JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

Cold Chain

It is expected that storage facilities will comply with the requirements of Part 4 of the Blood Safety and Quality Regulations, e.g. 2-6 oC for red cell storage. Calibration limits applied to monitoring devices should also be appropriate to meet these requirements. If alarm settings or storage specifications are outside these limits, a scientifically-based justification should be provided.

This article seeks to raise awareness with Hospital Transfusion Laboratories the areas which they will need to consider under the Blood Safety and Quality Regulations 2005.

  • The cold chain for the hospital transfusion laboratory starts from the receipt of the blood from the blood centre to the time the unit is transfused or otherwise disposed of.
  • GDP (Good Distribution Practice) requires us to – “ensure that storage conditions are observed at all times, including during transportation”
  • Cold storage
    • Temperatures should be measured continually
    • Continuous 24 hour, 365 day monitoring for temperature alarm conditions
    • Defined procedure for responding to alarms, and contingency arrangements for dealing with stock in prolonged alarm situations
    • Maximum and minimum recorded daily
    • Accuracy of ± 0.5 oC
    • Consider the location of the equipment
    • Red cell components must be stored within the temperature range
      • 2 - 6 oC core temperature
    • Chart recorder, digital readout, max/min thermometer, central monitoring system, BUT whichever you choose will need to be calibrated annually and you will need an in date certificate for the calibration equipment, traceable to National Standards.
    • Paperwork/electronic storage records kept for 15 years

Back to Basics – The following points should all be considered, decisions made, documented and the evidence kept.
  • Maintained electrical supply for unit / alarm
  • Alarm testing – SOP determining
    • How often
    • By whom
    • When, including weekends and out of hours?
    • Local and remote
    • Evidence kept
  • SOP for alarm incidents/ failure
    • At testing
    • Fridge or unit failure
    • Instruction for contact procedure, criteria for corrective action and contingency arrangements for stock transfer
  • SOP for cleaning fridges etc.
  • Fridge maintenance
    • Performed by whom
    • Current Certificate of calibration
    • Responsibility for satellite fridges, and if applicable clearly defined acceptance criteria and returns procedure Where lab not responsible for satellite fridge, any returns policy will require justification by strict lab audit of control/ monitoring procedures and records.
    • Review the need (written report) for each satellite fridge on an annual basis

Transportation

It is expected that storage facilities will comply with the requirements of Part 4 of the Blood Safety and Quality Regulations, e.g. 2-6 oC for red cell storage. Calibration limits applied to monitoring devices should also be appropriate to meet these requirements. If alarm settings or storage specifications are outside these limits, a scientifically-based justification should be provided.

  • Cold chain goods – things to consider
    • Route and time
    • Seasonal variations
    • Nature of the load – red cells, platelets, other – how many as minimum and maximum loads?
    • Labelling
    • Clearly defined and documented instruction on procedure to be followed, with guidelines on ‘do’s and don’ts’.
  • Transport - Guidelines for the Blood Transfusion Services in the UK
    • For red cell components, transit containers, packing materials and procedures should have been validated to ensure the component surface temperature can be maintained between 2 oC and 10 oC during transportation.
    • Additionally: The validation exercise should be repeated periodically
    • As far as practicable, transit containers should be equilibrated to their storage temperature prior to filling with components
    • If melting ice is used, it should not come into direct contact with the components
    • Dead air space in packaging containers should be minimised
    • Transport time normally should not exceed 12 hours
  • Validation
    • As defined in BSQR 2005 – “validation is the establishment of documented and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled”
    • Validation is performed in advance to ensure that transport of components provides the right storage conditions
    Consider:-
  • What is the intended use
  • What are the requirements
  • How to get the objective evidence
  • Documented evidence
How to get the objective evidence (to validate proposed transit procedure for each component type):
  1. Select the appropriate container
  2. Prepare protocol for validation trial (i.e. describing plan and defining acceptance criteria) The plan should include the following points.
  3. Take number of blood components packs considered to be maximum for the box
  4. If time expired components not available, Fill empty packs with water to the nominal volume of component.
  5. “Set up” temperature logger between units
  6. Cover with packing material, including ‘wet ice’ packs where applicable.
  7. Close box and secure
  8. Store filled container/s in area/s representative of worst case transit conditions (i.e. high and low temperature challenges)and “log” area temperature
  9. Leave for maximum journey storage time
  10. Remove units and logger
  11. interrogate both loggers
  12. note period units remained between 2 oC and 6 oC core temperature
  13. Note environments temperature range
  14. If unable to obtain suitable storage time repeat using alternative container and/or packaging procedure
  15. Repeat whole procedure with minimum load (e.g.1 unit)
  16. On completion write report, including procedure, results, conclusions and recommendations
  17. Ensure report is authorised for introduction of procedure into routine, that defined procedure is available to all groups of staff involved, and that report is accessible for audit
Electronic loggers This is a programmable device and logs temperature readings that can be permanently stored on a PC or network system. It can be programmed to take readings at specified intervals and logged for a specific period, and usually can be set for automatic or manual start and stop. Loggers can be used for:
    - transport validation
    - monitoring deliveries
    - fridge/freezer mapping
    - storage at room temperature mapping
What to consider when buying a “logger”
    - write a specification
    - calibrated
    - have dedicated software
    - battery shelf life and ease of replacement
    - interface to connect to PC
    - ensure no hidden costs
    - robust and waterproof
    - ease of use

    - Performance
      - hard/soft probes
      - Temperature range
      - Accuracy
      - memory/frequency
      - Manual/programmable
      - temperature response time
      - graphical/tabular reports
Other considerations
    - CE marked
    - Clear instructions for use
    - Training provided by company
    - Delivery time
    - Proven record of reliability
    - Mechanism for problem solving