Tag: Donor Processing

Automated and manual component processing including Reveos, Mirasol, PAS

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

Opinion: Vendor Compatibility with ISBT Codes

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While I was  Division Head, Laboratory Information Systems LIS elsewhere, we serviced a client hospital not using Medinfo for its patient hospital blood/transfusion services.  It used the blood bank module of a hospital information system’s laboratory system.

In their service level agreement, they wanted a complete list of all the ISBT product E codes that we used.  I found this strange and told them their system must have access to the ISBT database so they should have no problem in reading our codes directly.

The same hospital system was in use for our hospital system (excluding our blood banks, which used Medinfo and had no such problems.)  I discovered that this hospital system could NOT read any ISBT codes natively for the end-users, e.g. departments outside the blood bank.  Without informing us, the nursing staff were manually entering “something” into their system.   That something could be anything:  the system would accept any series of alphanumeric characters.  They could select any type for each component (e.g. RBC for a platelet, plasma for an RBC, etc.).  They had no reliable record of transfusion!

In fact, in that hospital information system, ISBT codes could only be read in their blood bank module, which we did not use at all.  That vendor subsequently purchased another software to read the labels, but I discovered that the new “solution” software still could not directly access the ISBT database!!  They still had no functionality to read ISBT labels on the wards!!  You still had to hard-code it into their system.

Thus, we were forced to give the new client a list of our current E codes.  I warned them that we did change these codes (e.g. when we adopted platelet additive solution).  It was their responsibility to change the “hard code” into their blood bank module of that vendor.

As regards our hospital information system, we had to “hard code” the ISBT codes into the order requests so they could use that to document the transfusion.  We also had to provide the descriptor for each and every code.

To this day, I am astounded that a modern hospital system still cannot read ISBT codes natively.  Surely, they could license a copy of the ISBT database—or at least let the end-user client license it and upload it into their system.

I am skeptical of a “one-size-fits-all” comprehensive, Swiss Army Knife like software that has some limited functionalities but lacks the details needed for actually using blood components.  I wonder if the compromises made to build this system make it similarly mediocre for other functionalities outside the blood bank sphere.

I consider myself very fortunate to have elected NOT to use this patient transfusion service module and go with a full-feature blood bank system.

Conclusion:

Be careful about trusting the vendor’s promises.  Check to see how they handle the ISBT labels.

17/10/20

Policy: ISBT Specimen Labelling Audit

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Principle:

ISBT specimen labels have a check-digit to reduce the risk of misreading the label.  They are generated by the blood bank computer system Medinfo.  Normally one group of labels is printed for all needs (donor unit, marker testing, donor immunohematology, and donor processing.  Reprinting the same number is restricted to minimize the risk of using the wrong label on a specimen or unit.  These labels are NOT used for patient testing.

ISBT specimen labels are only printed at the time of donor registration.  We must securitize them so that they are not used for other, potentially malicious purposes.  Remember:  a labelling mistake may cause fatality in a patient receiving the wrong blood component.

Policy:

  1. ISBT specimen labels are only for blood donor specimens, initially labelling of donor collections, and intermediate processing of components.
  2. They must be applied to the primary specimens directly at the donor’s bedside.
  3. They must be applied to aliquots from the original ISBT-labelled tubes.
  4. They may NOT be applied to any other specimen (e.g. for routine laboratory testing outside Transfusion Medicine)
    1. If an ISBT label not corresponding to the correct donor is discovered, an OVA or event report must be generated and investigated immediately.
  5. If additional ISBT labels are needed, this must be documented on a specific audit sheet with signature of the person taking the extra labels and a second person to witness their removal.  It will also be noted in the Medinfo system for auditing purposes.
  6. The audit sheet must be kept in a secure place for future reference in Blood Donor Center.

14/10/20