Are you willing to bear the standards?

May 22, 2019
Or are you a standard bearer already?

Products & Services

Logically, the use of data standards would make transactions so much easier to track and trace, as well as facilitate detailed analysis of product movement and process progression. Yet while the end game may be obvious, the journey to reach it apparently is fraught with obstacles, largely of a healthcare organization’s own making.

Snap judgments aside, Healthcare Purchasing News has surveyed its readers annually about their adoption and implementation of supply data standards, specifically the Unique Device Identification (UDI) system. During the last three years, the survey results illustrated some heartening news: A growing number of facilities ever-so- slowly is adopting and implementing UDI, while the number of facilities not using the UDI for a variety of reasons is trending downward.

In short, all of the educational sessions, editorial features and case studies during the last two decades at last may be solidifying opinions, generating traction and directing implementation.

Since its inception in 1977 HPN has covered and explored supply data standards from a variety of angles, including challenges and opportunities, features and benefits, costs and savings, spanning such efforts as the Common Category Database, the UPN initiative and the UDI initiative.

Early on, skeptics and cynics demanded case studies with virtually irrefutable proof that adoption and implementation would be painless and generate such a wealth of rewards that the supply data standard champion would be granted such heroic status to qualify for the parking space closest to the front door for the duration of his or her career at the facility, bumping the CEO to the next spot.

Well, hyperbole and unrealistic expectations and fantasy aside, some facilities have been making headway with supply data standards, scoffing at the naysayers and reaping realistic rewards for their organizations. And not just those daring and willing souls who go on the speakers circuit year-after-year, dutifully sharing their stories before audiences that feel they’ve heard it all before – and from the same names.

But how much have providers and suppliers progressed in the area of implementing supply data standards?

Sidebars below:
For some relayed success stories, see “Spotlighting the standards savvy,” and for some subjective measurements by supply data standards experts, see “Assessing standards momentum.” 

Balancing the scales

Despite all of the content publicized and shared about the features and benefits of implementing supply data standards using the UDI, these efforts apparently have not convinced everyone enough to make adoption and implementation a higher priority or even a necessity.

“Every area of the hospital benefits from data standards, especially as reimbursement is based more on the value delivered to patients, than on the volume of services performed,” said Karen Conway, Vice President, Healthcare Value, GHX, and a leading advocate for supply data standards. “Standardized supply data supports the ability to understand the relationship between the costs to deliver care and the outcomes achieved.”

Such understanding directs providers to adjust and hone their priorities.

“The priority for most hospitals and health systems has been to focus on the higher-risk, and usually higher-cost, items, such as implantables,” Conway continued. “The U.S. FDA also prioritized risk in its phased implementation of the UDI regulation, starting with Class III and implantable devices.”

These efforts enable providers to garner a plethora of additional data, too, with deep-reaching effects.

“Standardized product data supports post market surveillance to understand how products are performing in routine clinical practice,” Conway indicated. “This can enable more effective and faster response in light of adverse events, but it also helps understand which products work best on which kinds of patients. For this reason, many organizations have prioritized capture of standardized product data at the point of care.

“Ideally, hospitals and healthcare systems will identify products the same way, regardless of the function, system or purpose,” she noted. “For example, by using standards in transactions, hospitals can understand what products they purchased, which also supports recall management. Further, use of standards for both product and organization/location identification can improve contract price alignment and cost accounting.”

Providers and suppliers simply need to grasp the big picture that supply data standards brings to the healthcare industry, fueled by its components, insists Siobhan O’Bara, Senior Vice President, Industry Engagement & Services, GS1 US.

“The use of industry standards benefits numerous aspects of a healthcare organization’s processes and product usage,” O’Bara said. “It enables consistency and interoperability for data exchange between trading partners throughout the entire supply chain – from manufacturers all the way to the point of care. It also helps various departments within an organization to share information consistently so that an individual product is identified the same way throughout the healthcare provider’s operations. As a result of a standards implementation, every department and company across the healthcare ecosystem is able to talk about each product in a common language they all understand.”

O’Bara cites three common and familiar benefits to reinforce supply data standards’ inherent value.

  • Inventory management – Scanning unique device identifiers enables the provider to improve accuracy and realize efficiencies in its inventory management. Errors are reduced by eliminating manual data entry and an item’s current availability, location, and use is easily tracked by pulling up the electronic record according to the device’s GTIN. And if a product is recalled, it can be quickly located for efficient inventory cleansing.
  • Patient records – Scanning standardized device identifiers at the point of care makes it possible for healthcare providers to maintain the data in a patient’s Electronic Health Record (EHR). This information can be invaluable in the event of an adverse reaction or product recall.
  • Point-of-care medical device scanning – Scanning unique device identifiers (UDIs) at the point of care enables operational efficiencies, improved record-keeping, time savings and better patient care.
Patient care and procedural settings both can reap benefits from UDI adoption and consumption, particularly in the areas of implantable medical device data and the transactional aspects of the overall supply chain, according to Denise Maxwell-Downing, R.N., CNOR, Vice President, Clinical Quality and Patient Safety, SteriTrack, a Matrix IT company.

The lack of medical devices sporting a standardized method to identify a device across the product lifecycle made post-market surveillance, adverse event/recalls and comparative effectiveness difficult to achieve, Maxwell-Downing observed.

“This not only impacts patient safety, but also the healthcare organization’s ability to manage supply chain work flow processes efficiently and accurately,” she said. “The UDI for implantable medical devices is an essential piece of data enabling patient safety [that] allows for accurate one-to-one comparison of device performance and provides guidance for strategic procurement decisions.” Further, she added that UDI captured at the point-of-use provides accurate medical data that will improve outcomes across patient populations and will support the development of standardized practices and products.

Maxwell-Downing encourages healthcare leaders and professionals to learn from other industries how leveraging technology to automate the transactional supply chain generates considerable value.

“The operating room can be a siloed area of the healthcare organization that has no end-to-end automated process that supports the logistical coordination of activities and medical devices needed to prepare for and perform a patient procedure,” she said, referencing a GHX report from October 2012 on the state of the implantable device supply chain that posited the lack of visibility and control over medical devices costs the healthcare industry an estimated $5 billion per year due to inefficient, disconnected manual processes, as well as lost, expired and wasted product.

Maxwell-Downing acknowledges, however, that “even the most technologically sophisticated healthcare organizations manually capture much of their clinical supply documentation at the point-of-care, a practice that introduces the known potential for human-error when entering product information used during patient care.”

UDI adoption benefits include the reduction of obsolescent inventory, improved recall management, ensuring product pedigree and safeguarding the healthcare supply chain from counterfeit product, the common denominator across all these variables being patient safety, she added.

As Cory Turner, CMRP, Industry Strategy Director, Healthcare Supply Chain, Infor, travels around the country meeting with healthcare leaders from a variety of organizations he hears very similar messages.

“‘I need to track my OR and Cath Lab supplies in a more meaningful way,’” Turner recalled as the common refrain. “These items are typically more expensive and possess more of a direct patient impact. Being able to know every step a product takes is a key to success.

“As a former supply chain director for one of the largest IDNs in the southeast, our goal was to have complete visibility throughout the product life cycle, from the manufacturer all the way throughout the logistics process and eventually to the patient,” Turner continued. Having total visibility throughout was and continues to be on the minds of leadership and not just the supply chain leaders. OR and Cath Lab supplies affect the cost, quality and outcomes directly. They are most expensive items that must be the best quality in order to ensure the highest patient outcomes. This is the priority of all healthcare organizations…or it should be.”

Turner previously served at Greenville (SC) Health System, which earned “Supply Chain Department of the Year” status from HPN in 2013.

Making the economic case

Justifying any financial, operational and processional investment in supply data standards implementation requires hard- and soft-dollar savings estimates – essentially data.

Matrix IT’s Maxwell-Downing defines each category and cites a University of Tennessee Medical Center UDI Capture Work Group Case Study, published by the Association for Healthcare Resource and Materials Management in 2017 (http://www.ahrmm.org/resources/learning-udi-community/pdfs/repository/utmc-luc-case-study-2017.pdf), to buttress the logic.

Hard-dollar savings represent those dollars than can be seen in a budget and an organization can quantify, she indicated. Some examples of hard-dollar savings realized by healthcare organizations from UDI adoption and implementation include:

  • One-time inventory reduction of $2.5 million
  • One-time IT infrastructure investment of $1.2 million plus $150,000 annual maintenance that nets a positive $24 million in savings in first six years
  • Labor savings of 200 minutes per case for EHR to quality data registry submission
  • Process efficiency savings derived from not pulling products that won’t be used for surgical or invasive procedures that can increase the cost of a $1.50 sponge up to $8 based on all the handling and labor.
  • Soft-dollar savings represent those dollars that are more difficult to impossible to quantify, she noted. “Even though these savings are more difficult to quantify doesn’t mean they aren’t as important as the hard-dollar savings,” she said. Soft-dollar savings examples associated with UDI adoption and implementation include:
  • Strong teamwork, commitment to patient safety
  • Existing infrastructure, roles and processes are in place and easy to build on
  • High-functioning team [generating] quick delivery with minimal meeting time and no project leadership or executive escalation required
  • Access to clean, normalized data in a clear, readable format required by different stakeholders because those in supply chain need different data attributes than those in clinical areas
  • Labor savings via efficient recall processes such that instead of taking months or hours to determine who was affected the time can be reduced to 30 minutes

Sense and sensibility

Certainly, supply data standards experts can make equitable cases for UDI adoption and implementation across a variety of product or process areas, but how reasonable the expectations are for universal acceptance attracts healthy debate.

Mike Schiller, CMRP, Vice President, Healthcare Engagement, SteriTrack, a Matrix IT company, scoffs at even the hint of an excuse but acknowledges the lumbering hurdles to behavioral change.

“An unreasonable expectation, no,” Schiller told HPN. “Comprehensive adoption in every area, however, is where the real challenge lies, and no one does silos better than healthcare. There are several challenges that must be addressed and overcome across all the major stakeholder groups, including health IT, providers, manufacturers and distributors, before comprehensive adoption becomes a reality.

“AHRMM’s Learning UDI Community (LUC), and its numerous work groups, is a tremendous step in the right direction,” continued Schiller, who previously served as AHRMM’s Senior Director, Supply Chain, and prior to that had led supply chain departments at several children’s hospitals. “The LUC brings together these various stakeholder groups along with regulatory and issuing agencies to address the difficulties associated with UDI adoption as they seek to collectively develop standardized approaches and recommended practices to solving these challenges.

“As a result of the LUC and the steady beating of the UDI drum by industry speakers and educational initiatives, UDI awareness and knowledge has grown. However, total awareness has not been achieved as indicated by a recent survey we took at the 2019 Association of periOperative Registered Nurses (AORN) Annual Conference and Expo [in Nashville] where 38 percent of the [registered nurses] surveyed were unaware of the ‘FDA’s UDI Regulation,’” he added.

Maxwell-Downing, who previously served as Nurse Informaticist, Perioperative Services, at AORN for nearly 12 years, offers some contextual background to any awareness issues among registered nurses, indicating that AORN has provided formal UDI educational sessions for several years.

“When UDI education was presented the first year the attendees had a bewildered look with no hands raised when asked if they have heard of UDI,” Maxwell-Downing recalled. “It has been wonderful to see how the deer-in-the-headlights look has changed to a more collaborative discussion about the benefits and challenges of adopting and implementing UDI. Many still rank themselves as a UDI beginner, but 50 percent of the audience has heard of UDI now. To me, we are getting the UDI word out there to the front-line leaders and users, which will help move the bar.”

Schiller acknowledges that that the trend toward adoption continues to grow, but not as smoothly as it could or should. He hints at regulatory issues as one culprit.

“It is clear that there’s a building sense of frustration and confusion among healthcare providers,” he told HPN. “Which device class or classes need to be captured, barriers to interoperability across health IT platforms, competing priorities, as well as finite resources and bandwidth are all contributing factors. The reality is that as of today there is no specific, accreditation or regulatory requirements, for healthcare providers to capture the UDI aside from ‘Adverse Event Reporting’ and the FDA stating that implementing a UDI system will ‘adequately identify medical devices through their distribution and use.’

“For UDI adoption to accelerate across the healthcare field, organizations will need to strategically plan for and incorporate this into their short- and long-term clinical, operational and capital planning processes,” he insisted.

Schiller recognizes that the UDI system only has been in place for five years. The FDA UDI Rule was written into law in Sept. 24, 2013, and the first class of medical devices – Class III and Implantable Life Sustaining/Life Supporting devices – that needed to comply with the FDA’s UDI labeling requirements was implemented in September 2014, he added.

Priority-setting remains the key issue.

“I agree, it is a priority, but also a competing priority with other organizational initiatives,” he noted. “Infrastructure changes that need to be made to accommodate the UDI capture at the supply chain and clinical level require financial, technical and human resources to complete. These changes can take multiple years to complete along with the change management and culture change that needs to occur within the various departments across the healthcare organization.”

One competing priority involves EHR interoperability with UDI, according to GS1’s O’Bara.

“Healthcare providers are highly motivated to continuously improve their business processes and efficiencies as well as quality of care,” she said. “Because data standards offer system-wide opportunities for improvement, we expect to see widespread adoption to develop in time throughout providers’ operations. Standards are a critical piece of the electronic accuracy, interoperability and efficiency needed for better healthcare.

“Providers have been at the forefront of the transition to Electronic Health Records (EHRs) as part of a mandate within the American Recovery and Reinvestment Act enacted in 2009,” O’Bara continued. “An important part of the EHR regulation provides criteria for doctors and other caregivers to be certified for ‘meaningful use.’ The Meaningful Use Stage 3 requirements make it a requirement to capture UDI on implantable devices, beginning in 2018.

O’Bara offers up several GS1 documents as resources to help providers implement system-wide standards, including the GS1 US Implementation Guidance for Point-of-Care Scanning for Surgical Implants and “Examining UDI Capture & Orthopedic Implants” white paper. She further encourages providers to reach out to service and technology suppliers for “practical methods for information management and data capture [as] canning equipment and data infrastructure are key components to a provider’s implementation readiness.”

Infor’s Turner recognizes implementation as a daunting task that requires a solid internal framework, but starting small may be most advantageous.

“It is highly reasonable for healthcare providers to eventually adopt these best practices into all areas,” he said, “however, eventually is the key word. Being able to implement this has not been a small task for even the largest and most advanced IDNs in the country. Organizations must have a strong Supply Chain and IT infrastructure in place to be successful. This is needed due to large ties backward into the suppliers/manufacturers as well as forward into the clinical world, and these parties don’t always play well with each other. This is a huge factor in why the adoption of UDI, GTIN and other data standards has been such a slow-moving process. If we can ever get to a point in time where at least the OR and Cath Lab supplies are better managed and tracked, I feel that we can start making even bigger strides on cost control on our supply spend within our healthcare organizations.”

GHX’s Conway dismisses any question or talk of reasonableness as two areas must be on board simultaneously.

“As reimbursement shifts to a value-based model, it’s become a clinical and business imperative,” she said. “We have to understand all of the resources, including services and products, used to care for patients, the outcomes achieved and the associated costs. It’s a fundamental component to understanding the relationship between what delivers quality care, including reducing hospital acquired conditions, readmissions and waste, and the costs. The good news is, when we deliver better care and reduce errors, we lower total costs. But we cannot make improvements if we do not first understand what is currently involved in care delivery.”

Conway points to increased regulatory expectations and the data requirements to support advanced analytics within hospitals as requiring these changes.

“Both suppliers and providers are being expected to answer new questions by customers, patients, insurers and regulatory bodies, etc., all of which require more standardized and structured data,” she continued. “To complete the cost-quality equation, there are a myriad of questions we must answer. What procedures were done on which types of patients? Who was involved in the delivery of care? What supplies were used? What is the relationship between the price paid for products, the amount charged, and the reimbursement for the procedure in which those products were used? Standardized data is the key to accurately answering these questions.”