Blood collection is a uniquely regulated process, merging medical practice with manufacturing standards because blood is a biological product. Strict, standardized guidelines are necessary to minimize the risk of transmitting infectious diseases and ensure product quality across all collection facilities. The safety and integrity of the blood supply rely on a collaborative effort between governmental regulators that enforce the law and private organizations that establish consensus-based industry practices. This framework guarantees every unit of donated blood meets rigorous standards before transfusion.
The Government Regulator Ensuring Safety
The ultimate legal authority over the United States blood supply rests with the Food and Drug Administration (FDA), which regulates blood and blood components as biological products and drugs. The FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for enforcing mandatory standards for the collection, testing, and manufacturing of blood products, ensuring establishments maintain the safety, purity, and potency of the supply.
These mandatory requirements are codified primarily in Title 21 of the Code of Federal Regulations (21 CFR). These regulations implement the FDA’s statutory authority to enforce current Good Manufacturing Practices (cGMP) in blood banking, requiring facilities to adhere to a system of controls for quality production. The FDA conducts routine inspections to verify compliance, and non-compliance can result in legal enforcement actions, including the inability to operate or ship products interstate.
The FDA also issues guidance documents that represent the agency’s current thinking, detailing how blood establishments can comply with regulations. They mandate that establishments must determine the suitability of every donation and the eligibility of every donor before collection. The federal government’s role is legal enforcement, setting the minimum safety and quality standards every blood center must meet.
The Industry Standard Setter and Accreditor
Operating alongside the government is the AABB, the primary non-governmental standard-setting body and accreditor for the industry. While the FDA sets the minimum legal framework, the AABB develops comprehensive, technical Standards for Blood Banks and Transfusion Services that facilities voluntarily adopt to demonstrate quality beyond cGMP requirements. These consensus-based standards draw on the expertise of medical and scientific professionals.
Accreditation by the AABB signifies that a blood center has met rigorous standards for quality and safety, covering operations from donor screening to product labeling. The AABB’s standards are often more prescriptive and updated more frequently than federal regulations, reflecting current best medical practices. Many blood centers seek AABB accreditation because it is widely recognized as a benchmark for operational excellence.
The AABB’s standards are revised on a regular two-year cycle, ensuring practices evolve quickly in response to new scientific information or emerging threats. The association works closely with the FDA, but its accreditation process focuses on the detailed technical requirements for day-to-day practice. This parallel system of mandatory regulation and voluntary accreditation creates a comprehensive safety net.
Core Areas Covered by Collection Procedures
The guidelines established by these organizations mandate precise procedures across several key operational areas to ensure both donor and recipient safety. The most critical step is the rigorous assessment of donor eligibility, involving a detailed health history questionnaire and physical assessment on the day of donation. This screening identifies individuals who may pose a risk of transmitting infections or those for whom donation could adversely affect their own health.
During the physical assessment, procedures require checking the donor’s vitals and a validated hemoglobin or hematocrit screen to ensure an acceptable level of red blood cells. The phlebotomy procedure is highly standardized, mandating the use of a sterile, closed collection system to prevent contamination. This includes a strict, often two-step, skin disinfection protocol at the venipuncture site to minimize the risk of bacterial contamination.
Comprehensive documentation and labeling are required for every unit collected to maintain complete traceability from the donor to the patient. Each blood bag must be identified with a unique number linking it to the donor’s record, testing results, and collection facility. These stringent requirements ensure that if a safety issue arises, the affected unit can be rapidly traced and recalled.