Subcommittee Recommendations to be Considered

Working Group One: Tissue Source

The scope of the Tissue Source Working Group included donation authorization and informed consent, donor screening, the decision to proceed, tissue recovery /acquisition procedures, donor testing, and the chain of custody.

The Working Group met on June 16, 2023, August 24, 2023, March 14, 2024, and July 16, 2024.

Potential Recommendations

1. To close gaps and to promote collection of information that could inform donor eligibility policy when screening donors of cells and tissues, standardized donor medical history interview forms and related tools should be developed and recommended in guidance issued by professional societies and regulatory authorities.
2. To optimize control of contamination, effective practices surrounding cell and tissue recovery/acquisition procedures should be identified and standardized across industry.
3. To inform cell and tissue donor screening policies, information collected from investigations and adjudication processes involving reports of probable transmission of disease to organ or tissue recipients must be disseminated widely by all groups involved in investigations.

Working Group Two: Tissue Processing

The scope of the Tissue Processing Working Group includes the chain of custody of biological materials; bioburden assessment, culture method, and molecular method suitability; preservation and storage of materials; process validation and tissue suitability for release; donor eligibility determination; data collection that can inform standards and policies; and product distribution.

The Working Group met on June 13, 2023, August 22, 2023, March 12, 2024, and July 17, 2024.

Potential Recommendations

1. To optimize cell and tissue product traceability from donor to recipient and back to the donor, the use of electronic systems must be required by health authorities; electronic health records must have functionality to accommodate a variety of long, distinct identification codes assigned to products; and manufacturers' requests for product disposition information from end users should be required.
2. To overcome bioburden assessment and process validation procedures that are inadequate for detecting contamination of tissue products that pose the greatest risk to recipients, microbiological process validation and surveillance programs must be effective, standardized by experts, and followed by industry.
3. To improve accountability and reduce variability that can affect recipient safety, donor eligibility determinations made by responsible persons should be independently monitored and noncompliance formally addressed.
4. To inform national standards, recommendations, and policies, cell and tissue donor screening experiences, donor testing outcomes, and data regarding use of products must be periodically collected, formally analyzed, and published every 2-3 years.

Working Group Three: Tissue End-User/Consignee Receipt and Use

The scope of the End User-Consignee Receipt and Use Working Group includes tracking, coding, and records; inspection, storage, preparation for use; electronic health records (EHR) and biovigilance; linkages between inventory and recipients; and final disposition of transferred tissues.

The Working Group met on August 1, September 14, 2023, April 10, 2024, and July 11, 2024.

Potential Recommendations

1. To improve the capabilities and effectiveness of electronic systems that healthcare software companies provide for tracking tissue products, software standards-setting organizations should identify and finalize critical data elements that must be included to support tissue biovigilance, and the software must be capable of electronic exchange with EHRs.
2. To improve quality, equity, and outcomes related to tissue biovigilance, the federal agency with oversight of healthcare coverage should promulgate regulations that require healthcare facilities to use electronic documentation to track tissue products, ensure all critical data elements are documented, and require investigation of adverse events related to tissue recipient infections.

Working Group Four: Tissue Recipient Adverse Events/Reactions

The scope of the Tissue Recipient Adverse Events/Reactions Working Group included professional and public expectations of the tissue donation system; procedures and guidelines; and recognition, investigation, and reporting of adverse events. Considerations include existing federal regulations, state or local laws, voluntary professional standards, and assessments of compliance.

The Working Group met on July 31, 2023, September 7, 2023, April 15, 2024, and July 8, 2024.

Potential Recommendations

1. To improve communication from healthcare professionals to inform a patient who may receive a tissue product that there is a potential for risk of disease transmission, such as descriptions regarding higher risks attributed to tissue products that contain live cells, national guidelines should be developed to improve processes used to describe such risks and professional societies should be encouraged to promote those guidelines.
2. Federal and state regulations should publish guidelines to assist end users (i.e., physicians and hospitals), and physicians who treat tissue recipients, how to properly identify a reaction that may be attributed to a tissue product, and these regulators should require end users to report tissue recipient adverse reactions and to cooperate with investigations.
3. Recipients of human tissues should give informed consent for the products they receive. Labeling information to inform clinicians of risk (e.g., absence of bioreduction) is fundamental for informed consent.