreen, all-in-one computer, we modified our existing biological safety cabinets (BSCs) with an arm mount, as well as retrofit ports on either side for cable management. In addition, a scanner and label printer was installed at each BSC. Finally, although the pharmacy areas already had electronic balances for the manual gravimetric process, we upgraded to more robust balances with improved sensitivity.
Interface Development and Testing
The IV workflow software vendor and our institution’s information technology specialists were highly involved in the interface development and testing process. A testing and production environment, with interfaces corresponding to the appropriate order entry system, was required to perform adequate test scripts prior to go-live. A team of pharmacists built the database, which included user groups, settings, and drug information. One pharmacist was charged with inputting data—including drug information, stability, densities, and manufacturer information—which was independently checked by a second pharmacist. Pharmacists and pharmacy technicians carefully tested each drug and program setting and reported any issues to the vendor for resolution.
Staff training is essential to ensure the success of any technology implementation, as employees require an informed understanding of the product’s features and the importance of the software. We selected super-users, who were instrumental throughout the training process to assist with troubleshooting and to field questions from staff. Staff who hands-on training in a computer lab, and competencies were performed to confirm understanding. During the implementation process, it also became apparent that staff who may cross-cover the areas utilizing the software also must receive training, as they will be expected to maintain competency as well. Keep in mind that the learning curve for gravimetric verification will be steeper for an organization that has previously used only visual verification. Appropriate training and education were key to staff developing confidence with the new IV workflow process.
Benefits of IV Workflow Software
MD Anderson Cancer Center has experienced significant benefits as a result of using IV workflow software with gravimetric validation, including increased medication safety resulting from bar code scanning and gravimetric validation, the ability to identify errors in real-time, increased standardization, decreased waste, and enhanced reporting capability.
- Medication Safety. Bar code scanning is now integral to our IV preparation process, and we are able to intercept wrong drug or vehicle errors immediately when the technician begins preparation. Because the technician starts the process from an online work queue rather than a printed label, automatic updates occur to the order if there is a dose change or cancellation. The technician chooses the product available in the inventory and scans the vial bar code. If there is a bar code scanning error, the technician is not permitted to override, but would then need to verify that the product is correct; if it is, the technician must go back to the initial setup process to select the correct vial size and/or manufacturer. An accurate concentration of reconstituted vials is achieved with IV workflow gravimetric validation. The software weighs the amount of diluent injected into the vial and calculates a precise concentration, rather than an assumed concentration that occurs when using a manual reconstitution process.
- Identification of Errors in Real-Time. During dose preparation, errors are intercepted in real-time rather than after the completion of the dose, which minimizes waste. The software requires that the ingredients are weighed prior to injection into the bag, and the technician is alerted to errors if the wrong amount of drug is withdrawn into the syringe. The error must be corrected before the technician can proceed.
- Standardization. The IV workflow software ensures that all steps of the preparation process are standardized, which eliminates the variability inherent in a manual process. The label prints only after the dose is prepared without errors, following each step of the process. The pharmacist scans the final product and documents a visual inspection. The visual inspection can be achieved remotely if needed, since each preparation step is documented thoroughly.
- Decreased Waste. The inventory management capabilities of the software help control waste. All partial vials and unused preparations are recorded and tracked, and labeling vials and prepared bags with the appropriate beyond-use dates allows expired products to be tracked and discarded.
- Robust Reporting. The software provides detailed reports with metrics for productivity, inventory management, stock levels, and a thorough record of all steps that occur during the preparation process, including bar code error scans and out-of-tolerance weighing.
When moving from the manual gravimetric process to the automated workflow, proper management of the IV workflow software master drug database was critical to success. It is important to include the density of the drugs and vehicle in the database to ensure the most accurate calculation by the software; if these are not available, the drug or vehicle is assumed to have a density of 1 g/mL. Most drug manufacturers readily provide density information, but if the information is not available, our pharmacy research lab analyzes the drug. With the exception of chemotherapeutic agents in the taxane class, the available chemotherapy drug densities are between 0.988 g/mL and 1.087 g/mL. We anticipate that by increasing awareness of the importance of gravimetric verification and IV workflow software, manufacturers will be more willing to share density information with pharmacists.
Master database maintenance also requires the addition of new manufacturers to existing products, and involves adding the vial size, manufacturer, and bar code, information that is then verified by a second pharmacist. Lot management is the responsibility of our inventory pharmacy technicians, who add new lot numbers and vial expiration dates to existing products. This step also requires a mandatory second check.
There was some reluctance, especially from long-term staff, to accept the IV workflow software and the changes required to use it. Because each step in the process was standardized, technicians received error and warning messages if they skipped steps unintentionally or assumed the next step. Some staff members also expressed fear that the technology would make their roles superfluous. However, we did not use the increased efficiency gained from the technology to eliminate positions, but rather to reassign duties and create new projects. After about 3 months, as employees began to recognize the value of the software, reticence to buy in to the new process diminished. Experience has shown that new technicians are better able to understand the IV preparation process when they are trained on the IV workflow software first, rather than the manual process.
A final lesson learned is that adopting technology cannot solve every challenge. Introducing automation to an existing faulty process only complicates the problem. Therefore, evaluation of the pharmacy’s workflow processes and development of standard operating procedures are critical prior to implementation of any new system; this approach helps users understand how the technology can improve the process. Moreover, effective staff training is crucial to preventing workarounds.
Current Use and Next Steps
Our goal was to add all chemotherapy and hazardous medications into the IV workflow software database. This objective was achieved by starting with one drug at go-live, and slowly introducing a total of 28 drugs within 4 months. Three years after the implementation, we now prepare 76 drugs using the IV workflow software. All eight outpatient pharmacy locations are using the technology, which is employed in a total of 25 BSCs. To date, we have prepared over 285,000 doses using the software and the average turnaround time for dose preparation is 4 minutes.
Future goals include developing a bidirectional interface between the IV workflow software and our EHR software, which will enable us to receive accurate information about actual dose amount prepared and the National Drug Codes (NDCs) of the products used. The information sent back to the EHR system will allow a complete view of the patient’s medication record, and also provides an accurate amount of discarded drugs that can be billed per CMS, if needed. In addition, we plan to expand the use of the IV workflow software to our inpatient pharmacy areas, as well as use the IV workflow software for preparation of non-chemotherapy drugs. Preparation of batched, non-chemotherapy doses will be available in an upcoming version of the software. We encountered one setback when introducing non-chemotherapy drugs: the time and resources needed for manual maintenance of the database, including gathering density information and adding the multiple generic manufacturers of each drug, was significant. A larger number of those products exist compared to the relatively smaller number of chemotherapy drugs.
A desirable future capability of the IV workflow software includes the development of an interface with our inventory and purchasing software to decrease the manual steps required when adding inventory into the system. Also, due to a limitation in the industry, adding lot numbers to the IV workflow software will continue to require a manual process until lot number and expiration information is added to the drug product bar code.
Implementing IV workflow software has improved the utility of our gravimetric preparation process, increased safety with the addition of bar code scanning, facilitated the ability to identify errors in real time, increased standardization, and enabled electronic documentation. Proper management of the drug database and providing staff with effective training have been critical to maximizing the value of the software. Perhaps the most significant benefit of using the technology is the assurance that we are doing everything we can to ensure the safety of our IV products to protect our patients.
- Gravimetric Balances: Mettler XS4002S
- IV Workflow Software: BD Cato
- Biological Safety Cabinets: NuAire Class II A2
- Scanner: Datalogic Gryphon GD4400
- Label Printer: Zebra ZT420
- Touchscreen Computer: Tegular TS-3010-15
- US News & World Report Announces the 2016-2017 Best Hospitals. US News & World Report Web site. www.usnews.com/info/blogs/press-room/articles/2016-08-02/us-news-announces-the-201617-best-hospitals. Accessed September 23, 2016.
- Reece, KM, Lozano MA, Roux R, et al. Implementation and evaluation of a gravimetric i.v. workflow software system in an oncology ambulatory care pharmacy. Am J Health-Syst Pharm. 2016;73(3):165-173.
Kelley M. Reece, RPh, PharmD, is the ATC R2 IV room assistant manager at the University of Texas MD Anderson Cancer Center in Houston. She earned her pharmacy degree at The University of Texas Austin College of Pharmacy and completed a pediatric pharmacotherapy residency at Texas Children’s Hospital in Houston. Kelley has been working in the ambulatory treatment center at MD Anderson for the past 10 years, and is responsible for USP Chapter <797> and <800> compliance, hazardous drug safe handling, and implementation of the IV room gravimetric software system.
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