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Quality systems and total process control in blood banking

M F Callery1, D E Nevalainen, T M Kirst

  • 1Blood Center Training Systems, St. Paul, Minnesota.

Transfusion
|October 1, 1994
PubMed
Summary

Modern blood banking requires updated organizational structures to ensure quality improvement and total process control (TPC). Adopting quality systems, guided by FDA and professional organizations, is essential for future success.

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Area of Science:

  • Healthcare Management
  • Blood Banking Operations
  • Quality Systems Implementation

Background:

  • The blood banking industry has undergone significant recent changes.
  • Traditional business hierarchies and medical management models may no longer be optimal.
  • The complexity of implementing quality systems presents a challenge for many blood centers.

Purpose of the Study:

  • To evaluate the workability of current blood banking management structures.
  • To propose strategies for organizing blood banking operations for future success.
  • To guide blood centers in achieving quality improvement and total process control (TPC).

Main Methods:

  • Review of organizational development requirements for quality improvement.
  • Guidance from regulatory bodies like the FDA and professional organizations (AABB, ASQ, ASTD).

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  • Adherence to FDA quality assurance documents and the Code of Federal Regulations (CFR).

    • Main Results:

    • Methodical adherence to organization development principles enables quality improvement and TPC.
    • External guidance from FDA and professional organizations is available.
    • Reengineering organizational structures and processes is necessary for a quality and process control culture.

    Conclusions:

    • Blood centers can achieve quality improvement and TPC by implementing structured organizational development.
    • A shift towards a culture of quality and process control is crucial for modern blood banking.
    • Adapting organizational structures and processes is key to meeting future demands.