Welcome, Roll Call, & Call to Order
Chair Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH, welcomed the participants and the newest Advisory Committee members, Michelle Kameka, EdD, MPH, Glenn Ramsey, MD, and Eric Santiago-Justiniano, MBA. Ms. Fredrick also thanked the four Working Group (WG) co-chairs, as well as the staff for ensuring the meetings are seamless and effective. She turned the meeting over to James Berger, MS, MT(ACSP) SBB, for roll call. Roll was called and a quorum met.
Mr. Berger noted that Vice Chair Matt Kuehnert has taken another position and can no longer hold his position on the Advisory Committee. Also, Ms. Fredrick will be stepping down as Chair, which will be taken over by Claudia Cohn, MD, PhD.
Ms. Fredrick reviewed the purpose of the meeting.
Purpose of the Meeting
- What recommendations for 1) required data collection and infrastructure framework and 2) supply chain resiliency and access should be made to the Assistant Secretary of Health to further improve the blood and plasma industry response to public health emergencies and can be acted on in the next 1-2 years?
- What priority order is recommended to act on the recommendations?
- What follow-up interactions with the Assistant Secretary of Health are requested?
Ms. Fredrick provided a summary of the August meeting. The overarching themes identified include:
- establish a locus of authority to develop and guide national blood and plasma policy;
- require a comprehensive and agile business continuity plan to respond to future disasters;
- advance the next generation of blood products and therapeutics to ensure a safe blood supply;
- integrate a public-private collaboration into existing and new frameworks; and
- obtain public and patient stakeholder input.
The supply chain for blood is unique. During the pandemic, the system was disrupted (e.g., transportation and donations). She noted that stockpile resiliency requires that:
- the workforce has access to critical supplies, vaccine, and a safe work environment;
- a national stockpile, distributive or virtual, contains essential supplies, including reagents; and
- communication is clear and frequent among all stakeholders.
Data collection models already exist in health care, the blood and plasma industry, and the federal government. Specific to data infrastructure, she noted the need to:
- leverage existing models and ensure interoperability;
- develop national, real-time, confidential data collection; and
- leverage and expand existing donor data for public health systems that have established relationships with government agencies and hospitals.
Ms. Fredrick opened the floor to questions. No questions were raised. She turned the floor to Sally Caglioti, MS, MT (ASCP), to moderate the discussion concerning the draft recommendations for supply chain resiliency.
Presentation and Discussion Recommendations
Ms. Caglioti noted that blood donation will be addressed at a future meeting, but the Advisory Committee should not lose sight of this part of the supply chain. She read through the draft recommendation for supply chain resiliency.
Supply Chain to Produce Blood and Plasma Derived Products
Governance/Locus of Authority
Recommendation: Establish a defined locus of authority for national blood and plasma policy, with the Assistant Secretary for Health, coordinating with FDA, CDC, NIH, HRSA, ASPR, CMS, DoD, VA, and those non-government organizations that provide and transfuse blood and plasma products, and develop and implement a National Blood Policy inclusive of all blood and plasma products.
Supply Chain to Produce Blood and Plasma Derived Products
Recommendation: Develop policies and provide funding to strengthen the resiliency of the blood and plasma supply chain to ensure product availability to patients during national emergencies, to include:
- Charge an expert task force, to include funding, and develop a comprehensive risk assessment and business continuity plan to make recommendations for ensuring robustness of access to key supplies and devices that are essential to maintain a safe and available blood and plasma supply. The task force should include representatives from the blood and plasma industry, regulatory authorities, and manufacturers of plastics, testing reagents, and other critical supplies. The task force should explore options including the potential design of a stockpile as well as regulatory pathways to facilitate rapid approval of alternative manufacturing locations.
- Ensure that blood and plasma donation, processing and product distribution are designated as critical infrastructure and essential services within the Federal preparedness framework and receive appropriate funding during national public emergencies.
- Ensure blood and plasma center employees are designated essential personnel and are federally recognized with the same designation as critical healthcare workers during national emergencies and have priority access to vaccines, therapeutics, and to supplies that are critical for blood collection and manufacturing, including personal protection equipment (PPE).
- Appoint representatives from the blood and plasma industry to federal committees or task forces responsible for allocation of critical supplies and transportation and logistics resources during national emergencies and give priority access to transportation and delivery systems for blood and plasma centers to assure continued operations in situations where infrastructure is disrupted.
Ms. Caglioti opened discussion to the Committee.
The group engaged in editorial review. The edited version was moved forward for the final vote. Key points that were raised include:
- Mr. Berger explained that two proposals concerning blood donations have been submitted to implement a national blood donation campaign. While the original request from Congress did not come with funds, his group has identified end-of-year funds and plan to make an announcement in the next few weeks to continue the push for blood, plasma, and minority donations.
- Ms. Fredrick stated that the recommendations voted on today will be sent in a letter to Dr. Levine. An additional Advisory Committee devoted to blood donors and donation can be held. This may fit nicely with the work that is being done for the national blood donation campaign. This item can be raised in the letter to the Assistant Secretary to keep it in the discussion. It may be helpful to re-engage the Advisory Committee members who worked on the Congressional report when addressing this need.
Data Collection and Infrastructure Framework
Ms. Fredrick turned the floor over to Dr. Cohn to lead the discussion on data collection and infrastructure. Dr. Cohn thanked her co-chairs and the individuals who provided input on the draft recommendations She read through each recommendation and paused for discussion.
Introduction
Current monitoring of the blood supply, transfusion outcomes, and donor health in the United States has limited capabilities and effectiveness due in large part to a lack of continuity because it is composed of a network of independent blood providers, hospitals, supporting organizations, and federal agencies. To maintain a monitoring system that is responsive, efficient and ensures safe and available blood for all patients, real-time integrated data infrastructure is essential. The Committee has examined possible models to establish and implement a comprehensive, sustainable, minimally burdensome infrastructure that monitors and makes available 1) real-time data on blood availability/utilization, 2) adverse events and patient outcomes (i.e., hemovigilance), and 3) donor data to benefit public health. This is particularly important when considering the potential impact of public health emergencies on blood safety and availability. The role of blood providers in enhancing public health surveillance for emerging infections has been highlighted by blood donors’ contributions to data and therapeutics during the COVID-19 pandemic, and prior to that for surveillance of HIV, HBV, and HCV, among others.
The ACBTSA has previously proposed recommendations for a data infrastructure framework that would build upon current infrastructure and gap analysis. Specifically, a real-time blood inventory framework, a plan for a hemovigilance system, and coordination of research to monitor donor health—funded by a consistent and reliable mechanism—are needed. The recommendations of these three topics are outlined below.
In addition to a robust data infrastructure, governance of that integrated structure and use are critical for long term success and improvement in patient access and outcomes.
Recommendations:
1) Inventory/Supply Data Infrastructure
There is currently no single, comprehensive source of real-time blood inventory information in the United States. A national system is needed to monitor current inventory of blood providers and healthcare facilities through development of data infrastructure which would allow for alignment of transfusion demands and donor collections, reduction of blood shortages and wastages, and provide a rapid and reliable source of data-driven information in the face of national and regional disasters when there is an urgent need for blood. These objectives are ultimately patient safety issues.
Recommendation: Establish, implement, and fund comprehensive, sustainable, automated infrastructure that monitors and makes available real-time data on blood availability and utilization.
Charge an expert task force to:
- Assess development of existing public-private models for real-time blood inventory reporting from blood providers and hospitals based on well-defined common definitions that would ensure:
- improved patient outcomes
- data confidentiality, security, and privacy
- automated reporting by key stakeholders
- full funding shall be provided
- leveraging of existing electronic reporting platforms and codes for blood components
- capturing data from all blood centers and hospitals
- Assure that participation in data reporting infrastructure is rooted in legislation and/or regulation.
- Define governance and accessibility of data infrastructure by a neutral, coordinated group/agency that would manage and oversee the equitable exchange and use of data for monitoring the safety and availability of the nation’s blood supply.
2) Recipient Hemovigilance
It is recognized that hemovigilance is critical for monitoring the safety of the blood supply and further recognized that current hemovigilance systems are limited by poor hospital participation rates, the ACBTSA recommends an expansion of the current Hemovigilance module of the National Healthcare Safety Network with efforts focused on increasing participation throughout the US.
Recommendation: Building on current infrastructure and gap analysis, develop a plan for a hemovigilance and transfusion outcomes system and determine funding mechanism
- Charge an expert task force to explore:
- Existing models such as the statewide hemovigilance in the Commonwealth of Massachusetts, the NHSN at CDC, the BEST initiative at CBER (FDA) and other international surveillance models in healthcare and transplantation.
- Recommend public/private partnerships that develop or expand information technology systems so that hemovigilance data:
- are scalable and sustainable
- ensure data confidentiality
- leverage existing electronic reporting platforms
- capture data from all blood centers and hospitals
- Recommend that the necessity of funding be explored to implement these hemovigilance systems.
- Models of participation that are rooted in legislation and/or regulation to include accreditation by nationally recognized healthcare organizations such as The Joint Commission.
Recommendation 1
The group engaged in editorial review. The edited version was moved forward for the final vote. Key points that were raised include:
- The concept of ‘minimally burdensome’ was replaced with ‘automated’ to explain the goal of reducing required labor to meet this requirement.
- The need to identify funding for reimbursement was raised. It was decided that the task force will need to operationalize this. A sub-bullet was added regarding funding.
- The expert task force will work through how the data will be used and who will have access to it during an emergency. The rest of the time, a position should be funded to manage the data and produce a monthly or quarterly report of anonymized data to aid blood centers and hospitals as they manage their blood supply.
- The point was raised that greater transparency in data equals greater equity.
- The point was raised to the difficulty in getting a national data infrastructure off the ground. An upcoming National Academies of Sciences report on equitable distribution of transplant organs could provide a model for this effort.
- A suggestion was made to have the expert task force engage with EHR vendors. This may make automating the system easier and collection of data more efficient. It may be valuable to have an EHR vendor on the expert task force.
Recommendation 2 (TABLED)
The group engaged in editorial review. The final decision was to table this recommendation for additional discussion by a future WG. Key points that were raised during the discussion include:
- This version of the recommendation is vague and it is unclear what action the Assistant Secretary can take.
- Following the COVID pandemic, blood donors have become a source of information to make policy decisions. Blood donor data is valuable in addressing infectious disease concerns. A task force is needed to review current programs and the framework to build a more robust system that can be used in the future to inform policy.
- There was confusion as to why specific programs were named (e.g., TTIMS, REDS, and MASS-BD) and how they are to be used in this recommendation. In addition, the named programs have specific charge and it may not be possible to expand their scope.
- The biggest challenge for a new network is developing the IT infrastructure. While the named programs are specific, they set up an infrastructure for data collection that could be leveraged.
- This recommendation could be expanded to include public-private partnerships.
Recommendation 2 (PREVIOUS RECOMMENDATION 3)
The group engaged in editorial review. The edited version was moved forward for the final vote. Key points that were raised include:
- At this time, a robust hemovigilance system is needed, but the current system is only reporting what is captured by the blood banks, which underestimates the true incidence. The current system is incomplete and weak. This recommendation takes the first small steps to create tools to capture the necessary information. An expert task force is needed to explore the need for a more comprehensive and patient-based outcomes model.
- The model should include a representative institutions.
- Hemovigilance data should be scalable and sustainable.
- The recommendation should include language that requires a task force to consider potential reimbursement mechanisms.
Final Recommendations and Priority of Recommendations
Ms. Fredrick brought the final recommendations to the floor for a vote. The three recommendations (e.g., one for supply chain and two for data infrastructure) were voted on independently.
Supply Chain Resiliency
Biree Andemariam, MD, made a motion to accept the supply chain recommendation with the modifications as written. It was seconded by Lynne Uhl, MD. Ms. Fredrick asked if there were any voting members who disagreed with recommendation 1. The floor was silent. The voting members provided the affirmative aye. No voting members opposed the recommendation. The supply chain recommendation was moved forward.
Data Collection and Infrastructure Framework
The first data infrastructure recommendation was brought to the floor. Jim MacPherson, MS, MPH, made a motion to accept the first data infrastructure recommendation with the modifications as written. Ms. Caglioti seconded. The voting members provided the affirmative aye. No voting members opposed the recommendation. The first data infrastructure recommendation was moved forward.
The second data infrastructure recommendation (originally written as the third recommendation) on recipient hemovigilance was brought to the floor. Dr. Uhl made a motion to accept the second data infrastructure recommendation with the modifications as written. Dr. Andemariam seconded. All voting members voted in favor with no objections. Mr. MacPherson abstained.
The three recommendations as written will be sent to the Assistant Secretary. Ms. Fredrick addressed the priority order of the recommendations. She asked if anyone wanted to change the order of the three recommendations. There were no objections or request to modify the order. The recommendations will move forward in the current order.
Tabled Recommendation 2
The recommendation for blood donors and public health has been tabled. If the Advisory Committee wants to explore this recommendation further, a WG can be established and charged with evaluating the blood donor data for public health and report back to the Advisory Committee with a recommendation on whether or not to move forward.
Dr. Cohn made a motion to move the tabled recommendation forward with a WG. Raymond Goodrich, PhD, seconded this motion. The motion was voted on. There were no opposition.
The letter to Dr. Levine will include background information that summarizes the main points from the 53rd meeting. It will also include the recommendations in the order voted on during the meeting today. Ms. Fredrick asked for any additional information to include (e.g., importance of a meeting around blood donor and blood donor engagement around the National campaign). Ms. Caglioti noted the need to stress the urgency on these topics in the letter.
Dr. Cohn will meet with the Assistant Secretary to review the recommendations.
New Business
Mr. Berger brought forward the need to fill the two vacant positions: the American Association of Tissue Banks as well as a Vice Chair of Tissue and Organ Transplantation for ACBTSA.
Mr. Berger raised potential topics ACBTSA can address in the future. In particular, he suggested evaluating the guidelines on pediatric patient transplant testing. At this time, transplant recipients are tested for HIV, Hep-B, and Hep-C prior to transplant to determine if any post-transplant infections were donor derived. For pediatric patients (< 10 years), subsequent testing at time of admission is not necessary because the incidence is so low once perinatal infection is ruled out. At this time, the next ACBTSA meeting will be slated into the meeting calendar in two to three months to examine this issue.
Mr. Berger thanked Ms. Fredrick and Dr. Kuehnert for their leadership roles.
Mr. MacPherson also thanked Ms. Fredrick for her leadership during her tenure as Chair of the ACBTSA. He raised a concern about the editorial practice for review of recommendations. He noted that edit by email led to version control issues that caused confusion. He recommended that future task forces should meet to work through these efforts.
Ms. Fredrick thanked the Advisory Committee. It has been a privilege to serve the American people through government service. She gave a special thanks to Mr. Berger and his team, Dr. Basavaraju, and all of the government employees for their dedication, expertise, and support.
Adjournment
Mr. Berger closed the 54th meeting of the ACBTSA. The recommendations will be moved to the Assistant Secretary of Health. The meeting was adjourned at 3:40 p.m. Eastern.
ACBTSA SGE Members in Attendance (in alphabetical order)
Chair Jacquelyn (Jackie) Fredrick, MT (ASCP) SBB, MBA, Hon: DB/DPH
Biree Andemariam, MD
Sally Caglioti, MS, MT (ASCP)
Claudia Cohn, MD, PhD
Raymond Goodrich, PhD
Elisa Gordon, PhD, MPH
Jed B. Gorlin, MD, MBA
Michelle Kameka, EdD, MPH
Daryl Kor, MD, MSc
Jim MacPherson, MS, MPH
Paul M. Ness, MD
ACBTSA Representative Members
Susan Galel, MD
Bennie H. Jeng, MD
Glenn Ramsey, MD
Eric Santiago-Justiniano, MBA
Lynne Uhl, MD
ACBTSA Ex-Officio Members
Sridhar V. Basavaraju, MD, FACEP, CDR, USPHS
Scott A. Brubaker
Diane H. Corning, RN, JD
Marilyn E. Levi, MD
Absent
Andrew Cap, MD, PhD
David Perez
Ron Waeckerlin, MD
Mary Gustafson, MS, MT (ASCP) SBB
J. Chris Hrouda, MT (ASCP)
Gary Marklin, MD
Barbara Bryant, MD
Nicole Verdun, MD
