Category: Donor

Includes registration, questionnaire, physical exam and arm check, collection, marker testing, component separation, donor immunohematology testing

Issues with Labels

drzeyd

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

drzeyd

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

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

Blood Component Variances

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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

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

Interpretation of Donor Ortho Blood D Blood Group Reagents

drzeyd

Principle:

For the purpose of typing blood donors, we want to detect weak and partial D types and consider them as D-positive since even a portion of the D molecule is immunogenic and sensitization to it may cause anti-D hemolytic disease of the newborn.

Background:

Ortho Diagnostics Reagents use three different monoclonal antibody cocktails that react variably with the antigen D (Rh1)—these are found on TWO (2) cards:  Anti-A/B/A,B/D/CDE and Anti-DVI:

Anti-D/Anti-RH1—IgM monoclonal antibody clone D7B8 can detect most examples of weak and partial D including weak D types 1, 2, 3, 4.0, and D categories II, III, IV, V, VII, DBT, and R0Har.  It does NOT detect category VI.  Retest positive reactions of 2+ or less by an alternate method.  It may show different serologic activity compared to other D typing reagents.

Anti-CDE/Anti-RH1,2,3—IgM monoclonal blend of clone MS24 (anti-C), clone MAD2 (Anti-D), and clone C2 (Anti-E) can detect most cells expressing C, D, or E antigens.  Most examples of partial D including DVI and weak D express C or E antigens and will be detected directly by the included anti-D or indirectly by the anti-C or anti-E in the cocktail.  It does NOT detect Rh:33 (R0Har).

Anti-DVI/Anti-RH1 will agglutinate cells with a DVI phenotype, analogous to our previous DVI+ reagents.

Policy:

  1. Follow the manufacturer’s instruction for storage, handling, and usage of all reagents.
  2. If the D-control is positive, the reactions are indeterminate, repeat by another method.
  3. For donors, run all three anti-D reagents listed—do not use the patient typing algorithm or reagents.
  4. Use the following table for interpretation and further actions if needed:
Pattern #Anti-D/D7B8Anti-CDEAnti-DVID-Interpretation
1PositivePositivePositiveD-positive
2PositivePositiveNegativeDo additional testing
3PositiveNegativeNegativeDo additional testing
4NegativeNegativePositiveDo additional testing
5PositiveNegativePositiveDo additional testing
6NegativePositivePositiveD-positive, probable DVI variant
7NegativePositiveNegativeD-negative, probable rare genotypes r’ and/or r’’
8NegativeNegativeNegativeD-Negative

If the reaction is 2+ or less with the Ortho anti-D/D7B8 reagent or 1+ with either the CDE or DVI reagents is patterns 2, 3, 4, or 5 above, repeat by another manufacturer’s reagents, including DVI+ and DVI- sensitivities.

Medinfo-Ortho interface settings for Blood Donor Center:

Anti-D/D7B8Anti-CDED-Interpretation
3,41,2,3,4D-positive
3,40Indeterminate
00Indeterminate
01,2,3,4Do DVI REFLEX
REFLEX DVI If DVI-pos, then D-positive
REFLEX DVI If DVI-neg, then D-negative
00D-negative
~~Indeterminate

~ means any other result

Note all of the following:

  1. No reagents may be able to detect all D variants.
  2. ~ means any other value for that reagent (e.g. anti-D/D7B8 reactions 1, 2, mf, hemolyzed)
  3. Note that this new algorithm makes a 2+ reactivity with Anti-D/D7B8 as indeterminate.

References:

  1. Product Insert, Anti-A/B/A,B/D/CDE/Control Card, Revised January, 2015, Ortho Clinical Diagnostics, High Wycombe, Buckinghamshire/UK
  2. Publication J55650_EN, Instructions for Use, Blood Grouping Reagent Ortho Sera Anti-D(DVI) (Anti-RH1), Version 2.0, 2015-07-30, Alba Bioscience, Edinburgh, UK
  3. Standards for Blood Banks and Transfusion Services, 29th Edition, AABB, Bethesda, MD, USA