Enterprise labeling: Multi-modal model for modern supply chains?
Affixing the word “enterprise” as a modifier before any operation or task should help someone understand the operational expectations of the initiative at least, if not also the associated regulations, formats and controls.
For enterprise computing — particularly enterprise resource planning (ERP) — the phrase connotes the ease of transmitting data and information between devices, between departments, between facilities. The same holds fast for enterprise imaging in diagnostic radiology circles.
Dick Perrin, CEO, Active Innovation LLC, agreed that the intent of enterprise computing should support ease of data transmission and also “meaningful information resulting from the interpretation of that data.” But it also should encompass “the abilities to properly store, secure, and retrieve such data and information when needed for a particular enterprise and department objective,” he added.
Flexibility and fluidity of tasks get emphasis. Concepts like interoperability and scalability represent standard operating procedure. Standards may be important, but not confining, as standards and standardization don’t necessarily stifle configurability and customization.
“Interoperability and scalability should really be part of an enterprise philosophy for operations as necessary and essential for the specific activity,” noted Perrin, who is a former healthcare supply chain executive and a current supply chain information technology consultant and supply data standards advocate.
“But not all elements subject to enterprise labeling need to be interoperable,” Perrin indicated. “For example, radiology or medical records filing systems may be based on a set of patient record numbers in some format but these do not necessarily need to be interoperable between the departments served. Likewise passport numbers do not need to be interoperable with drivers’ licenses numbers or global passport numbers but should be linked as appropriate to meet identification/validation/security needs.
“On the other hand — enterprise labeling for medical devices or furnishings and equipment — need to be structured to meet all needs of the organization,” he continued, reiterating that they “do not necessarily need to be interoperable as the requirements for department support.” Such support could involve medical equipment maintenance versus Unique Device Identifiers (UDIs) for specific patients [that] should be considered for interoperability needs across systems, according to Perrin. Those systems may encompass ERP systems for receipt and inventory control and issue, surgical procedure systems, and related medical record systems and patient billing systems to meet both operation opportunities for enhanced operations as well as meeting data tracking requirements for quality of care and of course-related financial billing and for the patient and his or her care providers to be able to access Consolidated Clinical Data Architecture (CCDA) components as required by Meaningful Use Stage 2 and 3 certification requirements, he stated.
Ideally, enterprise labeling shares a similar philosophy. Imagine a label — whether printed on a paper sticker, inserted via chip or etched directly on a device or product — that includes a standardized set of data elements, regardless of location or end user or even information system, but also allows for organization-specific attributes to be recorded.
Intuitively, healthcare supply chain executives pursue enterprise labeling capabilities to enable and facilitate tracking and traceability of devices and products. As manufacturer recalls increase in number, process- and product-related breakdowns lead to infection and injury, and budgetary concerns call for economic justification, Supply Chain and Clinical leaders hope enterprise standards for labeling will facilitate access to critical data and information much more quickly — as in minutes, hours or days versus weeks or months. These efforts should enhance patient care outcomes and reduce costs.
In short, safety, security and sensibility seem to be driving enterprise labeling initiatives among selected healthcare organizations. But what drives a facility to participate? Does it have to have a complex, expensive IT system? A consolidated service center or shared services model? A high volume of products and services moving across a wide range and variation of facilities? How do you delineate enterprise labeling from discussions around “internet of things” and master data management that seems more applicable to larger urban hubs than smaller disconnected rural spokes?
Remote control
For Perrin, this relates to what he calls “the quandary of control.”
“In today’s environment it is relatively easy for anyone in any department to establish their own system for marking without consideration of any enterprise implications,” he told Healthcare Purchasing News. “One of the major issues facing supply chain professionals is recognition from others involved in systems that Supply Chain is increasingly reliant on information technologies and must be structured with interoperability in mind.
“In a research facility operating under grants, there are specific requirements for the marking and tracking of equipment that is acquired for research and clinical activities,” he said. “These responsibilities start with the folks in Supply Chain Management but are then handed off to the respective research area, laboratory, bio-electronics shop, clinical department, etc.
“The data on the label or the exterior marking on the RFID tag — active or passive — should be sufficient to specifically identify the enterprise — owning entity — as well as the base item information so that it can be tracked back to the appropriate system that is being used to track, manage, service, recall, report on device usage, etc.,” he added.
Sophie Rutherford, Vice President of Business Development, Jump Technologies Inc., encouraged facilities to think strategically about an enterprise labeling initiative that encompass many facets and workflows.
“Most hospitals today support only the use of labeling solutions for consumable items and potentially, asset tracking,” Rutherford said. “But restricting label solutions to only consumable items could be short-sighted and diminish opportunities, so planning and implementing at the enterprise level will drive greater benefit.
“Implementing enterprise labeling can eliminate manual processes, redundant workflows and promote a seamless exchange of data between systems,” she continued. “One of the additional benefits, and most relevant to healthcare systems today, is creating interoperability and new levels of transparency that can potentially extend the life of the existing ERP or materials system. With so many limitations in legacy systems, finding incremental technology that can store or share standard data elements across multiple systems becomes critical to automation and accuracy.”
Look beyond the label itself
Enterprise labeling involves more than just the labeling itself, insisted Jean-Claude Saghbini, Chief Technology Officer and Vice President, Inventory Management Solutions, Cardinal Health Inc. It also includes “the leveraging of the labeling to generate accurate and actionable data.
“IDNs implementing an enterprise labeling program should utilize advanced inventory management technology — RFID, for example — in order to build a data-enabled supply chain based on real-time data capture,” Saghbini said. “An enterprise labeling initiative would drive to the goal of enabling health systems to automate inventory management processes and integrate with multiple data sources, including patient records. The efficiency and savings gained from this connected supply chain will ultimately provide more time for the clinicians to spend on patient care, and help improve patient satisfaction.”
Saghbini pointed to the fact that the UDI system emerging from the Food and Drug Administration is designed to identify medical devices from the point of manufacture all the way through the point of patient use. “When this is entirely implemented, the label of most devices will include a UDI in human and machine-readable form,” he said. “UDI is foundational to more advanced labeling such as RFID, which enables RFID-labeled products to be read in real-time in the IDN from the time they are received, all the way to the time they are used at the point of care.”
Laura Johnson, Senior Account Executive, Life Sciences Industry Specialist, Loftware Inc., posited that “leveraging data elements required for labeling compliance requirements like UDI and pharmaceutical serialization can provide a hospital or hospital consortium an advantage over those that assign facility-based part numbers or inventory codes. Using the same UDI or Serialization identifiers as the original manufacturer will make the tracking of items easier to trace during time of recall,” she added.
Any enterprise labeling initiative must be pervasive to the organization, according to Perrin, starting with senior administration recognizing the need and following from there. “Clearly there are financial, clinical and operation considerations that also span in multiple areas links to integrated and often non-integrated systems,” he added.
“From the top, the standards should be set for the enterprise labeling and marketing programs,” Perrin continued. “These include the philosophy for marketing materials such as logos, letterheads, signage, etc. In turn, these standards and philosophy need to be accommodated as the needs for enterprise labeling of different items goes down the operational pyramid to support of divisions, sections, departments, etc.
Labeling standards as they are developed and promulgated should provide standards for colors, fonts, data elements to be included on internally generated systems, analysis of requirements for interoperability with other supporting systems. For example, surgical item tracking software with internally generated RFID tags needs to be interoperable with EHRs and probably EHRs for patient care tracking, financial issues and product recalls.”
See sidebars:
Enterprise labeling can be a trek worth taking
Enterprise labeling UDI in disguise or wasteful enterprise?
Where to start enterprise labeling — locations and products
Rick Dana Barlow | Senior Editor
Rick Dana Barlow is Senior Editor for Healthcare Purchasing News, an Endeavor Business Media publication. He can be reached at [email protected].
