Skating from behind the eight-ball

Feb. 23, 2021
Bar codes, RFID chips and tags can help supply chain with its breakaways and forward strides through COVID-19 vaccine logistics

At the close of January about a year after COVID-19 emerged in the United States, media provided a curious public with a range of data highlighting the number of vaccine doses administered to citizens. Depending on the source, more than 26 million to nearly 32 million doses were given, representing a miniscule slice of the American population.

No matter how the statistics were explained, the spread of about six million might give enthusiasts of DraftKings and FanDuel pause.

While the numbers draw quizzical looks about the state of public-sector vaccine supply logistics that Healthcare Purchasing News currently is exploring, they also pose a serious question: How might the extensive use of track-and-trace technology involving bar coding and radio frequency  identification (RFID) down to the “eaches” have contributed to the accuracy and precision of product movement from raw materials to manufacturing to distribution to administration or consumption?

Where to begin?

In theory and on paper at least, affixing bar-code labels or RFID chips on products may seem like a simple “no-duh” solution. But it may be a bit more complex than such perceived simplicity, according to Jessica Bernardo, Senior Product Marketing Manager, Label and Receipt Printer Solutions, Toshiba America Business Solutions.

Deploying the latest technology to improve efficiency and effectiveness indeed may help manage the complexity of distributing COVID-19 vaccines, Bernardo acknowledges.

“By facilitating data transparency, bar-code and RFID labeling enables vaccine operation professionals to make better decisions,” she told HPN. “From improving shipping and storage space utilization to where, when and who should receive vaccines. Most important, delivering this degree of accuracy saves lives.”

Federal, state and local agencies must weigh their options before finalizing an information technology solution to facilitate this process, Bernardo recommends, whether that be RFID or bar coding, both of which can reduce misidentification of medical assets.

“RFID technology saves time and money with real-time data capture by identifying the vaccine, its location and physical attributes, such as size, temperature and placement in a container or warehouse,” she said. “This data is available without human intervention, requires no line-of-sight to the container while simultaneously recording multiple data points.

“RFID technology also provides a wealth of data for later analysis,” Bernardo continued. “And automating this process greatly increases medical staff productivity. Eliminating manual data entry exponentially enhances accuracy while increasing the opportunity for patient interaction. Vaccine tracking also improves operations and staff efficiency. For example, RFID tags may create alerts helping ensure vaccines maintain temperature and use thresholds.”

Bernardo emphasizes the convenience and flexibility of bar coding as a relevant and useful choice, too, as the labels can be adapted to specific needs that may include tracking assets or fulfilling shipments.

“Bar-code printing is also affordable,” she noted, “in many instances only requiring the addition of specialized labels to accommodate medical applications. Print and apply systems furthermore automate multi-container labeling specific to medical applications (i.e., vials, tubes, bags). This automated process labels in a fraction of the time in comparison to manually affixing tags.”

Any track-and-trace effort applied to such an overwhelming logistics operation must begin at the source, urges Tony Cecchin, Vice President and General Manager, Global Supplies, Zebra Technologies, and President, Temptime.

“The key COVID-19 vaccine manufacturing and distribution services to date have focused on bulk container-based supply chain tracking and tracing along with temperature monitoring,” Cecchin said. “The federal government’s goal of accelerating vaccination throughput via a network of mass vaccination sites should require a vial-based focus to support the distribution efforts of the vaccine supply chain.”

This translates to automating the myriad vaccination locations, Cecchin deduces.

“The workflows at local vaccination sites will necessitate vial-level information that lends itself to 2-D barcoding and scanning as an alternative to manual data entry,” Cecchin insisted. “These vaccination sites include onsite vial management, patient injection recordation, second-dose administration tracking and wastage rate data collection. Moreover, the data needed to fight counterfeiting or support product recalls will require vial-level detail. In the short term, 2-D bar code and scanning technology can help accomplish this goal and is consistent with the policy set forth in the Drug Supply Chain Security Act of 2013.”

Cecchin views RFID tags as useful from bulk to last-mile delivery.

“RFID tags can be applied by vaccine manufacturers to multi-pack boxes enabling them to be scanned from manufacturing through the distribution process,” he observed. “This enables automated visibility of product shipments at the lot/batch level and accountability for vaccine dose management until the last-mile delivery. RFID tags provide another layer to anti-counterfeiting protection measures and allow an automated means of expediting vaccine dose receipt, distribution and use.”   

Compassion, understanding

Jason Rosemurgy, Senior Vice President, Sales and Marketing, Terso Solutions, cautions against criticizing the current logistics process too quickly due to the demand for product and service, the expediency of desired results and the depth of planning and preparation.

The logistics related to the COVID-19 vaccine deployment are unlike anything we’ve ever experienced in the healthcare – or any other – supply chain,” he said. “One of the fundamental pieces being that the right levels of vaccine must make it to the desired location, and to date, many of the big [third-party logistics companies] have done an outstanding job in designing and deploying solutions to handle broader logistical needs.”

Once the vaccine stock arrives on site, it’s up to the healthcare workers at those locations who are handling and administering the vaccine to run with the baton handed to them by the distributors, according to Rosemurgy.

“From what we’ve heard, this can be challenging and supported by many manual processes, including spreadsheets and handwritten logs,” he noted.

Rosemurgy acknowledges that RFID certainly can help track critical inventory in a more automated way and provide important data that is essential to the efficacy and safety of this inventory.

“Some vaccines need to be stored at ultra-low temperatures (-80 degrees C), which is crucial to a vaccine’s efficacy,” he indicated. “If a vaccine isn’t kept at these critical temperatures it is rendered ineffective. Terso offers an RFID-enabled ULT [product] that we have deployed at several hospitals throughout the U.S. to help them store COVID-19 vaccine safely. All these devices are secure (badge-access) as well, so no vaccine could be removed from its cold storage without the system knowing who accessed it and when. If a case, box or individual vaccine were RFID-tagged, all of this information would be captured as well, ensuring chain of custody for the healthcare provider. With the features of a fully automated RFID system, such as proactive temperature monitoring, hospitals can help mitigate issues, such as having to throw away spoiled vaccine if a freezer or fridge fails, which recently happened at a hospital on the East Coast.”

Rosemurgy briefly highlights several projects around tagging individual vials at the manufacturer level to help ensure complete traceability. “Because of the flexible nature and performance aspects of RAIN (UHF) RFID, product can be tracked throughout its journey along the healthcare supply chain from both close range and further distances,” he added.

Bar codes applied to the cases, boxes and vials of COVID-19 vaccines encode electronic information about the product, such as its [National Drug Code], lot number, expiration date and in some cases ─ a unique serial number, according to Kim Elmore, Senior Director, Pharmacy Contracting, Premier Inc. But electronically tracking vial to patient may be challenging right now.

“While it is likely that the bar codes on the cases and boxes will be scanned to populate devices and inventory management systems, there is currently no harmonized and widely adopted data system that relies on either the bar code or RFID to track inventory at a national level across all stewards,” Elmore pointed out. “The most predominantly used bar code will be the one printed on the vials. Most vaccinators use an [electronic medical record] system that is capable of associating the product information to a specific patient, and scanning a bar code on the vial to capture this information is much more efficient and more accurate than hand keying the information for every patient and dose.” 

Eye end game

John Freund, President and CEO, Jump Technologies Inc., expresses concern more for function over form.

“Bar coding and RFID technologies are both ways to capture data,” he said. “It is what you do with that data that is important. Standard supply chain data about shipments of the vaccine from manufacturer to distributor to hospital to patient is probably available today. However, being able to provide real-time, virtual inventory management is a significant value-add.”

As an example, Freund suggests four notable data points that could be tracked with a real-time cloud-based system:

  • How many vaccines did we ship to a given facility? “This helps hold facilities accountable for the distribution of the vaccine,” he noted.
  • How much do they still have in inventory? “Understanding where and how much inventory is available by state, county, city and facility would make it easy to redistribute vaccine supply across locations as demand shifts,” he said. “This also can help hospitals avoid stockouts. Knowing expiration dates would allow clinicians to make sure they are using the vaccine quickly enough so  it doesn’t go to waste – in relation to temperature and storage issues.”
  • How fast are they going through it? “This data supports distribution so the amount sent to a location corresponds to consumption rates. This also reduces hoarding and waste.”
  • When will they run out? “Insights into demand planning based on very short timeframes can help hospitals avoid stockouts.”

Freund encourages the use of bar coding beyond just the product.

“Most states are asking people to make appointments for the vaccine,” he said. “There could be a bar code that is generated by the facility that would integrate basic patient information, such as age, race, gender, ZIP code. This would help officials understand what percentage of a given population has been vaccinated, making it easier to understand the progress towards reducing the COVID threat.”

From the idealistic to the practical and pragmatic, the COVID-19 vaccine logistics process throughout the nation has experienced fits and spurts akin to bumper cars in a demolition derby.

Since the first doses were administered in mid-December 2020, “members of the media, government and the public quickly began to criticize the implementation and pace of this effort, calling for faster, more efficient distribution,” observed Carl Gustafson, Senior Consulting Director, Supply Chain Operations Services, Vizient. “Several global studies on the effectiveness of the cold chain supply of vaccines have concluded that the transport systems were not up to standard to ensure the quality and stability of the vaccine, according to the National Institutes of Health in a report published online in January 2020,” he added.

Gustafson recognizes the ideal end game that includes the interoperability of multiple technologies.

“By deploying RFID, bar codes, mobile computers, GPS and cloud-based blockchain technology solutions, the distribution of the COVID-19 vaccine can have complete transparency, surface problems or potential problems and improve process,” Gustafson forecast. “Every step in the chain of custody — from the manufacturer to the transporter to the healthcare provider — can be accomplished more efficiently and effectively than ever before. Traceability of the vaccine can begin with the initial shipment and through the transit process, continue to the medical facility, the healthcare worker and finally, to the patient.”

GPS-enabled RFID can smooth out the rough spots and speed bumps that may delay transport.

“Deploying GPS-enabled RFID tags to verify delivery and receipt and obtain reporting will support identifying weak links in the supply chain,” he predicted. “At the time of manufacturing, a GPS-enabled RFID chip should be placed within the pallet/package. The chip can provide information such as lot number, expiration date, cold-chain tracking, time, locations and who the vaccine was handed off to. Once en-route, the tags can then track cold-chain stability and if a temperature excursion occurs, send an alert in real time so that the situation can be remedied.”

Gustafson outlines that once the vaccine has been delivered and stored at the destination facility, [real-time location systems] can monitor staff involved in the dispensing of the vaccine, and bar-code scanners can track patient, lot number and expiration dating along with ensuring that the cold chain was not compromised onsite.

“Blockchain, tracking and monitoring sensors, hand-held bar-code technology and cloud-based solutions provide transparency, reporting and visibility into all supply chain attributes for  distribution,” he noted. “GPS-enabled RFID tags have the capability to provide notification for any fluctuations in the cold chain, and that can help prevent loss and compromised storage requirements of COVID vaccines, thereby increasing supply chain resilience.”

Peter Sturtevant, Senior Director, Community Engagement, GS1 US, recognizes that the supply chain has operated behind the eight ball for the bulk of 2020.

“Supply-chain and product transparency are foundational to establishing public trust in the vaccine supply,” he said. “The healthcare supply chain came under great scrutiny in the early stages of the COVID-19 pandemic when supplies of personal protective equipment and other products were disrupted by unanticipated and unprecedented demand.”

Now in 2021, the supply chain must navigate through the pitfalls and pratfalls of vaccine manufacturing, distribution and administration.

“Hospitals and other dispensers need to know when the vaccine will arrive and how many doses they will receive,” Sturtevant indicated. “Caregivers and patients alike will be more confident in the vaccine knowing that it has been tracked and traced through the supply chain, that it is legitimate – not a counterfeit – and it can be traced back if anything goes wrong. In fact, a report issued by Deloitte (, titled ‘Securing trust in the global COVID-19 supply chain’ states, ‘It is expected that the highly anticipated vaccines, needed by so many people, will have the highest risk of being falsified. This should be monitored and prevented to avoid significantly undermining public trust in safe vaccines. This is where track and trace play a critical role.’”

Two key elements compound the process, Sturtevant insists.

“Traceability is crucial to monitor shipping conditions and events, keeping in mind all the vaccines have differing cold chain requirements, among other things,” he said. “Distribution planning is further complicated by the need to deliver a second dose of the same vaccine for the same patients within a specified period of time, 21 or 28 days from administration of the first dose.”

The pharmaceutical industry already has been moving to full implementation of bar codes on its regulated products using GS1 Standards to meet the requirements of the Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA), according to Sturtevant.

“Standardized data, encoded in a bar code, makes it possible for supply chain partners to accurately pinpoint the details of the vaccine’s manufacture, including lot/batch number, expiration date and unique product identifier, [such as] a Global Trade Item Number or GTIN,” he continued. “In the COVID-19 vaccine rollout, supplychain visibility afforded by the use of bar codes, using GS1 Standards, will help improve efficient distribution and traceability to benefit patient safety. Throughout distribution, these bar codes can be scanned to capture all the relevant data so that the product can be tracked and traced quickly and accurately. The key to traceability in the healthcare supply chain is exchangeable data, made possible through the use of the GS1 System of Standards.”

Sturtevant cites World Health Organization (WHO) recommendations of affixing a 2-D (DataMatrix) bar code on secondary packaging (cartons), and if possible, also on the primary packaging (vial or prefilled syringe), according to a Deloitte report, which also notes that UNICEF recently announced it will utilize GS1 bar codes on packaging beyond the primary level to improve traceability of vaccines.

In the U.S. specifically, according to Sturtevant, drug identification and labeling requirements for the COVID-19 vaccines will require:

  • a 2-D bar code containing the National Drug Code (NDC) embedded in the GTIN
  • lot number
  • a placeholder expiration date of 12/31/ 2069 on secondary level packaging

“Global alignment on the use of global standards for identification and bar coding of the vaccines will enable traceability across borders to reduce falsification, enable precise product identification in patient health records and facilitate recalls or adverse event reports,” he added.

Examples abound

The public agencies managing the vaccine logistics and administration process perhaps should tap into the knowledge and experience of the private sector for recommendations, advises Cory Turner, CMRP, Senior Director, Healthcare Strategy, Tecsys Inc. Turner formerly has served as Director of Regional Distribution Center at Greenville (SC) Health System, which HPN named its 2013 Supply Chain Department of the Year.

“It’s not the time to reinvent the wheel,” he said. “It’s time to draw from some of the greatest healthcare supply chain strategists in the world running some of the largest healthcare delivery networks in the world. These healthcare organizations are proving that they have the technology, processes and staff in place to be able to scale up their vaccination operations. While some may need to add software or technology along the way, health systems are, by and large, engineered to manage lumpy patient throughput in a safe and secure manner. Proven tech like bar coding and RFID are well-incorporated into how they run their business already, so while this effort flexes their capacity, the tools they use to track and trace likely do not veer too far from existing best practice.”

Turner acknowledges that many players involved in the vaccination process may not be as well-versed in the particulars of the healthcare supply chain. “This means a sharp learning curve with any medical distribution processes, so familiar and intuitive technologies are the most reasonable option,” he observed.

Bar coding implementation may be the most logical first step, according to Turner.

“Pragmatically, bar coding is the lowest common denominator,” he said. “The tech to read them is inexpensive and mainstream, and the manufacturer already prints them on the packages. Scanning at receiving, lot tracking, and track and trace at the vial and patient level are all then just a quick scan of a bar-code gun. The same technology can be used to track assets, supplies, users and any other regulatory data point that may arise.

“As the rollout continues to scale, it will be important to identify chain-of-custody blind spots for when the vaccine shipments are broken down and distributed to makeshift locations like arenas and civic centers. We should know by now that the answer is not on a clipboard. These visibility gaps in the transportation leg of the journey are great candidates to leverage bar-code technology to preserve end-to-end traceability.” 

About the Author

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].