Plasma donors frequently ask whether their personal health information is shared across different facilities after a donation attempt. Donating plasma involves providing sensitive health and identity details, leading to understandable concerns about privacy. Donors often wonder if a deferral at one center will automatically prevent them from donating elsewhere, or if their full health record becomes public knowledge. This process is managed through mandatory regulatory and industry systems that balance the need to protect the plasma supply with a donor’s right to privacy.
Regulatory Requirement for Donor Screening Integration
Plasma collection is a highly regulated industry because the product is used to create life-saving therapies. The U.S. Food and Drug Administration (FDA) establishes strict requirements for testing every donation for communicable disease agents. This mandatory testing is the primary driver for information sharing across the industry.
The regulatory framework requires centers to prevent the distribution of unsafe plasma. Donors who pose a risk to the supply must be permanently disqualified from donating again. This ensures the safety of plasma-derived medicinal products, which are manufactured from large pools of donations.
If a donor tests reactive for an infectious disease marker, they cannot donate at any other licensed facility. Centers must maintain a system to identify and reject unsuitable donors, enforcing an industry-wide safety standard. The FDA mandates that establishments notify donors of their deferral status, especially when due to agents like Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
The Mechanism for Shared Donor Deferral Information
The mechanism for sharing deferral status across plasma centers is managed through the National Donor Deferral Registry (NDDR). This specialized database is used by participating licensed plasma collection centers across the United States and Canada. The NDDR serves as the central system allowing centers to check a prospective donor’s eligibility status before a donation.
The system tracks individuals permanently deferred after testing reactive for specific viral agents, namely HIV, HBV, or HCV. When a donor attempts to give plasma, the center queries the NDDR using identifying information. If a match is found, the donor is automatically rejected, enforcing the industry-wide safety exclusion.
The specific data points shared within the NDDR are highly restricted to minimize privacy concerns while maximizing public safety. The registry contains identifying information such as:
- The donor’s ID
- First and last name, and middle initial
- Date of birth
- Gender
The NDDR does not contain individual test results, comprehensive medical history, or the detailed health records associated with the deferral. The system simply confirms the status of permanent deferral due to a reactive viral test result.
Data Privacy Protections for Plasma Donors
Despite the necessity of sharing deferral status for safety, the underlying personal health information (PHI) of plasma donors is protected by rigorous federal privacy laws. The Health Insurance Portability and Accountability Act (HIPAA) applies to plasma donation centers, which are considered covered entities. They must adhere to stringent rules regarding the collection, use, and disclosure of a donor’s health data.
HIPAA rules dictate that a donor’s PHI generally cannot be disclosed to a third party without the individual’s explicit authorization. The sharing of limited identifying information for the NDDR is permitted as a mandated public health and safety activity, serving as an exception to the general rule of non-disclosure. Centers must disclose only the minimum amount of PHI necessary for the specific purpose, such as checking the registry.
The FDA requires plasma centers to keep donor deferral records confidential within their own facility. This confidentiality extends to detailed medical records, which are maintained locally. The legal structure ensures that donors unsafe for the plasma supply cannot donate elsewhere while safeguarding the detailed health information that led to the deferral.
Scope of Data Sharing Beyond Plasma Centers
Donors often ask if a deferral at a commercial plasma center will affect their ability to donate whole blood at organizations like the American Red Cross, or vice versa. The commercial plasma industry collects source plasma for pharmaceutical products and uses registries like the NDDR. These systems operate largely independently from the data systems used by whole blood collection agencies.
Both commercial plasma centers and whole blood collection agencies are regulated by the FDA and follow the same federal guidelines for infectious disease screening. However, their operational databases are usually siloed. A temporary deferral at a plasma center—for issues like low protein levels or frequent donations—is logged only in that company’s internal system.
This internal deferral would not be automatically visible to a non-affiliated whole blood center. The NDDR specifically focuses on permanent deferrals due to reactive viral marker tests (HIV, HBV, HCV) and is used only by the commercial source plasma sector. Data sharing between the commercial source plasma and non-profit whole blood collection industries is not fully integrated.