Current Problem: Opening a new donation site that allows blood products to be shipped across state lines requires an extensive licensure process, taking over a year despite using the same procedures and equipment as existing facilities.

Proposed Solution: Update the FDA licensure process to allow blood centers to quickly and safely meet changing demands for blood components.

Current Problem: As technology has advanced, we are left with some FDA infectious disease testing requirements that no longer increase blood safety.

Proposed Solution: Apply evidence-based decision making to eliminate unnecessary tests (e.g., HBsAg) while maintaining safety standards.

Current Problem: FDA overreach resulted in onerous and duplicative regulations blood centers will soon need to comply with that will increase costs and decrease patient access without any increase in patient safety.

Proposed Solution: Eliminate the FDA’s guidance and ensure any future LDT reform efforts carve out blood center tests that are already covered by multiple regulatory frameworks and are conducted for use by healthcare providers treating patients in a clinical setting.

Current Problem: U.S. Platelet Content Requirement (PCR), the number of platelets in a bag, is higher than necessary for ideal patient care, resulting in some unnecessary wastage.

Proposed Solution: Lower the PCR to expand platelet supply availability, improving access to millions of patients each year.

Current Problem: Inflexible regulation of plasma products requires blood centers to store plasma products no longer needed for transfusions to avoid wasting useful plasma.

Proposed Solution: Implement a rational, flexible approach, including FDA licensure of recovered plasma for more effective inventory management to maximize the optimal use of all donated blood components.

Current Problem: Restrictive time limits for blood processing make it challenging for blood centers to do some blood drives, especially in remote locations, and requires staffing during off hours to comply with processing time requirements that do not improve safety or efficacy of the blood products.

Proposed Solution: Allow blood to be held for up to 24 hours prior to processing, in line with current evidence.

Current Problem: While FDA has updated most of the deferrals for risk of HIV in line with modern test sensitivity, those recently incarcerated remain subject to a deferral 4 times longer than those at similar disease risk.

Proposed Solution: Reduce the deferral period for those incarcerated for more than 72 hours to three months, aligning with other similar risk deferrals.