Category: Donor

Includes registration, questionnaire, physical exam and arm check, collection, marker testing, component separation, donor immunohematology testing

ISBT Labels

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Principle:

ISBT labels are ONLY GENERATED THROUGH MEDINFO HEMATOS IIG SOFTWARE.  We do not buy preprinted labels or have a separate label-generating program.  ISBT labels are only attached to blood components after production of new or modification of existing blood components and are only printed if the Good Manufacturing Process GMP criteria are met and confirmed by the software.

The ISBT component label measures 10 x 10 cm and is divided into FOUR quadrants:

  1. Upper left:  Donor Unit number:  20201 (site location) then two digits for the year (e.g. 13) followed by the donor encounter number followed by a check digit.  Reference is made to the Circular of Information, patient identification, risk of disease transmission, and prescription-only status.
  2. Upper right:  ABO/D type
  3. Lower left:  E code corresponding to the component type specification, the designation of origin (volunteer vs directed vs autologous vs paid donation) plus the division number.  E codes are taken from the ISBT master database.  We use CE-approved codes (NOT US FDA).
  4. Lower right:  Expiration date and time using 24 hour system plus any other phenotype data and other testing.

ISBT Specimen Labels:

ISBT specimen labels are used for all samples at the time of donor collection and include a separate check digit to confirm that the barcode is properly read.  ISBT specimens can be used in all parts of Medinfo Hematos IIG software;  however, non-Medinfo systems not complying with the safety features of the Council of Europe (worst case scenario is Cerner Millennium and all other American software) may not be able to read them.

Since we do not preprint ISBT labels, there are no phase-out of labels, they are only printed immediately upon need.  As component production changes frequently, the actual ISBT designation from the ISBT database for the new component is used by Medinfo.

Policy:

  1. All blood components and solvent-detergent treated plasma SDP must be labelled with ISBT labels.
  2. All donor specimen labels must meet the ISBT standard, including the check-digit.
  3. No blood components may be dispensed to patients unless there is an ISBT label corresponding to the final component, including ALL modifications (aliquoting, irradiation, washed, pathogen-inactivated, etc.)
  4. No one should write anything on an ISBT label:  If there has been a change in the component, perform the modification through Medinfo HIIG and reprint the label.
  5. Do NOT attach any other labels to an ISBT label.
  6. Ensure that the final ISBT label at the time of dispensing is on-top of all other ISBT labels.
  7. The ISBT sequences will be reset each year at 2359 hours on 31 December by the Medinfo software engineer.
  8. The choice of E codes is made by the Division Head, Transfusion Medicine/LIS using the ISBT master database.

References:

  1. Guide to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement on Blood Transfusion, CD-P-PS, Current Edition
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  3. TRM.43600 and 43625 CAP Checklist, 2016

Opinion: Advantages of Using Both the Medinfo Donor and Patient Modules

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The donor module of Medinfo includes recruitment, logistics, registration, donor screening, collection, marker testing, donor immunohematology, and component production.  There is also a module for inter-depot transfer of blood units from the donor center to the hospital end-users.

The patient module includes patient testing (ABO/D typing, antibody screen, antibody identification), direct antiglobulin test, elution, component modification (washing, aliquoting, pooling), allocation/reservation of blood components for a patient, release of blood components, and their return.

Some sites elect to use their laboratory system’s blood bank module in conjunction with Medinfo donor module.  In this case, they receive each and every unit into their laboratory blood bank module and do all patient activities in it.  There is no link between patient and donor module.  They will have to monitor and transfer inventories in their laboratory system.

At a site using integrating both the donor and patient modules of Medinfo, they will be able to track units across the system to any hospital blood bank.  They will have access to the rules-based system to generate algorithms for use of blood components based on user-defined criteria.  They can instantly perform look back of donor units associated with adverse effects, and be able to rapidly quarantine components subject to recall from the manufacturer or product incidents.  Here are some examples of this functionality:

Example 1:  The hematologists want all their patients to receive leukodepleted irradiated RBCs and platelets at a site not using pathogen-inactivation.  Medinfo can prepare an algorithm by site, clinical diagnosis, or other criteria which will block release of those components that are not irradiated and leukodepleted.  Blood Bank staff will not be able to release anything else.  The donor module can prepare customized component or modification can take place in the hospital blood bank.

Example 2:  During production, it is discovered that units prepared in one of the centrifuges (or automated component equipment Reveos) became contaminated with a foreign substance.  In Medinfo.  In Medinfo, all units prepared during the affected time interval can be immediately quarantined across the system including all hospital blood banks and thus prevent their being transfused.

Example 3:  A patient has developed hepatitis C after transfusion.  Using the transfusion history, one can retrieve data on all transfused units.  The entire production process can be reviewed for each unit, including donor marker testing.  If a unit is implicated, then all patients receiving other components from that donor can be immediately identified for follow-up.

If a disaster occurs, one can quickly check Medinfo’s cumulative stock display of all components at all sites—donor unit and all hospital blood banks.  One can initiate transfer of units from unaffected sites to the disaster location.  This can be updated as frequently as needed—within seconds!

There are probably ways to accomplish this by using the laboratory information system, but it will be slower and require separate communication to the Medinfo donor site.  There will be no seamless integration and delay.

In summary, there are many advantages to using both donor and patient Medinfo modules.  Even at sites where there was separate transfusion service functionality, I elected to use both modules together for seamless integration.  It would be very time-consuming to manually check between the laboratory and Medinfo donor module.  Medinfo’s patient module offers has strong safeguards to prevent release of untested or partially tested units (example:  release of Kell-untested RBCs to a patient with anti-Kell) and a very robust electronic (computer) crossmatch.

11/10/20

Donor Prion Disease Precautions

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Principle:

Prion diseases, including variant Creutzfeld-Jakob disease (mad cow disease), can be efficiently transmitted by transfusion of blood components.  Since there is a variable, often long (measured in months to years) incubation time before the disease is manifest, it is important to note individuals at high-risk and exclude them from the donor pool.

This is the August 2020 revision of the previous CBER recommendation on this topic.

Policy:

The following categories of individuals are permanently prohibited from donation (whole blood, apheresis, or organ):

  1. Anyone who received human growth hormone derived from human pituitary glands
  2. Anyone who received dura mater grafts
  3. Anyone from families with a history of Creutzfeld-Jakob Disease or other prion diseases (including variant Creutzfeld-Jakob—Mad Cow Disease, Gerstmann-Straussler-Scheinker Syndrome, Fatal Familial Insomnia, Kuru)
  4. Anyone with a family history of dementia or any other chronic neurologic illnesses
  5. Anyone with first-degree relatives (parent, sibling, children) who have a prion disease
  6. Anyone who has used (injected) bovine insulin of UK origin since 1980
  7. Defer indefinitely a donor who has spent five years or more cumulatively in France or Ireland from 1980 to 2001.
  8. Anyone having resided in the United Kingdom or visited there for a total of at least three months between 1980-96
  9. Anyone who received a blood component transfusion in the United Kingdom, France, or Ireland since 1980.

Definitions:

  1. For the purposes of this policy, the United Kingdom UK is defined as any one of the following areas:  England, Northern Ireland, Scotland, Wales, Isle of Man, Gibraltar, Channel Islands, or the Falkland Islands.
  2. France refers only to mainland France and NOT to French overseas departments, e.g. Martinique, French Guiana, Guadeloupe, Mayotte, and Réunion

All donors (except autologous) must be asked questions to rule out any of the above possibilities.

References:

  1. Recommendations to Reduce the Possible Risk of Transmission of Creutzfeld-Jakob Disease and Variant Creutzfeld-Jakob Disease by Blood and Blood Components, Guidance for Industry, US Department for Health and Human Services. FDA, Center for Biologics Evaluation and Research CBER, August, 2020
  2. Association Bulletin #02-2, American Association of Blood Banks, Bethesda, Maryland, USA, 8/3/02
  3. FDA Guidance for Industry:  Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeld-Jakob and Variant Creutzfeld-Jakob Disease by Blood and Blood Products, FDA Guidance for Industry, 9/1/2002
  4. Belay E.D. and Schonberger L.B., The Public Health Impact of Prion Diseases, Annu. Rev. Public Health 2005. 26:191–212, Division of Viral and Rickettsial Diseases, Centers for Disease Control and Prevention, Atlanta Georgia,
  5. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  6. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Processes and Software Building 51: Donor D Typing

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For donor D typing, I always had both automated and manual methods set up on the blood bank computer system Medinfo Hematos IIG.  The automated method had a bidirectional interface between Medinfo and the instrument.   Medinfo did not need a separate middleware.  A truth table was prepared for acceptable results for automatic interpretation.  Other results had to be manually interpreted by someone with the appropriate security level.

For donors, I wanted reagents sensitive for partial or mosaic D types since any D epitopes are potentially immunogenic.  With some reagents, this meant using a DVI+ reagent and others both DVI+ and DVI- reagents.

The manual testing option is structured similarly.  Within Medinfo, it is easy to change the methodology if the system is so built.  Thus, if the analyzer for D typing is down, the staff can select the manual methodology.  Likewise, if one testing center goes off-line, the world can be completed at another site—no need to repeat testing already completed from the first site.  This flexibility can apply to any test in system.

The manufacturer’s recommendations for the particular reagents in use were strictly followed.  One used the range {0, 1, 2, 3, 4, Mixed Field, Weak} as acceptable.  Another used {0, 2, 3, 4}.  Controls were included.  Most importantly, Medinfo can be configured for any set of reagent values.

The attached flows show two different testing systems as examples of what can be built in the Medinfo system.

9/10/20

Processes and Software Building 50: Donor ABO Confirmatory Typing

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For donor ABO confirmatory typing, I always had both automated and manual methods set up on the blood bank computer system Medinfo Hematos IIG.  The automated method had a bidirectional interface between Medinfo and the instrument.   Medinfo did not need a separate middleware.  A truth table was prepared for acceptable results for automatic interpretation.  Other results had to be manually interpreted by someone with the appropriate security level.

The manual testing option is structured similarly.  Within Medinfo, it is easy to change the methodology if the system is so built.  Thus, if the analyzer for ABO typing is down, the staff can select the manual methodology.  Likewise, if one testing center goes off-line, the world can be completed at another site—no need to repeat testing already completed from the first site.  This flexibility can apply to any test in system.

The manufacturer’s recommendations for the particular reagents in use were strictly followed.  One used the range {0, 1, 2, 3, 4} as acceptable.  Another used {0, 2, 3, 4}.  Controls were included.  Most importantly, Medinfo can be configured for any set of reagent values.  Refer to the following flow diagram.

Confirmatory testing also includes D typing.  That will be considered in a future post.

6/10/20

Processes and Software Building 49: Donor Automated ABO Typing

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For donor ABO typing, I always had both automated and manual methods set up on the blood bank computer system Medinfo Hematos IIG.  The automated method had a bidirectional interface between Medinfo and the instrument.   Medinfo did not need a separate middleware.  A truth table was prepared for acceptable results for automatic interpretation.  Other results had to be manually interpreted by someone with the appropriate security level.

The manufacturer’s recommendations for the particular reagents in use were strictly followed.  One used the range {0, 1, 2, 3, 4} as acceptable.  Another used {0, 2, 3, 4}.  Controls were included.  Refer to the following flow diagram.

Most importantly, Medinfo could be configured for any set of reagent values.

2/10/20

Processes and Software Building 48: Donor Immunohematology Testing

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Donor immunohematology testing of components in progress is similar to patient immunohematology testing.  The tests include:

ABO forward and reverse testing

D typing by multiple monoclonal cocktails

ABO/D confirmatory testing

Antibody screening

Antibody identification

Truth tables are prepared for each test type with interpretations.  Results falling outside these ranges will require manual review and manual interpretation by a user with an appropriate level of privilege (usually senior technologist, supervisor, or transfusion physician.)

Unlike patient D typing, we want to detect partial or variant D types as D-positive since theoretically even a few epitopes of D present may be immunogenic to the patient.  In patient D typing, we can call partial D types as D-negative and use D-negative RBCs.  We don’t want to use partial D RBCs for D-negative women of child-bearing age!

This series will show several different test algorithms including both manual and automated methods.  The criteria for acceptability of the reactions are based on the manufacturers’ recommendations. 

Reflex ordering of antibody identification will occur if the antibody screen is non-negative.

28/9/20

Donor Center Materials and Equipment Strategy

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This is the policy I developed for HMC Doha Blood Donor Center:

Policy:

  1. This policy applies to all blood donor processing (including reagents, materials, equipment) in the Blood Donor Center.
    1. Immunohematology testing and donor infectious disease marker testing are not included.
  2. Equipment and reagents must be selected to meet/exceed productions standards set by the Council of Europe, International AABB, HMC policies and procedures, and Qatari law.
  3. Each equipment must have a fully functioning, reliable, bidirectional interface to Medinfo Hematos IIG and be fully interfaced
    1. Vendor is responsible to pay for the interface licensing for each piece of equipment.
  4. Materials/reagents/equipment must cover the following functionalities:
    1. Automated separation of whole blood and apheresis components into:
      1. Packed RBCs in additive solution
      2. Buffy coat derived platelet pools
      3. Apheresis-derived platelets, plasma, and/or RBCs
      4. Fresh frozen and FP24 plasma
    2. Pathogen inactivation of whole blood, platelets, plasma, RBCs
    3. Cryoprecipitate
    4. Cryo-poor plasma
    5. Frozen RBCs (high-glycerol method)
    6. Washed RBCs
    7. Thawed plasma
    8. Irradiated RBCs
    9. Reconstituted whole blood (PRBCs and thawed plasma)
    10. Leukodepletion of ALL components to current and future CE standards
  5. Equipment must have/meet:
    1. CE mark or equivalent (FDA, CSA, etc.)
    2. Sufficient throughput for the workload in the area assigned
    3. Scalability:  A path of upgrading to larger capacity/throughput equipment using the same reagent line of the vendor
    4. A minimum of two of each equipment type must be obtained to minimize disruption of blood supply.
  6. Vendors:
    1. Vendors must offer 24/7 service on critical equipment for donor blood component and patient compatibility testing
    2. Vendors who do not meet qualification standards must not be used.

References:

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

Re-Entry of Donors with History of Hepatitis On/After Age 11

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Principle:

Until this guidance, everyone with hepatitis at age ≥ 11 has been permanently deferred, regardless of the type of hepatitis.  Except for confirmed cases of HCV at any age, donors with other causes may be reassessed to determine if they may be re-entered into the donor pool.  I have also included assessing levels of anti-HBs as per my previous policy at HMC Doha.

Policy:

  1. All donors with a history of HBV (confirmed HBsAg and/or HBV-NAT positive) or HCV, regardless of the age it occurred, continue to be permanently/indefinitely deferred.
  2. Donors with anti-HBc with negative HBsAg and/or HBV-NAT may be further assessed by performing anti-HBs titering.
    1. If the level of anti-HBs >= 100 IU/L (mIU/ml), then the donor may be reentered.
    1. If the donor’s antibody titer < 100 IU/L, he may be offered HBV vaccination:
      1. If the post-vaccination HBV titer >= 100 IU/L, then he may be reentered.
      1. If the donor does not receive HBV vaccination, he remains deferred.
  3. Donors with a history of HAV, CMV, or Epstein-Barr hepatitis may be reentered into the donor pool without further testing.
  4. If the donor is uncertain what type of hepatitis he had, then perform:
    1. HBV testing (HBsAg, HBcAb, HBsAb, HBV DNA NAT)
    1. HCV testing (HCV Ab, HCV LIA, HCV RNA NAT
    1. Liver enzyme testing (ALT, AST)
  5. If there is evidence of current or past HBV and/or HCV, then the donor is still permanently deferred
  6. If there is evidence of ALT or AST elevation, the donor remains indefinitely deferred.

References:

Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday, FDA-2017-D-5152–Requalification for History of Hepatitis Guidance-Final, US FDA/CBER, September 2017