Compliance Flashcards (Danny)

CBER

• Division of FDA regulating blood, blood products, tissues, biologics

• Authority from PHSA & FDCA

FDA Biologics License Application (BLA)

• Required for interstate shipment of blood products

• Issued by FDA/CBER

Quality Assurance (QA) vs Quality Control (QC)

• QA: system-wide program ensuring compliance & quality, process-focused

• QC: routine testing of reagents, equipment, procedures, product-focused

Lookback Program

• Manufacturer investigates when post-donation info shows donor infection risk (e.g., HIV, HBV)

• NOT the responsibility of the transfusion service to initiate manufacturer lookback

Fatality Reporting

Manufacturer must report to FDA/CBER within 7 days of awareness

Records Retention – 10 years

Donor deferrals, donor records, recipient records, donor test results

Records Retention – 5 years

Recipient testing, transfusion reaction workups, proficiency testing, QC records

Blood Utilization Management

• Goals: better patient outcomes, lower healthcare costs, efficient use of blood supply

• NOT about fostering respectful interactions with physicians

Patient Blood Management (PBM)

• Hospital-based program to minimize inappropriate transfusion

• Uses evidence-based guidelines & clinician education

Rare Antiserum QC

Test with one known antigen-positive and one antigen-negative cell

Short Supply Arrangements

• Manufacturer’s responsibility, not transfusion service

• Procedures to ensure supply in shortage situations

Current Good Manufacturing Practices (cGMP)

• FDA-enforced standards for manufacturing, testing, and quality systems

• Applies to blood collection and processing facilities

AABB

• Professional organization; accreditation often required for hospital blood banks

• Publishes Standards for Blood Banks and Transfusion Services

CMS (Centers for Medicare & Medicaid Services)

Enforces CLIA regulations for lab testing, including transfusion services

Joint Commission (JCAHO)

• Accrediting body; evaluates hospital compliance with patient care standards, including transfusion safety

Proficiency Testing Requirement

CLIA mandates participation in approved PT programs for all regulated analytes

Inventory Monitoring

All blood bank staff are responsible for monitoring inventory levels

Shipping Blood Across State Lines

• Requires FDA-approved BLA

• Does NOT require AABB accreditation or CMS certification

Donor Deferral Lists

• Must be maintained for permanent and temporary deferrals

• Retained for at least 10 years

Transfusion Reaction Reporting

• Facilities must investigate all suspected reactions

• Report fatalities to FDA within required timeframe

Compliance vs Regulatory Agencies

• FDA: safety & efficacy of biologics/blood

• CMS: CLIA oversight of lab quality

• AABB: accreditation & best practice standards

• Joint Commission: hospital accreditation