Donor, patient, interdepot transfer, interfaces
I designed a completely quarantined process for collection, processing, and release of CCP at HMC Doha. This document shows the Medinfo process for site registration as a separate donor center code.
CCP could only be collected at this special site and only the apheresis bag could be used for collection. Regular donation options were not available at this CCP site nor was CCP collection an option at the regular donation sites.
4/1/21
When I first moved overseas from the United States, I brought the perspective of my American training and experience. I saw everything in my new blood bank through those eyes.
Yet, most of my staff were not American or even North American. Few were even native in English, and most of those were not American. They had different qualifications, many of which would not have been accepted by the American schemes. Still, they functioned well.
I also worked with the US military technologist staff during Gulf War One. Some did not even have a Bachelor’s degree; yet, they performed the work well.
I used many technologies that were not yet (or never) US FDA approved such as gel or glass bead typings and pooled buffy coat platelet production. There were rare reagents I could buy off the shelf (e.g. anti-Tja/PP1Pk).
Later, I adopted pathogen-reduction technology (Mirasol), automated component production (Atreus then Reveos), and platelet additive solution. I achieve a level of good manufacturing practice that would have been difficult to achieve by the FDA-approved methods.
My perspective had changed. In the Middle East, I studied many frameworks and came to the conclusion that the best approach was to customize them to our local needs. My particular experience was to start with one framework, i.e. Council of Europe CE, and then localize it.
To do this, I could not use an American turnkey blood bank software for either the donor or patient operations. I needed a flexible system that could be customized to my needs. Again, I chose a CE-marked system, Medinfo Hematos IIG that had already been adapted to many frameworks.
It is much easier to work solely within one system such as FDA. However, if I had done that, I would have lost so much flexibility and not had a system optimized for local conditions. I would not have used Mirasol, Reveos, Diamed, and many other reagents.
One big disappointment at such international meetings is the perspective by one country’s regulatory agency that they feel its regulations and framework will work well overseas. I would wager that those people were not well acquainted with international conditions.
Another frustration was attending another international meeting in which the presenters apologized for the source of information since it came from a foreign country (France) and not their own (United States).
No country has a monopoly on what is best for everyone. To share our experiences and compare is so valuable. No one assume his way is the best. In my career, I have had the richest experiences studying other perspectives and my organizations have benefited greatly from the exchange. We can all learn from each other. We are citizens of the world.
It now has been over eight 8 months since I prepared the CCP workflow in Medinfo. It was built on the framework of the manual CCP process including donor prescreening with an abbreviated donor questionnaire. It was really quite simple and used the donor and patient modules to create quarantine areas for donor screening, collection, processing, and hospital patient blood bank release.
Here are my current comments on the process:
Donor Qualification:
I would still exclude malaria and HTLV from the donor questionnaire and would update to UDQ 2.1. Since these donors have recovered from a potentially life-threatening illness, I would keep the Hgb threshold at 11 g/dl.
Donor Collection:
In the future, I would consider using one of the soon-to-be-released portable devices that continuously monitor vital signs with pO2 and EKG lead to rule out asymptomatic pulmonary or cardiac problems.
I would also consider using low-ABO-titer, group A, universally to meet the demand for group B and AB patients.
Donor Testing:
There is still no need to segregate and separately test CCP donor specimens from regular blood donor specimens. I would perform SARS-CoV-2 antibody testing and set a threshold for qualifying donors—that threshold will be based on the manufacturer’s recommendations. However, if the treating physician wanted to use a low-titer unit, I would permit this.
Donor Processing:
There is no need to change this from the current processes. Keep the CCP processing separate from the regular operations.
CCP Plasma Release:
I would keep the quarantine release and restrict it to the locations used for treating COVID-19 patients
Medinfo Software Modifications:
I would record the IgG and IgM titers for SARS-CoV-2 antibodies in each donation record. This would include testing and entering the results on donations prior to this testing. ISBT labels should include this antibody titer.
Hospital Information Software Modifications:
Set up restricted CCP ordering for the actual treating physicians only. Also provide the ISBT code and shortened descriptors to it if necessary (certain HIS vendors still cannot read ISBT codes natively).
The original CCP workflow is attached for reference.
This process was originally done in the first phase of CCP collection. I have updated it to include SARS-CoV-2 antibody testing.
Principle:
Due to the pandemic, we will initially MANUALLY collect an experimental, investigational-use-only plasma product from apheresis donors and treat it with Mirasol. THIS IS A EMERGENCY INTERIM PROCESS UNTIL THE MEDINFO HEMATOS IIG PROCESSES ARE PREPARED AND VALIDATED.
Policy:
References:
All blood components are considered medications and are subject to Good Manufacturing Practices as mandated by international accreditation standards. The whole process must be done reproducibly and precisely by specific personnel trained and documented to be competent. This includes collection of convalescent COVID-19 plasma.
Transfusion Medicine will provide staff who are deemed competent for the entire process of the collection, manufacture, and release of this unlicensed, emergency-contingency component.
It will help greatly if all candidates are prescreened to exclude the following candidates:
This is NOT a complete list of criteria. Transfusion Medicine personnel will screen according to the full donor criteria. Thus, donors passing the pre-screening may still be otherwise disqualified based on the detailed process.
I will be posting a detailed series about the manual and software-enhanced COVID-19 processes that I set up in Qatar at HMC Doha in March-April 2020.
In this series I will provide you with screen shots of my Medinfo Hematos IIG software design for each step in the process: collection, processing, testing, inter-depot transfer, and hospital transfusion service/blood bank release.
This GMP-compliant software-enhanced system is based on the manual system I set up in early March 2020 at HMC.
I want to thank Medinfo Hematos IIG for their rapid response to building this parallel system based on my standard processes in so short a time (two weeks) and my special thanks to the software engineering team at Vital Health Technologies, the agent for Medinfo in Qatar.
To start the series, I am providing the basic workflow for the system. As is normal in Medinfo software design, a full mapping of the processes are made. This workflow shows the new CCP ISBT codes and the quarantine collection and processing steps. The donor testing (marker and immunohematology) processes are similar to those for regular donor units.
This is basically the same process both manually and in the software. I always say:
A good software process is based on a good manual process!!
Please note the following workflow for our initial discussion.
This form is the result of a collaborative effort between my therapeutic apheresis team and me. I want to thank Dr. Saloua Al Hmissi, Consultant, Transfusion Medicine, and Ms. Mini Paul, Head Apheresis Nurse for all their efforts.
This form can be readily converted into a computer data entry form–depending on your software’s capabilities.
Principle:
Donor lymphocytes in an organ transplant may make antibodies and cause a clinically significant hemolytic anemia, i.e. a graft vs. host hemolytic anemia GVHHA. Optimal handling in these cases should include antibody screening/identification for all potential donors and recipients. The transfusion medicine physician should review the results for possible issues of antibody/antigen incompatibilities to proactively select matched blood components and avoid GVHHA.
In the Medinfo blood bank computer system, we can make custom rules to ensure release of only antigen-matched units as needed.
Policy:
Example: Donor has anti-Kell (K1) and patient is K1-positive. Use only K1-negative RBCs post-transplant.
References:
Principle:
We must select D-negative RBC units for transfusion if the patient is truly D-negative or if he/she is a partial D since transfusion of a partial D positive unit may induce antibodies against any part of the D molecule. Thus, for patients, we will consider patients with partial D as D-negative. Note that this is NOT the usual practice in the USA; however, AABB Standards do allow that we do NOT test patients for weak D and give D-negative RBCs instead.
Background:
Ortho Diagnostics Reagents use two different monoclonal antibody cocktails that react variably with the antigen D (Rh1)—these are found on the card: Anti-A/B/A,B/D/D/Ctrl:
Anti-D/Anti-RH1—IgM monoclonal antibody clone D7B8 can detect most examples of weak and partial D including weak D types 1, 2, 3, 4.0, and D categories II, III, IV, V, VII, DBT, and R0Har. It does NOT detect category VI. Retest positive reactions of 2+ or less by an alternate method.
Anti-D/Anti-RH1—IgM monoclonal antibody RUM1 can detect most examples of weak and partial D including weak D types 1, 2, 3, 4.0, and D categories II, III, IV, V, VII, DBT, and R0Har. It does NOT detect category VI. Retest positive reactions of 2+ or less by an alternate method.
Policy:
| Pattern # | Anti-D/D7B8 | Anti-D RUM1 | D-Interpretation |
| 1 | Positive | Positive | D-positive |
| 2 | Positive | Negative | Do additional testing |
| 3 | Negative | Positive | Do additional testing |
| 4 | Negative | Negative | D-negative |
If the reaction is 2+ or less with either the Ortho anti-D/D7B8 reagent or anti-D/RUM1 or if the patterns 2 or 3 above, repeat by another manufacturer’s reagents. In the meantime, consider the patient as D-negative.
Medinfo-Ortho interface settings for Patient Testing:
| Anti-D/D7B8 | Anti-D RUM1 | D-Interpretation |
| 3, 4 | 3, 4 | D-positive |
| 3, 4 | 0 | ~ |
| 0 | 3, 4 | ~ |
| 0 | 0 | D-negative |
| ~ | ~ | ~ |
Note all of the following:
References:
Principle:
When you cannot establish a direct link to the live Medinfo program, you must arrange for the local Medinfo engineers to create a local server that will have the current Medinfo donor database for use at outside campaigns where the internet connection cannot be used. This can also be used if for some reason the Blood Donor Center link is down in order to register donors and check the donor deferral database.
Policy:
Note: When the offline data is uploaded into Medinfo main database, it will be checked against the latest donor deferral database. The latter will be applied for the donation.
Dr. Zeyd Merenkov 