Medicare penalties for eligible providers who don’t meet Meaningful Use for electronic health records (EHRs) begin on January 1, 2015, and increase every year providers continue to fail to demonstrate they have achieved it. While the meaningful use of EHRs has historically been viewed as the responsibility of information technology (IT) staff and clinicians, there is growing recognition among healthcare organizations about the vital role that supply chain professionals must play in this critical undertaking.
Setting the stage for standardized data
Earlier this year, the Office of the National Coordinator (ONC) for Health Information Technology proposed that EHR technology be able to record and display unique device identifiers (UDIs) about patients’ implantable devices to be certified for Meaningful Use. Deploying certified EHR technology is one of the factors that affect a provider’s ability to avoid penalties under the conditions described above. While that language was later withdrawn, the ONC is expected to revisit the idea next year in parallel with its proposal for Stage 3 of Meaningful Use. That proposed rule could also include a requirement that hospitals and physicians document UDIs for implanted devices in EHRs.
Meanwhile, the U.S. Food and Drug Administration’s (FDA) Unique Device Identification rule requires manufacturers of medical devices to assign UDIs to their products at all packaging levels and label those products with the UDIs in both human and machine readable formats. Under the rule, manufacturers must also submit data on their products to the FDA’s publicly accessible Global UDI Database (GUDID). The deadline for Class III products to be in compliance with the UDI rule was September 24, 2014. All implantable devices regardless of class, plus products considered to be life-saving and/or life-sustaining, must comply by September 24, 2015, and the balance of Class II devices a year later.
The primary purpose of the UDI rule is to improve adverse event reporting and better manage device recalls. Capturing UDIs in EHRs is considered a key step toward achieving that goal.
But to successfully implement and use EHRs requires that healthcare organizations have a single source of truth for product data. That’s where supply chain comes in.
Supply chain in the lead
Today, supply chain departments already capture information on the medical-surgical products their facilities procure, and they store this information in their item masters. The item master drives not only supply chain processes, but also a broad range of clinical and financial functions. Therefore, it makes sense that the item master should also feed the EHR to support documentation of the products used in patient care. But using the item master to feed standardized product data to the EHR is not as simple as it might seem.
Healthcare’s dirty little secret: Item master data
While the item master should be a healthcare provider’s source of truth for product data, most item masters are filled with inaccurate, duplicate and erroneous data. The problem lies with the sheer volume of product data a facility must maintain as well as the number of changes made to products each year. Even the most well-staffed and technologically equipped supply chain teams face an insurmountable task managing this continuous data churn. Other contributing factors to bad item master data include technology limitations (MMIS/ERP), discrepant data sources, lack of adoption of data standards, variation in processes and poor data governance policies.
Bad data in is bad data out. A healthcare facility that feeds inaccurate data to its EHR cannot trust the outputs generated – from the information generated to evaluate the clinical effectiveness of products and procedures to data used to secure reimbursements from the Centers for Medicare & Medicaid Services (CMS) and private payers.
A healthcare organization’s supply chain team is ideally positioned to inform clinical and IT staff of the quality of its item master data so that, together, they can make an educated decision about what steps must be taken to clean and maintain product data before it reaches the EHR and impacts downstream processes.
Recognizing the value of the item master and its impact on clinical and business operations, more facilities are implementing virtual item masters that continually monitor an organization’s item master for changes and updates, and then systematically correct product data inaccuracies, remove duplicates and fill in missing information.
Standardization is far from simple
Healthcare providers will soon have greater access to standardized product data thanks to the FDA’s UDI rule. That said, just because the unique device identifiers exist in the GUDID, it is not easy for organizations to obtain the data in a manner that can be easily integrated into its various systems, from the enterprise resource planning (ERP) and materials management information system (MMIS) to EHRs, billing systems and product registries for clinical research.
Because the supply chain department ultimately owns data on all of the products procured by its facility, it is uniquely positioned to lead UDI adoption efforts. Furthermore, many supply chain teams are already capturing product data that is subsequently used for a variety of purposes (e.g., inventory management, analytics, etc.). They can use this knowledge and experience to help their organizations access the necessary data to achieve EHR Meaningful Use objectives.
Many healthcare facilities currently implement product data standardization initiatives in parallel with their EHR implementations, but not necessarily in a coordinated fashion. Having a collaborative, multidisciplinary team comprised of clinicians, IT staff, supply chain staff and other key stakeholders overseeing both of these major initiatives helps ensure a facility gets the most out of its technology, time and resource investments.
EHR implementations are time and resource intensive. To ensure a return on its investment, a provider needs to prove the meaningful use of its EHR. Providers also need to use their EHRs to drive revenue growth and better reimbursements by delivering more effective, efficient patient care across the continuum. Both require healthcare organizations to have access to accurate data on the products used in patient care.
As the owner of a healthcare facility’s single source of truth for product data – the item master – and the driver of product data standardization efforts, supply chain professionals are positioned to help their organizations achieve Meaningful Use of EHR systems and must play a key role in EHR planning, adoption and use.