Use of Expired Reagents

This is a sample document for use of expired reagents I wrote for HMC Qatar.

Principle:

Due to logistics issues including the long distance between suppliers in Europe and North America and Qatar and the importation/customs clearance of critical materials, Transfusion Medicine has developed a contingency variance policy to minimize disruption of the essential transfusion medicine testing and component preparation.  Approval for use of outdated reagents in special circumstances is not meant to be an excuse for untimely monitoring and improper ordering of supplies.

Definition:

Rare Reagent:  Any reagent that is either used uncommonly or is in short supply and difficult to obtain in a timely matter.

Policy:

  1. Maintain a minimum six (6) months’ supply of each reagent when feasible.
    1. This cannot be done for short-outdate reagents such as reagent red cells for panels and antibody screens.
  2. If an in-date reagent is not available for use, then an outdated reagent may be considered for use if:
    1. It passes an in-run quality control including negative and positive controls as applicable specific for the test in question.
    1. Supervisor reviews the results and approves their use:
      1. Results using such outdated reagents may only be used if they pass the validation rules in that procedure.
    1. The Division Head, Transfusion Medicine, or designate reviews the supervisor’s recommendations and approves their use.
  3. All such variances must be documented as follows:
    1. Variance document form
    1. In the comments for results within the Medinfo Hematos IIG software.

References:

Sections 1.3.2 and 7.0, Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

SARS-CoV-2 Antibody for CCP in Medinfo Hematos IIG

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:

  • Low titer CCP
  • High titer CCP
  • Acceptability for patient allocation

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:

  • If antibody >= 160, label as high-titer CCP and use for patient allocation.
  • If antibody < 160, label as low-titer, physician must override for patient allocation

Example 2:  IgG antibody with S/CO ratio > 12 is high-titer:

  • If S/CO >= 12 label as high-titer CCP and use for patient allocation.
  • If S/CO < 12, label as low-titer and discard.

Example 3:  IgG and IgM antibodies must have S/CO > 12:

  • If BOTH IgG and IgM antibody measurements have S/CO >12, use for patient allocation.
  • Otherwise, discard unit.

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.

Rules in Medinfo Hematos IIG Blood Bank Software

Medinfo Hematos IIG has an underlying framework of functionality.  It is flexible since it acts upon rules based on parameters (e.g. sex, age, diagnosis, test results, etc.)  You can change the processes in the system by changing the parameters without upsetting the underlying structure of the software.  This means you can make changes very simply and quickly without having to “hard-code.”

Rules are based on parameters which are entered into the system by the user or the results of previous action.  I am listing here some examples of parameters used to define processes in my Medinfo installations:

  • Demographics (e.g. age, sex, nationality, address)
  • Diagnosis
  • Ordering Physician
  • Project (e.g. research project)
  • Location (e.g. hospital ward or clinic)
  • Procedure (e.g. apheresis, surgical)
  • Test results (ABO typing, DAT, marker testing, control values)

Based on these parameters, the system may require:

  • Specific selection of component, derivative
  • Special processing of component
  • Selection of specific test methodology
  • Discard of blood component
  • Invalidation of test rests (e.g. positive D control)

Examples:

  • Restrict use of CCP if SARS-CoV-2 antibody titer is low
  • Discard component if HBsAb quantitation below a threshold (e.g. 100 IU/liter)
  • Hematology ward patients only to receive irradiated blood components
  • Patients in research project to have special testing always done
  • Patients with unexplained hemolysis to have special DAT performed (IgG, IgA, IgM, C3c, C3d)
  • If anti-Kell present, only use K-negative blood—if Kell positive or Kell untested, block allocation
  • If female donor, whole blood only to be processed for RBCs
  • Reflex testing (if HBcAb reactive, then HBsAb must be performed)

Overriding rules:

One can also define if the rules can be overridden by someone with appropriate credentials:

  • Use antigen-incompatible RBCs (e.g. C-positive in a patient with anti-C)
  • Use of non-irradiated RBCs if irradiator is broken

On the other hand, rules can be specified to prohibit overriding:

  • Use of group O RBCs in a patient with anti-H

Validation of Reporting Formats

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:

Opinion: Software Permissions for Blood Bank Staff

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:

  • All staff share the same access, regardless of position or department
  • Technical staff, including non-blood bank staff have global access to all functions
  • Non-blood bank staff can modify test results or comments

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:

  • Blood bank vs non-blood bank staff
  • Blood bank section and location
  • Technical privileges by rank:  trainee vs base technologist vs senior technologist vs supervisor vs technical director
  • Medical privileges by rank:  residents/fellows, junior medical staff, senior staff, head of sections/directors

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.

Teaching Document: Variances in Transfusion Medicine

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:

  1. Whenever there is need for a variance in the policies and procedures in Transfusion Medicine, the Division Head, Transfusion Medicine or designate must be informed.
  2. The Division Head or Designate will review and accept/reject the request.
  3. If accepted, the variance must be documented in writing by any of the following:
    1. A paper form (pre-blood bank computer system implementation) that can ultimately be scanned or an electronic version stored in Transfusion Medicine.
    2. A comment in an appropriate field in the Medinfo computer system
  4. All verbal authorizations for a variance (e.g. telephone call to Transfusion Medicine physician at night) must be recorded on a form and submitted to the responsible TM physician for review and signature.
  5. All variance documentation must be readily retrievable for analysis.
  6. All variances must be collated and assessed as part of the monthly quality review.

References:

  1. Technical Manual, Current Edition, AABB, Bethesda, MD, USA
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

COVID-19 Convalescent Plasma CCP Product Issue

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.

Issues with Labels

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

Universal Low-Titer Group O Whole Blood

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:

  1. Stock a limited number of OU whole bloods at the trauma/emergency room sites—based on inventory needs.
  2. Allow up to 2 doses (2 OU units/patient) before reverting to the MTP protocol.
  3. Prepare allocation rules to allow group OU whole blood and group O RBCs to be used for ALL ABO types except Oh, Ah, Bh.
  4. Medinfo Hematos IIG will use the new allocation rules for OU in emergency release situations only.  It will not be allowed for routine use.

References:

  1. Technical Manual, Current Edition, Bethesda, MD, USA
  2. Standards for Blood Banks and Transfusion Services Current Edition, AABB, Bethesda, MD, USA