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KSR Publishing, Inc.
Copyright © 2016

         Clinical intelligence for supply chain leadership



July 2014

People & Opinions

Worth Repeating

"It is estimated that US healthcare system costs attributable to the 5 most common HAIs (central line–associated bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, surgical-site infection, and Clostridium difficile infection) amount to $9.8 billion."

Carol McLay, DrPH, RN, CIC, Infection Prevention Consultant, and Chair of APIC’s Communications Committee

"Many facilities, even those not currently operating in states that require CS certification, are already stepping up and requiring it on their own because they recognize its value and are committed to quality and safety."

Josephine Colacci, JD, IAHCSMM Government Affairs Director

"Departments should have a set month each year for safety. During that month you review your PPE policies with your staff and do a hazardous assessment of your department. This way you ensure that staff understand the importance of protecting not only themselves but the patient."

Stephan Kovach, Education Director, Healthmark

"Most shippers can significantly reduce their freight spend by adopting advanced logistics techniques like consolidation and pooling but lack the technology and data to identify and prioritize opportunities and model the results. To capitalize on these savings opportunities, they need to invest in technology, or partner with third party logistics providers that offer technology and analytics as part of their portfolio."

Marc Mullen, Vice President and General Manager, Solution, Services and Marketing, Cardinal Health

"It is important that the CEO be informed on supply chain activities and trends in order to socialize the importance of supply cost management throughout the organization. The CEO needs to be convinced that the Supply Chain leader is not only reporting on metrics, but that Supply Chain is fully engaged in ongoing activities to effectively manage quality, service and cost in these areas."

Anthony Trupiano, Senior Vice President,
Supply Chain, WellStar Health System, Atlanta


Striving for status quo from status woe on supply data standards

by Rick Dana Barlow

As the executive management teams running healthcare provider and supplier organizations scramble to assign priorities to the burgeoning bulk of regulatory measures they face via reform they must keep the inertial butterfly or domino effect within sight.

Anything done likely affects everything else. That includes enacting standards for supply data, including the Food and Drug Administration’s Unique Device Identification (UD) initiative, and linking them to electronic health record meaningful use requirements, which was inked last fall and winter, respectively.

Healthcare Purchasing News wanted to explore the cascading wave of these decisions and invited commentary from a group of key standards advocates. They evaluated industry progress in the area of standards implementation (see March 2014 HPN) and explored the ripple effect going forward.

HPN: How will the UDI regulations affect progress in adoption and implementation by suppliers and providers?

Dennis Black, Director, E-Business, BD

I can’t imagine a supplier ignoring FDA’s UDI regulations. The FDA UDI regulations are already having a significant effect on medical device manufacturers. Medical device manufacturers are spending millions of dollars to comply with FDA UDI regulations. Suppliers like BD that implemented data standards on a voluntary basis decades ago are now modifying labels to comply with regulations. Millions more will be spent.

The FDA UDI regulations really don’t require much of healthcare providers. I don’t see the UDI regulations alone driving healthcare provider adoption.

Dennis Byer, principal, DSB Consulting

The UDI only requires manufacturers to implement, and the FDA has no jurisdiction over the hospitals. There has been discussion in Washington regarding a Meaningful Use Stage 3 requirement that hospitals be able to interface the UDI to the electronic health record. [Editor’s Note: The FDA accomplished this post-interview and announced in late February.] Currently, we are in Stage 2 of Meaningful Use, and there is discussion about extending the deadline for Stage 2 from the end of 2015 to the end of 2016. Assuming that there even is a Stage 3 for Meaningful Use, that would mean the hospitals would be required to implement the UDI at some point after 2016. If by chance Stage 2 is extended beyond 2016, the deadline for the hospitals might even be later. We need to move faster implementing the UDI, not slower.

Jay Crowley, Vice President and Practice Lead — UDI, USDM Life Sciences

Suppliers will be required to implement. Other activities, such as EHR meaningful use and reimbursement, will help drive provider adoption, but more needs to be done. A proposed MU3 requirement to document implantation in patients’ EHR will drive at least certain activities in the OR space. [Editor’s Note: Crowley formerly served as Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health, where he helped develop the UDI framework and key requirements.]

Joseph Dudas, Vice Chair, Supply Chain Management, Mayo Clinic

It will likely have a positive effect but far less than most expect. UDI regulations only address a small portion of the supply chain. The roll-out [timeline] is unnecessarily long, and the regulation does not specify a single standard. Also, there are virtually no requirements in the regulation for providers to adopt that I am aware of.



Curtis Dudley, Vice President of Integrated Business Solutions, Mercy

The UDI regulations are driving greater adoption of the standards by manufacturers, but the regulations don’t have specific requirements for providers. Since the regulation was released we’ve seen specific manufacturers that were previously reluctant to adopt the standard take significant steps toward standards adoption. It has been proposed that provider requirements be included in future meaningful use requirements, and Mercy supports this inclusion.

Keith Lohkamp, Product Director, Infor

The publication of the regulations has helped to drive forward the adoptions of standards. For suppliers that had been hedging their bets, the UDI regulations provided certainty that standards would be required, and the FDA accredited the two standards that manufacturers were using. For providers, the UDI regulation rekindled interest in adopting standards as they began to understand the impacts and opportunities. Although in some cases, compliance has distracted suppliers from implementation, we’re still seeing hospitals rolling out standards with their suppliers, both centrally in supply chain as well as in clinical departments.

Michael Pheney, Former Vice President, Healthcare, GS1 US

In the absence of FDA regulation, the industry had coalesced around the need for unique device identification, with trading partners across the supply chain spectrum collaborating on implementation projects. With the regulation in place, we will see an acceleration of implementation based on the risk-based timeline set by the FDA. Manufacturers will be held to mandated deadlines. The good news for manufacturers is that many had already begun the work required and are well on their way to becoming UDI-ready. Providers, who are not regulated by the FDA, in the meantime believe that the current UDI regulation is only the first step. It is conceivable that additional regulations will ensure UDIs are used throughout the entire healthcare supply chain and ultimately into the clinical space and electronic healthcare records. [Editor’s Note: Pheney left GS1 US in mid-May after press time.]

Joe Pleasant, ret. Vice President and CIO, Premier Inc.

Now that the specifics of the regulation are known I expect suppliers, distributors and their software companies to aggressively move forward with adoption in order to meet the deadline of the rule.

Providers are behind the suppliers in exploring their requirements for implementation. However, many of the leading-edge provider organizations are reaching out to their GPOs, suppliers and distributors to collaborate on the establishment of plans for adoption and implementation of UDI within their extended supply chain. By all parties collaborating on a plan for implementing UDI throughout the extended supply chain — manufacturer through Provider — we will achieve the benefits that other industries have realized. This collaboration will provide the peer pressure between supply chain partners that pushes the adoption and implementation. I believe the next 12 months will be very active in education and development of adoption plans among all participants and the following two years will be about implementation.

Jean Sargent, CMRP, FAHRMM, CRCST, Director, Consultants, MedAssets Advisory Solutions

The UDI will force the adoption by all manufacturers in one form or another depending on the type of products they manufacture. The FDA is working with accrediting agencies to be the eyes within the providers to monitor the progress of implementation towards patient safety enhancements.



Deborah Templeton, R.Ph., MHA, Chief, Care Support Services, Geisinger Health System

[This] temporarily gives a lift to HIBCC, and creates the need for a data pool, perhaps [overseen] by the FDA to ensure that vendors publish to that data pool.

[This] puts emphasis on proving the GS1 business case. The UDI regulations and potential future use — billing and claims info — has [given] us as providers a stronger platform to raise UDI integration into the medical record higher on the visibility and priority ladder. Also, it helps to make a stronger tie to clinical usefulness, in terms of tracking and trending for research, compliance with care standards and general recall and patient accessible information for implantable devices.

Alex Zimmerman, Director, Healthcare Supply Chain Informatics, Christus Health

I would expect to see a tremendous amount of progress stemming from the regulation. Already, a preponderance of Class III devices contains a valid UDI. The majority of these UDIs will not have to change after the regulation goes into effect. Much of the supplier progress going forward will be for the Class II and I products, but these manufacturers have some time to meet these deadlines and many of them have already adopted standards initiative strategically if not actively. Adoption will be slow from the providers as there is not a requirement for them to make use of them that they are not already doing and there isn’t a burning platform to change.

Enabling systems to scan and store the UDI, lot, batch, serial number and expiration is available at many institutions but its use isn’t easy to pin down. There has been talk about tying the UDI regulation to Meaningful Use Stage 3. If this happens you will definitely see a surge in interest and progress on the part of providers. This is something I support as it will hasten efficiency throughout the industry and help to broadly reduce the ever expanding cost of healthcare.

On the medical device/product side, which key segment (supplier vs. provider or both) should drive the adoption and implementation process (given that pharmaceutical suppliers drove NDC adoption and implementation in the 1970s) and why?

BLACK: For UDI specifically, the answer is manufacturers. Since the UDI regulations are specifically written for manufacturers — or "labelers" using FDA vernacular — it is evident that manufacturers must lead the implementation process. For UDI, it is manufacturers that must revise internal processes, modify labels, create new master data and invest in equipment.

Beyond the initial UDI implementation, the answer is the entire industry needs to drive implementation. If the entire industry doesn’t modify processes and adopt data standards, most of the millions invested in UDI will be wasted. Assigning numbers, printing bar codes and creating clean data is meaningless if we don’t get true adoption. If we can cleverly orchestrate the change management process across healthcare, we will all win. Most importantly, patients will benefit.

BYER: The FDA is "driving" the UDI and that’s not going to change. The UDI does not call for a single standard to meet the regulation. It currently allows three standards and that list could grow. It’s possible that while the UDI is supported globally, each country will have a different required standard for UDI compliance. From the manufacturer point of view, this is a real nightmare and will add cost.

Hospitals need to indicate to suppliers their requirements. The reality is that there will be multiple standards in play, multiple carriers of the data, different types of bar codes, several data sources and different types of technologies. All of these issues are obstacles that the hospital must overcome for full UDI implementation, and has mostly been overlooked by the industry.

CROWLEY: NDC adoption was driven largely by reimbursement activities, and there isn’t a direct parallel in the device space. The larger, societal benefits we all hope [this] will bring [includes] better post-market surveillance, faster time to market and more accurate and timely information. This will only come about through systemic implementation across the life-cycle of devices. I think needing to document UDI for certain devices, such as implants and [other expensive new technology] will require development and implementation of systems to support. If you’re capturing some information for reimbursement, then why not [do it] for all devices? IDNs need data to drive efficiencies, and device spending is a huge issue. They will want to capture all.

DUDAS: All should look at this as an opportunity as opposed to a cost. 

DUDLEY: Both providers and suppliers have significant roles to play in the adoption of the UDI. Our belief is that there should be only one standard, and GS1 is the preferred standards. It all starts with the manufacturer and Step 1 is to assign and apply the GTIN to each unit of measure of the product.  The provider needs to utilize the GTIN in all its supply chain transactions and put in place the capability to associate this identifier with the EMR. The overall objective is for both parties to streamline procurement transactions and enable reliable and effective outcomes based analysis.  There are truly two essential parties in this discussion — the makers and the users of goods. The makers have to provide the basis and the users have to productively use the standards to improve operations and clinical outcomes.

LOHKAMP: Both segments need to be actively involved in adoption and implementation. Suppliers can help encourage adoption but making standards part of their regular communication of information with their providers and in their EDI implementation guidelines. Providers need to push adoption along by continuing to ask suppliers for this data in a repeatable way while focusing on implementing use cases, such as scanning within their own organization. By having both parties push adoption and use, standards will become more than just a compliance requirement.

PHENEY: Frankly, both suppliers and providers should be driving implementation. There is no question as to the benefits. A study published in 2012 by McKinsey & Co. found that implementing global standards across the entire healthcare supply chain could save 22,000 to 43,000 lives and avert 0.7 million to 1.4 million patient disabilities. Rolling-out standards-based systems could prevent tens of billions of dollars’ worth of counterfeit drugs from entering the legitimate supply chain. Global standards could enable substantial safety benefits and enable healthcare cost reduction of $40 billion to $100 billion, the report found.

While med/surg suppliers work to support UDI regulation timelines, providers have the opportunity to leverage UDI to ensure patient safety, reduce costs and increased efficiencies once that information is incorporated into their systems and processes. In addition, pharmaceutical manufacturers are required to pass lot number information in supply chain transactions, while retail pharmacies will be required to maintain lot traceability information, as part of the Drug Quality and Security Act.

Each segment of the supply chain has much to gain from using standardized information, and is facing regulatory or business pressure to do so. GS1 Healthcare US is working with industry members during the transition, no matter where they are on the education or adoption and implementation scale.

PLEASANT: Several key medical device suppliers and leading-edge provider organizations will collaboratively drive the adoption and implementation. They will be assisted by the GPOs, professional associations and standards organizations. The software organizations will support their customers in making the needed changes associated with the implementation. [They] will provide the pathway for other organizations in their adoption and implementation.

SARGENT: I believe this is a true partnership working toward the common goal of patient safety. The supply chain efficiencies to be gained, in my opinion, are secondary to the positive effect on the ability to track recalls without missing affected patients due to lack of data/information. 

TEMPLETON: In truth, neither. If the healthcare consumer knew they had a choice and truly exercised their voice, it would be no different than the impact they had on driving retailers to improve systems and quit wasting our time in checkout lines. And isn’t it interesting [that] we are so demanding, we are willing to even become part of the checkout solution! Suppliers and providers will need to work together so that we can understand gaps and limitations on either side and work to build the bridges necessary to move forward.

ZIMMERMAN: I think the NDC adoption and implementation was significantly attributable to the pharmaceutical distributors. These organizations did a great deal to create systems, processes and mechanisms to support scanning of bar codes and tracking of products throughout the entire supply and demand chain. I haven’t seen any concerted effort or solutions on behalf of the medical supply distributors. Unless this changes I expect the adoption and implementation to grow grass-roots from the providers, both from the top-down from centralized supply chain groups and from the bottom up at best in class standalone facility-based practices.   

At this point, what are some provider demands and expectations for adoption and implementation that you believe are unreasonable and why?

BLACK: None of the healthcare providers that is actively implementing have made unreasonable demands. These healthcare providers are investing their time and resources to implement data standards. Some minor mistakes and miscommunication will occur on either side as we gain experience. We are also mutually refining our expectations of each other as we gain implementation know-how. The answers become clear during the implementation process.

The only unreasonable demands I hear come from some of the individuals and organizations (healthcare provider, manufacturers, GPOs, or distributors) that aren’t implementing. At times, the observers have different opinions than those that are implementing. Managing a project plan seems to illuminate what is necessary and drive collaboration.

BYER: My personal feeling is that the hospitals don’t have any unreasonable demands. They are faced with this enormous challenge of reducing their costs by 20 percent and improving their overall quality at the same time. The hospitals are responsible for patient care and are dealing with life-and-death situations. Overall, we should be facilitating hospital progress and improvements not creating obstacles. 

CROWLEY: We have to remember that UDI is brand new — and though manufacturers may have been applying standard identifiers voluntarily before — the regulatory mandate creates a whole new paradigm. And though UDI is ultimately very doable for manufacturers, it is not easy or trivial.  There are many ambiguities and issues that need to be understood and resolved. We need everyone to work together to drive an iterative, implementable solution based on actual use cases. Specific use cases need to evolve. For example, at what level does UDI need to be to provide value for stakeholders? Kits, orthopedic trays, etc.? [This] needs to play out to see what folks need. I don’t know who pays. Who pays now for inaccuracies? Ultimately, the manufacturers are responsible.

DUDAS: I recently heard that several providers are putting contract terms in place that not only require standards implementation but impose penalties for non-compliance. I applaud this but caution that only providers that can back up the requirement with proven adoption/implementation should take this approach. It will also be interesting also to see how often it is negotiated away.

My general observation is that several have taken their foot off the pedal, lost interest or are focusing on just a single supply chain management process, such as point of use. I would really like to see us regain the focus that we had a few years ago and commit to seeing this initiative across the goal line in a timely manner.

DUDLEY: Mercy and the Healthcare Transformation Group, which includes Mayo, Geisinger, Intermountain Healthcare, Kaiser and Mercy, in general have made reasonable demands of suppliers. We’ve been consistent over the last few years, speaking with one voice around [the following]: 1. Assign a GTIN to each unit of measure of your product. 2. Label your product with a linear 128 bar code. 3. Enable the ability to transact with the GTIN and GLN. 4. Make your product data available in the GDSN. 

Through participation in the industry workgroups on UDI standards, the most unreasonable debate centers on the number and type of product attributes available from the GDSN and what attributes are required to register a product. There seems to be much confusion on the part of the manufacturer about how to handle assigning and making available the product attributes. Some providers are complicating this issue by asking manufacturers to provide attributes that are not part of the original expectations. We believe this is unreasonable because many years ago, the UDI workgroups, which included leaders from all essential value chain segments, defined the 16 required attributes and the other optional attributes. This should be used as a starting point and future enhancement can build from this solid base. 

LOHKAMP: Providers often expect that implementation of standards, particularly product identifiers, will be simple with information readily availalble. But we are still at the early stages, meaning that data is not always readily available and processes are immature. Product information needs to be reconciled with current product information loaded into hospital supply chain systems or clinical details.

PHENEY: It is not that providers are making unreasonable demands. Rather, providers overall have been quiet while they waited for clarity in the regulation. With regulation now in place for both med/surg and pharmaceutical suppliers, there should be nothing stopping a hospital from reaching out to their partners to understand the timelines to receive standardized information. In addition, providers should be reiterating their support of using consistent information as a foundation for their processes, knowing the data will follow a product or drug through its lifecycle, from manufacture to ultimately use by the patient. The product information will be captured and stored in hospital or pharmacy inventory systems, and in the patient’s electronic health record. Given the increasing need for visibility in the supply chain, the sooner that information is used to track products and drugs all the way through to patient use, the greater the safety and care is for patients and for the healthcare industry.

Patient safety is the No. 1 goal, no matter what role you serve in the supply chain. GS1 standards are implemented with this goal in mind, but also drive efficiencies and cost-savings. Using consistent and global standards will enable providers to effectively manage drugs, products and devices used in patient care. The time has finally come, and providers should seize the moment to make implementation a reality at their institution.

PLEASANT: We need to collaboratively agree on the extended supply chain adoption plan that includes the requirements for each participant. This will make the expectation clear for all parties. The extended supply chain system will not be effective without clearly defined requirements for each participant and effective hand offs between each other. The UDI standard for product identification and the GLN standard for identifying each participant provide the basis for the handoffs and support of the collaboration required throughout the extended supply chain.

SARGENT: Unfortunately, there are not provider demands that I am aware of that are unreasonable as providers who are not in the midst of implementation are either not aware of what standards adoption is all about, or what they should be completing to work towards adoption, or they may not have the ability to move forward due to lack of understanding within their system.

TEMPLETON: Direct or permanent marking on implants without practical investigations that prove if the manufacturer or value-added partner achieves the ability to do it. Will the provider systems and human capability be able to use it in a safe, cost effective manner?

ZIMMERMAN: I haven’t seen any language from the FDA regulation that I would call unreasonable on providers because most of the burden to comply with the regulation falls to the manufacturers. I do think, however, there are some demands from providers to suppliers that are unreasonable and in turn expectations from manufacturers towards providers that are unreasonable. An example of the former is the Healthcare Transformation Group (HTG). HTG is a consortium of five large provider systems cooperating to urge suppliers to adopt a single standard for UDI, the GS1 standard. They are attempting to fashion the group as "the 10-ton gorilla" with the purchasing power to influence manufacturers to adopt GS1 or jeopardize sales. One could construe this behavior to be unreasonable in light of the FDA UDI which supports multiple standards and requires registration merely of a unique product code for each packaging level. Internal provider IT systems should be built to support this structure. If they are, it wouldn’t matter if the code resembles HIBCC or GS1 as long as the code is unique and can be referenced in the FDA GUDID. The value to providers is the ability to rely upon a unique bar code on each layer of packaging and the ability to make use of scanning technology throughout the entire provider site product continuum. Would you really want your physician not using the best products on you or a beloved family member because their products use HIBCC and not GS1?

Manufacturers also place some unreasonable demands on providers as well. I had one manufacturer gruffly inform me that "we adopted HIBCC years ago and you never used them, so why should we listen to you now?" Granted, this was a supplier who had been asked to switch to GS1 from HIBCC and, although the statement was a fair one it is unreasonable to assume that all providers are not using them or that they are not using them uniformly. The GS1 and HIBCC Web site offers scores of great examples where providers have used standards effectively for years. Many of these examples include scanning of products at the bedside and at the point of receipt or scanning and tracking lot/expiration/serial number and the ability to track recalls. In time, best practices will surface and efficient processes will emerge.

Just because a process is not used uniformly or efficiently across the spectrum of providers does not mean adopting data standards is meaningless. After all, if you consider in a traditional healthcare distribution model that the provider is the customer how far do you think the retail industry would have progressed with standards implementation if they waited for the average store customer to demand a UDI?