Category: Transfusion Medicine

Includes patient, donor, apheresis and related IT topics

Electronic (Computer) Crossmatch

drzeyd

This is a revised version of a previous post.

As much as 90% of the RBC component allocation can be performed without an actual crossmatch test (AHG or immediate-spin) provided that certain criteria are met.

Enforcing these rules, however, can be cumbersome unless one has blood bank software that verifies that each rule is met.  In the Medinfo patient module, the transfusion history database is checked automatically.  If the rules are met, then Medinfo allows the selection (allocation) of RBC units without performing a crossmatch test.  Otherwise, it will check to see if the AHG crossmatch has been done within the past 3 days.  If not, it will prompt for new crossmatch testing with a new specimen.  If the situation is urgent, one can go to Emergency Mode and release components without the crossmatch.

Principle:

In selected patient categories, no classical crossmatch may be required for release of RBC components.  The criteria are specified here as applicable in my build of the Medinfo Hematos IIG computer system HIIG.

Policy:

  1. An electronic crossmatch without antiglobulin or immediate-spin phase testing may be used for the following patient categories:
    1. The current ABO/D type matches the historical ABO/D type.
    2. The ABO/D type (forward and reverse) is clearly defined without any discrepancies.
    3. Two determination of the ABO/D group must be made:
      1. One from a current specimen (within the past 72 hours)
      2. The second by one of the following methods:
        1. Testing a second current specimen
        2. Comparison with previous records of ABO/D typing
        3. Retesting the same specimen
    4. The current antibody screen is negative
    5. There is no history of RBC antibodies or a non-negative antibody screen.
  2. If the criteria in #1 are not met, the AHG crossmatch is required in non-emergency situations.
  3. General computer system safeguards:
    1. The system contains the donor unit number, component name, confirmed ABO/D typing, two unique recipient identifiers, recipient ABO/D, antibody screen typing, and interpretation of compatibility
    2. A method exists to verify correct entry of data before release of blood or blood components.
    3. The system contains logic to alert the user to discrepancies between donor ABO/D group on the unit label and those determined by blood confirmatory tests and to ABO incompatibility between the recipient and donor unit.
  4. HIIG will enforce the above rules.

References:

  1. HIIG Workflow 1004, Patient Testing, Latest Version
  2. Section 5.16, Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  3. FDA Guidance for Industry:  Computer Crossmatch (Computer Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type), April, 2011

My Opinion: Separate Transfusion Medicine from the Laboratory and Clinical Departments

drzeyd

This is an update of a previous post.

Transfusion Medicine includes laboratory and non-laboratory functions.  The non-laboratory and purely clinical functions are unique and have no analogy within the general laboratory.  Likewise, from a clinical department perspective, transfusion medicine is not just a clinical service, but also a laboratory and a drug manufacturing center.

The transfusion service/hospital blood bank laboratory is the closest to a laboratory operation, but there is also component modification and complex manual testing, especially for reference immunohematology testing.  The staff must make detailed manual decisions, the errors for which could be life-threatening for the patient.

The blood donor center manufactures a pharmaceutical, i.e. blood components with collection, donor qualification, donor abnormal results review, infectious disease marker testing, component production, and donor immunohematology testing—all subject to Good Manufacturing Practices.  Never forget:  Blood is a drug!!  There is no other part of the clinical services or laboratory that manufactures drugs.

Transfusion Medicine is directly responsible for treatment of critically ill patients.  Therapeutic apheresis is essential for organ and stem-cell transplants, nephrology, neurology, etc.  No other laboratory section is directly responsible for treatment of critically ill patients.  Transfusion Medicine physicians are functioning as intensivists.  There is no hiding in the blood bank from clinical medicine.

It may also be an industrial manufacturing plant to extract various blood derivatives (e.g. factor concentrates, albumin, Rh immune globulin, etc.)  This is pharmaceutical manufacturing on a large-scale basis.  There is medical, technical, and special administrative expertise.

Many functions may operate 24/7. 

The unique blend of clinical skills is unlike anything else in the laboratory.  Thus, those outside the blood bank may not be familiar enough to decide the best course of action for transfusion medicine or for its operations.

The transfusion medicine physician must make acute, life-threatening decisions unlike anyone else in the laboratory 24/7 at all times.  The transfusion medicine physician may be on-call for donor issues and review of complex immunohematology problems to acutely decide which blood component (and phenotype) should be given as well as review all adverse reactions to transfusion.  The blood bank technologist is at the cutting edge of the battle with his testing and interpretations.  No other area of the laboratory is at such risk for injuring or even killing the patient.  There is high stress and burn-out.

I have talked with many blood bankers and many seem to share the exasperation that the laboratory or clinical departments do not understand or appreciate us.  Often, the laboratory looks at blood bank testing like that coming off a hematology or chemistry analyzer—although patients rarely would have severe morbidity or mortality like the blood bank from errors in those analyzers.

No laboratory pathologist has the pressure of the blood bank physician on-call.  It really is 24/7 and requires a broad, clinical background to make the right decisions.  It is very stressful and does not permit a good night’s sleep.

Thus, I make my case to separate us from the laboratory.  We can form our own more effective administrative organization and optimize our own planning.  Regretfully, I have never experienced or worked in such an administrative structure.  I also am a realist that cost-containment nowadays makes it much less likely high administration would permit this change.  This will probably never happen during my career.

Finally, Transfusion Medicine is an essential service.  Blood components are essential drugs.  The operations and staff must be free of political influences.  This is a service for the entire region or country like the fire department, civil defense, etc.  You are playing with fire when you disturb the blood bank.

DAT and Selection of RBC Units for Transfusion

drzeyd

This is an update of a previous post.

Principle:

In 1984 effective with the 13th Edition AABB Standards, the requirements for performing a direct antiglobulin test and autocontrol for compatibility testing were eliminated.  The DAT is very important to detect delayed hemolytic transfusion reactions, certain autoimmune conditions, and drug-related hemolysis.

Since that time, the immediate-spin crossmatch and now the electronic computer paperless crossmatch may be used for most compatibility testing in place of the classic, antiglobulin-phase (indirect antiglobulin test) crossmatch.

If an antiglobulin phase (IAT) crossmatch is performed, an RBC unit with a positive DAT will cause a false-positive reaction.  Since most crossmatching does not include the IAT, it will not be affected by the DAT status of a donor unit.

Policy:

  1. Donor RBC units will NOT be routinely tested for DAT as part of component processing.
  2. The type of compatibility testing selected for a particular patient should be the technically simplest one (no need to do extra work unless so instructed by the transfusion medicine consultant/designate):
  3. Do a full antiglobulin-phase IAT crossmatch if ANY of the following applies:
    1. There are no two independent ABO/D typings on the patient during the current admission.
    2. The ABO/D type of the current admission does not match the historical information.
    3. The patient has a detectable antibody at 37C
    4. The patient has a history of a clinically significant antibody but no current antibody
    5. Whenever the consultant, transfusion medicine/designate requests it.
    6. Whenever the Medinfo HIIG record so indicates (in comment section)
  4. Do the immediate-spin crossmatch if ALL of the following apply:
    1. Only one determination of the ABO/D type
    2. The historical ABO/D type agrees with the current type.
    3. There are no antibodies reacting at 37C AND there is no history of antibodies at 37C.
  5. Use the computer/electronic crossmatch if ALL of the following apply:
    1. There are two determinations of the ABO/D type and they both agree with each other.
    2. The historical ABO/D type agrees with the current type.
    3. There are no antibodies reacting at 37C AND there is no history of antibodies at 37C.
  6. When to do a DAT on a donor unit:
    1. Patient antibody screen is negative but the full AHG crossmatch is incompatible.
    2. Part of a transfusion reaction workup where the AHG crossmatch of donor cells and patient serum is incompatible.
    3. Whenever the consultant, transfusion medicine/designate requests it.
  7. If a donor unit is found with a positive DAT:
    1. Required testing and review:
    2. Test with polyspecific and monospecific IgG and C3d antisera
    3. Perform an acid-elution.
    4. Send the results to the transfusion medicine consultant/designate for review.
    5. The reviewer will enter his review in HIIG in the Donor Consultation Section both as global donor comment and a result-specific comment against the antibody screen result.
    6. Use of the DAT-positive donor unit:
      1. Most of the time you will not know if the donor RBC unit is DAT-positive since we mainly use the electronic crossmatch.  It will be used if all criteria are met.
      2. Otherwise, select another RBC unit for the AHG crossmatch.
      3. The final decision to use the DAT-positive unit will be made by the Transfusion Medicine consultant/designate.

Important:  Don’t do a classic AHG/IAT phase crossmatch unless you have to do it  (see conditions above.)  A donor unit with a DAT is unlikely to be clinically significant and may be transfused safely to the patient in most situations.  Patients receiving electronic-crossmatch and immediate-spin crossmatch are receiving units with positive DAT without incident.

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
  3. Technical Manual, Current Edition, AABB, Bethesda, MD, USA, 2012

Knowing Your Technical Staff

drzeyd

As a transfusion medicine physician, I was always being called to make decisions at all times when I was on-call.  This could be for qualifying donors, therapeutic apheresis, or most commonly to analyze complex immunohematology situations and transfusion reactions.

I had to make decisions on data that was presented to me by my staff on the phone.  I had to rely on the technical staff performing the test.  If I made a decision on their findings and their findings were incorrect, I was still responsible for the error as head of the department.

Nowadays with a blood bank computer system, I could remotely access the data as it appeared in the computer.  Still, how could I be sure that it was correct?

Based on my many years of experience, I have learned that I needed to know the capabilities of each staff member and to what extent I could rely on their results.  Not everyone could do complex cases.

I also listened to how they presented the data to me.  If it was disorganized or if they sounded uncertain, that was a red flag that something was wrong and I should be very careful about using the results.  In such cases, I told the staff member to call a senior person to repeat the work.  Of course, I did this in a delicate, face-savings way not to hurt the staff’s feeling.  I usually told them to collect a new specimen and have a second senior person to repeat the workup.

I also had to know the context of the workload at the time of the consultation.  Were there shortages of staff, were the staff stressed out, was there too much work for them to properly perform?  In those situations, I would authorize additional staff to come in and repeat the work.  I was very worried when outside hospital staff used to scream at my staff (usually junior doctors) and upset them.  In the emotional distress, they could make a dangerous mistake.  One of my roles was to serve as a counselor and de-stress my staff.

In summary, if you do not feel your staff can handle the work properly, don’t rely on the output.  Repeat the work, defuse the stress, fix the workload, etc.  As the transfusion medicine physician, it is also your neck on the line.  You are responsible to determine if you can trust the results to make a medical judgment.

Plasma Project Considerations for Middle East

drzeyd

This is an update of a previous post.

I have been involved with planning for several plasma fractionation projects in the Middle East.

Many clients expressed the interest in using local plasma to make plasma derivatives (e.g. factor concentrates, intravenous gamma globulin, albumin), feeling that local plasma was safer than using imported plasma.  Some of these are in short supply in the world market so the only way to ensure their uninterrupted availability is to consider to manufacture them for local consumption.

Still, the major issue today is that it is difficult for any country in the region to collect enough plasma to make such a project feasible.  When I first considered such planning, we were looking for as much as 250,000 raw liters of plasma annually.  Since then, there are newer technologies that allow much smaller batches to be cost-effective.  Alternatively, one could charge higher prices for using smaller batches from local plasma.

Still, it is likely that plasma must be imported to sustain a plant.  There are different regulations for plasma donor qualification country-to-country.  Many of these jurisdictions may do less screening and testing than is done for normal blood and apheresis donors.  Other countries use their blood donors with the same requirement for both commercial plasma and blood donations.

In this era of emerging infectious diseases, I personally favor using the stringent blood donor criteria—same as routine collections.  It is not what we know, but the unknown pathogens that are potentially the most dangerous.

In addition to building a fractionation plant, one must train staff for this highly technical operation.  This may require developing a special curriculum to prepare students for these jobs.

To export the plasma to certain regions, one may have to use plasma quarantine.  In this protocol, plasma is held or quarantined until the next donation is collected and passes screening.  This requires a robust blood bank production software such as Medinfo to track serial donations.

There are other processes to consider:  how to develop a transport network to keep plasma frozen at minus 80C viable in a region that reaches very high ambient temperatures.

I would recommend a graded approach to develop such an industry.  First I would negotiate a plasma self-sufficiency arrangement.  We would collect local plasma in the country and export it to a manufacturing plant in another country and the derivatives would be returned to us.  This may require inspection by the accreditation agency of the processing country to allow importation of the raw plasma for manufacture.

Since it is unlikely any one country has enough plasma for manufacture, recruiting neighboring countries to participate in a manufacturing plant is important.  Technology for such a plant is complex so establishing a joint venture with one of the plasma industry companies is essential.  Some manufacturers are very keen to develop extra capacity since there is a world-wide shortage of plasma fractionation and are even willing to help obtain external plasma sources for such a plant.

Such a plant is an excellent way to develop local talent to run such a plant, including training of local staff to be the industrial engineers in the plasma fractionation process.  It would take approximately two years of training to prepare engineers on-site at a plasma fractionation site if they have studied the necessary science and mathematics subjects.

Such a program would take several years of planning and development.  Some of the major steps needed include:

  1. Acquiring software for a blood center with plasma brokering capabilities.
  2. Passing accreditations such as international AABB and CE for transfusion medicine to allow export of our plasma to the external manufacturing site in the initial plasma self-sufficiency phase
  3. Identifying extended sources of plasma to feed a manufacturing plant.
  4. Preparing a curriculum suitable for training as staff for the plant.
  5. Establishing a joint venture to share technology with a major plasma company to design, build, and operate a plasma fractionation plant.

User Acceptance Testing

drzeyd

When a new software version was introduced in my system, first the vendor did a preliminary round of testing before submitting it to my Medinfo-Laboratory Information System team for validation.  I then prepared a training session for the Super Users and assigned them validation tasks.  When the validation was completed and accepted by me, then the software was submitted to the Hospital Information System HIS department, which conducted its own final acceptance training.  Following this, transfusion medicine staff were trained before the new software went live.

This is a sample user acceptance training document, which was prepared by Medinfo and myself and submitted to HIS for the upgrade from Version 3.8 to 5.0.  The patient module is shown.

The Medinfo Super Users performed the script while the HIS Quality Team viewed the actual output.  Notice for each Action step there is the Expected Result.

The evaluation for each step was recorded as part of this long and wide spreadsheet:

Evaluation of a Positive Direct Antiglobulin Test

drzeyd

This presentation is from my time at National Guard Health Affairs Riyadh and suggests an algorithm to assess the clinical significance of the reaction. In my opinion, the essence of immunohematology testing is the antiglobulin test so I would spend much time with technical and medical staff, including trainees/fellows (even those not based in transfusion medicine) to make certain they understood how to interpret it.

If it is a neonate and the mother is ABO-incompatible, always test against reagent A1 and B cells.

Super-Users: Engaging Laboratory Staff in Computer Operations

drzeyd

It is critical to engage the technical, medical , and (blood bank) nursing staff in this process,  That is why it is so important to identify a core of computer-literate users to help with the building and testing/validation.

I don’t mean finding staff who can already program or code.  Rather, I mean staff that are astute with knowing their work processes and who had good skills with Microsoft Office and Windows or equivalent.  I did not expect them to understand database structure or use structured query language.  They were chosen for their ability to learn quickly and their meticulousness.

For our blood bank system, I chose computer-literate technical staff to be involved in the build from the very beginning.  They learned how to test each module and to some degree support it.  These became my Super-Users and to this day support the system for many tasks.  These staff served as the system administrators and worked directly with me as the Division Head for Laboratory Information Systems.  They were not full-time and still had their other clinical/technical duties.  They liaised with the software vendors engineers.

Our blood bank system was NOT a turnkey system.  It was custom designed according to our workflows.  There were NO default settings!!  We had to be remember, ‘Be careful what you ask for, you might get it!’  In some countries, approved systems are turnkey and may allow only few changes to the core structure and thus may not be this optimized for the needed workflow;  often only cosmetic changes are permitted.

When we built our first dedicated blood bank computer system, the company would take a module and completely map out the current processes collaboratively with me.  After this, I analyzed the critical control points and started to map out the improved computer processes that would take over.  After that we would build that those processes in the software and test it.  If it failed, we would correct it and test again…and again if necessary.  Fortunately, the blood bank vendor did not charge us when we made mistakes.

Sadly, another vendor (non-blood bank), only gave limited opportunities to make settings.  If wrong, there might be additional charges to make corrections.  This other vendor really pushed the client to accept the default settings regardless whether or not they actually fit.  End-users were selected to make and approve the settings, but they were only minimally trained on how to make the settings.  It was a journey of the end-users being led to the slaughter—and being blamed for their settings when they accepted the vendor’s recommendations—they usually selected the defaults.  There wasn’t enough time for trial and error and correction.

The blood bank system Super Users were an important part of our process.  They were an integral part of the implement team and could propose workflows, changes, etc.—subject to my approval.  They learned the system from the start and developed invaluable skills that allowed them to support the system after the build.  Also, they could serve to validate the system according to the protocols I prepared.  Moreover, I took responsibilities for their activities and they were not left out to hang.

Every hospital blood bank location and the blood donor center had Super-Users.  These included:

  1. Blood Donor Center:
    1. Administrative Clerk for donor registration, consent, ISBT specimen labels, creation of new donors and patients for validation purposes
    2. Apheresis/Donor Nurse for donor questionnaire, donor physical examination, and donor collection
    3. Medical technologist for donor marker testing
    4. Medical technologists for blood component production including Reveos, Mirasol, platelet additive solution, pooling, and leukodepletion
    5. Medical technologist for donor immunohematology testing
    6. Medical technologist for inter-depot transfer of blood components
  2. Hospital Blood Banks and Transfusion Centers:
    1. At least one technologist at each site for inter-depot transfer, component medication (washing, irradiating, aliquoting, reconstituted whole blood), immunohematology testing, component allocation and release

The cost of using these staff?  They were paid overtime and were relieved of other duties when working on Super User duties.  This was much cheaper than hiring outside consultants who may or may not know our system well enough to perform these tasks.

By having a Super User at each site, I in effect had an immediate local contact person for troubleshooting problems who could work with the technical/nursing staff.  We did not rely on the corporate IT department for support and worked directly with the software vendor.  Response time was excellent this way.