Policy: ISBT Component Label Usage

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

Base Medical Technologist Assessment Examination

Background:

I prepared this exam for base transfusion service technologists and candidates. For prospective new staff, I would be more lenient and use it as a projective exercise in the potential abilities. However, for staff working one year in my blood bank, I expected a higher score. Each and every problem is based on issues they would actually encounter at work–nothing esoteric.

Answer the following questions:

  1. What is the blood type in each of the following results:
Anti-AAnti-BA1 cellsB cellsType?  
  4+  0  0  3+ 
  0  4+  3+  0 
ABO Typing Problems
  1. You are signing out a unit of FFP, Group A Pos, Unit #23556 for Mohd Ahmad Ali Al Harbi, MRN# 729887 in Ward 21.  The nurse comes with the requisition to pick up the thawed unit.  The requisition says to pick up the thawed FFP for Mohd Ali Ahmad Al Harbi, MRN# 728987 in Ward 21.  Can you release the unit?  Explain.
  1. The antibody screen and crossmatch results are shown on the following IgG Coombs card (Biorad):

The reactions I-II-III are the antibody screen results.  Note the crossmatches # 91 and 98.  Which one(s) is/are compatible?

  1. The following are actual ABO/D typing results with the Diamed (Biorad) reagents.  What are the ABO/D types?
  1. The Blood Bank is severely short of AB packed cells and AB plasma.  What other blood types can you safely issue?

Request for AB packed RBCs:  Permissible substitutions are:

Request for AB plasma:  Permissible substitutions are:

  1. A specimen for crossmatching is drawn at 7:30 a.m. on 26/10/20.  When does it expire?
  1. Emergency blood, group O positive is issued for a 30 year-old male victim of a traffic accident.  You receive the specimen and complete the crossmatching.  You find the unit is incompatible.  What do you do?
  2. A patient has anti-C antibody.  How do select the appropriate type of blood to give?  Select any or all that apply:
    1. First crossmatch the requested number of units, then if compatible, release them.
    2. First crossmatch the requested number of units, then antigen type them for “C”, release only the ones that are C-negative.
    3. First screen for C-negative units, then crossmatch and release compatible units.
    4. None of the above
  3. Evaluate the attached antibody screening and panel results:

37 year old pregnant female, no previous history:

26 year old G3P3 pregnant female in labor, O-positive, no previous transfusion or antibody history:

19/10/20

Processes and Software Building 53: Donor Extended Rh and Kell Typing

For this 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.

It was standard in my donor processing laboratory that extended Rh typing (EeCc) and Kell were performed.  We were in a region with many sickle cell and thalassemia patients.  Having all RBC units pre-typed in the Blood Donor Center expedited selection and release in the hospital blood bank—especially for matching K-negative units to K-negative patients and extended Rh phenotypes for sickle cell patients.

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

The manufacturer’s recommendations for the particular reagents in use were strictly followed.  Most importantly, Medinfo can be configured for any set of reagent values.

Please refer to the sample flowchart which also includes Cw and DVI+ typing.  The same process could apply to patient testing, but some reagents would use a DVI- reagent.

18/10/20

Opinion: Vendor Compatibility with ISBT Codes

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

Processes and Software Building 52: Donor Antibody Screening

For donor antibody screening, 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.

I did not use pooled cells, but instead 2, 3, or 4 cell screens at various times based on the available reagents.  Personally, I prefer a 3 or 4 cell screen which is more sensitive—I want homozygous Jka and Jkb cells present.  All positive cases had an antibody identification performed.  According to my medical decision, I did not routinely allow any donor to be collected if he/she had a positive antibody screen.  Some standards would permit the use of RBCs from such a case, but this was not my preference.  In cases with rare phenotypes, I would allow production of RBCs (e.g. Bombay donor with anti-H, patient with anti-Tja (PP1Pk)) for patients with those rare types.

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 antibody screening 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.  Controls were included.  Most importantly, Medinfo can be configured for any set of reagent values.

Also note that Medinfo will check for the donor’s previous testing history and compare results.  If there are discrepancies, this will require manual review.  Normally, a donor with a positive antibody history is indefinitely deferred.  The transfusion medicine physician could remove such a deferral if indicated.

Refer to the following flow diagram for a three-cell  and four-cell screens.

16/10/20

Massive Transfusion Protocols

This is a sample massive transfusion protocol originally prepared at HMC Doha with my input and Division Head, Transfusion Medicine. I have updated it to include use of fibrinogen concentrate and the option to use fresh whole blood (group O, < 14 day old in SAGM, low ABO titer IgM < 1:256).

The volumes for blood components is based on our automated production system Reveos with the RBCs in SAGM, platelets in Mirasol and additive solution, and plasma in Mirasol.

Policy: ISBT Specimen Labelling Audit

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

ISBT Labels

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

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

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