Blood Bank Equipment and Quality Management

Blood Bank Refrigerator

  • Essential equipment in the immunohematology department.
  • Provides safe and convenient storage for:
    • Whole blood
    • Blood components (e.g., blood cells, plasma)
    • Reagents
  • Ensures freshness and integrity of blood and blood components.

Refrigerator Cooling Cycle

  • Refrigerant leaves the evaporator as a gas at low temperature and pressure.
  • The compressor:
    • Establishes a pressure difference in the system.
    • Draws refrigerant gas through a suction valve.
    • Circulates refrigerant to the condenser.
  • Compressed gas enters the condenser at a higher-than-ambient temperature and is cooled to a liquid.
  • As liquid refrigerant leaves the condenser:
    • A capillary tube or expansion valve controls its flow to the evaporator.
    • The capillary tube forms a heat exchanger to further cool the refrigerant.
  • As the refrigerant leaves, it enters a low-pressure area, which allows it to:
    • Expand rapidly
    • Evaporate, absorbing heat from the refrigerator storage area
    • Cool the storage area and its contents
  • Refrigerant gas is circulated from the evaporator back to the compressor to repeat the cycle.

Operating Steps for Refrigerator

  • Install the refrigerator in the setting of use.
  • Plug in the line power.
  • When the refrigerator reaches the desired temperature, it is safe to use.
  • Laboratory technician should:
    • Continuously monitor the temperature of the refrigerator.
    • Periodically check backup power systems.

Plasma Freezer

  • Maintains freezing temperature at -30°C or -40°C for safe storage of:
    • Fresh frozen plasma
    • Red cells
    • Cryoprecipitate
    • Platelet concentrates
  • Each unit meets guidance parameters and requirements for safe storage of blood plasma.

Blood Bank Refrigerated Centrifuge

  • Designed for separating blood and blood components from whole blood, such as:
    • Platelet
    • Plasma
    • RBC
    • Cryoprecipitate

Centrifugal Force and Blood Separation

  • Centrifugal force separates blood components – red blood cells, platelets, and plasma – from each other.
  • Particles with different densities precipitate in layers.
  • Process:
    • A dose of whole donor blood is placed in a large centrifuge.
    • It is spun for a preset time (usually about 15 minutes) at a preset speed.
    • Red blood cells precipitate to the bottom of the bag.
    • Platelets are above the red blood cells.
    • White blood cells are above the platelets.
    • Plasma is at the very top.

Separation Process

  • Plasma and red blood cells are collected into different bags under optical supervision using a separator.
  • Platelets and white blood cells remain in the original bag.

Platelet Concentrate

  • Layers of platelets and white blood cells from three or four donors with the same blood type are allowed to flow together.
  • The by-product is returned to the centrifuge process.
  • A layer of leukocytes and thrombocytes is formed.
  • Leukocytes not used for blood transfusions are separated.
  • The process yields a platelet concentrate.

Blood Cell Viability

  • A nutrient solution is added to the red blood cell/platelet bag to keep the cells viable in storage.
  • Plasma is flash-frozen at -30°C in a process taking several hours.
  • Rapid freezing prevents clotting agents in the plasma from breaking down.
  • When plasma is thawed for transfusion, the clotting agents become active again.

Serofuge

  • Laboratory equipment used in blood banking to spin serum from whole blood red cells.
  • Centrifuges are typically run at speeds between 34003400 and 35003500 RPM for red cell washing and grading.

Red Cell Washing

  • For washing, tubes swing at a fixed positive angle to sediment cells rapidly at the bottom of the tube.
  • When decanting, the rotor holds tubes at a slightly negative angle, and the saline is decanted centrifugally.

Cell Washer

  • Equipment used for cell washing.

Platelet Incubators

  • Widely used in blood banks and clinical research laboratories.
  • Provides accurate and stable storage conditions for platelets.
  • Platelets are small cell fragments known for their role in wound repair/blood clotting.

Blood Tube Sealer

  • Seals the tube of the blood bag without causing hemolysis or leakage of blood.
  • The seal is wide and can be separated or teared with little or no force.

Gamma Irradiation Chambers

  • Used in hospitals and blood banks for irradiation of blood and blood products/components for clinical and research purposes.

Purpose of Irradiation

  • Cellular blood components are irradiated prior to transfusion to prevent the proliferation of viable T lymphocytes.
  • T lymphocytes are the immediate cause of Transfusion Associated-Graft Versus Host Disease (TA-GVHD).
  • TA-GVHD:
    • A rare complication (fewer than one per million transfusions result in TA-GVHD)
    • Has a fatality rate greater than 90%.
  • Patients at particular risk of TA-GVHD include:
    • Fetal and neonatal recipients of intrauterine transfusions
    • Selected immunocompromised recipients
    • Recipients of cellular components from a blood relative
    • Recipients who have undergone marrow or peripheral blood progenitor cell transplantation
    • Recipients of cellular components whose donor is selected for HLA compatibility

Heat Block

  • Blood banking equipment that enhances the temperature of the culture tube.
  • Professionals can enhance the temperature of the culture tube before testing.
  • Allows professionals to perform different testing at the same time.

Plasma Thawing Bath

  • Equipment designed for rapid and uniform thawing of fresh frozen plasma (FFP) bags at 37°C.
  • Made of a stainless steel chamber equipped with:
    • Digital temperature controller
    • A water circulating pump

Quality Management of Blood Bank

  • Quality Management of blood transfusion service is concerned with every aspect of transfusion practice.
  • Includes all activities involved such as:
    • Selection of prospective donor
    • Adequate collection of safe blood
    • Preparation of blood components
    • Laboratory Quality Testing
    • Safe and appropriate use of blood and blood components
    • Good record keeping and documentation, worksheet
    • Use of standard operating procedures
    • Implementation of safety guidelines
    • Skilled, capable manpower

Components of Quality Management

  • Quality in Procurement: (Donor, Material, Reagent)
  • Quality Preparation: (Effective Component Preparation)
  • Quality in Supply: (Storage, Transportation, Service)
  • Quality in Design & Development: (Improved Techniques & Procedures)
  • Quality needs to be systematically developed.

Quality Management System

  • Quality Planning
  • Quality Improvement
  • Quality Control
  • Quality Assurance

Policy Statement on Quality

  • Quality Planning
  • Records and Documentation
  • Work Instruction or Work Sheet
  • Blood Safety Planning
  • Quality Manual
  • SOP (Standard Operating Procedures)

Quality Control

  • The aim of quality control (QC) is to provide feedback.
  • Checks put in place to ensure that input, processes, procedures, and products meet the quality requirements as predetermined.
  • Detect and estimate error and alert on deterioration of quality.
  • Help in establishing product standards.
  • Identify deviation from expected result and help in correction.

Quality Assurance

  • Quality assurance provides information regarding levels of performance that can be used in setting priorities for process improvement.

Quality Improvement

  • Three main segments:
    • Product Improvement.
      • Quality Blood Bags.
      • Sterile procedure for collection.
      • Storage Environment.
      • Proper maintenance of records.
      • Component separation.
      • Use of latest technique for separation.
    • Process Improvement
      • Improve technique of collection.
      • Donor Comfort.
      • Donor Refreshment.
      • Highly skilled manpower to handle.
      • Internal & External Quality Control.
    • People Improvement
      • Motivation & leadership.
      • In-service training & skill developments.
      • Awards & recognition.
      • Seminar & workshops.
      • Empowerment of people.

Quality Assessment Tools

  • Validation.
    • To measure what is supposed to measure in the sample.
  • Calibration and Standardization.
  • Audit.
  • Drug Controller.
  • Error Management.
  • Quality Assessment Schemes:
    • Internal QAS.
    • External QAS.
  • QAT

Error Management

  • All staff have a responsibility to report errors.
  • Senior/supervisory staff must take note of reports and follow the procedure for formal notification and investigation.
  • Formal logging of errors, results of investigation, action taken to be recorded.
  • It generates a culture of awareness, not a fault-finding mission.

Quality Assessment Schemes

  • Internal Quality Assessment (IQA):
    • The assessment of a laboratory's overall quality system is found by the process of analyzing each half of a sample separately in the same manner and comparing the results.
  • External Quality Assessment (EQA):
    • The external assessment of a laboratory's performance is done using samples of known BUT undisclosed values and comparison against other laboratories' values of the same sample.

Legal Requirements

  • Legal Requirement & Licensing
  • Policy Statement
  • Type of Records
  • Material Management & Maintenance
  • Guidelines of Functioning (Manpower, Equipments, Procedures)
  • Training & Supervision
  • Method of Supervision & Auditing
  • Specification of All Blood Products

Quality Management Indicators in Blood Bank

  • Quality Control:
    • Screening of donor
    • Preparation of SOP
    • Blood Safety
    • Proper labeling
    • Maintenance of logbook
  • Quality Assurance:
    • Equipment Maintenance
    • Regular Calibration
    • Use of quality Reagent Materials
    • Standardization
    • Blood grouping & cross-matching
  • Quality Improvement