Category: Apheresis

Includes therapeutic and donor apheresis

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

Manual CCP Plasmapheresis Collection

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Principle:

Due to the pandemic, we will initially MANUALLY collect an experimental, investigational-use-only plasma product from apheresis donors and treat it with Mirasol.  THIS IS A EMERGENCY INTERIM PROCESS UNTIL THE MEDINFO HEMATOS IIG PROCESSES ARE PREPARED AND VALIDATED.

Policy:

  1. Good Manufacturing Practice applies:
    1. Manufacturers’ recommended processes for equipment and materials usage applies.
    2. All staff engaged in these processes must be competency assessed successfully.
  2. Pre-Screening:
    1. Clinical staff will use the prescreening document to select donors for pre-donation screening.
  3. Quarantine:
    1. All processes (day 0, day 1, day 2, and product modification and release) will be done in quarantine areas SEPARATE and DISTINCT from regular Transfusion Medicine activities.  This includes:
      1. Separate space and equipment must be provided.
        1. Equipment for this project may NOT be used for regular, non-quarantine processes
    2. Non-Transfusion Medicine staff will not be permitted in operational areas.
    3. Prospective donors will not be permitted in the processing, testing, storage, or blood bank work areas.
  4. Donation Process:
    1. Day 0:  Registration, check donor deferral database, questionnaire, physical exam including arm check, and specimen collection using ISBT specimen labels
    2. Use latest manual donor questionnaire.
    3. Day 1:  Donor marker and immunohematology testing, review of results, accept or reject donor for actual plasmapheresis
    4. Day 2:  Collect manufacturer’s recommended volume of plasma (500 ml if < 80 kg, 600 ml if >= 80 kg), aliquot, pathogen-inactivate (Mirasol), freeze at minus 80C
  5. Testing:
    1. Testing will be performed with regular blood donor specimens using ISBT specimen labels
    2. Testing must be done by donor-specific processes (not those for clinical patients)
    3. Testing must be directly interfaced to Medinfo Hematos IIG donor module
  6. Processing:
    1. Aliquoting, pathogen-inactivation, and labelling may proceed if the pre-donation screening results are acceptable.
  7. Storage:
    1. Long-term in minus 80C quarantine freezer
    2. Short-term at 1-6 C just after thawing in quarantine refrigerator
    3. Standard temperature monitoring and alarms apply
  8. Labelling:
    1. The backup manual labelling process applies
    2. The ISBT specimen label will the donor unit number
      1. Outdate will be 6 years if the product is stored at -65C, 1 year if stored at -18C
  9. Product Release:
    1. Orders must be on the PAPER requisition (old Blood Bank Order Form) with a patient prescription:
      1. No orders in Cerner
    2. Thawing plasma at 37C upon receipt of order by Transfusion Medicine staff
    3. Signing out component to clinical unit by Transfusion Medicine Staff
  10. Information Technology:  Medinfo Hematos IIG customized software to be implemented as soon as possible for all processes
  11. Not covered:  Transfusion Medicine is NOT responsible for:
    1. Triage of request for convalescent plasma
    2. Pickup and transport of components

8/4/20

Pre-Screening for Convalescent COVID-19 Donor Candidates

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All blood components are considered medications and are subject to Good Manufacturing Practices as mandated by international accreditation standards.  The whole process must be done reproducibly and precisely by specific personnel trained and documented to be competent.  This includes collection of convalescent COVID-19 plasma.

Transfusion Medicine will provide staff who are deemed competent for the entire process of the collection, manufacture, and release of this unlicensed, emergency-contingency component.

It will help greatly if all candidates are prescreened to exclude the following candidates:

Administrative:

Donors must come with a valid Qatari identity card:  no ID means no screening

Sex:

Males only to minimize the risk for transfusion-associated lung injury TRALI

Donor Feeling:

If the donor does not feel well, he should not come for screening/collection.

Food/Drink:

Donor must have eaten/drunk fluids within 4 hours of arrival for screening/collection.

Medication exclusions:

  1. Antibiotics within the past 14 days
  2. ACE inhibitors in the past 48 hours
  3. Beta blockers
  4. Anticoagulants
  5. Anti-anxiety or other psychotropic medications
  6. Other medications in the attached list DHQ 2.0

Medical exclusions:

  1. Stable vital signs
  2. History of seizures
  3. History of dementia or other chronic neurologic disorder
  4. Family history of dementia or other chronic neurologic disorder
  5. Significant cardiac arrhythmias
  6. History of hepatitis B, hepatitis C, HIV, brucellosis, Ebola

Travel history:

  1. 5 years cumulative residence in Europe including Ireland and France 1980-2001
  2. 3 months cumulative residence in the UK (and/or all its territories) 1980-1996
  3. Any visit(s) to West Africa

This is NOT a complete list of criteria.  Transfusion Medicine personnel will screen according to the full donor criteria.  Thus, donors passing the prescreening may still be otherwise disqualified based on the detailed process (testing, physical examination, etc.)

Interim Policy Updated Donor Medication Deferral List 190805 based on DHQ 2.0:

COVID-19 Convalescent Plasma Project, Winter 2020

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While I was still associated with HMC Doha, I developed and set up an expedited setup for COVID-19 convalescent plasma production, initially manual and then fully integrated into the Medinfo blood bank computer system.

Specifically, I built a customized version of our Medinfo blood bank system to replace the manual system and increase safety the safety and production throughput while maintaining good manufacturing practices GMP. The full system (manual first, then computerized) was implemented within two weeks including a completely separate quarantine convalescent COVID donor screening, collections, processing, and release.

Subsequent posts will detail my processes.

Now An Independent Consultant

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I am an independent consultant in Transfusion Medicine. Effective 16 April 2020, I am no longer associated with Hamad Medical Corporation or the State of Qatar.

I am willing to consider other opportunities in Transfusion Medicine (donor, patient, apheresis) and blood bank informatics.

Just before leaving HMC, I established the COVID19 convalescent plasma program with full good manufacturing practices using Medinfo Hematos IIG blood bank software.

I have 10 year’s experience in pathogen inactivation and blood component automated production. I established the first site using Terumo Atreus (later Reveos) with Mirasol pathogen inactivation AND platelet additive solution. I established Medinfo interfaces with all production equipment to achieve GMP.

I have worked with laboratory information systems, especially but not limited to blood bank systems (donor, component processing, donor marker testing, pathogen inactivation, platelet additive solutions) and serve as the Head of the Medinfo IIG (Nice, France) Software Users Group.

I was involved with planning for the national plasma fractionation project in Saudi Arabia. I have worked with this industry while I was practicing in the United States.

It is my philosophy to start with an international framework (e.g.FDA, CE) and localize it for the country’s particular needs. My operation sites have served as international reference sites for combined IT and medical/technical processes.