Processes and Software Building 50: Donor ABO Confirmatory Typing

For donor ABO confirmatory typing, I always had both automated and manual methods set up on the blood bank computer system Medinfo Hematos IIG.  The automated method had a bidirectional interface between Medinfo and the instrument.   Medinfo did not need a separate middleware.  A truth table was prepared for acceptable results for automatic interpretation.  Other results had to be manually interpreted by someone with the appropriate security level.

The manual testing option is structured similarly.  Within Medinfo, it is easy to change the methodology if the system is so built.  Thus, if the analyzer for ABO typing is down, the staff can select the manual methodology.  Likewise, if one testing center goes off-line, the world can be completed at another site—no need to repeat testing already completed from the first site.  This flexibility can apply to any test in system.

The manufacturer’s recommendations for the particular reagents in use were strictly followed.  One used the range {0, 1, 2, 3, 4} as acceptable.  Another used {0, 2, 3, 4}.  Controls were included.  Most importantly, Medinfo can be configured for any set of reagent values.  Refer to the following flow diagram.

Confirmatory testing also includes D typing.  That will be considered in a future post.

6/10/20

Processes and Software Building 49: Donor Automated ABO Typing

For donor ABO typing, I always had both automated and manual methods set up on the blood bank computer system Medinfo Hematos IIG.  The automated method had a bidirectional interface between Medinfo and the instrument.   Medinfo did not need a separate middleware.  A truth table was prepared for acceptable results for automatic interpretation.  Other results had to be manually interpreted by someone with the appropriate security level.

The manufacturer’s recommendations for the particular reagents in use were strictly followed.  One used the range {0, 1, 2, 3, 4} as acceptable.  Another used {0, 2, 3, 4}.  Controls were included.  Refer to the following flow diagram.

Most importantly, Medinfo could be configured for any set of reagent values.

2/10/20

Processes and Software Building 48: Donor Immunohematology Testing

Donor immunohematology testing of components in progress is similar to patient immunohematology testing.  The tests include:

ABO forward and reverse testing

D typing by multiple monoclonal cocktails

ABO/D confirmatory testing

Antibody screening

Antibody identification

Truth tables are prepared for each test type with interpretations.  Results falling outside these ranges will require manual review and manual interpretation by a user with an appropriate level of privilege (usually senior technologist, supervisor, or transfusion physician.)

Unlike patient D typing, we want to detect partial or variant D types as D-positive since theoretically even a few epitopes of D present may be immunogenic to the patient.  In patient D typing, we can call partial D types as D-negative and use D-negative RBCs.  We don’t want to use partial D RBCs for D-negative women of child-bearing age!

This series will show several different test algorithms including both manual and automated methods.  The criteria for acceptability of the reactions are based on the manufacturers’ recommendations. 

Reflex ordering of antibody identification will occur if the antibody screen is non-negative.

28/9/20

Opinion: Selecting a Site to Assess a Candidate Software

You have already sent out an RFP (request for proposal) for a laboratory software and have received several responses.  Regardless what the vendor provides, you need to contact a comparable site to your own and assess how well the solution is working.

The key word is COMPARABLE.  The site should have similar functionality (breadth of test and process menus), test and activity volume.  If you have multiple sites, does the candidate site have the same?

Technically, to assess response time, you should select a site that uses the same platform (e.g. Microsoft SQL Server, Oracle, etc.) and operating system (Windows, Linux, UNIX, etc.)

At one institution I worked at, they went on a site visit, but it used the software on a different platform (UNIX). They wanted to use it on Microsoft SQL Server.  They were happy with the observed response times during the visit, but when they installed it on their chosen platform, it was very slow.  You cannot compare an apple to an orange (or in this case to a prune).

I would ask to speak to key players at the site visit without the vendor being present.  Hopefully, they will be honest with you about their experiences.  I was once very surprised that I was asked to allow for a site visit for a non-blood bank software for which I had serious concerns.  I would not serve as a site visit.

26/9/20

Processes and Software Building 47: Apheresis Plasma

At HMC during my tenure, all plasma products—whole-blood and apheresis-derived were pathogen inactivated with riboflavin (Mirasol).  In our software processes, I had options to release both Mirasol-treated and untreated (the latter in emergencies) and to aliquot either as needed.  The same processes applied to COVID-19 convalescent plasma CCP except that they were performed in a quarantine production area.  There were specific ISBT codes for CCP.

24/9/20

Processes and Software Building 56: RBC Distribution Rules

In Medinfo HIIG, one sets parameters to determine which antigens must be matched to allow a RBC product to be released.  These criteria may include:

Number of and timing of ABO/D typings

Permissible ABO/D substitutions

Emergency release

Required antigen matches

Optional antigen matches

Exact wording of conditional and blocked combinations

For ABO/D typing, a minimum of two typings must be on record for routine release and the last typing done within 72 hours.  If not, emergency release must be selected.  ABO-incompatible selections must be blocked.  For D-negative patients, only D-typed units may be selected.  D-incompatible transfusions will trigger a message to use D-compatible for females <50 years.

Required antigen typings include using antigen-negative for patients having antibodies against the specified antigen, e.g. D-negative RBCs for patients with active anti-D, c-negative for patients with anti-c, K-negative for anti-K, etc.

Certain antibodies will trigger a message to flag the use of unmatched units but not block the release.

The attached document shows sample settings for RBC release.  Note that these rules are user-definable.

31/10/20

Processes and Software Building 46: Reconstituted Whole Blood

Exchange transfusions using reconstituted whole blood were much more common in the past.  Much of the time IVIG now takes care of hemolytic disease of the fetus/newborn HDFN.

In Medinfo, we took a fresh (<= 14 day old) packed RBC in SAGM, group O, Rh-compatible and mixed it with a unit of group AB plasma—the desired hematocrit could be achieved by adjusting the amount thawed plasma that we added.  The product could then be aliquoted and irradiated.  Note that I medically chose to use either FP24 or FFP.

Here is the Medinfo process:

19/9/20

Laboratory Software from Hell 1

In my career, I have dealt with many different laboratory software vendors.  Regretfully, not all encounters have been straight-forward. 

Things that bother me:

  • Current state:  whoever prepared it for the client, didn’t care or understand the local processes and came up with a generic:  order it, collect it, receive it, do it, report it for each and every test
  • No training for super users:  more like lambs being led to the slaughter
  • No discussion of options:  pushing client to take the default settings
  • Corrections to build:  only giving one shot to do it right, further corrections cost $$
  • Scenarios:  vendor shows specially crafted scenarios that “work” but when you ask the vendor to do a random, non-scripted scenario, it crashes
  • Scalability:  limited scalability on client’s chosen platform
  • Reference site does not match the test volume or activities of the client, uses different platform, and thus cannot be compared

I will give further examples in upcoming posts.

18/9/20

Processes and Software Building 45: Modifying RBC Components

Components may be modified either in the Blood Donor Center or in the hospital blood bank.  In either case, they use the PRODUCTION section of Medinfo to perform these operations.

These operations may include:

  • Irradiation
  • Tight-packing (removal of the supernatant, especially for intrauterine or neonatal transfusions)
  • Washing
  • Aliquoting (division of the primary RBC bag and possibly further division of one of the secondary bags)
  • Final labelling of the modified component

The weight of the component is converted to the volume by the software.

The end-user can specify which modified components were available.  As with any ISBT-labelled products, any changes will trigger a new ISBT E code and label.

16/9/20

Processes and Software Building 44: Pooling Components

Medinfo Hematos IIG has a pooling operation that can be used for pooling platelets, plasma, cryoprecipitate, etc.  It is a one-step operation.  In the set-up, one specifies the maximum number of components to pool together for each component type.  In general, they are of the same ABO type;  however, at HMC Doha I did allow mixed ABO platelet pools to avoid wastage of platelets that would otherwise be discarded—this may not be allowed in all jurisdictions.

The following examples show pooling of FFP, FP24, cryoprecipitate, and cryo-poor plasma:

13/9/20