Tag: Donor Processing

Automated and manual component processing including Reveos, Mirasol, PAS

Processes and Software Building 9: Enforcing GMP

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Enforcing Good Manufacturing Process Through A Dedicated Blood Bank Software

Blood components are a drug and like medications must be consistently produced and follow Good Manufacturing Practices GMP.  The following system that I set up for HMC Doha Qatar blood collection and processing is an example of the impact of Medinfo donor software on enhancing our safety and GMP compliance.  In earlier posts, I provided the Medinfo flowcharts for these processes.

This is an outline of the processes I built in conjunction with the Medinfo software engineers:

  1. Registration:
    1. Read the barcode on the specified picture ID (usually a Qatar Residency/Citizen card).
      1. Retrieve the prospective donor’s demographics in English and Arabic from the Ministry of Interior.
      2. Check the donor deferral database (Qatar has only one), defer if contraindicated according to the rules built into Medinfo.
    2. Choose the type of donation (apheresis or whole blood;  volunteer, directed, or autologous).
    3. Print a consent form and ISBT specimen labels for the donation.
  2. Pre-Collection Screening:
    1. Perform the donor questionnaire on-line in English or Arabic:  this has contingent fields and could exceed 60 questions depending on the answers provided.
    2. Proceed to donor physical exam (vital signs and arm check).
  3. Collection:
    1. Collect the whole blood or apheresis component and specimen tubes:  determine if the collection meets the volume requirement and time limit.
    2. Send the specimens for donor marker and donor immunohematology testing.
    3. Send the raw components for processing.
  4. Donor Marker Testing:
    1. Perform NAT, EIA, and LIA marker testing according to algorithms defined in Medinfo.
    2. Perform follow-up reflex marker testing according to Medinfo criteria.
  5. Component Processing:
    1. Process the raw whole blood in the Reveos machine into PRBCs, leukodepleted plasma, and buffy coat platelets.
    2. Filter/leukodeplete the RBCs.
    3. If marker test results pass:
      1. Pool the buffy coat platelets according to the platelet yield index for a yield of 2.4E11/dose.
      2. Add platelet additive solution PAS and pathogen inactivate (Mirasol).
      3. Pathogen inactivate the whole-blood-derived plasma.
      4. Divide the apheresis plasma into 200-250 ml aliquots and pathogen inactivate.
    4. Divide the apheresis platelets to provide a yield of 2.4E11 in each dose, then pathogen-inactivate (PAS had been added at the time of the apheresis collection).
  6. Donor Immunohematology Testing:
    1. Perform ABO/D testing and antibody screen (identification if positive):
    2. If antibody screening positive, discard the component.
      1. If ABO discrepancy, send for manual review and approval, otherwise discard.
  7. Labelling, Storage, and Transfer:
    1. If all criteria were met, attach the final ISBT label (this can only be printed based on the acceptance of each component).
    2. Place the components into storage (37C, 1-6C, or <= minus 18C).
    3. Distribute to the hospital blood banks using Inter-Depot Transfer function.

I emphasize that only if all criteria across all areas pass is the final ISBT label printed.  Medinfo is not a label printing program.  It enforces the rules ruthlessly.  My technical staff tell me that it is merciless—as it should be for patient safety.

Attachments:  None—please refer to earlier posts regarding collection, processing, donor testing, and inter-depot transfer.

28/6/20

Processes and Software Building 8: Reveos and Mirasol

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Automated Component Processing:  Reveos and Mirasol Pathogen-Inactivation

The production instruments have more complicated interfaces than the testing equipment discussed in the previous post:

In the collection area (on-site or remote), the cvolume of the whole blood and collection time are recorded in Medinfo and based on the rules, production may only occur within specified volume and collection time.  Otherwise, Medinfo will block further processing.

The ISBT unit number of the whole blood units are read by the Reveos.  Only those units passing the collection criteria will proceed to separation.

In about 20 minutes, the Reveos machine will simultaneously process four units of whole blood into packed RBCs, leukodepleted plasma, buffy coat platelets, and residual buffy coat.  The volumes of the RBCs, plasma, and platelets are recorded in Reveos.  For the platelets, the platelet yield index is also provided.

Within Medinfo, these parameters are compared to criteria of acceptability according to the manufacturer.  Volumes for the platelets and plasma must be within certain ranges to permit pooling and pathogen inactivation and additive solution.  Medinfo will not permit these subsequent procedures if the values are out of range and the intermediate components will be discarded.

Here is a sample of Reveos acceptable ranges for component volumes:

E4207 – Whole Blood CPD 450 mL

Volume Consequences

< 400 mL Discard

400 – 500 mL OK

> 500 mL Discard

E5259 – Leukodepleted Packed Red Blood Cells

Volume Consequences

< 230 mL Discard

230 – 330 mL OK

> 330 mL Discard

E2807 – Platelets Concentrate 20-24°C

Volume Consequences

< 20 mL Discard

20 – 55 mL OK

> 55 mL Manual decision

E2555 – FP24:  Plasma Frozen <= 24h

Volume Consequences

< 170 mL Discard

170 – 360 mL OK

> 360 mL Manual decision

All these production parameters are permanently stored in Medinfo as part of the production record of that unit.  The actual location (bucket) of the whole blood unit in the Reveos is also available.

RBCs are manually leukodepleted and the final volumes recorded in Medinfo based on weight.  Based on the platelet yield index, platelets are pooled and the final volume recorded.   Those permissible volumes are next treated with platelet additive solution PAS and then pathogen inactivated.  The acceptable volumes are based on the process used, e.g. platelets in plasma versus platelets in PAS.

How a sophisticated blood bank software like Medinfo enforces good manufacturing process at all stage of production will be a future topic.

To Be Continued:

26/6/20

Manual CCP Plasmapheresis Collection

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Principle:

Due to the pandemic, we will initially MANUALLY collect an experimental, investigational-use-only plasma product from apheresis donors and treat it with Mirasol.  THIS IS A EMERGENCY INTERIM PROCESS UNTIL THE MEDINFO HEMATOS IIG PROCESSES ARE PREPARED AND VALIDATED.

Policy:

  1. Good Manufacturing Practice applies:
    1. Manufacturers’ recommended processes for equipment and materials usage applies.
    2. All staff engaged in these processes must be competency assessed successfully.
  2. Pre-Screening:
    1. Clinical staff will use the prescreening document to select donors for pre-donation screening.
  3. Quarantine:
    1. All processes (day 0, day 1, day 2, and product modification and release) will be done in quarantine areas SEPARATE and DISTINCT from regular Transfusion Medicine activities.  This includes:
      1. Separate space and equipment must be provided.
        1. Equipment for this project may NOT be used for regular, non-quarantine processes
    2. Non-Transfusion Medicine staff will not be permitted in operational areas.
    3. Prospective donors will not be permitted in the processing, testing, storage, or blood bank work areas.
  4. Donation Process:
    1. Day 0:  Registration, check donor deferral database, questionnaire, physical exam including arm check, and specimen collection using ISBT specimen labels
    2. Use latest manual donor questionnaire.
    3. Day 1:  Donor marker and immunohematology testing, review of results, accept or reject donor for actual plasmapheresis
    4. Day 2:  Collect manufacturer’s recommended volume of plasma (500 ml if < 80 kg, 600 ml if >= 80 kg), aliquot, pathogen-inactivate (Mirasol), freeze at minus 80C
  5. Testing:
    1. Testing will be performed with regular blood donor specimens using ISBT specimen labels
    2. Testing must be done by donor-specific processes (not those for clinical patients)
    3. Testing must be directly interfaced to Medinfo Hematos IIG donor module
  6. Processing:
    1. Aliquoting, pathogen-inactivation, and labelling may proceed if the pre-donation screening results are acceptable.
  7. Storage:
    1. Long-term in minus 80C quarantine freezer
    2. Short-term at 1-6 C just after thawing in quarantine refrigerator
    3. Standard temperature monitoring and alarms apply
  8. Labelling:
    1. The backup manual labelling process applies
    2. The ISBT specimen label will the donor unit number
      1. Outdate will be 6 years if the product is stored at -65C, 1 year if stored at -18C
  9. Product Release:
    1. Orders must be on the PAPER requisition (old Blood Bank Order Form) with a patient prescription:
      1. No orders in Cerner
    2. Thawing plasma at 37C upon receipt of order by Transfusion Medicine staff
    3. Signing out component to clinical unit by Transfusion Medicine Staff
  10. Information Technology:  Medinfo Hematos IIG customized software to be implemented as soon as possible for all processes
  11. Not covered:  Transfusion Medicine is NOT responsible for:
    1. Triage of request for convalescent plasma
    2. Pickup and transport of components

8/4/20

Blood Donation Process Overview

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This is a sample Medinfo overview document for the blood collection process for HMC Doha that I designed in conjunction with Medinfo France and Medinfo Doha. This includes, registration, donor consent, questionnaire, physical examination, and collection.

COVID-19 Convalescent Plasma Project, Winter 2020

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While I was still associated with HMC Doha, I developed and set up an expedited setup for COVID-19 convalescent plasma production, initially manual and then fully integrated into the Medinfo blood bank computer system.

Specifically, I built a customized version of our Medinfo blood bank system to replace the manual system and increase safety the safety and production throughput while maintaining good manufacturing practices GMP. The full system (manual first, then computerized) was implemented within two weeks including a completely separate quarantine convalescent COVID donor screening, collections, processing, and release.

Subsequent posts will detail my processes.