Tag: Donor Processing

Automated and manual component processing including Reveos, Mirasol, PAS

Data Entry Verification: Updated Version

drzeyd

This is an update from the previous version posted to include low-titer group A FFP/FP24 and low ABO-titer group O whole blood.

Principle:

This policy outlines steps taken to minimize the risk of data entry errors and is based on a dualistic approach:  review of results by a senior technologist and/or supervisor and various computer safeguards built into the Medinfo Hematos IIG blood bank computer HIIG system.  This policy also discusses the verification (here called authorization) and purge processes of HIIG.

Policy:

  1. Review by senior technical, supervisory, or transfusion medical staff:
    1. Designated test procedures require review by a second technologist before authorization.
    2. Complex immunohematology testing and specimens showing aberrant results (e.g. ABO/D discrepancies) are reviewed by the supervisors or designates and ultimately a transfusion medicine physician before authorization.
  2. Computer system HIIG rules:
    1. Privileges:
      1. System restricts which staff can perform specific tests
    2. Patient/donor identity:
      1. System asks end-users to verify patient/donor identity before starting any access to the patient/donor record.
      2. System performs historical database checking and flags any inconsistencies (e.g. historical ABO/D typing differences, etc.)
    3. Testing:
      1. Only selected staff have privileges to authorize or purge.
      2. ABO/D testing algorithms require entry of reactions, not interpretation of results and are compared to a truth table.
        1. Aberrant results require special review before ABO/D typing results can be authorized/purged.
        2. D-controls must be negative to allow D typing results to be authorized for liquid D-typing reagents.
      3. DAT results require appropriate controls to meet truth-table criteria.
      4. Eluates require last wash to be negative before authorization
    4. Blood components:
      1. Selection of RBC or plasma units requires two independent sample determinations within 72 hours of each other.
      2. ABO-incompatible RBC or FFP/FP24 transfusions are not allowed.
      3. Titer-based ABO blood group selection:
        1. Low titer group A FFP may be used as universal plasma like group AB.
        2. Group O whole blood with low anti-A and anti-B titers may be used for all ABO types.
        3. Acceptable titer threshold is specifically defined as parameters in Medinfo.
      4. Donors with any detectable clinically significant antibodies are permanently deferred.
      5. Depending on the patient’s antibody history, release of RBC units may require antigen-matched units.  Examples:
        1. Mandatory matching (only antigen negative matched units allowed—no antigen positive or antigen-untyped units):  Antibodies against H, D, c, K, k, Kpa, Kpb, Jsa, Jsb, Jka, Jkb antigens, anti-PP1Pk
        2. Priority matching (incompatible or untested can be approved by a transfusion medicine physician):  C,E, e, Fya, Fyb, M, S, s
        3. Antigen matching not required:  Lea, Leb, N
      6. Least-incompatible crossmatch require special authorization to release
      7. Protocols to force irradiation or other modified components can be setup in HIIG.
    5. Donors:
      1. Donor tests have same criteria as the same test used in patient testing for controls, etc.
      2. Donor demographics are read directly from the Ministry of Interior database—no manual entry (bar code only used).

References:

  1. Workflows for Hematos IIG (1001 through 1005), 2013-2020
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  3. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Opinion: Understanding Each Step of the Process

drzeyd

During an AABB inspection many years ago, I observed the Lead Assessor interacting with a medical technologist at the bench.  As expected, the Assessor asked in detail about the test and where the documentation and any teaching aids were located.  Most importantly, the tech was asked to explain the procedure step-by-step and if they knew WHY each step was done and how the various outcomes affected the test.

In my opinion, the WHY is the most important issue.  In our testing and processing, we are not baking a cake.  We do not need a mindless automaton to perform the steps without knowing what they are doing.  To get it right, the technologist must understand why he/she does each and everything—and what are the consequences for not following the procedure precisely.  If the staff member knows this, he/she has respect for the process and is more likely to adhere to the proper method.

In my interactions with my staff, I want to engage them in the importance of their testing to the patient’s care.  If they know that the result may affect the care, they may become more respectful of their work since they are part of the patient care team.

I want them to understand what each of the various results will mean to the patient, i.e. how he will be handled.  I give them updates about the patient’s condition.  A caring technologist is more likely to follow the steps properly.  They understand that a deviation from the process may adversely affect the patient.

To this day, I often go to the technologists and quiz them about what they are doing, e.g. why do they add a particular reagent, why the incubation time is 15 minutes versus 60 minutes.  I encourage them to check and recheck what they are doing if they have any doubts.  Working the bench is not a quiz or examination.  If they are uncertain, I want them to seek out the information, ask questions.  In fact, I tell them there is no shame in saying, “I don’t know”—but be certain to add, “I will find out what to do.”

Blood bank can be fatal to those who guess.  Each of us must know our individual limitations and seek the necessary knowledge.  In fact, many of my assessments are open-book.  They can use any resource in the blood bank or references on-line.  This is real life:  I discourage them from relying on memory if they are understand.  Our end point is the correct action.

13/12/20

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

drzeyd

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

drzeyd

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

drzeyd

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

drzeyd

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

drzeyd

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

drzeyd

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