But you may see stars along the way
by Rick Dana Barlow
If you choose to embark on an enterprise labeling journey, experts contend that even a road paved with good intentions won’t necessarily guarantee a smooth ride.
Here are a few of the pitfalls, pratfalls and traps you may face and how to overcome them.
Overlook simplicity and mobility.
“An enterprise labeling solution has to be simple for the end user,” said Sophie Rutherford, Vice President of Business Development, Jump Technologies Inc. “If it’s complicated, creates additional work, or offers a challenging user interface, it will discourage use and reduce compliance. Ultimately, end users need to see value in using the solution and understand how it directly benefits their role or department. So the solution needs features that make workflow easier, better, more efficient, with demonstrable results in process efficiencies and automation, resulting in improvements in cost, quality and outcomes.
“For a success enterprise-wide approach, the solution must have full mobility,” she continued, “allowing the end user to move around freely from one area to the next without docking, logging in/out, or using separate devices. A cloud-based solution will provide the mobility and remote access required for a multi-site, multi-hospital IDN. Without this ease of use and mobility, it’s likely the system will be implemented, but then over time, usage and compliance decline. A cloud-based solution also supports scalable growth within an organization and not be limited to network requirements, software upgrades, or hardware deployment. Ultimately this provides enormous cost savings to a health system.”
Shortchange training and stock material.
“When healthcare facilities make the decision to implement an instrument tracking/asset management system, as a component of enterprise labeling, the software and related installation costs associated with data entry and employee training can require a considerable investment of time and money,” said Mark Ebenstein, Vice President, Kem Medical Products Corp. “These costs can often stretch the budget and can sometimes lead to the cutting of corners when the time comes to purchase hardware, such as scanners, printers, etc., and other ancillary items, such as labels and ribbons.
“The irony is that the performance and integrity of the label itself is of utmost importance. If the label fails, the system fails,” Ebenstein added. “In order to achieve success, labels need to meet a definitive set of criteria. Label stock should be validated for 100 percent sterilization efficacy by independent laboratory testing. The label adhesive must provide reliable adherence to hard surfaces, both contoured and textured, as well as all types of sterilization wrapping materials. Finally, the print capability of the label must consistently deliver clear, concise images for scanning. Labels should not smear, smudge or scratch off easily.
“Making the investment to utilize specialized label technology is a crucial component for ensuring the successful usage of an instrument tracking/asset management system.”
No depth beyond the surface.
“One of the major pitfalls at the conclusion of such labeling initiatives can be that underlying processes do not change to take advantage of the labeling to gain efficiencies,” said Jean-Claude Saghbini, Chief Technology Officer and Vice President, Inventory Management Solutions, Cardinal Health Inc. “As such, the expected gains from the effort can go unrealized. One way to address this pitfall is to leverage the labeling process to incorporate smart labels, such as RFID labels. Then, complement that with smart RFID technology throughout the procedural spaces and the OR, which enables automated real-time inventory management and usage capture. This RFID implementation rapidly generates gains and efficiencies to justify continuing to expand the labeling efforts.”
Misread the scope of change management.
“You need to understand the hardware and software and ensure it can read and parse the data scanned appropriately,” said Cynthia Shumway, Director, Business Applications, Intermountain Healthcare Supply Chain Organization. “If you have noncompliant product in the supply chain, develop a strategy — do we temp label, do we return and get compliant product, etc.? Change management is needed, particularly in the clinical arena. You may be modifying bedside practices so you need to partner with clinical leadership for a shared vision/benefit — patient benefit versus supply chain efficiencies.”
Implement in “secret.”
“The most obvious issue is to design a system or implement capabilities without talking to anyone else in other departments about the potential impacts,” said Dick Perrin, CEO, Active Innovations LLC. “‘Hi, I added this label to this device to accomplish this purpose… Does that have any impact or potential benefit to you?’ Obviously the key to achieving the goals of the departments managed by the Supply Chain professional are dependent on communications and collaboration and shared visions with other departments supported and served.
“Some other sources of information and perspectives that you may consider on the pervasiveness and extreme importance of enterprise multi-modal labeling include the following:
- Government Labeling Solutions & Defense Department Labeling,” (https://www.teklynx.com/en/industries/government). With TEKLYNX bar-code labeling software, government suppliers can comply with the identification requirements for items of military property that are produced.
- Test Report — U.S. Army Automated Movement and Identification,” (www.usarmyamis.army.mil/Contracts/aitv/TC-AIMS-II_MSL-PrinterReport.pdf). Military Shipping Label (MSL) Assessment for AIT-V…. 220.127.116.11 software for both standalone and enterprise applications to enable.
- Enterprise Information Security and Privacy,” (https://books.google.com/books?
isbn=1596931914) C. Warren Axelrod, Jennifer L. Bayuk, Daniel Schutzer – 2009 – Business & Economics — D.S. 4.1 Background Information classification is the act of labeling information. Military information labels include top secret, secret, and unclassified.
“Remember that UID (unique identifier data) in the military parlance (they use UID to identify a tank or other assembly with costs typically over $5,000) is different than UDI (unique device identification), but there are lots of overlaps,” he added.
Ignore full automation and standardization.
“Even as customer expectations continually climb, so do the challenges in managing the supply chain to meet those customer expectations,” said Laura Johnson, Senior Account Executive, Life Sciences Industry Specialist, Loftware Inc. “The ever-more-complex, global nature of the supply chain makes it that much trickier to maximize efficiency and ensure responsiveness. Labeling, which is a critical component, also becomes more complex to manage with increasing customer and regulatory requirements. Companies can’t arrive at an effective supply chain strategy if they don’t consider how labeling intersects with the evolving demands of the supply chain. If the label isn’t right, it can disrupt manufacturing, inventory, and movement of product. Production and distribution can grind to a halt, resulting in unhappy customers, potential fines, and as a result, major losses in revenue and profit.
“With enterprise labeling, this all-important function is standardized across the enterprise and fully automated, which not only boosts efficiency but also reduces the chances of error,” she continued. “Enterprise labeling can enable business partners to print labels approved for use, which can ensure consistency and eliminate the costly practice of relabeling goods upon receipt.
“Medical device manufacturers and other life science companies have invested heavily in enterprise-wide business systems,” she added. “However, device and packaging labels are often created using disparate processes and data that aren’t integrated with a company’s core system. Thus, they aren’t drawing on data that is the single source of truth. Nor are they able to tap the business rules laid out in an enterprise system. The resulting errors, inefficiencies and mislabeling can significantly impact the bottom line. This is why it’s so critical to have the correct labeling solution in place — especially when it comes to patient safety.”
Much depends on how you define it
by Rick Dana Barlow
For some healthcare providers, the concept of “enterprise labeling,” growing in popularity outside of healthcare in the manufacturing, retail and service industries, but generating waves among healthcare product manufacturers, seems like apparel brand name Von Dutch pinstriping on a classic car restoration.
Much depends on how the industry defines “enterprise labeling” for the mass market of healthcare providers and suppliers. Does it involve a single printed label or two printed labels? Will one-dimensional labeling satisfy requirements or 2-D or even 3-D? How about a radiofrequency identification chip/tag that can be “programmed” with product as well as patient information, the latter of which entered by the provider because the supplier would not necessarily have access to private patient data. Does the chip, label or tag include everything necessary to transact business end-to-end from raw materials supplier through manufacturing, distribution, consumption/usage, disposal, billing and reimbursement?
Does something like that even exist anyway?
“I’m not aware of other initiatives to capture everything on a label or chip,” noted Cynthia Shumway, Director, Business Applications, Intermountain Healthcare Supply Chain Organization. “However, if you’re referencing optimizing a label to connect supply chain and clinical data, then here is my two cents. We, at Intermountain have not wanted to be in the re-labeling business. Our goal is to optimize the FDA standards and utilize the label on the package. This provides us with a common product identifier between business and clinical systems, serial and/or lot tracking information and product expiration management.
“In addition, our strategy is to capture this information with scanning from end-to-end as applicable,” Shumway said. “For example, it doesn’t make sense to scan an individual tongue depressor at the bedside, but it does make sense to scan cases, boxes, etc., to improve efficiency in the supply chain processes. This same strategy drives us to start small in areas primed for success rather than bite off the whole apple.”
Labeling remains a fragmented exercise among healthcare organizations, acknowledged Jim Francis, Chair, Supply Chain, Mayo Clinic.
“Labeling for tracking medical products, etc., is currently a process that varies entity by entity based on technology, capabilities, charge/no charge items, etc.,” Francis said.“ We track items primarily for inventory management, replenishment, and billing purposes. Most healthcare organizations are waiting until UDI brings a solution that leads to standardization and the ability to track items from manufacturer until recording in the medical records.
Francis doesn’t see healthcare providers coalescing around an enterprise format beyond the UDI where this movement should concentrate around standardization.
“The current process is entity-specific based on distribution model, technology, billing practices, etc.,” he said. “It is not standardized today, but will be with a single [electronic medical record], supply replenishment system and the standardization of charge master activities, tracking and the implementation of UDI.”
If enterprise labeling somehow entails healthcare providers labeling products that already sport manufacturer labels, Andy Fairlamb, Executive Director, Supply Chain, Mercy East Communities, Resource Optimization & Innovation (ROi), expressly states he’s not a proponent.
For him, the manufacturer label, complying with UDI requirements, should be Lean enough.
“Within the procedural areas, such as operating room, cath lab, labor and delivery, interventional radiology, etc., it is important to track the UDI from inventory receipt to a specific patient,” Fairlamb said. “For the most part, that can be accomplished without having to implement an enterprise labeling initiative. It is critical to be thinking Lean when implementing new processes, and adding the step of labeling is really not Lean. The key is to utilize the barcodes that manufacturers place on the products. Many of them have moved to 2-D barcodes, where one scan will capture all the information needed. Scanning individual barcodes for lot numbers, serial numbers and expiration dates is still better than having to place a new label on the individual products beforehand. So, hopefully, by utilizing manufacturer barcodes, you only have a small subset of items — if any — that would require a provider applying a label.”
Fairlamb further noted that outside procedural areas, bar-code scanning compliance rates on products that are not medications hovers around 50 percent. He also emphasized that “the key to scanning is to have the system that is capturing this information configured properly to take in the scanned information and parse it out into the correct data fields.”
Fairlamb also doesn’t think the ideal of an enterprise label that includes all-encompassing product and patient data is even feasible because you wouldn’t want a supplier having access to patient information anyway.
“Patient information stays within the EHR,” he said. “When a product gets used, the barcode or RFID tag gets scanned and that unique product identifier is tied to a specific patient in the EHR. It is not important that a specific product has patient information tied to it, but for patient information to have specific product information tied to it. Barcodes are just a way to get information into a system. The key is the EHR. That is where all the information needs to be housed.”
Parallel labeling procedures simply don’t make sense in the face of the UDI, according to Fairlamb. This would involve all the information necessary for the product — including a way to track backwards in the supply chain to the sourcing companies; the hospital label would include all the information necessary for the patient — including a way to track their medical history via EHR to link to billing and insurance.
Of course, the one challenge with the UDI right now is that it’s predominantly focused on items that go inside the patient and not necessarily on items getting applied to a patient, he indicated. Other supplies may fall under a room charge that replaces individual charge stickers.
“We use the manufacturer barcode as it’s unique to that company and includes what’s needed,” he said. “As companies move to 2-D bar coding they can add data to the label, such as lot number and expiration date. Ideally, though, a provider should be able to scan the product barcode label and the patient ID to link the two. Or they simply could tie in that process to the EHR.”
That’s how the Mercy system handles pharmaceutical usage through its Mercy Meds program.
“We would scan the drug package and the patient ID before the drug was used on the patient,” he said. “The UDI requires you to do that with implantable products because that is designed to assist in any possible recall issues but also helps with billing, reimbursement and inventory management.”
When you re-label products then you may have to sequester those products by patient and that becomes an additional logistical process that shouldn’t be necessary, according to Fairlamb.
“You can tie products used on patients downstream at the point-of-care through point-of-use systems,” he said. “We use Omnicell’s OptiFlex for that and it also helps us track inventory. Under a Lean process we would classify adding another label to the product as a wasted activity because you can capture that data in other ways.”
If you’re considering implementing some type of enterprise labeling initiative, where to start within the organization and which products should be targeted first remain two fundamental questions.
Cynthia Shumway, Director, Business Applications, Intermountain Healthcare Supply Chain Organization:
“Start where the products and suppliers are already compliant and in high-risk areas such as [cardiovascular] and orthopedic implants where there is immediate benefit to connecting the patient to the lot/serial number that facilitates improved recall management.”
Sophie Rutherford, Vice President of Business Development, Jump Technologies Inc.:
“When implementing an enterprise labeling solution, begin with the ‘source of truth’ for relevant information or data – the ‘keeper’ of all metadata and attributes of items to be labeled. This might actually encompass multiple systems or even an EDW (Enterprise Data Warehouse).
“The low-hanging fruit in this initiative is the med/surg commodity items. These are items that have been bar-coded for years; the required information and standardization should already be in place. Bar-coding these items will provide transparency to inventory on-hand, throughout various locations, as well as improve the cycle and physical inventory count process.
“The next areas to address are the assets and equipment that can be bar-coded to track unique serialized data, along with preventive maintenance and/or retirement dates associated with the equipment. An enterprise labeling solution that can centralize and manage data, and show how assets are maintained, can have significant impact the [return on investment] of a system implementation because it directly affects capital investments.
“Finally — the most difficult area for implementation of an enterprise labeling solution — is the OR, where there’s a wide array of consigned inventory, instruments and trays. Consigned inventory, while not an asset of the hospital, still needs to be tracked and accounted for, particularly with UDI requirements and recall tracking. Instruments and trays present a great opportunity for barcoding technology, because a single barcode can track movement, replenishment, even patient charges, for multiple items associated with it. This saves time in component management and line item entry. The ‘gotcha’ is maintaining the individual components, which so frequently change as contents of procedure trays are updated.
“In med/surg areas, it’s most relevant to have patient chargeable items bar-coded to capture the patient charge. But there is a lot of buzz in the industry about this area.Some hospitals have a threshold for the items that are chargeable, for example, items with a cost greater than $25. Others don’t charge for line items, but roll the item cost into a procedure charge or a room charge. And some hospitals have a flat reimbursement rate, so it doesn’t matter what is charged. They’re reimbursed the same.
For asset management, bar-coding equipment that has preventive maintenance requirements will deliver the most value. In accordance with guidelines set by The Joint Commission, Occupational Safety and Health Administration, and other key regulatory agencies, it’s critical to ensure equipment is calibrated and maintained according to the required preventive maintenance schedule. There’s significant risk and liability in failing to do so.
In the OR, bar-coding consigned and implantable items with the UDI-required barcode meets multiple goals, including improving patient safety, enhancing device post-market surveillance and supporting medical device innovation. When fully implemented, UDI will deliver benefits to everyone involved in the healthcare system, including patients. Similarly, barcoding instruments and trays helps create visibility to the movement and location of these items, provides location tracking in the event of a recall or FDA requirement, and shows availability of items for scheduled procedures.
Laura Johnson, Senior Account Executive, Life Sciences Industry Specialist, Loftware Inc.:
“Supplier visibility matters. Fostering effective supplier relationships is necessary and can lead to partnerships that are willing to assist each other. Utilizing EDI or other type of electronic notifications that include UDI or product serialization details will help hospitals streamline receiving and then provide a mechanism for tracking goods throughout the supply chain to the end user. Many companies focus on transactional efficiency, and have forgotten to focus on supplier development, reliability, and visibility. It isn’t how effective a company manages the purchase order. Instead, it is about the effectiveness of managing the supplier relationships and joining together to streamline the initial product identification and tracking the movement of goods more efficiently.
“High-dollar or high-risk products should be the initial focus, followed by or being in lock step with the phased approach of UDI (Class II and III) or pharmaceutical serialization (Class 1 and high risk). This will provide hospitals with ability to receive products that are already labeled in compliance with the regulations.”
Dick Perrin, CEO, Active Innovation LLC:
“The process should really start at the top of the organization and trickle down. The general philosophy is that departments will develop their own systems and approaches to meet their operational needs but these should be done in a broader context of organization — or enterprise — policies and procedures to ensure optimum results.
“In today’s world, one of the most significant opportunities to face material managers/supply chain professionals is the adoption of the UDI standards into their organizational systems. Most still do not recognize this as a major opportunity or understand the significance of the far reaching implications. Supply Chain management systems (ERPs) are the base starting point for data capture, and the UDI data in turn flows to other departments and their systems. Some of this data will be received from RFID tags, and others will be from bar-code labels in linear or in data matrix formats. The systems that the Supply Chain executive puts together and implements must consider the enterprise requirements for this data that is patient-critical for quality of care, achieving the ability to track and analyze outcomes and to accomplish financial requirements.
“The initial starting point has to be with consideration of capital equipment for big-dollar items and items requiring tracking for servicing, calibration, etc. to meet patient care requirements. From there it trickles down to all other items handled and again the emphasis should be first on cost — highest cost items most obviously need systems designed to facilitate tracking, such as pacemakers and stents, down to routine consumables, such as bandages and dressings.”
Jean-Claude Saghbini, Chief Technology Officer and Vice President, Inventory Management Solutions, Cardinal Health Inc.:
“IDNs should start implementing advanced labeling, such as RFID, in the areas where they could get the most benefit and the largest ROI. These would be the procedural areas, including the cath lab, electrophysiology lab, interventional radiology lab, and operating room. Labeling should be implemented for the high-value medical devices and implantables, including stents, pacemakers, heart valves and tissue.”