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Helping you ensure a Safe and Reliable Blood Supply

Blood services organizations are commissioned to perform one of the most important roles in society today – providing a safe supply of blood to communities in need. Today, these life-saving organizations are faced with critical challenges that must be addressed to safeguard the world’s blood supply into the future.

Blood is a highly perishable product and blood organizations must constantly recruit donors to replenish the blood supply. By improving critical processes and ensuring the confidence of the donor community, blood organizations can retain more of their donor base, and ensure an adequate supply of blood to help more people in times of need. More efficient processes generate savings that can be used to accelerate donor recruitment efforts to bring in new sources of blood.

Safety and Quality

The blood services industry is impacted by safety and quality issues like no other industry. A single contaminated blood donation can impact communities’ trust and have a devastating impact on the blood provider. Effective quality management addresses every aspect of blood collection and transfusion processes. It includes donor selection, collection processes, preparation of blood components, laboratory testing, distribution and ensuring safe, appropriate use of blood and blood components.

To ensure the quality of the blood supply, blood organizations must maintain full traceability of their blood supply from donation through transfusion. Risk of contamination goes beyond just maintaining proper screening processes. The organization’s people, processes, suppliers, and equipment must all be of the highest quality to eliminate problems and reduce the amount of blood that must be wasted.

Cost of Compliance

Federal regulations exist as a framework to help blood services organizations ensure a safe, reliable and adequate supply of blood. Blood organizations must maintain compliance with internal requirements, industry standards, cGMPs, ISO 9000 and with the biologic requirements of regulatory agencies including the FDA, Health Canada, Pharmaceutical Inspection Convention Society, and the respective Health Ministries under which they operate. Many are also accredited to the Quality System Essentials of the American Association of Blood Banks (AABB).

Over the years, regulatory agencies have progressively strengthened overlapping safeguards that protect patients from unsuitable blood and blood products. Blood organizations that do not operate in compliance face the serious risk of regulatory penalties including warning letters, fines, consent decrees, and plant shutdowns. While these have a direct impact on a blood organization’s ability to operate, they also have a much more damaging effect – they can create public fear about blood safety, affecting donations and the availability of blood. To avoid these issues, blood organizations are spending ever greater sums to simply maintain regulatory compliance.

Blood Industry Strategies

Blood services organizations typically utilize a variety of manual and semi-automated systems to manage quality and compliance efforts. While these systems have created some efficiency within their functional areas, they lack the integration capabilities necessary to ensure the complete visibility and consistency needed to ensure regulatory compliance. Because of the number of manual and disconnected systems, the time, labor and costs to maintain paper-based and semi-automated IT systems have increased dramatically, without solving the core quality and compliance problems.

Ensure blood supply safety, quality, and traceability through closed-loop processes, from donor recruitment through transfusion.
Reduce costly waste and increase the availability of safe blood through proactive error management.
Ensure the most current documents are available through streamlined document management processes for the collection, processing, compatibility testing, storage and distribution of blood and blood components for transfusion and further manufacturing.
Automate assignments and monitoring of training tasks to ensure personnel are up to date on latest SOPs and required training and certifications.
Ensure that the entire organization is knowledgeable about changes, especially those made to testing procedures for infectious disease screening.
Lower IT and administrative costs with a modern cloud QHSE platform, available anywhere, anytime including bloodmobiles.
Blood sampling.

Partnering with you to provide a Safe and Reliable Blood Supply

The future growth of blood services organizations depends on their ability to address the critical challenges of donor recruitment, safety and quality, and cost-effective regulatory compliance. Current manual, paper-based, and semi-automated processes have created disconnects and inefficiencies between various processes that lead to inconsistency and increased expense, without delivering results. ComplianceQuest’s Modern Cloud Quality, Health, Safety and Environmental Management System (QHSE) Platform helps blood services organizations overcome their most critical challenges including blood shortages, safety and quality, and the rising cost of regulatory compliance. By streamlining all quality and compliance activities, ComplianceQuest helps you create efficient, effective processes while reducing operating costs.

Regulations Addressed

21 CFR Part 606, 1271
cGMP, cGTP, CLIA
WHO Annex 2 Part 822, 823, 840
Blood EU 2002/98/EC
Tissue EU 2004/23/EC
ISO 18001/45001
ISO 31000

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