Sample Validation Change Protocol: Donor Hgb Levels

Changes to donor criteria can occur at any time.  This example is the change in donor criteria for males to 13.0 g/dl based on AABB Bulletin #16-05.

I made a validation protocol, which was subsequently performed by a Donor Center Medinfo Super-User.   The data was then sent to me for review and then accepted.

Note that females were included in the testing for regression purposes.  Females were only permitted to donate RBCs—all other components were discarded in production. Contraindication information appears in RED.

Permissible RBC Type Mismatching

The following was my interim policy at HMC for permissible matching and mismatching. This assumes that the patient is not being transfused while in a hypothermic state.

The prohibited options were blocked in the Medinfo Hematos IIG computer system. WAIHA least-incompatible release required physician approval. This protocol did not apply to low-titer group A or low-ABO-titer whole blood units, which were not available at the time.

Biologic Product Deviations

Principle:

Any nonconforming product that is released for patient use must be reported through the official channels.  Since there is no equivalent to the US CBER, this policy outlines the process for the HMC organization, the only provider of blood components for the State of  Qatar.

Definition:

Nonconforming Blood Component:  Any blood component not meeting the production criteria set in the policies, processes, or procedures of Transfusion Medicine.  Some examples include:

  • Low-volume RBC or FFP/FP24 units
  • Reduced yield platelet units
  • Units made with materials/supplies that have been recalled by the manufacturer
  • Units produced on equipment or tested with reagents that the manufacturer has recalled from use
  • Units contaminated during the production process

Policy:

  1. Nonconforming components must not be released unless they are reviewed and approved by the Head, Transfusion Medicine.
    1. Full written documentation of the review and the reasons for acceptance must be recorded.
    2. Such acceptance must be exceptional—there must be emergency reasons to resort to using such components.
      1. Minor nonconformances such as units with low volume or reduced platelet levels may be considered for use at times of critical shortage of blood components if they otherwise meet acceptability criteria.
  2. If anyone suspects there has been release of a nonconforming blood component, they should immediately contact the Division Head, Transfusion Medicine.
  3. The Division Head, Transfusion Medicine will conduct an immediate investigation to determine the veracity of the allegation.
  4. If the suspicion is confirmed, the Division Head, Transfusion Medicine will immediately contact the Chairperson, Pathology and Laboratory Medicine.
  5. The Chairperson in conjunction with Head, Transfusion Medicine, will inform the Medical Director and other senior administrative officials as indicated.
  6. A lookback will be initiated to determine if any patients have received the nonconforming components.
  7. The results of the lookback will be reported to the Chairperson, Pathology and Laboratory Medicine and the Medical Director.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Body Fluid Exposures

Principle:

New rules have been approved by US FDA CBER for body fluid exposure, tattooing, body fluid exposure, and body-piercing.  By similar logic we will extend this also to HIJAMA.  We will not make any changes to our sexual history/practices or history of sexually transmitted disease treatment or clotting factor deferrals (except fibrinogen.)

Policy:

  1. Effective immediately, we will accept donors AFTER THREE MONTHS from the following activities:
    1. HIJAMA (ritual blood-letting)
    2. Tattooing
    3. Body piercing (e.g. piercing for ear-rings)
    4. Contact with blood of another individual through percutaneous inoculation such as a needle stick or through contact with a donor’s open wound or mucous membranes
  2. A TWELVE-MONTH DEFERRAL still applies after receiving a blood component or blood derivative except clotting factors (excluding fibrinogen concentrate.)
  3. Transfusion of clotting factors remains a permanent/indefinite deferral.

Reference:

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, Guidance for Industry,  U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, April 2020

Physician Review and Data Entry of Transfusion Reactions

Physicians must enter their interpretations and recommendations for each transfusion reaction review.  In addition, they may enter comments against any of the data.  This post shows the process used in Medinfo Hematos IIG.

By highlighting Interpretation (left side), they then click on the Result Field (right side) and select their interpretation from the drop-down menu.  They can also select other and then enter a comment.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Clarification on Quality Control of Reagents for Antibody Screening and Identification

Principle:

This policy is a reiteration of current policy to QC reagents used for antibody screening and identification to document how current practice meets these requirements.  This policy is NOT a change from current practice.

Policy:

  1. Each cell used for antibody detection must be checked each day of use for reactivity of at least one antigen using antisera of 1+ or greater avidity:
    1. We will use reactivity encountered during the daily antibody testing:  reactions of 1+ in each screening cell will be deemed acceptable.  For panel cells, reactions of 1+ or greater for any specificity will be deemed acceptable.
  2. Typing reagents such as anti-D, anti-K, anti-Fya, etc. must be checked each day of use.
    1. Already defined explicitly in SOPs
  3. Anti-IgG reactivity of antiglobulin reagents may be checked during antibody screening and crossmatching:
    1. Currently performed as per manufacturer’s instructions (e.g., Immunocor, Biorad, Grifols, Ortho) for gel and tube reagents.
  4. Typing sera and reagent cells must be checked for reactivity and specificity on each day of use, including a check against known positive and negative cells or antisera:
    1. Already defined explicitly in SOPs

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition
  3. TRM.31400, CAP Checklist, current version

Blood Supplier Quarantine

This is the process I used at HMC Qatar.  Note that Medinfo would quarantine units directly and block their allocation, reservation, and modification for patients.

Principle:

The State of Qatar does NOT import blood components.  The sole producer and supplier is the HMC Blood Donor Center BDC.  BDC will block release of quarantined products and contact any private hospitals not using Hematos IIG that have already received said products.

Definition:

Blood component:  Specific parts derived from whole blood during the manufacturing process:  packed RBCs, platelets, plasma, cryoprecipitate, cryo-poor plasma, reconstituted whole blood

Solvent Detergent-Treated Plasma SDP:  Plasma made from large pools of ABO-identical plasma, treated by solvent-detergent-treated methods for pathogen inactivation (Octaplas purchased from Octapharma AG, Wien Österreich)

Policy:

  1. If a blood component or SDP is withdrawn from use, the affected components or SDP will be quarantined immediately in Medinfo Hematos IIG to prevent their release.
    1. This immediately blocks its release for patient use or modification at any site using Hematos IIG.
  2. If a component or SDP has already been released to an outside hospital not using Hematos IIG (i.e. prior to the formal notification of quarantine), the Blood Donor Center Supervisor or designate will contact the facility that has received the product and inform them to quarantine the product.
  3. Quarantined units should be returned to the Blood Donor Center.
  4. Documentation of the contact will be made against the component record in Hematos Medinfo IIG in the comment field.
  5. All such cases should be referred to the Division Head, Transfusion Medicine, for review.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Therapeutic Apheresis Volume Calculations

You can get the values off the therapeutic apheresis machine, but in the middle of the night when you have to write orders, it is convenient to estimate the volumes (whole blood, plasma, RBCs).  These are the values from my lectures to hematology fellows while I was at HMC Doha:

Whole Blood:

Weight in kg X 70 ml/kg = whole (whole) blood volume adult

Weight in kg X 85 ml/kg =whole blood volume for child (prepubertal)

Weight in kg X 100 ml/kg = whole blood volume for neonates/premature

Example:  70 kg adult has 4900 ml blood volume (I round up to 5 liters)

Plasmacrit + hematocrit = 1.00 in fractions (100%), ignore buffy coat volume

Plasmacrit = 1- hematocrit

Plasma volume:

Plasma volume = whole blood volume x plasmacrit = whole blood volume X (1-hematocrit)

RBC volume:

RBC volume = whole blood volume x hematocrit

Estimates for blood components:

The volumes will depend on the original amount collected (e.g. 450 vs 500 ml),  original preservative solution used (e.g. CPD), use of automated component production such as Terumo Atreus or Reveos, use of RBC additive solution (e.g. SAGM), leukodepletion, platelet additive solution, pathogen inactivation.

At HMC Doha, the average values were:

300 ml for leukodepleted RBCs in SAGM prepared by Reveos

300 ml for platelet pools in Mirasol and platelet additive solution (residual WBC < 1E6)

300 ml for plateletpheresis concentrate (2.4E11) in Mirasol and platelet additive solution

250 ml for leukodepleted, pathogen inactivated plasma

External Disaster Plan, Simplified

Principle:

Maintaining an adequate blood supply and expedited compatibility testing are critical in disaster planning.  Medinfo Hematos IIG allows us to get dynamic updates of our blood supply and dynamically reallocate blood components as needed.

Policy:

  1. Determinate total available blood supply across all locations by using the Cumulative Stock Display program in Medinfo Hematos IIG.
    1. Recheck stock at least every hour during the disaster.
  2. At each transfusion service site, in conjunction with a Transfusion Medicine Consultant:
    1. Cancel reservations for elective surgical and non-emergency medical cases of affected ABO/D types.
    2. Retain reservations for antigen-matched, oncology, NICU, and high-risk obstetrical cases.
  3. Inform Donor Recruitment/Logistics to send SMS, radio, and television messages for blood donors—all types.
  4. Contact ALL staff and have them report to duty.
    1. At the Blood Donor Center, the Head Nurse, Recruitment, Supervisor, Component Processing, and Supervisor, Marker Testing will contact staff.
    2. At hospital transfusion services, the site supervisor will contact all staff.
  5. Process blood components using automated component technology (Reveos).
  6. Perform all donor marker testing including single-well NAT.
    1. Abbreviation of donor marker testing is only at the discretion of the Division Head, Transfusion Medicine.
  7. Transfusion Services:
    1. Release blood component according to the various protocols as needed:
      1. Massive Transfusion Protocols
      2. Emergency release
      3. STAT
      4. Priority
      5. Routine
  8. Compatibility testing will be electronic, immediate-spin, or full AHG as per our protocols.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Data Entry Verification

Principle:

This policy outlines steps taken to minimize the risk of data entry errors and is based on a dualistic approach:  review of results by a senior technologist and/or supervisor and various computer safeguards built into the Medinfo Hematos IIG blood bank computer HIIG system.  This policy also discusses the verification (here called authorization) and purge processes of HIIG.

Policy:

  1. Review by senior technical, supervisory, or transfusion medical staff:
    1. Designated test procedures require review by a second technologist before authorization.
    2. Complex immunohematology testing and specimens showing aberrant results (e.g. ABO/D discrepancies) are reviewed by the supervisors or designates and ultimately a transfusion medicine physician before authorization.
  2. Computer system HIIG rules:
    1. Privileges:
      1. System restricts which staff can perform specific tests
    2. Patient/donor identity:
      1. System asks end-users to verify patient/donor identity before starting any access to the patient/donor record.
      2. System performs historical database checking and flags any inconsistencies (e.g. historical ABO/D typing differences, etc.)
    3. Testing:
      1. Only selected staff have privileges to authorize or purge.
      2. ABO/D testing algorithms require entry of reactions, not interpretation of results and are compared to a truth table.
        1. Aberrant results require special review before ABO/D typing results can be authorized/purged.
        2. D-controls must be negative to allow D typing results to be authorized for liquid D-typing reagents.
      3. DAT results require appropriate controls to meet truth-table criteria.
      4. Eluates require last wash to be negative before authorization
    4. Blood components:
      1. Selection of RBC or plasma units requires two independent sample determinations within 72 hours of each other.
      2. ABO-incompatible RBC or FFP/FP24 transfusions are not allowed.
      3. Donors with any detectable antibodies are permanently deferred.
      4. Depending on the patient’s antibody history, release of RBC units may require antigen-matched units.  Examples:
        1. Mandatory matching (only antigen negative matched units allowed—no antigen positive or antigen-untyped units):  Antibodies against H, D, c, K, k, Kpa, Kpb, Jsa, Jsb, Jka, Jkb antigens, anti-PP1Pk
        2. Priority matching (incompatible or untested can be approved by a transfusion medicine physician):  C,E, e, Fya, Fyb, M, S, s
        3. Antigen matching not required:  Lea, Leb, N
      5. Least-incompatible crossmatch require special authorization to release
      6. Protocols to force irradiation or other modified components can be setup in HIIG.
    5. Donors:
      1. Donor tests have same criteria as the same test used in patient testing for controls, etc.
      2. Donor demographics are read directly from the Ministry of Interior database—no manual entry (bar code only used).

References:

  1. Workflows for Hematos IIG (1001 through 1005), 2013-2020
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  3. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition