Category: Patient

Includes compatibility testing (AHG, electronic, immediate-spin), antigen typing, antibody screening and identification, direct antiglobulin testing, elution, transfusion reaction and drug reaction workups, component typing tests upon receipt in hospital blood bank, release and return of components

Inter-Depot Transfer: Further Thoughts

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In my recent post, I provided sample flows and parameter mapping for delivery of blood components.  The final components from the component preparation center may be sent to various depots (freestanding location and/or hospital blood banks.  There should be complete traceability for every step (from donor reception, collection, testing, and processing) transport between locations, and finally the exact storage site, which might include which refrigerator/freezer/incubator and even shelf/position number for each component is stored.  The end of that document showed rules for type/antigen matching.

For disaster planning, rapid inventory enumeration by type is very important.  This can be very time-consuming manually.  With our Hematos blood bank system, we could quickly get total inventory across the Qatar or by hospital in less than one minute.  We could also quickly find antigen-matched units across the system and reserve it at any one site for another if necessary.

Smart blood bank dispensing refrigerators, as offered by Haemonetics and Angelatoni, may also serve as depots and take the place of a hospital blood bank for some dispensing.  These solutions can also capture vital information about the storage conditions of the components and prevent release if the storage criteria are not met.  They can also interface with blood bank computer systems and use the main system’s logic for the dispensation rules.

Upon receipt at the hospitals from the blood processing center, the forward ABO and D typing must be confirmed.  We used D reagents which detected partial D so that we would call such donor units as D-positive.  However, if a patient type reagent insensitive to partial D types were used, it is possible for a unit to be typed as D-negative whereas in the donor center it might be D-positive.  Sometimes, nothing types consistently as D-positive:  all you can say is that with a particular reagent and lot number, there is or isn’t reactivity.

The greatest complexity is for RBCs since potentially so many antigens exist.  Criteria for matching/ignoring certain antigens must be made.  Critically significant antibodies such as the Kell, Duffy, Kidd, and certain Rh (D and c) must be antigen matched.  A robust blood bank computer system can enforce these rules.

For other components, antigen/typing may be less important.  In fact, in most situations, any type of platelets can be given to anyone (except neonates).  Despite the potentially incompatible plasma, there is rarely significant hemolysis.  In fact, if pooling platelets without regard to blood types is done, a platelet transfusion is a common cause of a positive direct antiglobulin test DAT—something that is not clinically significant.  No one died of a positive DAT by itself for this reason.

Specific rules for compatible plasma types are important, but nowadays, low-titer group A plasma may be used like universal AB plasma.  The challenge is to be able to perform the ABO titration (specifically anti-B) quickly—titration can be a slow process, even with automated equipment.  A similar situation for low-titer, universal group O whole blood requires both anti-A and anti-B titration (I will return to this topic in a future post).

RBC Antigen Matching

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In the previous post, the Medinfo document for Inter-Depot transfer had many pages of rules for matching RBC antigens.  Multiple actions were available:

  1. Forced Match, no release of untested or antigen-mismatch (e.g. anti-Kell requires specifically tested K-negative RBCs).
  2. Match Optional (e.g. anti-Lea/Leb does not require Lewis-matched blood):  system would flag a comment showing the antibody specificity, user would respond Y/N, and select units
  3. Least-Incompatible (e.g. WAIHA):  requires sufficient privilege (senior technical or transfusion physician) to authorize release
  4. Permitted Incompatible (e.g. give C-positive to patient with anti-C in times of shortage or complex multiple antibodies without fully matched blood available):  requires sufficient privilege to release
  5. Fully Allowed (e.g. group O RBCs to group A, AB, B patients)—no flagging, allocation of units permitted
  6. Prohibited Under Any Circumstance—NO Override Permitted (e.g. group O for Bombay Oh, c-positive for anti-c, K-positive for anti-K)

To avoid mistakes, the blood bank computer system enforced the rules.  There was no mercy.  Only specific individuals could override this( in many cases, but certain allocations (e.g. group O RBCs to a Bombay Oh patient) were not permitted under any circumstances.

Prophylactic Antigen Matching:

Please also refer to my prophylactic antigen matching post made last week for the rules I selected for Qatar.

Prophylactic antigen matching is common in Europe.  I have been doing this during the many years I have worked in the Middle East.  Most patients were not local nationals but transient.  They would return to their home countries where blood bank testing (antibody screening/identification/antigen matching) or intrauterine exchanges might not be always available.

For pregnant patients, we would prophylactically match K-negative and c-negative—regardless if there were antibodies detected—R1R1 units for R1R1 patients.  At the end of my time in Qatar, we had several pregnant women with various Rh deletions, so we added routine extended Rh(D) and Kell typing to all.

For sickle cell patients, especially African type, I would prophylactically match Rh antigens (D, C, c, E, e) and Kell because of the polymorphisms in the CE gene, some of which may lead to pan-Rh antibodies.

I would consider selective prophylactic antigen matching in chronically transfused populations, again regardless if clinically significant antibodies were detected.

If a patient makes any antibody, regardless if is clinically significant or not, I would consider that patient as a candidate for prophylactic antigen matching (but NOT necessarily for a clinically insignificant antibody).

In Qatar, blood bank services (testing and components) were not charged to the patient.  In many other parts of the world, blood bank is a cost center.  No prophylactic antigen matching may be routinely performed.  If it is done, it must be charged to the patient or the hospital must assume the cost.  I have gone to conferences in such locales where not even R1R1 patients were not matched and subsequently developed anti-c, which complicated management.  It would have been cheaper to do the antigen matching than to pay for the consequences of the alloimmunization.

Overview: Inter-Depot Transfer and Allocation of Blood Components

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While I was working in Qatar, this was the overall process for transfer and allocation of blood components. Once they were finally labelled (only possible if all criteria had been meet), they were transferred from the Blood Donor Center BDC to Hamad General Hospital Blood Bank, from which they were distributed to all hospital blood banks in Qatar. Similarly, units could be transferred between the various hospital blood banks.

One could track components as being in:

  1. BDC
  2. Transit BDC to HGHBB
  3. HGHBB inventory
  4. Transit HGHBB to another hospital blood bank
  5. Transit between any two hospital blood banks

An inventory manifest would be printed to show all transferred units.

For patient use, allocation rules applied which would determine if an electronic or a full antiglobulin-phase crossmatch could be used and whether specific antigen-matched components were required.

There were also separate rules for emergency release if the standard criteria could not be met.

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

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.