Category: Blood Bank IT

Includes all areas: Donor, patient, marker testing, component preparation

Setting Up Universal Low-Titer Group O Whole Blood

drzeyd

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

COVID-19 Convalescent Plasma CCP Interdepot Transfer

drzeyd

This is a part 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 transfer protocols and allowable destination sites are listed for this product.

Teaching Document: Validation Process

drzeyd

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

COVID-19 Convalescent Plasma CCP Thawing and Marker Testing

drzeyd

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

Bedside Monitoring of Transfusion

drzeyd

Once the blood component has left the hospital blood bank, it should be directed transported to the patient’s bedside for immediate transfusion.

At the bedside, the transfusionist (usually a nurse or doctor) must verify the information on the blood component labels (both the ISBT and specific reservation one for the patient).  With a bedside device, this includes:

  1. Scan the patient armband for hospital number
  2. Scan ISBT label:
    1. ABO/D type and any other antigen typings
    2. Blood component type (RBCs, platelets, plasma, etc.)
    3. Expiration date/time of the component
  3. Verify Reservation Label (on back of unit)— centrally performed in blood bank computer system based on #1 and #2 above:
    1. Intended recipient name and hospital number
    2. Compatibility status (compatible, least-incompatible, etc.)
    3. Expiration date/time of the compatibility testing/crossmatch
  4. Record Documentation During Transfusion:
    1. Physical inspection of the unit
    2. Time stamp of transfusion start
    3. Vital signs before starting transfusion
    4. Periodic vital signs during transfusion
    5. Time stamp of stopping transfusion
    6. Any adverse effects during the transfusion
    7. Any adverse effects after the transfusion (remote vital signs, oxygen saturation, EKG lead—if appropriate monitoring device attached to patient (e.g. Umana T1 device).

All of these parameters can be entered into a hand-held device that transmits them to the blood bank computer system (e.g. Medinfo Hemotrace.)

The Blood bank computer system (patient module) should verify that this is the proper unit for the intended recipient and that the transfusion is starting within the reservation limit of the unit and serves to verify the information on the reservation label attached on the back of the blood unit.

With a device such as  the new Umana T1 device from the GPI group, the vital signs together with an EKG lead and oxygen saturation can be automatically uploaded into the handheld device that feeds into the blood bank computer system such as Medinfo Hematos IIG and/or directly transmitted to the blood bank software.  This device can continuously record this information for several days and detect post-transfusion adverse effects such as TRALI/TACO and delayed hemolytic transfusion reactions.

Note:

Some other nursing hand-held devices are available for recording patient data but many cannot read the ISBT unit number or descriptor information.  They also do not check with the blood bank computer system to check if the right unit of blood is being offered to the patient during the validity of the transfusion period (four hours after leaving the blood bank).

Stem Cell Collection Logistics

drzeyd

Everyone is excited at the potential of using stem cells for research and therapy. Below is my presentation of the logistics necessary to get those stem collected in an orderly manner, especially in this time of the COVID-19 pandemic. It will also consider blood bank software logistics.

COVID-19 Convalescent Plasma CCP Donor Questionnaire and Collection

drzeyd

This is a part of a series of posts on the actual Medinfo design of the CCP donation and release processes.  The site and donor registrations were covered in a recent previous post.

Donor Questionnaire and Physical Examination:

After registration, there is the online CCP donor questionnaire and vital signs entry.

Note that the CCP donor will automatically be excluded from other types of donation.  All other types will appear as contraindications in RED below.

Donor Apheresis Collection:

The actual donation process is the same as for plasmapheresis donors: