The process of compounding sterile products, by its nature, must be exact and uncompromising. It requires copious, detailed documentation and must conclude with verification by a pharmacist; however, the pharmacist cannot guarantee the contents of the final product without visualization of the compounding steps, and manual documentation methods leave ample room for error.

Texas Health Presbyterian Hospital Flower Mound (THFM) is a 101-bed community hospital located 30 miles northwest of Dallas. The hospital utilizes an electronic health record (EHR) with computerized prescriber order entry and automated dispensing cabinets facility-wide. The pharmacy department operates 24/7 and is staffed by 15.5 FTEs, including department management. Within the pharmacy is a USP <797>- and Texas State Board of Pharmacy-compliant IV cleanroom.

Concerns with the Manual Approach
Under our original manual system, a pharmacy technician gathered the necessary labels, medications, and supplies for sterile compounding and followed the hospital’s policies and procedures to make each dose. Technicians relied on the syringe pull-back method for compounded sterile preparation (CSP) verification. Thereafter, the CSP, syringes, and empty vials/bags were brought out of the cleanroom and delivered to the pharmacist for inspection and approval. The process was identical for the preparation of patient-specific doses and batch orders. Because the pharmacist did not witness the actual compounding steps, and no visual record of these steps was available, it was impossible to guarantee that the medication was compounded properly. Not only was this problematic because of the possibility of errors, but it was also in violation of the Texas State Board of Pharmacy requirement that a pharmacist perform in-process checks to validate that CSPs are made correctly.

Compounding sterile products requires attention to detail, and when the process is completely manual, these duties quickly can become mundane. Consider the specific documentation required for every type of CSP made. Each new item or batch necessitates the development of a compounding recipe, the creation of a compounding worksheet template, and the generation of example labels, and this documentation must be maintained every time the product or batch is made. Previously, our pharmacy relied on multiple large binders to manage this information.

Vetting Technology Options
In order to add in-process checks and eliminate the manual documentation of compounding, a team comprising the pharmacy director, coordinator, and two technicians with extensive compounding experience was assembled and tasked with evaluating multiple IV workflow software products. The goal was to identify a solution that utilizes a camera system in the IV cleanroom or hood to allow pharmacists outside of the cleanroom to view the various steps of the compounding process, along with software to simplify the documentation of compounding activities.

Some vendors offer solutions that include computer screens and digital cameras mounted on or in the IV hoods, while others include printers that are placed in the cleanroom. Options that include full-size computer screens, cameras, or printers that require multiple data ports and emergency backup power outlets in the cleanroom may be troublesome to incorporate if the space is not already wired appropriately. Cost can be another hurdle; multiple pieces of required hardware can add up to a considerable capital equipment investment.

Implementing a Technology Solution
THFM elected to purchase the PharmacyKeeper Verification (PKV) photo-based, workflow management system because it entailed no upfront capital equipment costs. Rather, the system utilizes Web-based software and iPad minis. Using the wireless Internet connection eliminates the need to retrofit the IV room with additional power outlets or data ports. In addition, the PKV software is intuitive and accommodates our existing processes, with sufficient flexibility to manage any future workflow changes.

The PKV system has the capacity to interface with many EHRs, but because of internal limitations making it difficult to add a new interface to our EHR, the software was implemented without the interface. While this approach reduces the amount of patient data that autopopulates into the application, the system’s flexibility and ease of use make it an attractive option even without the interface. In addition, the application has the ability to maintain a database of medications and their corresponding bar codes, as well as prebuilt recipes configured by THFM pharmacy administrators. This is a standard option included with the PKV software.

The sterile compounding process at THFM now incorporates the PKV application using tablets, with the software accessed via an Internet browser. When a new compound or batch order is received in the pharmacy, the technicians create the order in the PKV system, and the software prompts the workflow process, including all the compounding steps for those products that have pre-configured recipes within the system.

Steps in the Compounding Process
The following steps comprise the compounding process:

1. Component check. Technicians use Bluetooth scanners paired with tablets to scan the vials or bags being used to make the order. The system compares the scanned bar codes with the prebuilt recipe and alerts the technicians if an incorrect item is scanned.
2. Photo documentation. Once the accuracy of the components is confirmed, the technicians take the products into the cleanroom where another tablet is located. Inside the cleanroom, the second tablet is used to take pictures of the vials/bags, their lot numbers, and the quantities of each diluent and medication before they are used.
3. Pharmacist approval. Next, the final product and remaining supplies are brought out to a pharmacist who logs into the PKV system to compare the patient label to the scanned components and the pictures of the quantities used. This comparison meets the stipulations of the “in-process check” requirement. After confirming the CSP was made appropriately, the pharmacist approves the order and prints a label that includes a pre-established beyond-use date for the dose based on the specific compound being made, as well as the names of the technician and pharmacist.

Implementation and Training
During the implementation, the vendor or a superuser trained each technician. Early in the process, the additional steps required by the new system added about 5 to 10 minutes to the compounding process, but as staff became more proficient, the time added was minimal. One of the most significant challenges was learning what steps required photo documentation and how to appropriately use the tablet to obtain those images. Additionally, it is important to invest sufficient time during system configuration to ensure that as many bar codes as possible are loaded into the system; this reduces interruptions by eliminating bar codes that do not match the items used in prebuilt recipes.

As with any new process, early auditing of the staff provided feedback regarding how to optimize use of the application to meet the department’s expectations. After feedback was provided and multiple recipes were prebuilt to simplify the order creation process, staff fully embraced the PKV software as a required part of the compounding workflow and now use it for all preparations compounded in the pharmacy.

Future Benefits
The reporting functionality of the PKV system allows users and managers to track each item made, the length of time each step required, and the technician or pharmacist responsible for completing each step. Further analytics are being released that will provide facility summaries detailing the average duration of each workflow step by user or time of day. At THFM, some of the available metrics have limited use, as an interface with the EHR is not present and the delivery tracking functionality in the PKV system is currently not in use. In the future, we will investigate utilizing the tracking feature without an interface.

Overall, the PKV system, with its attendant bar code scanning technology, has been a positive change to the sterile compounding process at THFM. Also, the PKV software has provided technicians and pharmacists with a way to visually validate the steps taken during the compounding process. Because the photos are stored on the vendor’s servers at no additional charge, they are available for future quality or regulatory inspection purposes. The product has exceeded our expectations, and we look forward to additional improvements as MedKeeper plans to release additional modules.

Todd K. Connor, PharmD, MS, is the director of pharmacy at Texas Health Presbyterian Hospital Flower Mound. After earning his PharmD from the University of Houston College of Pharmacy, he completed a 2-year residency/MS degree program at Riverside Methodist Hospital and The Ohio State University. In Todd’s various management roles, he has focused on leveraging technology to create safe processes for patient care.