Blood Component Transport Temperature Monitoring

Principle:

Blood components must be maintained at specified temperatures to avoid hemolysis, bacterial contamination, and maintain full efficacy (e.g. coagulation factor activity.)

Policy:

  1. Freshly collected whole blood for blood component preparation must be kept between 20-24C if  platelets are to be made.  Otherwise, it must be maintained between 1 and 10 C.
  2. Prepared RBCs and thawed plasma must be transported between 1 and 10 C.
  3. Platelets (pools and apheresis), thawed cryoprecipitate, and granulocyte concentrate must be transported at 20-24 C.
  4. Frozen components (frozen RBCs, FFP, FP24, cryoprecipitate) must be kept frozen during transport.
  5. There must be an appropriate means of documenting that the proper temperature was maintained.  Examples of compliance may include:
    1. LCD stickers that change color if the component goes outside the selected temperature range.
    2. Digital temperature recording systems—Examples:
      1. TempTale ® or other temperature recording devices (added to a transport container without a temperature-controlled container)
      2. Temperature controlled transport containers with integral recording systems
      3. The recording session for each transport episode should be downloaded, reviewed and saved.
  6. If the temperature goes outside the specified temperature range, the components cannot be used for transfusion or manufacture.
  7. All devices must be validated to meet their specified temperature-recording capabilities before being used.
  8. Specific SOPs for the use of the selected monitoring devices must be prepared and in use.

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

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.

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.

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

Setting Up Universal Low-Titer Group O Whole Blood

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:

  1. Select cut-offs for anti-A anti-B titer.  This should be determined by the blood bank medical director.
    1. I recommend saline 1:64 for both titers based on recent THOR (Thrombosis Hemostasis Oxygenation Research) meetings
  2. Assess availability of automated immunohematology analyzers for titration.
    1. Titration may take up to 30 minutes per sample, during which time the machine cannot be used for any other purpose.
  3. Perform a survey of the anti-A and anti-B titers in your blood donor population.
    1. At my sites, about 50% had titers less than or equal to 1:64.
    2. Determine how stable the titer is:
      1. Does the titer change between whole blood donations?
  4. Prepare as follows:
    1. Collect whole blood units in CPD.
    2. Filter with a platelet-sparing whole blood leukodepletion filter.
  5. Add a new blood type OU (for group O whole blood universal) for plasma in your blood typing algorithm.
  6. Establish new allocation rules to permit group OU whole blood for all ABO types.
  7. Software:
    1. Set up new truth table in your blood bank computer system.
    2. Validate the modification in your blood bank donor and patient modules.
    3. Update ISBT code for this new product, verify your transfusion service module can read this.
  8. Determine the target inventory level for universal plasma (group AB and low-titer A) based on current/past usage.
    1. I started with a trial of a small inventory of 8 units to cover 4 patients each receiving a maximum of 2 units at one trauma site.
    2. Consider a dose of two as equivalent to an MTP dose in an adult.
    3. If more than 2 units  are needed, revert to the MTP protocol.

Special notes:

  1. At my last location, we had only 3 analyzers capable of doing the titration.  Thus, we could only do 6 titrations per hour at the expense of stopping all other testing.  You will have to coordinate the titration with your other immunohematology testing.  Also, you must verify if all these equipment can interface to your production software.  In my system, any test (including titration) could be performed at any location and its results be used for production purposes.
  2. Donor ABO antibody titers may fluctuate.  I would not use previous results to qualify a donor to be OU.  I would repeat the anti-A and anti-B titer each donor encounter.

References:

  1. Technical Manual, Current Edition, Bethesda, MD, USA
  2. Standards for Blood Banks and Transfusion Services Current Edition, AABB, Bethesda, MD, USA
  3. Medinfo Hematos IIG Donor Production Module

Teaching Document: Validation Process

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:

  1. A written validation protocol must be prepared in the advance and at least including the following:
    1. Specific parameters and number of iterations to be performed
    1. Designated staff to perform validation
    1. Documentary evidence of the testing
    1. Specific acceptability criteria
  2. The completed validation protocol must be submitted to the Division Head, Transfusion Medicine, or designee for review.
  3. Once the validation plan has been reviewed, it must be performed by the designated staff.
    1. Software validations will be performed in a specific test environment, not in the live, production system.
  4. The completed validation document, including screenshots of the software functionality if applicable, must be submitted to the Division Head, Transfusion Medicine for review.
  5. The equipment or software may only be used if the acceptability are met AND the validation is approved by the Division Head, Transfusion Medicine or designee.
  6. The completed validation protocol will be stored in the document control system.

Reference:

Standards for Blood Banks and Transfusion Services, Current Edition, Bethesda, MD, USA

Blood Component Variances

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:

  1. All transfusion services must inspect all blood components upon receipt (e.g. for leakage, broken seals, improper temperature, clots, discoloration, gas, etc.).
  2. Labels must be compared to the consignment sheet for complete concordance.
  3. If units are found that are not listed or mislabeled, they must be reported in writing to the Donor Center and returned as-is for investigations.
    1. If the unit is leaking or broken, ensure standard/universal precautions are taking to minimize contact with the fluids.
    2. Damaged blood components must not be used.  Units with mislabelings or other discrepancies between the labels and the consignment sheets may be used when such errors are corrected and officially reported by the Donor Center.
  4. Use the standard incident (occurrence variance) report form (OVA) for each and every variance.
  5. The submitting location should keep a copy of the OVA and immediately forward the original to the Transfusion Quality Section.
  6. The Donor Center should investigate the variance and prepare a written investigative report and submit to the Division Head, Transfusion Medicine.
    1. Donor Center investigations should be completed within one calendar week.
  7. The Donor Center should forward a copy of the completed written investigation to the transfusion service which initiated the investigation.
  8. The copy of the investigation report should be attached to the OVA and kept at the local site.
  9. Transfusion Quality shall include these variances in its monthly reports.

References:

Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

COVID-19 Convalescent Plasma CCP Thawing and Marker Testing

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