As 2020 nears its end, all eyes are on the release of a COVID-19 vaccine. The CDC considers vaccination a critical component of the United States COVID-19 strategy. Political figures have promised hundreds of millions of vaccine doses and fast-tracked vaccine timelines in an effort to curb thel virus.
How will agents in the healthcare system prepare for millions of vaccinations?
Recently, the Department of Health and Human Services (HHS), along with the Department of Defense (DOD), released materials outlining strategies and regulatory requirements for the upcoming COVID-19 vaccinations. One of these documents—the CDC's COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations—is meant to help the healthcare system (and partners) plan for mass vaccine distribution.
But the healthcare industry is already dealing with a tsunami of legislation, policies, and standards stemming from COVID-19. Between social distancing guidelines and emerging COVID-19 requirements, healthcare is buried in red tape.
This new Interim Playbook, however, has unique technological considerations pertaining to data handling that deserve immediate attention. The sooner your healthcare system implements and adheres to the processes outlined in the guide, the better your position once the vaccine is released.
Today, we want to discuss the data implications of the COVID-19 Vaccination Program. A large chunk of the CDC's Vaccination Playbook directly deals with data collection, protection, and storage (which should be no surprise in today's healthcare privacy landscape). For the purposes of this post, we'll focus on the role of data management under the vaccination distribution model.
The COVID-19 Vaccination Interim Program
"The goal of the U.S. government is to have enough COVID-19 vaccine for all people in the United States who wish to be vaccinated." — CDC Vaccination Program Interim Playbook
The distribution, administration, and tracking of a pandemic-driven vaccination is novel in recent history for the healthcare space. For obvious reasons, the incredibly demanding and ambitious goal of distributing a vaccination to hundreds of millions of Americans requires lock-step collaboration across jurisdictions.
The CDC's COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations sets the standards and processes that healthcare systems will use to distribute the vaccine in their jurisdiction. It serves as a guide for states and territories (e.g., USAPI, American Samoa, Guam, Republic of Marshall Islands, etc.) as well as public and tribal healthcare systems.
For vaccine preparedness, the CDC is awarding over $200 million in jurisdictional funds. The "awardees" are required to use the new Interim Program to guide their vaccination plans. In other words, this new document should directly guide every healthcare system's vaccination plans. In fact, the guide suggests that healthcare systems "must address all requirements outlined in the playbook and clearly describe their responsibility for ensuring activities are implemented."
To be clear, this is a dense document that will directly impact compliance, funding, and vaccine data capture for healthcare systems. The CDC says that it will update the playbook regularly, so this is the de facto guide for vaccination preparedness and reward capture. The 75-page document covers how to safely store vaccinations, deal with crisis and risk, adhere to regulatory guidelines, communicate with the public, and order vaccinations. There's also a sizable chunk that deals directly with data, digitization, documentation, and reporting.
We predict these data-driven capabilities will be the wrinkle in most healthcare systems' vaccine plans. According to Gartner, 41% of healthcare systems are "digitally fragile." This isn't surprising. EHR — which has been highly standardized and regulated for the past decade — is still a thorn in the side of healthcare systems, with 36% of hospital administrators admitting they struggle significantly with EHR implementation and interoperability. Considering this, we think it's crucial to discuss digitization in the realm of this new vaccine plan. After all, if healthcare systems still struggle with decade-old EHR systems, how will they handle a disruptive digitization framework set to take hold over the next few months?
The Role of Data, Analytics, and Digitization in the National Vaccine Response Protocol
From the local and state level to national governments, the process of planning, developing, distributing, and managing a vaccination for COVID-19 hinges on digitization. In fact, we would consider digitization to be the primary lever needed to unlock a comprehensive distribution platform to align with CDC protocols. Not only will digitization reduce some of your regulatory burdens (digitizing and submitting documents is far easier than submitting physical paperwork in a hectic environment), but it's a stamped requirement for many of the steps in the CDC's protocol.
Let's look at how digitization is a key element in the CDC's vaccine program:
Vaccination Provider Enrollment (Page 21)
To participate in the COVID-19 vaccination program (i.e., to receive COVID-19 vaccines), healthcare providers must enroll in the COVID-19 Vaccination Program in their jurisdiction. Typically, this means enrolling with the local health department or some level of local health department leadership. As it currently stands, there's a blending of requirements. You must comply with the CDC's vaccination playbook, but there are also state-by-state vaccination plans that may pose unique requirements.
Looking over the CDC COVID-19 Vaccination Program Provider Agreement, we see some immediate digitization requirements.
- submit (electronically) a vaccination record for each vaccination dose within 24 hours to your local public health authority. In other words, a system must be in place that facilitates rapid data capture and submission without impacting quality-of-care—something that should sound all-too-familiar for healthcare facilities.
- "keep all records related to COVID-19 vaccine management for a minimum of 3 years, or longer if required by law." Again, this requires digitization. The pure scale of physical space and security requirements that would be needed to house vaccination files in paper format is unfeasible.
- report any adverse event (AE) to the vaccine to the CDC's Vaccine Adverse Event Reporting System (VAERS).
- complete a CDC COVID-19 Vaccination Provider Profile form for each location where you administer the vaccinations. Both the agreement form and this profile form may be submitted electronically.
- report any vaccinations that were wasted, spoiled, unused, or expired to the proper healthcare authority.
- "onboard COVID-19 vaccination providers to the jurisdiction's IIS or other external system using an expedited process."
- "report COVID-19 vaccination provider enrollment data electronically to the CDC twice a week."
These procedures all require a layer of digitization and business process outsourcing (BPO). Submitting, retaining, and securing digital forms for every vaccination is a multi-faceted requirement. You must simultaneously leverage internal EHS systems while still adhering to these new guidelines for swift digitization and submission. We highly recommend that healthcare systems onboard BPO to help them rapidly fill-out, submit, and retain all forms without impacting quality-of-care or productivity.
COVID-19 Vaccine Storage and Handling (Page 33)
Like any vaccination, the CDC expects that COVID-19 vaccinations will be kept at specific temperatures and storage conditions. According to the CDC, the cold chain (i.e., the entire vaccine distribution supply chain) requires three core components:
- Well-trained staff
- Reliable storage and temperature monitoring equipment
- Accurate vaccine inventory management
In particular, we want to discuss the second and third components of the cold chain: temperature monitoring and inventory management.
The CDC highly recommends that healthcare systems use digital data loggers (DDLs) to record temperatures. If any temperature excursions happen, a digital report of these issues must be submitted to the local healthcare authority. So, again, we see an intersection of compliance and digital transformation for logging temperature data and quickly sending that digital log to your local healthcare authority (this is a recurring trend in this document) if any temperature excursions happen.
COVID-19 Documentation and Reporting (Page 35)
As expected, there's plenty of details on documentation and reporting. And unsurprisingly, most of this documentation is digital. In fact, healthcare providers are expected to report dose and exchange data directly to their jurisdiction's data systems or the Immunization Data Lake. In other words, there's going to be a convergence of data requirements. Theoretically, jurisdictional data solutions will connect to EHRs and a broader federal data lake, but we aren't exactly sure how this will work in practice. What we do know is this: you will be required to electronically submit data and documents after immunizations, before and after second doses, for coverage, inventory, ordering, and distribution. In other words, expect a fair chunk of the vaccine plan to involve sending digital documents back-and-forth throughout the vaccine supply chain and (hopefully) throughout your own healthcare system to integrate meaningful vaccine data into your EHR.
COVID-19 Vaccination Second-Dose Reminders (Page 37)
According to the CDC, "two doses of vaccine, separated by 21 or 28 days, will be needed" for the COVID-19 vaccination. This presents another layer of complexity into the vaccination protocol.
How do you remind people to come back after 21 days? The CDC recommends both providing a record card to patients with a date as well as using the "most appropriate and effective method of issuing second-dose reminders." This shouldn't be difficult to manage, since most healthcare systems have some form of reminder system in place. But you need to make sure that it's capable of handling this new influx, and you will certainly need to consider how you're going to digitally record every patient.
This is a great spot for BPO. You'll have to submit records to your reminder system for each vaccine patient. While your reminder system may already be tied into your EHR, we aren't positive how the cross-play between jurisdictional systems and EHS systems will play out yet. So we recommend preparing for duplicate data inputting processes.
COVID-19 Requirements for Immunization Information Systems or Other External Systems (Page 38)
The CDC requires jurisdictions to create IIS (or vaccine registries) to record vaccine dosage information. Spelled out in the playbook is a variety of requirements this IIS must meet (e.g., security, compliance, infrastructure, etc.), and it must be able to ensure data "are available, secure, complete, timely, valid, accurate, consistent, and unique." Again, this is difficult for both jurisdictions and providers. While the CDC is making a Vaccine Administration Management System (VAMS)—which is a mobile patient registration and vaccination data solution that inherently meets CDC reporting requirements—they've left the bulk of the data reporting responsibilities on jurisdictions, territories, and independent healthcare systems.
According to the CDC, IIS and other external systems that support COVID-19 response efforts must have solid "infrastructure, engaged partners, high-quality data, and efficient processes for managing vaccination." This is another area where collaboration with BPOs is critical. The pure scale of this digitization and digital connectivity puts immense pressure on healthcare systems. In an environment where healthcare's cracks are already exposed due to COVID-19, managing this will require significant assistance from data entry and digitization professionals.
COVID-19 Vaccination Program Communication (Page 42)
Here's an interesting component of the vaccine response plan: communication. The CDC requires jurisdictions to "implement timely, evolving plans as the foundation for their overall COVID-19 vaccination communication efforts." In other words, communication is a critical driver of this vaccination plan. This is a massive part of the document.
It details how to cater messages to specific audiences, each phase of communication during the vaccine development process, and specific messaging considerations. We're going to nit-pick the components of this messaging strategy that will require collaboration with BPOs. However, this is FAR from an exhaustive list of requirements.
- track and monitor public receptiveness to COVID-19 vaccination messaging." This will be a data-driven effort that will require both digitization and repetitive, BPO-friendly tasks.
- use multiple channels of media to reach the public (e.g., social media, TV, radio, texting, etc.) This will require a layer of marketing as well as the right systems to facilitate digital campaigns.
- ensure active, timely, accessible, and effective public health and safety messaging along with outreach to key state/local partners and the public about COVID-19 vaccines.
All of this will require digitization and digital transformation, especially to facilitate a large and complicated response across agencies and public bodies.
Here are some select materials that may help fill in any blanks you have on the digital side of this vaccination response plan.
- Immunization Information Systems (IIS) Data Quality Blueprint
- Data Quality Assurance in Immunization Information Systems: Incoming Data
- IIS Data Quality Best Practices
- Consolidating Demographic Records and Vaccination Event Records
- Immunization Information System Inventory Management Operations
- Vaccine Code Set Considerations
- Vaccine Safety Datalink
How DRS Can Help
At DRS, we're prepared to help you maximize your COVID-19 vaccine response plan. Our industry-leading digitization and digital transformation solutions quickly build out the infrastructure you need to facilitate rapid reporting and data intake. From document imaging and backlog capture to BPO and healthcare information management, our solutions bring peace-of-mind to healthcare systems preparing to undergo one of the most challenging, intense, and rewarding periods in the history of public health. Contact us to learn more.