Tag: Donor Collection

Recruitment and Collection

Therapeutic Phlebotomy Process–Updated

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Principle:

Therapeutic phlebotomy is a medical procedure that requires a written physician’s order and review/approval by a transfusion medicine physician.  Transfusion Medicine is responsible for the procedure and makes the final decision of the conditions of the procedure (volume of whole blood and venue).

Policy:

  1. The most responsible physician or a member of his clinical team will write a specific order for therapeutic phlebotomy including:
    1. Clinical diagnosis
    2. Medications
    3. Quantity and frequency of the procedure
  2. No procedures will be done without a physician’s order.
    1. Verbal orders may be given directly to the responsible transfusion medicine physician.
  3. Blood Donor Center nurses will NOT process orders from outside Transfusion Medicine.  Final approval is only by a transfusion medicine physician.
  4. Phlebotomy Process:
    1. Blood Donor Center nurses will obtain informed consent for the procedure.
    2. Blood Donor Center nurses or donor technicians will take the vital signs (BP, pulse, temperature, weight, and respiratory rate) and will examine the patient’s arms for suitability for phlebotomy.
    3. The doctor’s order along with the vital sign data will be given to the responsible transfusion medicine physician for review.
    4. The transfusion medicine physician will:
      1. Use the criteria of the Therapeutic Phlebotomy Annual Review
      2. Review the written (or verbal) order.
      3. Determine the exact quantity of whole blood to be removed.
      4. Determine if it is safe to perform the procedure in the Donor Center or:
      5. Advise the ordering physician of an alternate, appropriate venue (ICU, ER, CCU, etc.)
      6. Write the final order for the procedure in the appropriate Transfusion Medicine record.
    5. The actual phlebotomy will be performed the same as a whole blood donation using sterile technique including arm preparation.
  5. The collected volume will be discarded immediately after drawn.
    1. No therapeutic phlebotomy whole blood collections will be used for transfusion.
  6. Records of the following will be retained:
    1. Clinical doctor’s order
    2. Vital signs of patient
    3. Patient’s consent
    4. Any notes, including descriptions of reactions
  7. Reactions to the phlebotomy procedure will be handled the same as donor reactions.
  8. Any variances to the above process must be approved by the transfusion medicine physician, forwarded to the Head, Transfusion Medicine, for his review, and documented on the appropriate variance form.

References:

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

Annual Review:  Therapeutic Phlebotomy Criteria and Treatment Goals

Autologous Transfusion

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This a revised version of a previous post for the processes of autologous transfusion that I developed at HMC Doha.  It can serve as a template for other sites and was also a teaching document for the Transfusion Committee members.

Background:

There are four basic types of autologous transfusion:  preoperative, perioperative hemodilution, intraoperative, and postoperative drainage/collection.  The use of all of the above techniques can significantly decrease the need for homologous blood and as an added benefit reduce the risk of the disease transmission and immunosuppressive effects of such homologous transfusions.

Preoperative collection can make available packed red blood cells, whole blood, platelets, FFP, and/or cryoprecipitate.  However, at most two units of blood per week can be collected.  RBC’s can be stored for up to 42 days in the liquid state, frozen RBC’s up to ten years, platelets up to five days, and fresh frozen plasma and cryoprecipitate up to one year.  The last collection cannot be less than 72 hours prior to the surgery time.  Units can be collected as long as the patient’s hematocrit remains above 33%.  Supplemental iron and erythropoietin can increase the number of units harvested.  The biggest obstacle to using this service is the coordination of the patient scheduling for this procedure.  The blood bank does not have the resources to prospectively analyze the surgical scheduling and make the various appointments, contact the attending physician, etc.  Thus, this service is vastly underutilized.

PHD or Perioperative hemodilution (also called acute normovolemic hemodilution) is useful in cases when the anticipated blood loss is at least one liter and the initial hematocrit is at least 34%.  This includes essentially all types of surgery, but in particular cardiac, vascular, orthopedic, and urologic cases.  The patient’s hematocrit Hct. is lowered to the range of 20-25% and the blood is replaced by crystalloid in a ratio of 3:1–i.e. three times as much fluid as blood, or in the case of colloid replacement, a 1:1 ratio of colloid plus 0.5 to 1.0 ml. of crystalloid.  Crystalloid has the advantage of being readily removed by diuretic use.  However, this technique should not be undertaken when vascular access is inadequate or appropriate monitoring devices are lacking.  The physician performing PHD must be familiar with the compensatory mechanisms normally invoked when the hemoglobin is acutely lowered.

Another new twist to PHD is the perioperative collection of platelets by a special attachment to a cell-saving machine.  This could allow collection of a typical apheresis load, about 6 to 10 units of fresh platelets for potential use.  There are currently studies underway to determine if this has particular clinical advantages to warrant the additional cost.

Intraoperative salvage may be performed with a number of canister or automated devices.  The latter is usually used when there are large volumes (usually 3 or more units) of blood to be salvaged.  Depending on the body site, the recovered material is at least filtered and may or may not be washed.  Care must be taken to collect the blood at a low suction rate and with minimal turbulence to minimize hemolysis.

Postoperative drainage collection of certain sites such as post-knee replacement surgery or chest wounds involves a canister collection device.  This blood may or may not be filtered before reinfusion.

Note that perioperative and intraoperative material can only be transfused up to six or eight hours at room temperature or 24 hours if refrigerated at 1-6 degrees (depending on the method used) post collection to minimize the risk of infection.  Intraoperative collection may be contraindicated in cases of cancer and if the bowel has been violated.

Other Issues:

The transfusion criteria for autologous blood is the same as for allogeneic units.

The same compatibility testing algorithm applies both the autologous and allogeneic units.

Policy:

  1. Scope:
    1. Predeposit collection of Whole Blood/RBCs and plasma is under the authority of Transfusion Medicine.
    2. Perioperative hemodilution, intraoperative cell salvage, and postoperative drainage collection is under the authority of the National Transfusion Committee in conjunction with the Departments of Surgery and Anesthesia.
      1. The Division Head, Transfusion Medicine will liaise with the clinical departments as needed.
      2. Transfusion Medicine may provide blood collection bags for perioperative hemodilution upon request.
    3. Transfusion Medicine does not receive autologous collections—perioperative, intraoperative, or postoperative drainage collection.
  2. Processes directly under Transfusion Medicine authority:
    1. Autologous collection of whole blood/RBCs (pre-deposit) for elective surgeries may be considered especially if:
      1. The patient has a dangerous antibody for which antigen-matched units cannot be easily obtained (e.g. anti-k (cellano), anti-PP1Pk (anti-Tja), anti-H (Bombay and Para-Bombay phenotypes).
    2. Autologous collection of plasma may be considered for patients with IgA deficiency with documented specific anti-IgA antibodies.
    3. Other requests will be reviewed by the Head, Transfusion Medicine or designate.
    4. The final decision to proceed with items 2.1 and 2.2 will be made by the Head, Transfusion Medicine or his designate.
  3. Process for Transfusion Medicine Autologous Procedures
    1. The requesting physician shall provide a written or electronic order to the Blood Donor Center.
    2. The request will be reviewed by a transfusion medicine physician.
    3. If rejected, the requesting physician will be notified with the reason for the rejection.
    4. If approved, the donor shall be screened by the usual donation process except:
      1. Hgb >= 11 g/dl will be acceptable for whole blood collection.
      2. Females may also donate autologous plasma.
      3. The last autologous donation will be at least 72 hours before the elective procedure.
    5. Marker testing:  Components from autologous donors with confirmed positive cases of HBV, HCV, or HIV will NOT be used for autologous donation and will be destroyed.
    6. Computer:  Autologous collections will be entered as specifically at the time of registration in the Medinfo  Hematos IIG blood bank computer system and be labeled as autologous in their corresponding ISBT labels.
    7. The transfusion criteria for autologous units shall be the same as for homologous blood.
    8. Both autologous and allogeneic units will follow the same compatibility testing algorithm.
  4. Responsibilities:
    1. Predeposit:  Directly under the control of Transfusion Medicine for all aspects:  policies, procedures, and direct performance of the procedures, including annual review of criteria
    2. Perioperative:  Division Head, Transfusion Medicine involved in conjunction with Surgery and Anesthesia through the National Transfusion Committee.
    3. Intraoperative:  Division Head, Transfusion Medicine involved in conjunction with Surgery and Anesthesia through the National Transfusion Committee.
    4. Postoperative:  Division Head, Transfusion Medicine involved in conjunction with Surgery and Anesthesia through the National Transfusion Committee.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA, 2014
  2. TRM.41600 CAP Checklist Standard

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

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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.

Universal Low-Titer Group O Whole Blood

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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

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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

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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

Stem Cell Collection Logistics

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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.