Tag: Processes and Software Building

Detailed discussion of Medinfo processes for all blood bank donor and patient services

Processes and Software Building 46: Reconstituted Whole Blood

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Exchange transfusions using reconstituted whole blood were much more common in the past.  Much of the time IVIG now takes care of hemolytic disease of the fetus/newborn HDFN.

In Medinfo, we took a fresh (<= 14 day old) packed RBC in SAGM, group O, Rh-compatible and mixed it with a unit of group AB plasma—the desired hematocrit could be achieved by adjusting the amount thawed plasma that we added.  The product could then be aliquoted and irradiated.  Note that I medically chose to use either FP24 or FFP.

Here is the Medinfo process:

19/9/20

Processes and Software Building 45: Modifying RBC Components

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Components may be modified either in the Blood Donor Center or in the hospital blood bank.  In either case, they use the PRODUCTION section of Medinfo to perform these operations.

These operations may include:

  • Irradiation
  • Tight-packing (removal of the supernatant, especially for intrauterine or neonatal transfusions)
  • Washing
  • Aliquoting (division of the primary RBC bag and possibly further division of one of the secondary bags)
  • Final labelling of the modified component

The weight of the component is converted to the volume by the software.

The end-user can specify which modified components were available.  As with any ISBT-labelled products, any changes will trigger a new ISBT E code and label.

16/9/20

Processes and Software Building 44: Pooling Components

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Medinfo Hematos IIG has a pooling operation that can be used for pooling platelets, plasma, cryoprecipitate, etc.  It is a one-step operation.  In the set-up, one specifies the maximum number of components to pool together for each component type.  In general, they are of the same ABO type;  however, at HMC Doha I did allow mixed ABO platelet pools to avoid wastage of platelets that would otherwise be discarded—this may not be allowed in all jurisdictions.

The following examples show pooling of FFP, FP24, cryoprecipitate, and cryo-poor plasma:

13/9/20

Processes and Software Building 43: Manual Whole Blood Processing

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This was the HMC methodology for manual whole blood processing to prepare packed RBCs, plasma, cryoprecipitate, and cryo-poor plasma using blood bank centrifuges (not Reveos).  It did not include preparing platelets since we did not have manual buffy coat processing equipment.  In this algorithm we did not specifically release whole blood as a final product (although we did have the capability of activating this in emergency situations).

10/9/20

External Disaster Plan

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Principle:

Maintaining an adequate blood supply and expedited compatibility testing are critical in disaster planning.  This plan is assuming that the Blood Donor Center is functional and can process donors and make components.

Medinfo Hematos IIG System is critical to monitoring inventory, preparing blood components expeditiously using Good Manufacturing Processes, and distributing blood components in a timely controlled manner.

Policy:

  1. Determinate total available blood supply across all locations by using the Cumulative Stock Display program in Medinfo Hematos IIG.
    1. Recheck stock at least every hour during the disaster.
  2. At each transfusion service site, in conjunction with the Transfusion Medicine Consultant:
    1. Cancel reservations for elective surgical and non-emergency medical cases of affected ABO/D types.
    2. Retain reservations for antigen-matched, oncology, NICU, and high-risk obstetrical cases.
  3. Inform Manager for Donor Recruitment/Logistics to send SMS, radio, and television messages for blood donors—all types.
  4. Contact ALL staff and have them report to duty.
    1. At Blood Donor Center, the Head Nurse, Recruitment Manager, Supervisor, Component Processing, and Supervisor, Marker Testing will contact their respective staff.
    2. At various hospital blood bank transfusion services, the site supervisor will contact all staff.
  5. Process blood components using automated component technology (Reveos).
  6. Perform all donor marker testing including single-well NAT.
    1. Abbreviation of donor testing is only at the discretion of the Head, Transfusion Medicine.
  7. Send blood components using Inter-Depot Transfer function of Medinfo.
  8. Transfusion Services:
    1. Release blood component according to the various protocols as needed:
      1. Massive transfusion protocol
      2. Emergency release
      3. STAT
      4. Priority
      5. Routine
  9. Compatibility testing will be electronic, immediate-spin, or full AHG as per our protocols.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Revised 10/9/20

Processes and Software Building 42: Platelet Pooling

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Outside the USA, platelet pools stored at room temperature may be valid for up to 7 days, especially if pathogen-inactivation is used.  The following workflow shows both Mirasol pathogen-inactivated and standard platelets.  The standard platelets are then irradiated.  Both types can be aliquoted.

A major advantage in using a specific blood bank computer software is to enforce the Good Manufacturing Process.  Medinfo is merciless:  there are no exceptions without authorization and that is restricted by the security policies.

In the recent Reveos post, the upper and lower platelet volume specifications were discussed.  The platelets are weighed and the volume is calculated.  If a manual or another method for preparing platelets is used, then the according values can be specified.

To Be Continued:  8/9/20

Processes and Software Building 41: Off-Line Medinfo Donor Transactions

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Principle:

Normally, outside donor campaigns still connect to the main server via wireless 4G/5G with a VPN.  However, if there is a “dead” spot, Medinfo can provide a local area network using one of the PCs/laptops to serve as a server.  The local server receives an uploaded image of the donor database.  Upon return to the donor center, the local server’s data is uploaded and synchronized.

When you cannot establish a direct link to the live Medinfo program, you must arrange for Medinfo/VHT to create a local server that will have the current Medinfo donor database for use at outside campaigns where the internet connection cannot be used.  This can also be used if for some reason the Blood Donor Center link is down in order to register donors and check the donor deferral database.

Policy:

  1. For each outside campaign, there should be a pre-campaign visit to verify the availability of internet to connect to Medinfo.
    1. If the internet connection is working, use Medinfo using the 4G/5G access points.  Otherwise:
    2. If none, inform Medinfo/VHT to prepare a local server—at least ONE DAY in advance of the campaign.
      1. Provide Medinfo/VHT one of the portable computers to download the database and software.  This will be the offline server for the campaign.
      2. Link the offline server to the other portable computers for the campaign (see the corresponding Medinfo job aid).
      3. Use the local network (offline server and other portable computers) for registering donors.
      4. Upon return to the Blood Donor Center, upload the data as indicated in the Medinfo job aid.
      5. Continue the regular processes after uploading.

7/9/20

Processes and Software Building 40: Reveos Detailed Settings

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A major advantage in using a specific blood bank computer software is to enforce the Good Manufacturing Processes.  Medinfo is merciless:  there are no exceptions without authorization and that is restricted by the security policies.

The following tables show the values established at HMC Doha during my tenure.  These values were recommended by the Terumo BCT Reveos engineer after his direct, hands-on set-up of the equipment.

The minimum and maximum volumes for platelets are specifically designed to work for pooling the buffy coats before Mirasol pathogen inactivation.  There are different settings for platelets suspended in plasma versus those suspended in platelet additive solution PAS.

Similarly, there are specific volume ranges for plasma so that pathogen inactivation can be performed according to Terumo BCT recommendations.

To Be Continued:  4/9/20

Processing and Software Building 39: Atreus and Reveos

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Automated component processing is an almost hands-free separation of into packed RBCs (ready for leukodepletion), buffy coat platelets (ready for pooling), leukodepleted plasma, and a residual buffy coat.  The older Atreus device takes about 10 minutes for one whole blood unit whereas the newer Reveos device needs slightly more than 20 minutes to process four whole blood units.  At the end of processing:

  1. RBCs are ready for leukodepletion using the integral filter provided with the kit.
  2. Plasma is ready for pathogen-inactivation and freezing.
  3. Buffy coat platelets are ready for pooling using the Platelet Yield Index PYI.
    1. Further processing (filtration and Mirasol treatment) occurs if the donor marker testing results pass
  4. Residual buffy coat is not a clinical product but may be used for quality control for stem cell processing and/or cell line expansion

The process in Medinfo is as follows:

  1. Receive the whole blood units for processing by reading the ISBT specimen barcode.
  2. Collection data (volume, time to complete collection, time of collection, etc.) is transferred to the component processor.
  3. Select the processing machine:  Atreus vs. Reveos
  4. Select the protocol:  2C (RBCs and plasma) versus 3C (RBCs, platelets, and plasma)
  5. Further processing as per the flow diagrams.

At HMC Doha, Medinfo developed the first bidirectional interfaces to both Reveos and Atreus.

To Be Continued

2/9/20

Processes and Software Building 38: Component Processing Overview

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As with each major area of Transfusion Medicine, a current state is captured.  From this, a future state overview is then developed.

At this time, the client should study his current state and the future state and see how he can bolster the critical control points and build them into the processes.

In this series of posts, we will consider:

  1. Component production by Reveos automated component processing
  2. Component production by Atreus automated component processing—replaced by Reveos
  3. Manual component processing
  4. RBC leukodepletion
  5. Platelet pooling
  6. Mirasol pathogen inactivation for platelets and plasma
  7. Platelet production with platelet additive solution PAS
  8. Cryoprecipitate and cryo-poor plasma production
  9. Labelling

The example of current and future state shown is what Medinfo and I built for HMC Doha:

To Be Continued

1/9/20