Category: Apheresis

Includes therapeutic and donor apheresis

Opinion: Ready after Fellowship?

drzeyd

I was recently interviewing a candidate for consultant in Transfusion Medicine.  Several months previously he had completed a fellowship in Transfusion Medicine in the United States.  He was applying for a position in my hospital in Qatar, which included seven hospitals and a blood donor center.  He had no training in donor management or therapeutic apheresis.

The successful candidate was to rotate on-call to cover all hospitals and the blood donor center.  He had never worked outside the United States.  Routinely, he did not review antibody panels since those workups were usually sent to the local blood provider there.  In his training, he had strictly followed US FDA and American version of AABB Standards.  His training center did not routinely do extended phenotypes (C, c, E, e, and Kell).  Extra testing and phenotyping had to be explicitly ordered by the clinician to get reimbursement.  Thus, there was no prophylactic antigen matching done on patients.  He did not feel comfortable reviewing antibody panels.

He had no experience with universal leukodepletion, pathogen-inactivation, platelet additive solutions, or automated component production such as the Terumo BCT Reveos.  He did not interpret donor marker testing results.

On the contrary in our organization, the transfusion medicine physician had to review all antibody panels (usually he was the most knowledgeable person for this).  We followed the Council of Europe CE and other practices that did prophylactic antigen matching.  We were also in charge of donor qualification and therapeutic apheresis and reviewed any product deviations from the Reveos and donor marker testing.

Clearly, this candidate did not practice transfusion medicine in the way that was necessary for our operations.  We could not cut him loose and make him responsible for a hospital transfusion service or the blood donor center.

Let us contrast this candidate for one being recruited for anatomic pathology/histopathology.  Grossing specimens, performing frozen sections, reading slides, diagnosing cases are the same everywhere in the world.  After completing his American certification, he could perform his profession almost anywhere in the world.

Transfusion medicine practices need to be localized and the selection of blood components and donor qualification are different.  Most of the world does not follow US FDA and has access to blood components, tests, and other technology that is different and maybe more advanced than his training in the USA.

I gave him a clinical scenario to interpret.  An AB patient with anti-K needs to be transfused with plasma.  Are there any special requirements for the plasma?  What if the only AB donor had anti-K would you use it?  What if the only RBCs available had not been phenotyped for Kell?  What would you do?

He did not know that we discard plasma with clinically significant alloantibodies routinely.  He did not want to phenotype the RBC unit for this patient since this had not been explicitly ordered by the clinician.

My recommendation was not to hire this candidate if there were others who had worked in European or similar systems to our own practices.  In effect, to use this physician, he would have to undergo a mini-fellowship to learn our practices since they were contrary to ours.  Unfortunately, we were very short-staffed and did not have resources to offer this training.

In summary, blood bank practices are very localized.  If you are considering to hire staff from other countries not following your standards, you must assess if the candidate is flexible to change his practices and/or whether you have the resources to train the physician.

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 Registration

drzeyd

I designed a completely quarantined process for collection, processing, and release of CCP at HMC Doha.  This document shows the Medinfo process for donor registration as a separate donor center code.

Check donor history and donor deferral database.  If there is no previous encounter, generate a new donor file:

At the completion of this action, the Blood Donation Record with the donor unit number (in this example 2200000099) and consent form in English and Arabic is generated.

CCP could only be collected at this special site and only the apheresis bag could be used for collection.  Regular donation options were not available at this CCP site nor was CCP collection an option at the regular donation sites.

8/1/21

Logistics and Processes for a COVID-19 Convalescent Plasma Program

drzeyd

I prepared the following plan for a CCP program for HMC Qatar in March, 2020.  The workflow is divided into four (4) modules:

  1. Registration/Interview/Physical Examination/Apheresis Collection
  2. Donor Marker Testing and Immunohematology Testing
  3. Production/Aliquoting/Pathogen-Inactivation/Storage
  4. Product Thawing/Product Release

Module 1:

  1. Collection/registration/screening must be in a separate area from regular blood and apheresis donations.
  2. Donors must provide consent.
  3. ISBT specimen labels must be used on each tube collected.
  4. We need a minimum of two apheresis nurses, one for the registration/screening/post-donation observation and one for the actual apheresis procedure.
  5. If there will be multiple serial donors, then we need a waiting area (each donor at least 2 meters apart).
  6. Donor screening must be in sound-proof area so that other waiting donors cannot hear the interview/questionnaire process.
  7. Amount that can be collected depends on body weight:  500 ml for <80 kg and 600 ml for >= 80 kg, collection may occur twice per week
  8. Collection time includes 15 minutes for registration/interview/physical examination, 60-75 minutes and 15 minutes for cleanup/disinfection before the next case, approximately 2 hours per donation.
  9. A post-donation observation area (minimum 15 minutes after collection) with apheresis nurse nearby in case of reactions is needed if there will be multiple donors.
  10. Specimens will

Module 2:

  1. Donor testing and donor immunohematology will be done with other donor specimens in our regular location

Module 3:

  1. Apheresis collection must be processed and stored separately from regular blood/apheresis donations.
  2. Processing will occur only after the results are shown to meet all criteria.
  3. Pre-collection testing (test-only donation) would permit processing without waiting for results.
  4. Storage at minus 80C may be for a minimum of six (6) years but this may be extended if needed.
  5. All acceptable components will have a final ISBT label—no products without the ISBT label will be transfused.  The ISBT label indicates that the unit meets all donor criteria for convalescent plasma.

Module 4:

  1. Product modification (thawing) and release (sign out from blood bank) must be in a separate area(s) from the regular hospital blood bank.
  2. Release of convalescent plasma follows the same process as regular component release
  3. Transfusion of convalescent plasma at the patient’s bedside follows same process as regular component transfusion
  4. Nursing and other staff performing the transfusion must pass competency assessment.
  5. Plasma will be transfused as ABO-identical or compatible unless low ABO-titer group A is used.
  6. Plasma must be free of clinically significant antibodies

Workflow Considerations:

  1. Donors must be restricted to the waiting, collection, or post-donation observation areas.
  2. Donors must NOT pass through production, testing, or component release areas (just as they are currently restricted in the Blood Donor Center and HMC hospital blood banks/transfusion services).

Logistics:

  1. Throughput is a maximum of 4 donors (2000 to 2400 ml plasma) per eight-hour shift with one apheresis nurse and one donor apheresis (Trima) machine.
  2. The processes are scalable with additional staff and machines (e.g. with 3 machines and nurses, then 12 donors and 6000 to 7200 ml of plasma collected).
  3. Thawing of 1-2 units of plasma takes up to one hour.  Contact the quarantine blood bank at least one hour before the desired pick-up time.
  4. The four modules above can be in separate areas not adjacent to one another.  Modules 1, 3, and 4 must be quarantine areas where access is limited.  Module 2 can be performed with regular donor specimens using standard precautions.
  5. We can provide training for transfusion of blood components and competency assessment to any location transfusing this product.

Information Technology:

  1. All modules will be connected to the Medinfo Hematos IIG dedicated blood bank computer system.
  2. All records of collection/production/testing/storage/modification/release will be stored therein.
  3. All ordering of convalescent plasma components will be through Medinfo.
  4. External test results (e.g. future antibody titering) can be added to the component information.
  5. Links to the Hospital Information System (Cerner) may be considered after the Medinfo processes are fully functional.

COVID-19 Convalescent Plasma CCP Site Registration

drzeyd

I designed a completely quarantined process for collection, processing, and release of CCP at HMC Doha.  This document shows the Medinfo process for site registration as a separate donor center code.

CCP could only be collected at this special site and only the apheresis bag could be used for collection.  Regular donation options were not available at this CCP site nor was CCP collection an option at the regular donation sites.

4/1/21

Therapeutic Apheresis Policy

drzeyd

This has been revised to recommend the use of a continuously recording portable vital signs device such as Umana’s UT1M (GPI, Italia) which includes PAO2 and heart rhythm measurements.

Principle:

All therapeutic apheresis procedures are potentially life-threatening and must only occur by an order from a transfusion medicine physician with experience/competence in such procedures.

Definitions:

  • Referring Physician is the clinical physician requesting a therapeutic apheresis procedure.
  • Transfusion Medicine Physician is a physician in the Transfusion Medicine Section with medical privileges for therapeutic apheresis procedures.  This includes the Head, Transfusion Medicine, consultants in Transfusion Medicine, and designated specialist physicians in Transfusion Medicine.  The final decision to accept/reject the patient is made by the transfusion medicine physician.
  • Covering Physician is the clinical physician designated by the referring physician to be physically present and covering the patient in case of any adverse reactions during a therapeutic apheresis procedure.
  • Apheresis Nurses are nurses in Transfusion Medicine who are designated by this section for performing therapeutic apheresis procedures.
  • Medical Privileges are determined by Transfusion Medicine in conjunction with the medical privileging by the Medical Director.

Policy:

  1. The referral physician will discuss the request for a therapeutic apheresis with the designated transfusion medicine physician.  The referral physician must certify that the patient can tolerate the procedure based on his medical condition.
  2. The transfusion medicine physician will review the patient’s clinical and laboratory data, with special note of the history of allergies, medications, previous transfusion reactions, and current vital signs.
  3. Vascular access will be initially assessed by the apheresis nurse.  Any questionable situations will be reviewed by the transfusion medicine physician.
  4. The following laboratory values (less than 24 hours old) must be available before the procedure may begin:
    1. CBC including platelet count
    2. PT and APTT
    3. Fibrinogen
    4. Serum calcium
    5. Serum protein and albumin
    6. LDH for TTP cases
  5. A valid type and screen must have been done within the previous three days of the procedure.
  6. Upon review of # 2 through 5, the transfusion medicine physician will determine if the procedure is indicated and will communicate this to the referral physician, who will sign written order in the patient chart.  Appropriate replacement fluids will also be mutually agreed upon in advance of the procedure and ordered by the transfusion medicine physician.  The order specification must include:
    1. Name of procedure and specification (e.g. therapeutic plasma exchange, isovolemic)
    2. Replacement fluid type and volume (e.g. 3 liters 5% albumin, 2 liters, FFP, cryoprecipitate, normal saline)
    3. Blood component orders if indicated (e.g. RBC exchange) and timing (before, during, and/or after the procedure)
    4. Calcium replacement (e.g. 2 grams calcium gluconate IV in 100 ml normal saline to run during the procedure)
    5. Any special laboratory testing post-procedure
  7. The apheresis nurse will follow the orders of the necessary prescribed replacement fluids (FFP, albumin, PPF) in the quantities necessary for the exchange.
  8. The referring physician will obtain the signed, informed consent from the patient.
  9. If vascular access is unsatisfactory, the referring physician will obtain the proper access (central line, AV shunt, etc.).
  10. The referring physician will arrange for a physician member of his team to be present at the actual therapeutic procedure.  This physician designate will be responsible to treat any complications arising from the procedure.
  11. Vital signs and weight will be obtained before starting the procedure.
  12. If the procedure is outside an intensive care unit and the patient is critically ill, consider the use of a portable attached monitoring patch (such as the Umana UT1M device).  The device will give alarm if any measurement is outside the defined ranges.
    1. If any blood components are administered, keep the patch attached to detect TRALI/TACO and other adverse transfusion reactions.
  13. When approved by the Blood Bank Director or designate with proper venous access and informed consent, the apheresis may start the procedure in the presence of the patient’s covering physician.  The procedure will be performed in a designated hospital area.
  14. The procedure must be documented on the appropriate therapeutic apheresis order and procedure worksheets.

References:

  1. Standards for Blood Banks and Transfusion Services Current Edition, AABB, Bethesda, MD, USA
  2. CAP Standard TRM.42245 regarding therapeutic apheresis procedures

Revised 3/1/21

Medinfo COVID Convalescent Plasma Workflow Revisited

drzeyd

It now has been over eight 8 months since I prepared the CCP workflow in Medinfo.  It was built on the framework of the manual CCP process including donor prescreening with an abbreviated donor questionnaire.  It was really quite simple and used the donor and patient modules to create quarantine areas for donor screening, collection, processing, and hospital patient blood bank release.

Here are my current comments on the process:

Donor Qualification:

I would still exclude malaria and HTLV from the donor questionnaire and would update to UDQ 2.1.  Since these donors have recovered from a potentially life-threatening illness, I would keep the Hgb threshold at 11 g/dl.

Donor Collection:

In the future, I would consider using one of the soon-to-be-released portable devices that continuously monitor vital signs with pO2 and EKG lead to rule out asymptomatic pulmonary or cardiac problems.

I would also consider using low-ABO-titer, group A, universally to meet the demand for group B and AB patients.

Donor Testing:

There is still no need to segregate and separately test CCP donor specimens from regular blood donor specimens.  I would perform SARS-CoV-2 antibody testing and set a threshold for qualifying donors—that threshold will be based on the manufacturer’s recommendations.  However, if the treating physician wanted to use a low-titer unit, I would permit this.

Donor Processing:

There is no need to change this from the current processes.  Keep the CCP processing separate from the regular operations.

CCP Plasma Release:

I would keep the quarantine release and restrict it to the locations used for treating COVID-19 patients

Medinfo Software Modifications:

I would record the IgG and IgM titers for SARS-CoV-2 antibodies in each donation record.  This would include testing and entering the results on donations prior to this testing.  ISBT labels should include this antibody titer.

Hospital Information Software Modifications:

Set up restricted CCP ordering for the actual treating physicians only.  Also provide the ISBT code and shortened descriptors to it if necessary (certain HIS vendors still cannot read ISBT codes natively).

The original CCP workflow is attached for reference.