Category: Transfusion Medicine

Includes patient, donor, apheresis and related IT topics

Automation and Synergism: Joint Use of Reveos and Mirasol

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This is the virtual talk I gave at the Russian Transfusion Congress in Moscow on 13 May. It gives a brief description of automated component processing and riboflavin-based pathogen inactivation and then discusses the use of these technologies together to free up labor and enhance the quality of products, i.e. improved GMP, especially if a dedicated blood bank computer system is used to enforce production rules.

Policy Donor Medical Questionnaire

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Policy Donor Medical Questionnaire

5.2 POLICY:  DONOR MEDICAL QUESTIONNAIRE

Policy:

  1. All policies, processes, and procedures must comply with local, national, and applicable accreditation standards (i.e. AABB, CAP, and JCI).
  2. All donors will be positively identified with a picture ID and by their Medinfo Hematos software identifiers (donor ID and session registration/specimen number).
  3. Donors will be assessed confidentially in a private area.
  4. Donors will be asked questions based on the latest Uniform Donor Questionnaire with additional localization questions for Qatar.
  5. Donor must understand either English or Arabic.
    1. Otherwise, they cannot be accepted for donation.
  6. Donors passing the donor questionnaire will be processed for the donor physical examination.

References:

  1. HMC 1001 Setting Specifications, Version 1.5, Hematos IIG, Medinfo, Nice France
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Blood Components in Emergencies

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This is an updated version of a lecture I gave to medical students at National Guard Health Affairs in Riyadh. I have included new blood component types such as universal low-titer group O whole blood, universal low-titer group A plasma, and refrigerated platelets.

Processes and Software Building 4: Super Users

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Super-Users:  Engaging Laboratory Staff in Computer Operations

This is an update of a previous post.

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
    1. Apheresis/Donor Nurse for donor questionnaire, donor physical examination, and donor collection
    1. Medical technologist for donor marker testing
    1. Medical technologists for blood component production including Reveos, Mirasol, platelet additive solution, pooling, and leukodepletion
    1. Medical technologist for donor immunohematology testing
    1. 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.

The following document is a sample document of the assigned Super User duties during a validation.

Donor Registration Process

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5.1.1 PROCESS:  Donor Registration

Process:

  1. Donor presents acceptable picture ID with a unique alphanumeric identifier.
  2. Donors without Qatari ID must be approved by the Coordinator, Donor Recruitment, a donor center physician, or Head, Transfusion Medicine.
  3. Donor ID is scanned into Hematos IIG.
  4. Donor is assigned Hematos IIG Donor ID if not already in the system.
    1. Donors with previous ID will be given a Hematos ID
    1. All donors are registered only using the Hematos ID
  5. Medinfo Hematos IIG software checks donor deferral database
  6. Donor is accepted for medical questionnaire only if he has no contraindications.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Donor Registration Policy

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Number:  5.1

Policy:

  1. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, ISO, and JCI).
  2. All prospective donors must show an approved identity document with picture (e.g., Qatari ID, other GCC ID, passport) that confirms their identity with a unique alphanumeric identifier.
  3. All positively identified candidates will be assigned a Hematos donor ID if they do not already have one.
  4. All donors with the previous old donor ID will be assigned a Hematos donor ID.  All future donations will be done using the Hematos ID.
  5. All positively identified candidates must be checked in the donor deferral database.
    1. Only those without contraindications may be accepted for further processing.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Donor Recruitment and Campaigns Process

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5.0.1 PROCESS:  Donor Recruitment and Campaigns

Process:

  1. Company or organization contacts Coordinator, Donor Recruitment to schedule donation OR:
  2. Coordinator, Donor Recruitment contacts companies or organizations to schedule donations.
  3. The Coordinator, Donor Affairs, is responsible for all recruitment activities:
    1. Serves as initial contact point for organizations and companies desiring to have a donor campaign.
    2. Schedules donor campaigns in advance, arranges for emergency collections as needed.
    3. Assigns donor recruitment staff to visit and inspect prospective donation sites.
    4. Arranges logistics of resources for donor campaigns (personnel, equipment, vehicles, supplies)
    5. Coordinates with HMC Public Relations and the media
    6. Prepares news media to encourage donation
  4. All contacts and schedules are entered into Hematos IIG.
  5. Donor recruitment materials are left at donation site to encourage donation and provide means for donors to schedule their donations during the campaign.
  6. Donor recruitment staff prepare the donation site at time of donation.
  7. Donation processes are conducted in accordance to policies, processes, and procedures for registration, donor questionnaire, physical examination, and collection.
  8. Hematos IIG is accessed by either wireless connection (VPN) or off-line data dump to check donor against donor deferral database.
  9. Blood is stored at suitable temperatures at collection site and in transit back to Donor Center.
  10. Campaign blood components and specimens are received in Donor Center and transferred for further processing and testing.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Donor Recruitment and Campaigns Policy

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5.0 Donor Recruitment and Campaigns Policy

Policy:

  1. All policies, processes, and procedures must comply with local, national, and applicable international accreditation standards (i.e. AABB, CAP, ISO, and JCI).
  2. All recruitment information must be entered into Hematos IIG.
  3. The Coordinator, Donor Affairs, is responsible for all recruitment activities.
  4. Donor recruitment staff will visit scheduled donation sites in advance and assess their suitability and prepare them for use before the start of each campaign.
  5. Donor recruitment materials and announcements will be left at each location during the inspection visit.
  6. Collected blood will be stored at room temperature during the collection on-site and transported back to the Donor Center in suitable validated containers to maintain storage at desirable temperature.
  7. The processes and procedures for normal donation, e.g. registration, donor questionnaire, physical examination, and collection apply.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Daratumumab (Anti-CD38) Interference with Compatibility Testing

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This is a revised version of a previous post.

Principle:

Daratumumab is a monoclonal antibody that binds to CD38 antigen, which is expressed weakly on the surface of all RBCs.  It may thus cause a positive direct antiglobulin test DAT and so interfere with compatibility testing if an antiglobulin phase is required.

This effect may persist up to 6 months after discontinuing the drug.  The monoclonal antibody does not interfere with routine ABO/D typing.

Special techniques (neutralization of CD38 antibodies by CD38 anti-idiotypic antibodies, or soluble CD38 antigen) may remove the panreactivity but may not be generally available.  DTT, a sulfhydryl reagent may denature the native CD38 antigen on RBCs but it should be used under a biologic hood.

Kell antigens will be denatured so Kell antibodies cannot be detected after treatment so Kell-negative RBCs should be used.  In the Gulf Area, this is about 72% of RBCs.

Policy:

  1. The clinical services must inform Transfusion Medicine of patients who will be receiving daratumumab therapy BEFORE treatment is started.
  2. Transfusion Medicine staff will enter a general comment (i.e. not associated with a particular result) in the patients Medinfo HIIG record:  PATIENT ON DARATUMUMAB.
  3. If not already done, Transfusion Medicine staff will perform an extended antigen typing:  at least C, c, E, e, K, k, Kpa, Jka, Jkb, Fya, Fyb ,M, N, S, s, Lea, Leb, P1—even if no antibodies are currently identified.
  4. Transfusion Medicine staff will send each such patient’s record to a Transfusion Medicine Physician to determine the blood type including extended antigens to match for future transfusions.
  5. When compatibility testing is requested, perform it as per our SOPs.
  6. If available, prepare DTT-treated cells for testing but realize that this will denature Kell antigens.  Use K-nell RBCs.
  7. Release least “incompatible” RBCs must be approved by the Transfusion Medicine Physician.
  8. When the DAT becomes negative (i.e. up to SIX months after cessation of Daratumumab therapy), routine compatibility testing and RBC selection will apply.

References:

Trick or Treatment, Anti-CD38 Reactivity and How to Treat It, AABB Satellite Symposium transcript, U. Cincinnati and RedMedEd, October, 2015 (attachment)