Includes compatibility testing (AHG, electronic, immediate-spin), antigen typing, antibody screening and identification, direct antiglobulin testing, elution, transfusion reaction and drug reaction workups, component typing tests upon receipt in hospital blood bank, release and return of components
The following was my interim policy at HMC for permissible matching and mismatching. This assumes that the patient is not being transfused while in a hypothermic state.
The prohibited options were blocked in the Medinfo Hematos IIG computer system. WAIHA least-incompatible release required physician approval. This protocol did not apply to low-titer group A or low-ABO-titer whole blood units, which were not available at the time.
Physicians must enter their interpretations and recommendations for each transfusion reaction review. In addition, they may enter comments against any of the data. This post shows the process used in Medinfo Hematos IIG.
By highlighting Interpretation (left side), they then click on the Result Field (right side) and select their interpretation from the drop-down menu. They can also select other and then enter a comment.
References:
Principle:
This policy is a reiteration of current policy to QC reagents used for antibody screening and identification to document how current practice meets these requirements. This policy is NOT a change from current practice.
Policy:
References:
Principle:
Maintaining an adequate blood supply and expedited compatibility testing are critical in disaster planning. Medinfo Hematos IIG allows us to get dynamic updates of our blood supply and dynamically reallocate blood components as needed.
Policy:
References:
Principle:
This policy outlines steps taken to minimize the risk of data entry errors and is based on a dualistic approach: review of results by a senior technologist and/or supervisor and various computer safeguards built into the Medinfo Hematos IIG blood bank computer HIIG system. This policy also discusses the verification (here called authorization) and purge processes of HIIG.
Policy:
References:
Background:
Although we did extended Rh and Kell typing for all cases with a non-negative antibody screen, we did not routinely do this for patients with a negative antibody screen.
Principle:
Based on recent cases of rare phenotypes in the Rh system (e.g. r’r’), we will proactively test such patients most likely for this.
Policy:
Extended Rh (C, c, E, e) and Kell typing should be done on all patients meeting the any of the following criteria:
Reference:
Standards for Blood Banks and Transfusion Services, AABB, Current Edition, Bethesda, MD, USA
This is the sample examination I made for the senior-most staff and candidates. This is really a projective exercise. How far can you go with this? The candidate must specify what additional information he/she needs to complete the assessment.
Name: Badge #:
Date of Exam:
Answer the following questions:
| Anti-A | Anti-B | Anti-A,B | A1 cells | B cells | O Cells | ABS | Type? |
| 0 | 4+ | 3+ | 0 | 0 | 0 | 0 | |
| 3+ | 0 | 3+ | 1+ | 4+ | 0 | Neg | |
| 3+ | 1+ | 3+ | 0 | 3+ | 0 | Neg | |
| Weak | 0 | 2+ | 0 | 4+ | 0 | Neg | |
| 0 | 0 | 0 | 4+ | 4+ | 4+ | Pos, all cells | |
| Weak | 0 | 0 | 4+ | 4+ | 4+ | Pos, all cells | |
| 0 | 4+ | 3+ | 4+ | 2+ | 0 | Pos, SCIII | |
| Mf | 0 | 0 | 0 | 4+ | 0 | Neg |
ABS = antibody screen; mf = mixed field reaction
Assume that all reactions are the same by both the tube and gel methods.
In the above table, list any discrepancies in each of the testing panels. Describe what additional tests or information, if any, are required to resolve the type.
| Anti-A | Anti-B | Anti-D | D-control | A1 cells | B cells | O cells | ABS |
| 4+ | 4+ | 4+ | 3+ | 4+ | 4+ | 4+ | Pos All cells |
| Anti-A | Anti-B | Anti-D | D-control | A1 cells | B cells | O cells | ABS |
| 0 | 0 | 4+ | 2+ | 4+ | 4+ | 0 | 0 |
| Anti-A | Anti-B | Anti-D | D-control | A1 cells | B cells | O cells | ABS |
| 0 | 0 | 4+ | 2+ | 4+ | 4+ | 2+ | 2+ |
Anti-A—0, Anti-B—0, A1 cells—4+, B cells—4+, ABS—3+ in SCI/II/III
What actions will you take now? What blood type will you release for subsequent RBC requests? Be explicit!
| M | N | S | S | Fya | Fyb |
| 0 | 0 | 0 | 0 | 0 | 0 |
Interpret these results.
Pretransfusion DAT: negative
Post-transfusion DAT: negative
Hemolysis Check—post-transfusion sample—strongly positive
Hemolysis check—pre-transfusion sample—negative
Clerical Check—OK
Pretransfusion ABO/D: B-positive—reverse typing normal
Post-transfusion ABO/D: B-positive—reverse typing normal
Returned unit ABO/D: B-positive
Repeat crossmatch—compatible
Give possible reasons for these findings. What further investigations would you do?
48 year old female with septic arthritis and severe anemia (Hgb 6.9 g/dl) and positive autocontrol 2+ (Polyspecific 2+, IgG 2+, C3d nil) and negative antibody screen:
The eluate panel results follow:
Please give your interpretation of the findings. Be sure to specify other information you may require if any.
71 year old female with aortic stenosis admitted for surgical correction, blood type AB positive, antibody screen 2+ positive in all 3 cells, autocontrol negative, no history of recent transfusions.
Extended phenotype is:
C+E+c-e+K-k+Kpa-Kpb+Fya+Fyb-Jka-Jkb+Lea+Leb-P1+M+N-S+s-Lua-Lub+
Note: Cell #1 reacts 2+ at LISS/Coombs using monospecific IgG IgG/Coombs Card.
60 year old male with paraplegia for surgery, B-positive, auto-control negative, no recent transfusion history:
39 year old, pregnant female—no previous history:
36 year old pregnant female, O-positive:
Interpret the panel. What RBC phenotype would you transfuse?
60 year old male with paraplegia for surgery, B-positive, auto-control negative, no recent transfusion history:
Most Transfusion Medical Directors are not information technology IT people. Still, regardless if you direct a hospital blood bank/transfusion service, a blood donor center, or both, you will still have to evaluate software for your operations. You will probably have to sign off on the selection of a system and on the final build before going live.
This can be a formidable task, especially since none of us were trained in IT. In my opinion, you can still do this based on your knowledge and experience and make a successful choice.
The most important thing is to KNOW YOUR OPERATIONS!! Someone in your organization should map out all your processes, preferably as flow charts. Optimize your manual processes. Look at your critical control points: How does the software enhance operations and safety? How does the candidate system enhance security and consistency? Does it bolster the critical control points?
My experience has been that the best software build is the one based on a good manual system. Study the new candidates: how do they enhance your operations? Now reconstruct your processes with the enhanced features of the new system.
Don’t be afraid to ask for help. Check your local resources and/or consider outside consultants if necessary. The latter should have experience in working with blood bank systems and ideally have worked with your candidate vendors.
Human beings are not consistent creatures. We often do not like following a series of steps in a processes, we like to skip around. All of this is very dangerous to patient care. The ideal system enforces consistency and integrity. I actually like it when my staff complain that the software is merciless—they cannot take shortcuts. They must follow each step in order!
Choosing a module from within a laboratory or hospital information system LIS/HIS will facilitate integration with the rest of system. However, such modules (mainly limited to hospital blood banks) do not have all the features that a dedicated blood bank software has For example, will they prevent release of unphenotyped or Kell-positive units in a patient with anti-Kell?
If you choose the dedicated system option, you must determine if a functioning interface to the LIS/HIS exists. If not, what is the time frame to make the connection? Very importantly, check that your specifications are actually built into the interface. Almost every LIS/HIS vendor says that they can make an interface, but are they communicating what you need? If you talk English and they answer you in Sanskrit, are you effectively communicating?
I prefer a dedicated blood bank system for both patients and donors, especially one that allows you to create rules to handling different situations like electronic/computer crossmatch, irradiation, etc. Integrating both patient and donor operations will facilitate operations, especially in times of disaster and product recalls/quarantines.
Make certain that there are interfaces available for your analyzers and blood production equipment (e.g. Ortho Vision Max, Reveos, Mirasol, etc.). Check these out on a site visit. Many vendors promise that they can communicate with your equipment, but you must verify this yourself.
You are the pilot. Is the transfusion or donor information organized to facilitate your decision making? Is it available all on one screen? Do you have to flip across many screens to get the information (e.g. transfusion history, transfusion reactions, DAT, antibodies, donor history, marker testing) you need?
If you are directing a donor center, you will most likely need a separate dedicated software. Usually, donor center software does not directly integrate into the LIS/HIS. However, at least your patient hospital blood bank module must be able to read your ISBT labels properly.
I recommend a visit to a site comparable to your current operations. Look for ease of use, response time, and talk privately with the end-users at the site. Ask your IT staff to help you select a site that uses the same operating and database software (e.g. Oracle) as you will be using.
How readily can the system be modified for new practices? With COVID-19, SARS, ZIKA, etc. there have been many changes in regulations in a short time. How long will it take your vendor to update your system? Is the system compliant with your local regulations and international accreditation standards?
Structurally, the optimal system is one that is a framework where almost all changes can be handled by changing settings or parameters. The underlying structure does not change so this facilitates making the modification. There is no need to “hard code” the changes. You are not writing a new software structure. Warning: many blood bank softwares do not have this framework or flexibility—it takes a long time often even to make minor changes or updates.
Using blood bank software is like playing with fire. Defects in design can adversely affect patient care. The vendor will install the software with settings, but it is still YOUR responsibility to verify it works according to the specifications.
I recommend engaging computer-literate end-users (nurses, doctors, medical technologists, recruitment staff) .from the very beginning of the actual software build. These staff can become Super Users to handle minor issues and train other staff and can help perform your software validations.
In summary, you will have to accept the choice of vendor and the final software build. Find resources to help you with these tasks. Never forget that what you are doing could adversely affect patient care if you are not vigilant!
4/11/20
Principle:
The use of irradiated components is to inactivate antigen-processing cells, which have been implicated in transfusion-associated graft versus host disease (TAGVHD). This condition is may be fatal and has been reported in a variety of clinical settings, both in immunocompromised and immunocompetent hosts.
Since we pathogen-inactivate platelet components, we are only irradiating RBC components. There is no need to irradiate any plasma components (e.g. FP24, thawed plasma, cryoprecipitate, or cryo-poor plasma.)
WARNING: Do not irradiate stem cell units!!
Policy:
If you are uncertain whether to irradiate, ask the supervisor or the transfusion medicine physician.
References:
4/11/20
I was recently talking with one of the hospital software system administrators from my previous site. He had originally worked on building the Medinfo system, but was then reassigned to the laboratory modules of the hospital information system.
His alarming comment to me was that the Medinfo build was completed so there was no need to worry about it now—it was finished. I guess he was looking from the perspective of the general laboratory software. There is no need to make major changes to the build, just update interfaces and troubleshoot.
I was surprised. He had no idea of how many times we have to update the structure for new rules and regulations, and changes in blood bank practice—let alone emerging pathogens such as ZIKA, dengue, Chikungunya, and most recently, COVID-19.
My daily morning routine was to survey several blood bank websites with changes to blood donor criteria including US FDA CBER, read the transfusion journals (Transfusion, Vox Sanguis, etc.), AABB, and ASFA. If there were any changes pertinent to our organization, I had to make interim policies and procedures, and finally prepare specifications for changes in the Medinfo software.
The Medinfo engineers would prepare flow charts of the proposed changes and implement them in a test environment for the Super-Users to test. I had to prepare validation protocols for the testing, and then review the validation results and finally approve the adoption of the changes.
I cannot remember even a month going by without some revision in the donor protocols. When COVID-19 came, I had to prepare a parallel, but separate, processing and allocation/release system.
This was a never-ending story that kept the Super Users and the local Medinfo engineers busy. I always reminded the hospital information system staff that playing with blood bank software was like playing with fire: there is a good chance you will get burned if you do not set it up properly.
31/10/20
