Tag: Donor Processing

Automated and manual component processing including Reveos, Mirasol, PAS

Release of COVID-19 Convalescent Plasma CCP

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Principle:

Testing, allocation, release, and transfusion of this special plasma will be similar to normal blood components except that the storage, modification, and release will handled at special quarantine location(s).  Release and modification of components is to be handled separately from the regular hospital blood bank/transfusion service.

Abbreviations:

CCP:  COVID-19 convalescent plasma

ID:  Infectious Disease Department (clinical COVID19 treatment unit)

QHBBB:  Quarantine hospital blood bank (which stores, thaws, and releases CCP)

Policy:

  1. Any potential recipient for CCP must have a CURRENT type and screen test (< 72 hours old.)
    1. A repeat type and screen should be ordered every 3 days during the time that CCP may be used.
  2. All CCP orders must be submitted to the ID senior consultant for triage.
  3. If the order is accepted by that authority, then an order and a doctor’s prescription for CCP must be both prepared and submitted to the QHBB.
  4. QHBB will allocate ABO-compatible CCP units and attached blood bank computer-generated release labels and forms to it.
  5. Designated ward staff will pick-up the CCP at the QHBB.
  6. Allow 1 hour for the plasma to be thawed.
  7. Only order when the transfusion is scheduled—1 hour before the intended transfusion date/time.
    1. Sign-out will follow normal procedures, same as other blood components.
    2. Ward staff must provide a doctor’s prescription for CCP and a fully completed request.
    3. Ward staff will directly transport the CCP to the intended transfusion site.  They should immediately transport it to the patient transfusion site.
  8. Transfusion will be performed according to standard procedures:
    1. Positively identify the patient.
    2. Use a standard 180 micron blood filter.
    3. Transfusion should be done as quickly as possible to avoid potency loss
    4. Fill out the transfusion record and return a copy to the QHBB.

Processes and Software Building 56: Multi-Site Patient and Donor Considerations

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As our hospital network expanded, there were many patients who moved between locations.  They might first start in an emergency room and then be transferred to a specialty hospital.  These locations might be served from different hospital blood banks/transfusion services.  What happens if work is progress from one site when the new site receives the patient.  Must the previous workup be repeated or could it be used for transfusion at the next site?

For example, the ABO typing could be performed at one site and the antibody screen at a second site, and the antibody identification at still another site.  Could the results be used across the entire system?

I had multiple hospital blood banks and blood donor centers.  The general and specialty laboratories had multiple sites.  The hospital information system was set up so that the various tests could only be performed at specific designated sites.  This posed problems as patients were moved around or if some site(s) became inoperative since the specimens then had to transported at great distances for testing.  Only a few basic STAT tests were available at all sites.

It was my decision to allow all test categories at all sites, e.g. a DAT request from any site, any methodology, could be used to satisfy the order.  Similarly, all donor processes were available at all donor centers (the processes could be completed at one or more sites).  Different hospital blood banks had different equipment but all the test categories were the same across site—the methodologies might differ.  We had at least four different DATs across our system.

The interface between the blood bank and hospital system worked as follows:  In the hospital information system HIS, test orders pointed to a category of testing and any methodology for that category at any site could be used in the blood bank system for testing and reporting back to the HIS.  Any test in a category from any site could be used to satisfy the test request.  Blood bank staff would choose the particular test methodology to use.  It was NOT specified by the HIS!

In summary, for blood banks and donor centers within our system, the work could be flexibly moved between sites.  There was no need to repeat testing when a patient transferred to a new site.  The only type the work was repeated if testing was done at an institution outside our system.

Biologic Product Deviations

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Principle:

Any nonconforming product that is released for patient use must be reported through the official channels.  Since there is no equivalent to the US CBER, this policy outlines the process for the HMC organization, the only provider of blood components for the State of  Qatar.

Definition:

Nonconforming Blood Component:  Any blood component not meeting the production criteria set in the policies, processes, or procedures of Transfusion Medicine.  Some examples include:

  • Low-volume RBC or FFP/FP24 units
  • Reduced yield platelet units
  • Units made with materials/supplies that have been recalled by the manufacturer
  • Units produced on equipment or tested with reagents that the manufacturer has recalled from use
  • Units contaminated during the production process

Policy:

  1. Nonconforming components must not be released unless they are reviewed and approved by the Head, Transfusion Medicine.
    1. Full written documentation of the review and the reasons for acceptance must be recorded.
    2. Such acceptance must be exceptional—there must be emergency reasons to resort to using such components.
      1. Minor nonconformances such as units with low volume or reduced platelet levels may be considered for use at times of critical shortage of blood components if they otherwise meet acceptability criteria.
  2. If anyone suspects there has been release of a nonconforming blood component, they should immediately contact the Division Head, Transfusion Medicine.
  3. The Division Head, Transfusion Medicine will conduct an immediate investigation to determine the veracity of the allegation.
  4. If the suspicion is confirmed, the Division Head, Transfusion Medicine will immediately contact the Chairperson, Pathology and Laboratory Medicine.
  5. The Chairperson in conjunction with Head, Transfusion Medicine, will inform the Medical Director and other senior administrative officials as indicated.
  6. A lookback will be initiated to determine if any patients have received the nonconforming components.
  7. The results of the lookback will be reported to the Chairperson, Pathology and Laboratory Medicine and the Medical Director.

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

Blood Supplier Quarantine

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This is the process I used at HMC Qatar.  Note that Medinfo would quarantine units directly and block their allocation, reservation, and modification for patients.

Principle:

The State of Qatar does NOT import blood components.  The sole producer and supplier is the HMC Blood Donor Center BDC.  BDC will block release of quarantined products and contact any private hospitals not using Hematos IIG that have already received said products.

Definition:

Blood component:  Specific parts derived from whole blood during the manufacturing process:  packed RBCs, platelets, plasma, cryoprecipitate, cryo-poor plasma, reconstituted whole blood

Solvent Detergent-Treated Plasma SDP:  Plasma made from large pools of ABO-identical plasma, treated by solvent-detergent-treated methods for pathogen inactivation (Octaplas purchased from Octapharma AG, Wien Österreich)

Policy:

  1. If a blood component or SDP is withdrawn from use, the affected components or SDP will be quarantined immediately in Medinfo Hematos IIG to prevent their release.
    1. This immediately blocks its release for patient use or modification at any site using Hematos IIG.
  2. If a component or SDP has already been released to an outside hospital not using Hematos IIG (i.e. prior to the formal notification of quarantine), the Blood Donor Center Supervisor or designate will contact the facility that has received the product and inform them to quarantine the product.
  3. Quarantined units should be returned to the Blood Donor Center.
  4. Documentation of the contact will be made against the component record in Hematos Medinfo IIG in the comment field.
  5. All such cases should be referred to the Division Head, Transfusion Medicine, for review.

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

External Disaster Plan, Simplified

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Principle:

Maintaining an adequate blood supply and expedited compatibility testing are critical in disaster planning.  Medinfo Hematos IIG allows us to get dynamic updates of our blood supply and dynamically reallocate blood components as needed.

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 a 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 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 the Blood Donor Center, the Head Nurse, Recruitment, Supervisor, Component Processing, and Supervisor, Marker Testing will contact staff.
    2. At hospital 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 marker testing is only at the discretion of the Division Head, Transfusion Medicine.
  7. Transfusion Services:
    1. Release blood component according to the various protocols as needed:
      1. Massive Transfusion Protocols
      2. Emergency release
      3. STAT
      4. Priority
      5. Routine
  8. 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

Irradiation of Blood Components

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Principle:

The use of irradiated components is to inactivate antigen-processing cells, which have been implicated in transfusion-associated graft versus host disease (TAGVHD).  This condition is may be fatal and has been reported in a variety of clinical settings, both in immunocompromised and immunocompetent hosts.

Since we pathogen-inactivate platelet components, we are only irradiating RBC components.  There is no need to irradiate any plasma components (e.g. FP24, thawed plasma, cryoprecipitate, or cryo-poor plasma.)

WARNING:  Do not irradiate stem cell units!!

Policy:

  1. Irradiation of packed RBCs will be given to the following patients:
    1. All candidates for stem cell transplantation SCT or patients post-SCT
    1. All severely immunosuppressed, excluding AIDS patients including:
      1. Congenital immunodeficiency states
      1. Intrauterine (i.e. fetal) transfusions
      1. Premature (less than 1500 grams or 28 weeks gestation) infant transfusions
    1. Neonatal Intensive Care Unit patients
    1. All hematopoietic tumors, including
      1. Hodgkin’s disease/lymphoma
      1. Non-Hodgkin’s lymphomas
      1. All acute leukemias
      1. Myelodysplastic states
      1. Myeloproliferative states
      1. Histiocytosis X, Langerhans histiocytosis
      1. Aplastic anemia
    1. All recipients of directed donations of any type, i.e. apheresis or components prepared from whole blood
    1. Recipients of HLA-selected platelets or platelets known to be HLA homozygous
  2. Irradiation Specification:
    1. Irradiate just prior to release if possible to minimize potassium leakage.
    1. Target 2500 cGy (rads) of gamma irradiation to the mid-plane of the canister of a free-standing irradiator is used or to the central mid-plane of the irradiation field if a radiotherapy instrument is used
  3. Using returned irradiated RBCs:
    1. If an irradiated unit is returned and otherwise meets re-release criteria, it may be used for up to 28 days after the irradiation or the normal outdate limit, whichever is less.
    1. For pediatric use (< 20 kg.), if the component was irradiated more than 24 hours previously, wash it prior to transfusion.

If you are uncertain whether to irradiate, ask the supervisor or the transfusion medicine physician.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, American Association of Blood Banks, 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

4/11/20

Donor Unit Discrepancies

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Principle:

All donor unit mislabeling is potentially life-threatening and must be stringently investigated as soon as possible after the discrepancy is detected.  Most importantly, if there is one error, there may be possibly ADDITIONAL donor unit errors (e.g. switch of donor tubes or units, etc.).  All donor units processed in the same batch must be also quarantined until the discrepancies are resolved.

The blood bank computer system will detect many errors;  however, if the donor unit or its samples are mislabeled in the beginning, these may not be detected.  Medinfo enforces checks on the final ISBT label and will compare current results to the historical record and will alert to any errors. Additionally, the use of ISBT specimen labels will obviate the risk of barcode reading errors.

Definitions:

Responsible blood bank physician:  specialist or consultant physician on-call at the time the discrepancy is detected

Policy Details:

The following steps MUST be performed as soon as possible:

  1. The Component Processing Supervisor or Senior Technologist must be IMMEDIATELY notified of any discrepancy.
  2. The Blood Bank Supervisor will inform the Division Head, Transfusion Medicine.  If the Head is not available, notify the Transfusion Medicine on-call.
  3. Quarantine ALL donor units collected and processed in the same batch.
  4. Obtain copies of all testing including photos of the gel/glass bead cards documenting the discrepancy.
  5. Obtain copies of all worksheets used in donor processing for the affected batch.
  6. Perform repeat ABO/D typing of ALL DONOR UNITS in the affected batch.  Any further discrepancies must be investigated and resolved.
  7. Identify all staff who were involved in handling the donor unit (phlebotomist, blood bank technicians processing and labelling the unit).  Identify those associated directly with the error.
  8. Submit all documents and photos to the Blood Bank Supervisor or designate.
  9. Prepare an occurrence/variance OVA report documenting all the data, findings, and interpretations.
  10. All investigations must be reviewed by the Supervisor, responsible blood bank physician, and one of the senior consultants.
  11. All such investigations must then be finally reviewed and approved by the Division Head, Transfusion Medicine or his designate.  Only when the issue(s) are completely resolved and investigation is approved may the donor unit be properly relabeled and released into available stock.  Also, only at that time may the other units in the affected batch be released into available stock!!
  12. Photograph the correctly relabeled unit and attach it to the other documentation of the incident.
  13. If the discrepancy cannot be resolved, ALL units in the affected batch must be discarded.
  14.  The implicated staff’s personnel record should be reviewed for previous errors.   Appropriate disciplinary action should be taken and documented in the personnel record.  If a verbal warning is given, it should still be documented in the written record.
  15. If there is a systemic cause for the error, appropriate measures should be taken to minimize reoccurrence.
  16. All actions must be in accordance with the institution’s policies and regulations.

2/11/20

Blood Bank Software is Dynamic, NOT Static

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I was recently talking with one of the hospital software system administrators from my previous site.  He had originally worked on building the Medinfo system, but was then reassigned to the laboratory modules of the hospital information system.

His alarming comment to me was that the Medinfo build was completed so there was no need to worry about it now—it was finished.  I guess he was looking from the perspective of the general laboratory software.  There is no need to make major changes to the build, just update interfaces and troubleshoot.

I was surprised.  He had no idea of how many times we have to update the structure for new rules and regulations, and changes in blood bank practice—let alone emerging pathogens such as ZIKA, dengue, Chikungunya, and most recently, COVID-19.

My daily morning routine was to survey several blood bank websites with changes to blood donor criteria including US FDA CBER, read the transfusion journals (Transfusion, Vox Sanguis, etc.), AABB, and ASFA.  If there were any changes pertinent to our organization, I had to make interim policies and procedures, and finally prepare specifications for changes in the Medinfo software.

The Medinfo engineers would prepare flow charts of the proposed changes and implement them in a test environment for the Super-Users to test.  I had to prepare validation protocols for the testing, and then review the validation results and finally approve the adoption of the changes.

I cannot remember even a month going by without some revision in the donor protocols.  When COVID-19 came, I had to prepare a parallel, but separate, processing and allocation/release system.

This was a never-ending story that kept the Super Users and the local Medinfo engineers busy.  I always reminded the hospital information system staff that playing with blood bank software was like playing with fire:  there is a good chance you will get burned if you do not set it up properly.

31/10/20

Minimizing Plasma Wastage

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Principle:

Plasma products (FFP, FP24, thawed plasma) are only available in limited quantities so wastage must be minimized.  Thawed plasma has full factor activity for 24 hours; after 24 hours, all factors are still present at near normal levels except factors VIII and V.  AABB Standards permit continued usage of thawed plasma stored between 1-6 Celsius as the component, “thawed plasma” for 5 days.

Thawed plasma may also be prepared directly at the time of production (i.e. without freezing) for certain cases (MTP, liver transplant protocol, plasma exchange) to shorten the release time.  It is called liquid plasma since it was never frozen but should be considered equivalent to thawed FP24 if used within 24 hours or thawed plasma if used between 24 and 120 hours.

Liquid plasma, as we use here, is prepared directly from plasma treated with Mirasol and generally used within 5 days;  however, in Medinfo HIIG, this plasma may have an outdate of 26 days in accordance with 21CFR610.53, but it is not used beyond five days except if approved by the Senior Consultant/Division Head of Transfusion Medicine.  Since it is used within 5 days, it is equivalent to thawed plasma.

Definitions:

Responsible blood bank physician: specialist or consultant physician on-call at the time the discrepancy is detected

Policy Details:

  1. Plasma is dispensed without regard to the Rh(D) of the donor.
  2. Check if thawed plasma or liquid plasma (<5 days) is available first.
  3. Do not thaw plasma until the clinical service is ready to transfuse it.
    1. Tell clinical service to contact transfusion service 2-3 hours before intended transfusion time.
    2. Exceptions: liver transplant surgery, massive transfusion protocol, therapeutic apheresis, class 1 emergency requests
  4. If thawed plasma or liquid plasma is kept in the blood bank but not  used:
    1. Reassign to another patient of compatible ABO type as thawed FFP/FFP24 if < 24 hours post-thaw or <24 hours of production if liquid plasma (see attached table).
    2. If thawed > 24 hours or liquid plasma between 24 and 120 hours post processing, reassign component as thawed plasma and use for up to 5 days.  It is preferable to use thawed plasma < 24 hours old for neonates.
  5. Thawed >120 hours post-thawing and/or liquid plasma > 120 hours post-production should be discarded.
  6. Plasma usage and wastage will be monitored and reported to the Transfusion Committee.

Note:

Thawed plasma released from transfusion service should be discarded if returned.

References:

  1. Technical Manual, Current Edition, Bethesda, MD, USA
  2. Standards for Blood Banks and Transfusion Services Current Edition, AABB, Bethesda, MD, USA
  3. 21CFR610.531(c):  Whole Blood and Blood Components Storage Temperatures and Dating Periods, Current Version

PERMISSIBLE FFP/FP24/THAWED PLASMA SUBSTITUTIONS

PATIENT BLOOD TYPEUSE THE FOLLOWING:
  
OALL BLOOD TYPES
AA or AB
BB or AB
ABAB

24/10/20

Policy: ISBT Component Label Usage

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Principle:

Blood components will only receive final ISBT labels for the purpose of transfusion upon completion of the production processes specific for that component and will be specifically prepared by the Medinfo Hematos IIG software in accordance to Council of Europe CE Standards.

An improper label, be it for the wrong unit, or improper designation can have catastrophic results to the recipient.  This is why this is such a CONTROLLED process under Medinfo Hematos IIG.  There are label-printing softwares available that do not follow these rules, but I consider them dangerous to use since these safeguards are not enforce—they are NOT permitted here.

Policy:

  1. The formatting of ISBT labels is addressed in the Interim Policy: ISBT Labels (a previous post).
  2. The selection of the ISBT E codes will be made by the Division Head, Transfusion Medicine and Laboratory Information Systems.
  3. Blood component labels, either final or in-process are ISBT-specific and may only be generated by the Hematos IIG computer system.
  4. The ISBT specimen are generated at the time of donor registration.
    1. ISBT specimen labels are of limited number and cannot be reprinted by operational staff.
      1. Reprinting is only allowed by Transfusion LIS with approval of the Division Head, Transfusion Medicine/Laboratory Information System
  5. Final ISBT blood component labels may only be attached at the successful completion of component processing according to the HIIG workflow processes specific for each component.
  6. ISBT labels are also generated and attached after component modification (washing, irradiating, aliquoting, pooling) in accordance with the respective HIIG workflow processes.
    1. Multiple modifications may be performed before the final ISBT label is generated by HIIG.
  7. No modifications of the HIIG-generated ISBT labels is permitted.
  8. No manual corrections or attachment of additional, non-ISBT labels is permitted.
  9. During computer down-times, manual (non-ISBT) labels may be generated internally and will be replaced by the formal ISBT label using Manual Stock Entry after resumption of HIIG.
  10. For solvent-detergent-treated plasma SDP (e.g. Octaplas), the following applies:
    1. SDP (Octaplus) ISBT labels are prepared and attached by the manufacturer Octapharma during the manufacturing process and will be used/read as such.
    2. Thawed SDP will receive a new ISBT label at the time of thawing.

References:

  1. HIIG Workflows, Component Processing, 1002
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  3. Policy:  ISBT Labels, Current Edition—previously posted
  4. TRM.43625 CAP Checklist

20/10/20