

Automated and manual component processing including Reveos, Mirasol, PAS
Principle:
Blood components must be maintained at specified temperatures to avoid hemolysis, bacterial contamination, and maintain full efficacy (e.g. coagulation factor activity.)
Policy:
Note the different temperature ranges for refrigerated components stored in the blood bank (1-6C) versus transport (1-10C).
References:
Section 5.6.5, Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
When I started my COVID-19 convalescent plasma CCP collection in early March, 2020, there were few antibody tests available. However, I anticipated that eventually we would want to include antibody results with the donor record. Antibody results were not used originally at all in the criteria for CCP acceptability for release.
There are many assays by type of antibody (total, IgG, IgA, IgM) and quantitation by titer and/or signal-cutoff ration S/CO. Any of these parameters may be used to define rules for acceptability to complete production and/or allocate to patients. Instrumentation used for titering/quantitation may be interfaced to the blood bank software.
Here is my generic approach to including these results with the donation record. In Medinfo HIIG, it is possible enter test results retrospectively and these can be used set rules for acceptability. Please consult with my detailed post on using rules against parameters.
All of this is easily implemented since all test information will be stored as parameters. From these parameters we can construct rules for:
Also, one can override the rules if the clinician and the transfusion medicine physician agree. For example, there is a severe shortage of group B CCP so use of low-COVID-antibody titer group B CCP could be allowed.
The key is to build whatever test methodology you use and include the manufacturer’s cutoff for low versus high titer interpretation. These results can be printed on the ISBT label as well. One can easily build multiple methodologies and acceptability criteria if different tests are used at different testing sites in your system—just as can be done for other tests (ABO/D, antibody screen, etc.) If one changes methodologies in the future, Medinfo will still use the same rules that applied for the day of production.
Here are some sample test rules:
Example 1: Total COVID antibody > 160 is high titer:
Example 2: IgG antibody with S/CO ratio > 12 is high-titer:
Example 3: IgG and IgM antibodies must have S/CO > 12:
Another option would be just to record the quantitation for each antibody type and list this on the ISBT label and permit its release regardless of the value. One could also permit low-anti-B titer group A plasma with whatever rules you set up.
In my career, I have worked with many different hospital and laboratory computer systems. One of my greatest frustrations has been providing software permissions to staff at all levels, from clerical, nursing, technical, and medical—inside and outside the blood bank.
The software permissions that I am specifically referring to are those with the blood bank software. These I directly controlled as Division Head of Transfusion Medicine and Laboratory Information Systems. I am not talking about virtual private networks or Citrix or cloud-based software controlled by the hospital IT department.
Here are some examples of inappropriate permissions:
The golden rule is to only give access that is needed for each staff’s job designation. Staff must sign an agreement not to access the system except for work and not release anything to non-designated personnel.
I recommend separating privileges by:
Permissions within a test category may include test ordering, result entry, verification/authorization, and/or purging. In the donor center, it may include registration, donor qualification, collection, donor marker testing, donor immunohematology, component processing, component modification, and/or inter-depot transfer of components. Management tools included in the software may also be restricted to high-level staff.
In this time of COVID and staffing shortages, we may be training new staff to work in the blood bank. During their training, these trainees can be competency assessed and be given access to limited functions. In Medinfo Hematos IIG, you can give staff custom permissions test-by-test so for example, if they are deemed competent for ABO/D typing, you could restrict their access to only those tests as an interim measure.
Having customized access for each employee can be nightmare for the systems administrators so this granular special access must be kept to a minimum. However, it is good to know that you do have this capability if needed.
This is the early Qatar experience of treating severe COVID-19 using locally produced Covid convalescent plasma CCP. At that time, the plasma was not tested for SARS-CoV-2 antibody levels.
https://drzeydbloodbank.files.wordpress.com/2021/01/jmv.26537.pdf
Principle:
Fresh group O whole blood has viable platelets, plasma, and RBCs. Fresh whole blood may provide better resuscitation than individual components. It can replace MTP component therapy of separate RBCs, plasma, and platelets. We will use low ABO-titer whole blood units (here called O universal OU) in selected trauma cases, based on availability.
Testing for low-titer (both low-titer anti-A and anti-B) units is time-consuming and monopolizes the automated immunohematology analyzers. This is the rate-limiting step.
Policy:
References:
This post outlines a framework for establishing the use of universal group O whole blood. Manual titering large number of donor specimens in my organization is not precise. Using an automated system will also increase the precision of the results. The rate-limiting step is the ability to do the anti-A and anti-B titers.
Process:
Special notes:
References:
This is a teaching document for medical technology and transfusion fellows to explain the general structure of a validation.
Principle:
All validations must be planned. A validation protocol must be prepared with specific criteria for acceptance. All validations with attached evidence must approved by the Head, Transfusion Medicine.
Policy:
Reference:
Standards for Blood Banks and Transfusion Services, Current Edition, Bethesda, MD, USA
Principle:
AABB Standards requires that all variances are documented and investigated and corrective actions taken when necessary. Any time a blood component is found to be defective (e.g. broken seal, leaking, discoloration, clots, etc.), mislabeled, or testing results incomplete or not documented, the cause should be investigated by the Donor Center and reported back to the initiator of the report in writing.
Policy:
References:
Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA
This is a part of a continuing series of posts on the actual Medinfo design of the CCP donation and release processes and covers CCP plasma thawing/labelling and donor marker testing. It highlights specific changes made for the parallel CCP system.
Thus, the machine interfaces for testing are the same as for regular testing and are not included in this document. Likewise, donor immunohematology testing is the same as for regular donors and is not addressed here