Category: Apheresis

Includes therapeutic and donor apheresis

Processes and Software Building 47: Apheresis Plasma

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At HMC during my tenure, all plasma products—whole-blood and apheresis-derived were pathogen inactivated with riboflavin (Mirasol).  In our software processes, I had options to release both Mirasol-treated and untreated (the latter in emergencies) and to aliquot either as needed.  The same processes applied to COVID-19 convalescent plasma CCP except that they were performed in a quarantine production area.  There were specific ISBT codes for CCP.

24/9/20

SARS-CoV-2 Vaccines and Donor Qualification

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Principle:

Under AABB and FDA rules in the Uniform Donor History Questionnaire, unlicensed, investigational vaccines have a 12-month deferral or as indicated by a responsible physician.  In light of the anticipated vaccination trials for COVID-19, this policy gives interim guidance until more definitive information is available.

For COVID-19 Convalescent Plasma CCP donation, investigational vaccine recipients should not donate COVID-19 convalescent plasma until further information is available about their antibody profile.

Policy:

Any donor who has received a COVID-19 (SARS-CoV-2) vaccine will be deferred as follows:

  1. Whole blood or apheresis donation (except COVID-19 convalescent plasma):
    1. Live, attenuated vaccine:  14 days post vaccination
    2. Non-replicating, inactivated, or RNA-based vaccine:  NO DEFERRAL
  2. COVID-19 Convalescent Plasma CCP Donation:  DO NOT ACCEPT

Reference:

Text from the AABB Weekly Report:

Novel Coronavirus Update, Regulatory Update:  Investigational Vaccines and Deferral for Donor of Blood and Convalescent Plasma, AABB Weekly Report, 7 August 2020

“FDA recognizes AABB’s DHQ which includes unlicensed (experimental) vaccines on the medication deferral list as a 12-month deferral or as indicated by the responsible physician.

“For routine blood donation, the responsible physician may wish to consider the potential infectious risk associated with the vaccines, and the use of short deferral periods (e.g., 14 days) for live attenuated vaccines and no deferral for non-replicating, inactivated or RNA-based vaccines.

“We agree that no deferral is necessary for routine blood donors who might have received the mRNA-1273 Moderna vaccine.

“At this time, we suggest that individuals who have received a COVID-19 investigational vaccine should not donate COVID-19 convalescent plasma until further information is available about their antibody profile.”

Donor Deferrals for Body Fluid Exposure

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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.

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.
  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

Selection of Components for ABO-Incompatible Renal Transplants

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Principle:

Kidneys have strong expression of ABO type and must be matched the same way as RBC components.  In the case of ABO-incompatible renal transplants, we must not give significant amounts of plasma incompatible to the ABO type of the donor kidney.  Plasma must also be compatible with the patient’s ABO type for RBC transfusions.  The amount of residual plasma in PRBCs is limited since we use an additive solution SAGM.  Likewise, platelet components are suspended in platelet additive solution with only minimal residual plasma.  Cryoprecipitate has only minimal plasma and is given without regard to the patient’s ABO type.

Policy:

  1. RBC components:  Use ABO-compatible RBCs in SAGM.  DO NOT USE WHOLE BLOOD!!
  2. Platelet components in platelet additive solution PAS (normally available component):  Any ABO type may be given
  3. Platelet components in plasma:  Only group AB platelets may be used.
  4. Plasma (any type FFP, FP24, solvent-detergent treated, or thawed):  Only group AB plasma may be used
  5. Cryoprecipitate:  Any ABO type including mixed types may be used, mixed types are preferable to neutralize the minimal ABO-incompatible plasma.

References:

  1. Standards for Blood Banks and Transfusion Services, AABB, Current Edition, Bethesda, MD USA
  2. Technical Manual, AABB, Current Edition, Bethesda, MD, USA

Review of Product Inserts

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This is a policy I made for NGHA Jeddah many years ago but is still useful today.

Principle:

All technical staff are required to read and understand the manufacturer package inserts that apply to the procedures that they perform.  This policy establishes a means of documenting compliance with this requirement.

Policy Details:

  1. Technical staff are defined as anyone who uses the reagent in the performance of a procedure or process or anyone reviews or supervises that process or procedure.  This includes the supervisor, medical technologists, medical technicians, nurses, phlebotomists, and assistants.
  2. All technical staff are required to read and understand ALL product inserts for each procedure applicable to the section(s) that they work in—apheresis, donor room, component preparation, and/or transfusion service.
  3. If they have any questions about a particular insert, they should refer it to the supervisor, senior technologist (Med Tech 1), or in the latter’s absence, the blood bank medical director/section head.
  4. Each staff member must sign the Manufacturer’s Package Insert Review Form for that particular policy/procedure, including his signature, employee identification number, and date.
  5. Each Manufacturer’s Package Insert Review Form will be retained with a copy of the package insert by the Blood Bank Supervisor in a special file while the material is being used and for at least five (5) years after a new or revised manufacturer package insert is applicable.
  6. A new Manufacturer’s Package Insert Review Form should be used for each revision of the insert.

Insert Review Form

Type of Insert:  New  Revised
Product Name:
Date of Insert:

I have read this insert and understand its contents and accept responsibility for following its instructions and directions.

Staff Name & Badge #–PRINT!SignatureDate
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   

Sample Resident Examination for Donor Center

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Reading Assignments:

  • Chapters 5-9:  Blood Donation and Collection in Technical Manual, 16th Edition
  • Standards for Blood Banks and Transfusion Services, AABB, 25th Edition

Study Questions:

  1. Which of the following candidates is acceptable for donation?
    1. Saudi, visited Sudan 11 months ago as part of National Guard exchange
    2. Saudi former student lived in UK for 2 years from 1993-95
    3. Normotensive taking amlodipine and valsartan
    4. Psoriatic using Tegison
    5. Male adult using ibuprofen for lower back pain
    6. Female 4 weeks post-partum
    7. Husband of patient with recent onset of hepatitis B infection
    8. Male stopped taking ampicillin one week ago for acute pharyngitis
    9. Donor with WBC count 12000/cmm but otherwise normal
  2. Which of the following donors is suitable for autologous donation?
    1. Cataract surgery patient
    2. Well, but had gastroenteritis 3 days ago
    3. Pregnant with Hgb 11 g/dl
    4. CGL patient with Hgb 13 g/dl
    5. Hodgkin’s disease patient Hgb 12 for exploratory laparotomy
    6. Patient with rare antibody anti-Tja, Hgb 13 for cholecystecomy
  3. How do you handle the following events?
    1. Donor draw fills bag with bright red blood in 30 seconds
    2. Donor faints when needle is shown
    3. Lipemic serum during donor plateletpheresis session
    4. Donor with numbness and tingling of extremities during donor apheresis session
  4. How would you handle the following therapeutic phlebotomy requests?
    1. Hgb 22 g/dl, suspected polycythemia rubra vera
    2. Hgb 13, suspected hemochromatosis patient
    3. Hgb 16, renal failure patient post-erythropoietin treatment
    4. Unstable angina, Hgb 9
  5. What is the final volume of each of the following blood components?
    1. Whole blood
    2. Packed RBCs—state hematocrit as well
    3. Washed RBCs
    4. Irradiated packed cells
    5. Platelet pool—state number of platelets
    6. FFP
    7. Cryo-poor plasma
    8. Cryoprecipitate
  6. What are the outdates of each of the following components?
    1. Packed RBCs
    2. Platelet pool
    3. FFP frozen at -35C
    4. Granulocyte concentrate
  7. Which donor units are acceptable for transfusion?
    1. HBsAg negative, HBcAb positive, HBsAb > 20 IU/liter
    2. HCV Ab positive, RIBA-3 negative, HCV-RNA negative
    3. Syphilis positive, FTA-ABS negative

Revised:

29/8/20

Advanced Hematology Resident Training in Donor Center and Apheresis

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Objectives:

  1. Donor criteria based on AABB standards
    1. Is it safe for the donor to donate?
    2. Medical history
      1. Current medical conditions
      2. Past medical conditions
  2. Medications
  3. Vaccinations
  4. Travel history
  5. High-risk behaviors
  6. SARS/MERS
  7. COVID-19 convalescent plasma CCP
  8. Prion diseases
  9. Donor medical examination
  10. Is it safe for the recipient to receive the donor’s blood?
  11. Donor registration issues
    1. Positive identification
    2. Donor deferral database
  12. Donor phlebotomy
    1. Safe volume to donate
    2. Anticoagulant-preservative solutions
    3. Time limit for phlebotomy
    4. Post-donation care
  13. Donor reactions—Dx and Rx of the following:
    1. Vasovagal
    2. Seizures
    3. Air embolism
    4. Arterial stick
    5. Hematoma
  14. Donor Apheresis
    1. Plateletpheresis
    2. Plasmapheresis
    3. Plateletpheresis with concurrent plasma collection
    4. RBC collection
    5. Combined platelet, plasma, and RBC collection
  15. Autologous donation
    1. Predeposit
    2. Perioperative
    3. Intraoperative
    4. Postoperative
  16. Donor self-deferral
  17. Therapeutic Phlebotomy
  18. Therapeutic Apheresis
    1. Therapeutic plasma exchange/plasmapheresis
    2. Leukapheresis
    3. Thrombapheresis
    4. Red cell exchange
    5. Stem cell collection
    6. Column absorption technologies
    7. Clinical indications
    8. Writing orders for above procedures
  19. Component Processing:
    1. Manual
    2. Automated—Reveos
    3. Pathogen Inactivation Mirasol
    4. Buffy coat vs classic platelet-rich plasma platelets and pools
    5. Platelet Additive Solution PAS
    6. FFP, FP24, thawed plasma
    7. Cryoprecipitate
    8. Cryo-poor plasma (plasma, cryoprecipitate-removed)
    9. COVID-19 convalescent plasma CCP

Clinical Responsibilities (after proven competence):

  1. Triage of donor requests
  2. Handling of donor reactions
  3. Approval of therapeutic phlebotomies
  4. Assistance with therapeutic apheresis

Assessments:

  1. Pre-training/baseline
  2. Competency documentation for clinical responsibilities (#11 above)
  3. Post-training

Working Hours:

  1. 0900-1700, Saturday through Wednesday
  2. Must carry pager for clinical responsibilities

Reviewed 17/8/20

Therapeutic Apheresis Responsibilities

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Transfusion Medicine TM:

  1. Head, TMS, or the covering TM physician discusses case with the most responsible physician MRP; the plan of action mutually is agreed upon.
  2. Head, TM, or the covering TM physician gives verbal or written orders to apheresis nurse, including:
    • Type of procedure (RBC exchange, plasmapheresis, plasmapheresis with column absorption, leukapheresis, thrombopheresis, stem cell collection)
    • Machine parameters if indicated (e.g. fraction of cells remaining FCR, target hematocrit, unit hematocrit for RBC exchanges)
    • Amount of exchange in liters (e.g. one-volume, two volume, etc.)
    • Fluid balance (e.g. isovolemic, volume-reduced, volume enhanced)
    • Replacement fluids and volume (e.g. normal saline, 5% albumin, ACD-A, blood components, solvent-detergent treated plasma SDP)
    • Calcium replacement (calcium gluconate IV)
    • Orders for laboratory testing prior to and after the apheresis (usually CBC, PT, APTT,  fibrinogen, total protein, albumin, calcium, LDH for TTP/HUS)
  3. Apheresis nurse convey the order to the ward/clinic.
  4. The requesting clinical service will place the order in the hospital information system.
  5. If a verbal order is made, TMS physician will sign his verbal orders, a copy of which will kept in the Apheresis Unit.
  6. If the hospital computer system is used, the TM physician will enter his orders and the apheresis nurses will take off the orders electronically.
  7. If a stem cell product is collected:
    • TM will label it with a unique alphanumeric identifier barcode, i.e. an ISBT specimen label with check-digit that is generated by the Medinfo Hematos IIG system .
    • Cellular Therapy Laboratory staff in conjunction with the apheresis nurse will sign-out the collection from TM to CTL using two donor identifiers:  patient name and the unique alphanumeric sequence barcode (same as process of sign-out of blood component).
  8. Note:  Use of Medinfo HIIG for stem cell collection is out of scope of TM.

Cellular Therapy Laboratory:

  1. Directly receive collected product from apheresis nurses will use the procedure outlined in 7.2 above.

Most Responsible Physician:

  1. Initiates request for apheresis with Division Head. Transfusion Medicine or covering Transfusion Medicine physician.
  2. Obtains informed consent from patient
  3. Arranges for proper venous access (rigid-bore central line or AV shunt)
  4. Is responsible for clinical support during the procedure
  5. Provides medication changes (e.g., substitution of non-ACE-inhibitors for hypertension therapy) as requested by the Head, TMS or Transfusion Medicine Physician

Ward/Clinic Nursing Responsibilities:

  1.  Ward/clinic nursing staff effect written orders to obtain replacement fluids (albumin, blood components, crystalloid), calcium, and order tests in hospital computer.
  2.  Ward nurses provide support (e.g., obtain medications, blood components, and miscellaneous items such as gauze, etc. and bring them to patient’s room) DURING THE PROCEDURE.
  3.  As per Apheresis Policy (TRM-PM-410-000-000-01), the assigned staff nurse from the unit shall contact the Blood Donation Center.
  4. The assigned clinical staff nurse from the unit should call the local Blood Bank to request preparation of the requested components, e.g. RBCs, FFP, or cryoprecipitate and follow up.
  5. To avoid unnecessary delays before calling the Blood Donor Center Apheresis Staff Nurse the assigned unit staff nurse shall inform the Blood Donation Center Charge Nurse when the following have been completed and are available on the ward:
    • Signed, informed consent
    • A central line with a large bore double lumen.
    • Completed blood laboratory results
      • Only results within 24 hours of the intended procedure may be used to write the order.
      • In some cases, more recent results may be required (e.g. TTP) at the discretion of the Transfusion Medicine physician.
    • The ordered replacement fluids such as normal saline, thawed or liquid plasma, cryo-poor plasma, albumin and red cell units available in the ward
    • Calcium gluconate (ordered amount in 100 ml normal saline) available
  6. The assigned apheresis nurse shall then perform the required therapeutic apheresis procedure strictly following the related TRM standard operating procedure.

Note:

  1. Apheresis is a SCHEDULED, high-priority procedure like other invasive procedures. The ward must make certain that the patient is available for the procedure at the scheduled time and place.
  2. Normally, apheresis procedures are performed 0600 to 1500 hours daily.
  3. The service is ONLY available 24/7 for emergency procedures outside this time frame. Emergencies must be approved by the TM physician.
  4. Transfusion Medicine does not guarantee that non-emergency procedures will be performed outside the 0600-1500 time frame.
  5. The most-responsible physician MRP is responsible for the patient’s concern form, establishing the proper venous access (rigid-bore central line), and providing coverage ON-SITE during the procedure. The apheresis nurse may not leave the patient’s bedside during the procedure.
  6. The apheresis nurse reports directly to the Division Head, Transfusion Medicine or the covering TM physician, not to the ward or MRP.   Any issues about changing the apheresis orders must be approved by the Head, TM or the covering TM physician.
  7. All other procedures must be cancelled during apheresis.
  8. If the patient is not available at the specified, scheduled time, the procedure will be cancelled.
  9. If ward or MRP support is not available, the procedure will be cancelled.

Therapeutic Apheresis

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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 the Department of Pathology and Laboratory Medicine in conjunction with the HMC 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. 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.
  13. 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