Using drug, supply data standards to make MVPs out of MVCs

Carrie Gorman, Account Executive, Healthcare, Tecsys Inc., synopsizes the process this way: “‘State’s decision’ means 50 decisions,” she quipped.

“The H1N1 [vaccine] was distributed at a federal level, and the result was a far smoother process than the COVID-19 vaccine,” she recalled. “Because the COVID-19 vaccine has been distributed on a state level, it’s been a race for every state to individually figure out a plan to receive the vaccine then distribute to the sites, vaccine scheduling, vaccine rollout phases and what data needs to be reported. Layer on top of that wildly variable levels of technical infrastructure across state lines, with some scraping by with a paper process to log which vaccine was distributed while more sophisticated vaccine programs have iPads and QR codes to link the patient to the supply data.

“As a result, the vaccine rollout process has been executed 50 different ways, with varying levels of success,” Gorman continued. “It stands to reason that data standards require coordination, and the most feasible way to coordinate across multiple agencies is to mandate standards at the highest level. Federally orchestrated, the adoption of data standards [is] much easier and allows for consistent distribution and scheduling processes across the country.”

Gorman goes so far as to acknowledge with little surprise how the healthcare industry historically has fallen into the “laggard” category for innovation.

“While ‘data is king,’ adopting consistent data standards across the healthcare industry in order to extract its value has been a challenge,” she said. “It is no secret that healthcare is notoriously slow to adopt new technologies, business practices and inventory methodologies compared to other industries. Because the healthcare industry is always focused on the patient, the treatment of care has significantly evolved, while the business processes to support that care continue to be very manual. In some hospitals, the same business processes from the 1960s are still used today. Adopting a set of consistent data standards across healthcare has not been any different. Manufacturers have been slow to get on board to publish data, [and] hospitals have been slow to use the data to make actionable decisions. Because the adoption of data standards has been slow across healthcare, programs may need to be created to encourage the urgency of adoption of consistent data standards.”

If it’s good for grocery…

“One of the biggest challenges is that there is not a defined, shared pedigree standard today for healthcare products,” he noted. “In the grocery industry, there is a ‘Farm to Fork’ concept where we know the pedigree of ingredients, where each of the ingredients originate. That comes from the Food Safety Modernization Act in 2011. We do not have a comparable construct in healthcare.

“Forecasting is another challenge for vaccine work given unknown variability in how many patients a vaccine site can expect on a given day, and therefore what staff and supplies should support it,” Costante continued. “If a site overstocks, vaccines may expire while on hand when they could have been used elsewhere. Understock and people get sent home with no vaccine. Locations err on the side of overstock, but the challenge exists.”

Costante sees no reason why the strategies and best practices used within hospital settings cannot be applied to vaccination clinics.

“A cloud-based materials management system supports the inventory operations Vizient is providing at vaccination centers,” he said. “This system allows receiving, requisitioning and inventory functionality all in an app that the materials team can use in the field. If a cloud-based system is not an option, tried-and-true low-tech approaches can be extremely useful – KanBan cards, visual reorder cues, cycle counting, burn-rate analytics can all provide visibility to stock levels and continue to provide critical supplies to clinical operations.”

A-C-T now

The essential recipe for success includes accurate, consistent and timely data, proscribes Meryl Bloomrosen, Senior Director, Federal Affairs, Premier Inc.

“We need to do a better job ensuring that supply data standards are robust, accurate and operational across all the disparate systems that exist within healthcare institutions,” she said. “Many of the data sources we work with today are either robust or accurate, but rarely both.

“Tracking COVID-19 vaccine inventory and distribution as well as vaccination scheduling and administration activities involves various public and private sector information technology (IT) systems, including inventory management systems, electronic health records (EHRs), vaccination appointment/scheduling systems and immunization information systems, and is subject to federal and state reporting requirements,” she added.

Bloomrosen indicates that data and interoperability standards for immunizations and guidance for their adoption have been underway for several years by standards development organizations, such as HL7. Further, she notes The Office of the National Coordinator for Health Information Technology Certification Program for EHRs also includes criteria for standardized data transmission (using HL7) from EHRs to immunization registries.

“Yet even if the data was perfect and loaded into ERP, EHR and billing systems, there is currently limited interoperability,” she lamented.

Angela Fernandez, Vice President Community Engagement, GS1 US, echoes the need for accuracy, consistency and timeliness (A-C-T) of data.

Two things stand out for Fernandez, and they both apply to successful tracking of any product, not just vaccines.

“The first is data quality and stewardship that begins with the supplier and is needed throughout the supply chain, including at the point of care,” she indicated. “Without accurate and complete data, the full power of standards cannot be realized, so data management needs to be a priority for the entire healthcare industry to improve operations and results. The digitization of all supply chain data creates opportunities for exchanging information that could not happen without the technology to support it. And remember, the system is only as good as the data that runs it and should continuously be maintained to stay current. The ability to share accurate and complete product information is imperative for all pharmaceutical products, including vaccines.

“Second, the implementation of GS1 Standards requires a coordinated approach between manufacturers, distributors and dispensers to ensure products are uniquely identified and scanned,” Fernandez continued. “Dispensers including clinicians, pharmacies and vaccine administrators, can capture, identify and share data pertaining to orders, inventory and administration by scanning the products at the point of care/use. Obtaining and incorporating scanners into clinical workflows improves end-to-end traceability even at the point of care – supporting patient safety – so it is a priority for healthcare providers to consider.”

Fernandez admits that COVID-19 vaccine distribution and administration may be complex and challenging, due to the scale and urgency of the rollout on a federal, state and county/local level.

“But the building blocks for successful inventory management and track-and-trace are no different than those that are regularly addressed by pharmaceutical companies,” she said. “At a high level and across the board, these include strong, reliable data management programs that leverage standards as a common language to enable effective information exchange, and system-wide coordination between trading partners.”

Missing links

Chalk it up to data in health information management systems and data in logistic information management systems not being linked, observes Chris Caulfield, Vice President, Temptime Operations, Zebra Technologies.

“Dose administration data and records are being fed into one system and vaccine recipient information is being logged – often manually – into another system,” he said. “Finally, the vaccine recipient is provided a paper card as a reminder of what vaccine they received and when they should return for their second dose. This is an antiquated system [that] places the burden of ‘getting it all right’ and getting the information into the proper system with the people at the point of vaccination. A 2-D bar code/RFID system would automate the administrative tasks at the point of vaccination and allow the healthcare professionals to focus on the vaccine recipient and administration of COVID-19 vaccine doses. A coordinated system could be deployed with federal, state and local governments feeding their data into the system. However, the federal government, as the purchaser of the vaccine, would need the vaccine manufacturing companies to support the deployment of these initiatives and implement them at the vaccine manufacturing sites.” 

How low do you silo?

Ashok Muttin, Founder & CEO, SupplyCopia, points to the traditional system silos in healthcare as the culprit for tracking and tracking vaccine inventory, just as they have done with other products and supplies.

“Tracking systems set up by the CDC are disconnected from systems including health system inventory systems and patient EHRs, so capturing vaccine tracking data, including lot numbers, and connecting it to patient data, is a big leap,” he said. “Currently, we’re capturing a lot of patient data on paper.”

Muttin further singles out the multiple settings where vaccinations are taking place – from nursing homes to retail pharmacies to drive-through clinics – actually make tracking that last mile of the supply chain even more challenging. “The further the patient is removed from their traditional EMR – whether that’s with their primary care physician or a health system – the more difficult it will be to align vaccine data with digital medical records,” he noted. “This will also make it harder to track vaccine outcomes and adverse events based on patient-specific health conditions. Clearly, we need to find ways today to close gaps and reduce risk. Tying vaccine tracking to medical records will be needed to understand efficacy and have visibility to adverse events over time.”

Muttin contends that Health Information Exchanges (HIEs) with ties to state immunization registries already maintain connections that can support ongoing tracking, but they also need to connect with non-traditional settings with widespread access points.

“How will we get information, match it to the correct patient, track therapeutic use to understand results as we go forward? Who got a vaccine, which did they get, who got both doses, what side effects did they experience – and importantly, did they contract COVID-19 later?” he asked. “We’ll need to improve system data sharing to combine immunization information with key data elements from providers after the first wave of vaccines is complete, and throughout the process of administering boosters.”

Muttin also expresses concern about the efficiency and accessibility of patient registration systems used for vaccine administration.

“Many of these systems, which are internet or cloud-based, require a level of sophistication and connectivity that has limited their use within communities that have less access to technology and among older populations,” he observed. “This has made it difficult to get some people most in need of the vaccine into the queue.”

Muttin urges that work must continue on adopting and implementing data standards.

“Let’s not stop working to ensure health systems are able to use data standards to identify every item they contract for, purchase, store and ultimately consume,” he said. “Ultimately, how efficiently our supply chain runs – whether we’re looking locally, nationally or globally – is still dependent on how well we identify and understand the products needed for patient care.”