Updated COVID-19 Donor Eligibility Requirements

Principle:

This policy is based on the 19/1/21 CBER document Updated Information for Blood Establishments Regarding COVID-19 Pandemic and Blood Donation.

Policy:

  1. There is no COVID-19 laboratory testing requirement for routine blood donor screening.
  2. Donors must be in good health and meet all blood donor eligibility criteria on the day of donation.
  3. The blood establishment’s responsible physician must evaluate prospective donors and determine eligibility according to the blood donor criteria.
  4. Donors with a diagnosis of COVID-19 or who are suspected of having COVID-19 and who had symptomatic disease should refrain from blood donation for at least 14 days after COMPLETE resolution of symptoms.
  5. Donors who had a positive diagnostic test (RT-PCR SARS-CoV-2 or equivalent) but never developed symptoms, should refrain from blood donation for at least 14 days after the date of the positive test result.
  6. Donors who are positive for SARS-CoV-2 antibodies but did not have prior diagnostic testing and never developed symptoms can donate WITHOUT a waiting period and WITHOUT a diagnostic test (RT-PCR).
  7. Vaccination deferrals are as follows:
    1. Recipients of nonreplicating, inactivated, or mRNA-based COVID-19 vaccines can donate blood WITHOUT a waiting period if #2 above applies.
    2. Recipients of live attenuated viral COVID-19 vaccines should be deferred for 14 days after receipt of the vaccine.
    3. Recipients who are uncertain which COVID-19 vaccine was administered, should wait 14 days.

Note that these rules do not address the special case of COVID-19 convalescent plasma donors.

References:

Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Transfusion, CBER, US FDA, 19/1/21

Comments in Medinfo Hematos IIG

This post is the policy for using comments in Medinfo software.  A subsequent post will show the process of entering comments.

Principle:

There are several different types of comments in HIIG:

  • Donor Global
  • Patient Global
  • Analytical Comments
  • Result Comments
  • Contraindication Comments

Global Comments appear on the first main screen of either the donor or patient record.  The presence of comments is indicated by a bar at the bottom of the screen (in yellow or blue saying Presence of Comments.  Double-clicking opens the list of entered comments.

Examination/Results Comments appear only when you open the result to which it is attached.  You must know in advance to which result they are linked to find them.

Contraindication Comments appear when entering a donor deferral code

At HMC, we will enter examination/results comments again as global comments (donor or patient) so it is easy for staff to retrieve them and see them with all other comments.  You can do this by cut and paste.

Physicians may enter any of these comment types.  Comments may be entered before or after a test is authorized/verified.  If entered after authorization, the test must be modified to accept the comment and require a special password (not the user sign-into HIIG).  Only results/examination comments are visible in the patient’s medical record.  Global, analysis, and contraindication comments are visible only in HIIG!  Donor comments are only visible in HIIG.

The presence of comments documents physician review of abnormal results as required by the various accreditation standards.

Policy:

  1. Only designated staff may enter comments.
  2. Comments entered after authorization/verification of results will modify the donor/patient record and require a special, high-level password distinctly different from the normal user password.
  3. Enter comments in the following situations:
    1. Telephone call documentation (e.g. critical values).
    2. Interpretations of donor or patient test results, transfusion reactions, etc.
    3. Instructions for the selection of specific and/or modified blood components
    4. Donor eligibility issues (e.g. donor marker testing abnormalities and disposition)
    5. Donor reactions
    6. Donor counseling documentation (e.g. donor counseled at 0930 on 24/3/14 about his abnormal result).
    7. Any special instructions to staff
    8. Any other situation where the transfusion physician/supervisor or designate determines it is desirable to enter a comment
  4. Copy all results/examination-comments and also enter then as global comments against the patient or donor record as applicable.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Workflows 1001-1005, Medinfo Hematos IIG, 2013-2014.

Therapeutic Phlebotomy Process–Updated

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

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

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

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