Tag: Donor Processing

Automated and manual component processing including Reveos, Mirasol, PAS

Process: Interdepot Transfer

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Enumeration:  5.9.1

Process:

  1. All transfers of blood components will be done through the dedicated blood bank computer system Medinfo Hematos IIG.
  2. Ensure that the final ISBT label is attached.
  3. Each unit must have a final ISBT label attached.
  4. Prepare a consignment list for the units to be transferred.
  5. Transfer the units in temperature controlled and monitored, validated containers.
  6. Upon receipt at the destination, check the temperature log or liquid crystal sticker to confirm the unit(s) have been maintained at the proper temperature.
  7. Upon receipt at the destination, repeat the ABO forward and D type of the transferred RBC units and the reverse type of the plasma units.
  8. Subsequent transfers between hospital blood banks do not require repeat ABO/D typings.
  9. Inspect each unit for leaks and physical appearance (e.g. clots, leaks, discoloration).
  10. Enter the new stock into the local hospital’s inventory.
  11. Use the specific transfer algorithms programmed into the Medinfo Hematos IIG software.
  12. All variances will be reviewed by the supervisor and a transfusion medicine physician.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Policy: Interdepot Transfer

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Enumeration:  5.9

Policy:

  1. All transfers of blood components will be done through the dedicated blood bank computer system Medinfo Hematos IIG.
  2. Only units passing all donation criteria including testing and processing will be eligible for transfer.
  3. Each unit must have a final ISBT label attached.
  4. Quarantined units will be discarded through Medinfo at the blood processing site.
  5. Units will be transferred in temperature controlled and monitored, validated containers.
  6. Upon receipt, the ABO forward and D type of the transferred RBC units will be repeated at the first hospital blood bank.
  7. Subsequent transfers between hospital blood banks do not require repeat ABO/D typings.
  8. Each unit will be inspected for leaks and physical appearance (e.g. clots, leaks, discoloration).
  9. Only units whose temperature monitoring passes criteria for transit shall be used.
  10. The specific transfer algorithms will be programmed into the Hematos IIG software.
  11. All variances will be reviewed by the supervisor and a transfusion medicine physician.
  12. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, and JCI).

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Policy: Component Processing

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Enumeration:  5.8

Policy:

  1. All processing will be in accordance with good manufacturing practices.
  2. All testing will follow manufacturer’s recommended testing methods.
  3. The specific processing algorithms will be programmed into the Hematos IIG software.
  4. Validation of the processing will be performed by Hematos IIG, which will control final ISBT labelling
  5. All abnormal results will be reviewed by a transfusion medicine physician.
  6. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, and JCI).

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Process: Donor Marker Testing

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5.7.1 PROCESS:  Donor Marker Testing

Process:

  1. Specimens will be received from the collection areas.
  2. Specimens will be processed (e.g. centrifuging, aliquoting if required) by marker testing personnel.
  3. The mandated tests will be performed on the designated equipment by marker testing personnel.
  4. The results will be sent by computer interface into Hematos IIG whenever possible.
  5. Appropriate reflex and other algorithm-mandated testing will be performed.
  6. Abnormal results will be reviewed by a transfusion medicine physician.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Opinion: Selecting a Pathogen Inactivation System

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Transfusion-transmitted infectious disease are a continuing threat.  Despite donor infectious marker testing and new donor questioning, there are many threats which are not addressed by these measures.  Also new pathogens are being identified for which there are no tests or specific donor questions available.  How can we handle these new threats?

Pathogen inactivation can significantly reduce infectious agents in blood components, although the degree varies depends on the agent.  Theoretically any agent with nucleic acid—RNA or DNA is affected.  The only class of agents not affected at all are prions, which have NO nucleic acid at all.

In general, a photoactive agent is added to the blood component which binds to the nucleic acid.  Photoactive agents include riboflavin, psoralen dyes, and methylene blue.  Then the component is irradiated, the time proportional to the volume of the unit.

The component is then exposed to ultraviolet light to photoactivate it, which disrupts the DNA and RNA present, including in the white cells.  Thus, NO irradiation or bacterial culture is required.

Here are my questions to consider when selecting a pathogen inactivation system:

Targets?  Platelets vs plasma vs whole blood?

Methylene may be used for plasma, but riboflavin or psoralens may be used for platelets or plasma.  Whole blood inactivation with riboflavin is CE-approved.

Photoactive dye:  Is it riboflavin vs psoralen vs methylene based?

Riboflavin is vitamin B2—the amount used is small and does not need to be removed whereas the psoralen must be removed for clinical use.

Does the photoactive material need to be removed before transfusion?

You can immediately use the riboflavin-treated component but the psoralen must be removed before transfusion—this may take 6 or 20 hours depending on the licensing of the product.

What is the loss of platelets or coagulation factors after treatment?

With treatment by all methods, there is some loss of platelets and coagulation factors.  The platelet loss may be greater in psoralen-based methods and require additional components be added to the pool to reach the desired dose.  Likewise, plateletpheresis components treated with psoralen may require a recalibration of the donor apheresis equipment to collect more platelets per dose to compensate.  There may be some RBC loss additionally in whole blood pathogen inactivation.

What is the efficacy of pathogen reduction for the infectious agents, particularly the ones in your region?

Example:  How well does the treatment handle local agents like Hepatitis E?  Psoralen agents may be less effective than riboflavin for this agent.

Does it work with platelet additive solution PAS?

There are minimum and maximum volumes for pathogen inactivation set by the manufacturer.  Can you get sufficient yields within these volumes?

How good is the data management system?  Can it be integrated with your blood bank computer system?

Can the equipment be integrated with your system?  This is important to set rules and enforce good manufacturing processes GMP.

Does it work well with an automated blood component production system?

Such automated systems like the Reveos can free up personnel for pathogen inactivation.  Can the volumes produced be handled effectively by the pathogen-inactivation method?  Do the timings for separation of components work synergistically with the pathogen inactivation method?

Vendor issues:  how well will the local agent provide support?  Is someone else in your country or region using the system?

You need an experienced vendor to provide optimal support.

Allocation Rules for Platelets and Plasma

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Medinfo Hematos IIG software is rules-based so the institution may set its own custom rules for all processes.  One chooses a framework and then adds any additional rules it needs for optimization.  Turnkey systems do not offer this flexibility.

The rules for platelet and plasma components are much simpler than those for RBCs since usually we only consider ABO type.  There are two modes:  regular and emergency, the latter applying if not all the patient testing (including historical checking) is available.  The components, on the other hand, must meet all criteria before being considered for patient use.

Please note that any donor with antibodies is automatically excluded from plasma and platelet production based on our donor testing criteria.

Example rules for plasma follow:

For platelets, note that for adults and anyone else >= 20 kg, I gave any type of platelet pool or plateletpheresis component without regard to ABO matching.  With our production method, I did not give Rh immunoprophylaxis to females of child-bearing age receiving platelets from D-positive donors based on our clean (essentially RBC-free) Reveos automated production process.

For platelets, there were also different allocation rules for regular and emergency mode:

Similarly, allocation rules for granulocytes, etc. can be made and enforced by the software.  Low-B-titer group A universal plasma would also be easy to implement.