The attached PDF illustrates a sample validation of reporting formats for transfusion service testing. The validation criteria are explicitly stated. The evidence, in forms of screen shots, is attached to the PDF. The data is reviewed and then accepted by me as the Division Head, Laboratory Information Systems.
Please note in this sample, no actual patient data was used. All testing was done in a non-production environment.
Here are the embedded screenshots:
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.
Principle:
In accordance with AABB Standards, all actions contrary to the standard operating procedures and policies of Transfusion Medicine must be specifically approved by the Head, Transfusion Medicine or designate.
Documentation of variances must be organized in a system for ready retrieval for analysis. They should not be entered into a system that is cumbersome to find the entered variances.
Examples include but are not limited to: Rh(D)-incompatible transfusions, least-incompatible crossmatch, extension of expired rare reagents, etc.
If the same variance is occurring frequently, it should be determined if modifications in the underlying documentation (policies, processes, procedures) should be made.
Policy:
References:
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.com/wp-content/uploads/2021/01/jmv.26537.pdf
This is the conclusion of a continuing series of posts on the actual Medinfo design of the CCP donation and release processes and covers the transfer of completed units to the hospital blood banks. It highlights specific changes made for the parallel CCP system I developed at HMC Doha.
A blood component is either located at a production site, a destination hospital blood bank site, or in transit. Here a quarantine production site is specified. The actual release process is documented in this post.
In summary, with the exception of the donor marker testing and immunohematology testing, all other CCP processes are handled by special quarantine processes. There are abbreviated marker testing specific for plasma and a special Predonation screening to minimize wastage of the expensive apheresis kits.
I prepared this policy for HMC Qatar, which did not perform genotyping.
Principle:
Weakened expression of the D antigen may be due to either quantitative or qualitative defects. Qualitative defects (partial or mosaic D) are uncommon.
Patients with quantitative defects have the whole D molecule and will not make anti-D upon exposure to D-positive RBCs.
Patients with partial or mosaic D may form antibodies against the portion of the D molecule they lack. However, not all partial D types may make anti-D upon exposure. Since we cannot specifically test for this condition, we shall consider females of child-bearing age with weak D as potentially partial D and use D-negative RBCs.
Genotyping for the D gene may define better which partial D types need to receive RhIG or D-negative transfusions.
Definition:
Weak D is defined as weak (1+ or weaker) reactions with one or more routine reagents or reactions only at antiglobulin phase (i.e. Du testing).
Policy:
References:
Technical Manual, Current Edition, American Association of Blood Banks, Bethesda, Maryland, USA
Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
You can have the most sophisticated blood bank software, but if you can’t read the labels or if they fall off, you have a disaster. These are my thoughts from implementing our blood bank computer system back in 2013.
Check Digits:
Both ISBT specimen and product labels have an internal system to verify that they have been read correctly. Within the blood bank software, this should not be a problem. However, can your third party such as a hospital information system HIS read them?
ISBT Compatibility:
The institution’s HIS could not read the component labels. To this date, the problem has not been fixed. As a workaround, we sent them the ISBT label codes directly from the blood bank software. The only complete transfusion record was in the dedicated blood bank computer system, not the HIS. You could not rely on the bedside nursing entry at all.
The HIS did not use the ISBT database and had no values for the E codes. Again, we had no choice but to send an abbreviated E-code descriptor to them. We did not use their transfusion module at all, but one of our clients did. They had to hard code the list of E codes in use with their descriptors into their HIS.
Label Adhesive
We tested candidate labels at room temperature, 1-6, minus 18, and minus 80 C. We found that most of the labels’ adhesive were not sticking at minus 80. For some, you could literally blow on the blood bag and the label fell off. I imagined a scenario in which I opened a freezer and saw the blood bag labels all lying separately at the bottom.
RFID Tags:
Do you use an RFID tag integrally attached to the ISBT label OR do you stick a separate RFID tag? If the latter, how do you ensure that you put the proper tag on the proper bag?
Readability:
Readability: Can all your blood bank devices read your printed labels? Do you have to adjust the printers for this? Whose responsibility is it to do this?
Labels printed outside the blood bank:
If you receive patient specimens from outside the blood bank, can your devices read them? Who is responsible to adjust the printers in the wards and clinics?
Validations:
Who validated that the HIS prints the accurate complete label for the right patient? We discovered that this was not the case with our HIS and needed correction by them. Remember that any processes affecting Transfusion Medicine should be assessed by Transfusion Medicine. Do not accept verbal assurances from anyone, not even your HIS.
2/2/21
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:
Dr. Zeyd Merenkov 