WORK GROUP TITLE:
UDI Capture Work Group
CASE STUDY PARTICIPANTS:
Jordan Noyes, Contract Operations Specialist at Beaver Dam Community Hospitals, Inc. (BDCH)
CASE STUDY ORGANIZATION:
Beaver Dam Community Hospitals, Inc. (BDCH) is a non-profit, non-stock corporation serving the greater Dodge, Columbia, and Fond du Lac County regions of Wisconsin. The new Beaver Dam Community Hospital opened for service on February 11, 2006. The 60-bed acute care hospital combines advanced medicine and technology with a state of-the-art facility to create a healing environment of care for patients and their families.
Jordan Noyes, Contract Operations Specialist at BDCH, describes his organization’s work to use device identifiers (DIs)1 as a “visionary movement,” noting how the 60-bed, acute-care rural hospital is tackling the same challenges around product data standardization similar to other leading health systems across the U.S.
Noyes says the main driver behind their data standardization project is preparedness for the Class I compliance date of September 24, 2018, which is the U.S. Food and Drug Administration’s (FDA) deadline for medical devices to enumerate their products with unique device identifiers (UDIs) and submit standardized data to the Global Unique Device Identification Database (GUDID). Over 50 percent of medical devices are already required to be labeled with UDIs based upon the passing of medical device class go-live dates.
Noyes and his team are currently exploring how to leverage supplier DIs in the operating room (OR) to capture implants electronically via barcode scanning at the point of use for documentation in electronic health records (EHR). This will involve storing product DIs in the organization’s enterprise resource planning (ERP) system and feeding them from the item master to their EHR system, both of which are McKesson Paragon products. Noyes said automating the product data capture process in this way should reduce the risk for human error, increase productivity and improve data accuracy in the EHR for greater patient safety.
Eventually, Noyes and his team would like to leverage DI capture in the procure-to-pay process, all the way through to patient billing.
DATE INITIATIVE WAS IMPLEMENTED:
CHALLENGES TO IMPLEMENTING A UDI CAPTURE SOLUTION:
Noyes and his team are currently in the process of identifying barriers to DI implementation and developing a plan to overcome them. So far the greatest barrier they’ve identified is their ERP system. The system has the capability to store DIs, which are the index keys to all records in AccessGUDID. While the ERP system has the capability to store the DIs, it does not have the ability to transmit those DIs to the organization’s EHR system allowing a link between the scan at the point of care and the ERP system. If the ERP system does not have these capabilities, the BDCH IT team will need to implement an intermediary software to serve as an interface between the ERP, EHR, and scanning systems for DI capture and transmission.
The other challenge Noyes identifies is the need for change management to show how DIs can facilitate process improvement in the OR workflow. He notes that because DI implementation will impact how product data is captured at the point of use, there has been some resistance to change among frontline users. BDCH recently hired a new director of surgery, whom Noyes and his team are working with to show the value of DIs for improving the workflow that comes with product data standardization and process automation.
- Supply Chain is driving the UDI initiative
- Chief Medical Officer (CMO)
- Chief Financial Officer (CFO)
- Surgical team
- IT department
BDCH is currently in the “information gathering” stage of DI implementation. Noyes and his team are working to gain buy-in from various stakeholders across the organization (e.g. clinicians, IT) and put into place a plan to move forward.
According to Noyes, a recent Lean Rapid Improvement Event (RIE) related to inventory management paved the way for their DI implementation work. Through the cross-functional RIE event, the organization discovered it was overstocking product inventory for surgery. This presented an ideal opportunity to demonstrate how product data standardization and process automation could help with inventory management, particularly for implants.
Noyes and his team plan to start DI implementation with BDCH’s primary implant supplier (Zimmer). Once they have configured their ERP system to store DIs in the item master and feed them into the EHR system, they will download the DIs for the implants they use in surgical procedures from GUDID to provide one source of information and avoid the need for ongoing downloads from the manufacturer. If they have concerns with the Zimmer data in GUDID, they will contact Zimmer to identify issues. As mentioned above, the supply chain team is currently working with the IT team to get the necessary technology in place.
TECHNOLOGY USED OR IMPLEMENTED AS A RESULT OF THIS INITIATIVE:
- McKesson Paragon ERP system
- McKesson Paragon EHR system with barcode scanning capability. BDCH utilizes other applications in certain departments, such as MedHost for the emergency department (ED), but they all filter up to Paragon.
- A software interface that will facilitate the feed of DIs from the ERP system to the EHR system.
According to Noyes, support from executive leadership is critical:
“Everyone understands there will be an outlay of capital on the front-end to get it done; our analysis shows we will make it up on the back end in automation and labor savings. The first thing we did was take it to the executive team to secure buy in, because you are talking about changing procedures across the organization.”
Noyes feels he and his team should have engaged the IT team earlier in the process because the initiative will require a great deal of work on their part.
Noyes and his team will continue to work with IT to determine what technology is needed to capture product DIs in the ERP system, transmit them to the EHR system and facilitate barcode scanning of products at the point of use. Next they will develop a new process in conjunction with their clinicians. Noyes fully understands successful implementation and ongoing compliance hinges on securing clinician buy-in from the outset. Once these two steps are completed, they will implement the ERP/EHR software interface, secure Issuing Agencies2 DIs from Zimmer and run trials to determine the effectiveness of their work.
1 An FDA-accredited issuing agency (IA) is an organization that operates a system for assignment of UDIs according to the UDI Rule. FDA has accredited three issuing agencies – GS1, HIBCC and ICCBBA.
2 Each issuing agency has an alternative name (aka) for the DI of UDI. The aka name used by each issuing agency is listed below:
GS1 - Global Trade Identification Number (GTIN)
HIBCC - Universal Product Number (UPN)
ICCBBA Processor Product Identification Code (PPIC)