Weak Link Exposed
Knox County’s missing COVID-19 vaccine shipment reveals the vulnerabilities at the end of the national supply chain.
UPDATE: This article has been updated with information about investigations into the missing vaccine incident.
Knox County Mayor Glenn Jacobs has ordered an audit of Knox County Health Department procedures and Health Department Director Dr. Martha Buchanan has asked the Knoxville Police Department to investigate the disappearance of COVID-19 vaccine after it was delivered late last month.
Officials have not released information about post-delivery monitoring of the missing vaccine shipment.
In a news release issued Monday, Jacobs said there is no evidence of foul play in the disappearance of 975 doses of Pfizer-BioNTech vaccine, but decided to seek the probes after discussions over the weekend with Knox County District Attorney General Charme Allen.
“Nothing so far has indicated malicious intent or criminal activity and we want to confirm that,” Jacobs said. “We do know a serious mistake was made because of a series of process issues at the Health Department. We need to fully understand every aspect of the mistake to be sure it won’t happen again.”
The Health Department has said it believes an employee accidentally threw the vaccine away, thinking the box it arrived in contained nothing but dry ice.
“As public health officials, we fully understand the gravity of the situation, and we welcome the third-party reviews,” Buchanan said in the statement issued by the mayor’s office. “We are eager to fully cooperate with the investigations. As we learn more about what exactly occurred, we will continue to implement process improvements and stronger safeguards.”
Pugh CPA, the county’s external auditing firm, will look at the Health Department’s processes and recommend improvements, officials said, and KPD will look at possible criminal violations, though theft isn’t currently suspected.
Scott Erland, KPD’s public information officers, confirmed the investigation is active but did not offer any details.
“As with any investigation, the role of the KPD is solely to determine the facts of the case,” he said. “Upon the completion of the investigation, the KPD will present its findings to the Knox County District Attorney’s Office. Due to the ongoing investigation, the KPD cannot offer additional comment at this time.”
The missing doses have not been recovered, and an explanation of exactly what happened to the shipment after an employee apparently threw it away remains elusive.
In addition to human error, the incident suggests a failure of the vaccine electronic monitoring processes and a breakdown in communication among government agencies.
“I was alarmed like everyone else about the loss of such vital supplies,” said Thomas Goldsby, the James A. Haslam II Chair of Logistics at the University of Tennessee. “That said, I was not entirely surprised by it, either. The chaotic approach to distributing and administering vaccines is rife with ‘defect opportunities.’”
Those defect opportunities are most likely to occur at the end of the line, he said, especially if the destination sites — hospitals, clinics, health departments and the like — aren’t prepared to handle sensitive and newly developed vaccines.
“That’s where the real vulnerabilities come in,” said Goldsby, who teaches in the Haslam College of Business’ nationally renowned supply chain management program. “The Health Department was put in a difficult situation.”
The Health Department was the last stop in a supply chain that began at Pfizer’s plant in Kalamazoo, Mich. UPS delivers Pfizer’s vaccine in states east of the Mississippi River, and according to Pfizer uses both air and land transport to move the shipments.
Though some states have centralized distribution points within their borders, Tennessee does not. The state’s approach is correct, Goldsby said, because it reduces the number of points where errors can occur.
“A simple rule in logistics is that fewer ‘touches’ on inventory is generally better because you always introduce the risks of damage and loss when you handle inventory, he said. “Again, this general assertion assumes that the party that ultimately holds the inventory is capable of maintaining its integrity.”
The Health Department initially used the Moderna vaccine exclusively, and only began receiving shipments of the Pfizer vaccine last month.
The Pfizer vaccine must be stored at minus-95 degrees Fahrenheit, and the manufacturer ships it packed in dry ice. Pfizer also sends a box of supplemental dry ice to warmer climates so the temperature can be kept low enough to prevent spoilage over time. The boxes are similar in appearance and have special markings but aren’t labeled.
The Health Department received its first shipment of Pfizer vaccine the week ending Jan. 23 and subsequently administered the doses. The Pfizer vaccine requires two doses given 21 days apart, so other shipments were planned.
When the second shipment arrived the week ending Jan. 30, an employee apparently thought both boxes contained only dry ice and discarded them, according to Buchanan.
The Health Department didn’t discover the shipment was missing until a third shipment arrived in the first week of February, prompting the employee to remember discarding the boxes the previous week.
The initial human error was compounded by the apparently improper disposal of the dry ice. Even after the initial misidentification of the container, the mistake would have been caught had Health Department employees properly disposed of the contents.
Unlike ice formed by frozen water, dry ice doesn’t melt (though many people use the term anyway). Dry ice is solidified carbon dioxide that turns directly from a solid to a gas when it thaws, a process known as sublimation.
“When (dry ice) melts, it forms a gas and is expelled into the atmosphere, said Kim Schofinski, deputy communications director for the Tennessee Department of Environment and Conservation. “Normally once it is melted, there is nothing remaining to be disposed of. If someone has unmelted dry ice, they should not put it in a garbage disposal, sewer or garbage can.”
If a Health Department employee had allowed the dry ice to sublimate in a well-ventilated area, as recommended, he or she likely would have noticed the tray of vaccine vials amid the disappearing ice.
Instead, Buchanan said, the dry ice was disposed of with the department’s garbage, which is risky because pressure can build up inside its container and cause a small explosion. The county’s solid waste contractor, Waste Management, would have taken the load to the Chestnut Ridge Landfill in Heiskell.
State officials didn’t notify the Health Department in advance of the shipment’s arrival, Buchanan said last week, and were apparently unaware there was anything amiss with the delivery until her office informed them.
COVID-19 vaccines are supposed to be monitored from the time they leave the manufacturing facility until the moment they are injected into the arms of citizens. That means that officials should have been able to pinpoint its location even after the vaccine was thrown away, as long as the transmitting device remained intact.
“Conceivably, it could be tracked,” Goldsby said, though he added: “The integrity would come into question. You’d be concerned about anything that’s outside of your control for any length of time.”
Responsibility for tracking the vaccine changes upon delivery, however.
The COVID-19 vaccine transportation protocols require Pfizer to track shipments using GPS-enabled temperature monitors, which record the location and temperature of each shipment.
Eamonn Nolan, senior media relations manager for Pfizer, did not answer detailed questions from Compass about shipments but did issue a statement addressing the Knox County incident in general.
“This occurred after Pfizer safely delivered the vaccine within all specifications to the point of use facility, and the order was accepted,” Nolan said. “Once the vaccines are received and accepted by the point of use facility, the facility is responsible for monitoring the temperature or location.”
Third-party monitoring is supposed to occur, however. The U.S. Department of Defense entered into a $25 million contract in November with Controlant Global, an Icelandic company that created Pfizer’s monitoring platform, for Operation Warp Speed so monitoring could continue until the vaccine is actually administered.
Bill Hall, the deputy assistant secretary for public affairs for public health with the U.S. Department of Health and Human Services, said Tennessee officials are responsible for post-delivery monitoring.
“When an order of vaccine arrives at an administration site, the state takes over the ownership and tracking of the order from that point forward,” Hall said in an email. “We are aware of the situation in Tennessee and are assisting the state with their investigation of this incident.”
So far, federal, state and local officials have not released any information about whether post-delivery tracking actually occurred, much less what it possibly revealed about the whereabouts of the vaccine.
Bill Christian, associate communications and media relations director for the Tennessee Department of Health, has not responded to questions about tracking and protocols.
County officials on Monday stopped short of saying tracking data exists, but said the investigations will look into how the shipment was monitored.
Goldsby said keeping the process as seamless as possible and standardizing it for easy replication is preferable to introducing variations that can lead to confusion.
“The concern with adding any steps, no matter how minute, is that you introduce the opportunity for defects,” Goldsby said. “The seemingly easy step of turning the GPS off and back on can introduce error in the process. Simple processes with fewer steps are always preferred for this reason.”
Buchanan said the incident would not affect the anticipated vaccination schedule moving forward, but the Health Department has informed state officials that it would prefer receiving the Moderna vaccine only. The request came before the discovery of the missing Pfizer vaccine and isn’t related, according to both state and local officials.
The Moderna vaccine is distributed in batches of 100 doses and doesn’t need to be stored at temperatures as low as required for the Pfizer vaccine.
“Moderna is easier to store and handle, due to less stringent temperature requirements, and is packaged in smaller allotments, which makes Moderna a better choice for KCHD to share with partners and take to smaller community vaccination clinics,” Health Department Communications Director Kelsey Wilson said.
The Health Department has also instituted some procedural changes aimed at preventing future losses. More personnel will be involved in accepting vaccine shipments — at least two employees will be involved and every box will be fully inspected, Wilson said. A calendar reminder will be used to remind staff when to expect second doses and checks conducted to make sure notifications aren’t blocked by email firewalls.
In the short term, UT’s Goldsby said the Biden administration’s decision to launch the Federal Retail Pharmacy Program, which will distribute vaccine directly to Walgreens, CVS and other pharmacy stores, is welcome. The companies, he said, have refined and proven logistics systems that should easily handle the demands on facilities at the end of the supply chain.
Another COVID-19 vaccine being produced by Johnson & Johnson could be a game-changer in terms of mass distribution once it’s approved, according to Goldsby. He said the Johnson & Johnson vaccine, which trials have shown is slightly less effective than the Moderna and Pfizer vaccines but only require one dose, will be easier to scale and transport.
“It’s more conventional in its formulation so you can use conventional production and conventional distribution,” Goldsby said. “We’re going to be able to dramatically increase production.”
Goldsby said the federal government’s efforts to date have been mixed, with research and development far outperforming logistics.
“Operation Warp Speed was amazing for bringing the vaccines into creation,” he said, “but woeful in terms of distribution.”