Tag: Donor Processing

Automated and manual component processing including Reveos, Mirasol, PAS

Processes and Software Building 42: Platelet Pooling

drzeyd

Outside the USA, platelet pools stored at room temperature may be valid for up to 7 days, especially if pathogen-inactivation is used.  The following workflow shows both Mirasol pathogen-inactivated and standard platelets.  The standard platelets are then irradiated.  Both types can be aliquoted.

A major advantage in using a specific blood bank computer software is to enforce the Good Manufacturing Process.  Medinfo is merciless:  there are no exceptions without authorization and that is restricted by the security policies.

In the recent Reveos post, the upper and lower platelet volume specifications were discussed.  The platelets are weighed and the volume is calculated.  If a manual or another method for preparing platelets is used, then the according values can be specified.

To Be Continued:  8/9/20

Review of Product Inserts

drzeyd

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

drzeyd

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

Processes and Software Building 40: Reveos Detailed Settings

drzeyd

A major advantage in using a specific blood bank computer software is to enforce the Good Manufacturing Processes.  Medinfo is merciless:  there are no exceptions without authorization and that is restricted by the security policies.

The following tables show the values established at HMC Doha during my tenure.  These values were recommended by the Terumo BCT Reveos engineer after his direct, hands-on set-up of the equipment.

The minimum and maximum volumes for platelets are specifically designed to work for pooling the buffy coats before Mirasol pathogen inactivation.  There are different settings for platelets suspended in plasma versus those suspended in platelet additive solution PAS.

Similarly, there are specific volume ranges for plasma so that pathogen inactivation can be performed according to Terumo BCT recommendations.

To Be Continued:  4/9/20

Processing and Software Building 39: Atreus and Reveos

drzeyd

Automated component processing is an almost hands-free separation of into packed RBCs (ready for leukodepletion), buffy coat platelets (ready for pooling), leukodepleted plasma, and a residual buffy coat.  The older Atreus device takes about 10 minutes for one whole blood unit whereas the newer Reveos device needs slightly more than 20 minutes to process four whole blood units.  At the end of processing:

  1. RBCs are ready for leukodepletion using the integral filter provided with the kit.
  2. Plasma is ready for pathogen-inactivation and freezing.
  3. Buffy coat platelets are ready for pooling using the Platelet Yield Index PYI.
    1. Further processing (filtration and Mirasol treatment) occurs if the donor marker testing results pass
  4. Residual buffy coat is not a clinical product but may be used for quality control for stem cell processing and/or cell line expansion

The process in Medinfo is as follows:

  1. Receive the whole blood units for processing by reading the ISBT specimen barcode.
  2. Collection data (volume, time to complete collection, time of collection, etc.) is transferred to the component processor.
  3. Select the processing machine:  Atreus vs. Reveos
  4. Select the protocol:  2C (RBCs and plasma) versus 3C (RBCs, platelets, and plasma)
  5. Further processing as per the flow diagrams.

At HMC Doha, Medinfo developed the first bidirectional interfaces to both Reveos and Atreus.

To Be Continued

2/9/20

Advanced Hematology Resident Training in Donor Center and Apheresis

drzeyd

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

Processes and Software Building 38: Component Processing Overview

drzeyd

As with each major area of Transfusion Medicine, a current state is captured.  From this, a future state overview is then developed.

At this time, the client should study his current state and the future state and see how he can bolster the critical control points and build them into the processes.

In this series of posts, we will consider:

  1. Component production by Reveos automated component processing
  2. Component production by Atreus automated component processing—replaced by Reveos
  3. Manual component processing
  4. RBC leukodepletion
  5. Platelet pooling
  6. Mirasol pathogen inactivation for platelets and plasma
  7. Platelet production with platelet additive solution PAS
  8. Cryoprecipitate and cryo-poor plasma production
  9. Labelling

The example of current and future state shown is what Medinfo and I built for HMC Doha:

To Be Continued

1/9/20

Basic Hematology Fellowship Rotation in Transfusion Medicine

drzeyd

Objectives:

  1. Donor Center
    1. Donor eligibility criteria
    2. Whole blood collection
    3. Donor apheresis (platelets, plasma, dual-RBC)
    4. Donor reactions
  2. Therapeutic Apheresis
    1. Plasma exchange
    2. Leukocyte reduction—stem cell collection
    3. Reductive thrombapheresis
    4. RBC exchange
    5. Column-absorption procedures including phototherapy
  3. Component Preparation
    1. Preparation and release issues
  4. Transfusion Service:
    1. Blood component therapy
    2. RBC blood groups
    3. Compatibility Testing
    4. Antibody Identification and clinical significance
    5. Transfusion reactions
    6. Direct antiglobulin test clinical significance
    7. Drug-related hemolysis

Venue:

TMS Donor and Transfusion Services

Conducted by:  Head, TMS, and senior TMS technical staff

Evaluation:

Discussion of topics with TMS Head and written final examination

Source Materials:

  1. Technical Manual, AABB
  2. Standards for Blood Banks and Transfusion Services, AABB
  3. Apheresis, Principles and Practice, AABB

This is a full-time, one-month rotation—attendance in mandatory.  Vacations should NOT be taken during this rotation.

Originally Prepared for NGHA Riyadh 31/3/09

Reviewed 26/8/20

Whole Blood

drzeyd

In my long career, there have been cycles in transfusion practice.  Today’s dogma becomes yesterday’s heresy and then later again the dogma.  Just consider the selection of blood components before the introduction of cyclosporine for intended renal transplant recipients.

In training, I was told NEVER, NEVER use the intended donor’s blood for the renal recipient.  This would immunize him against the donor tissue antigens and cause the transplant to fail.

Several years later after cyclosporine, we were doing a booming business of directed RBC transfusions from the donor to his/her recipient.

Just a few years ago, I used blood component therapy for all, especially trauma patients.  Give the victim what he lacks:  for oxygen-carrying capacity, RBCs;  for volume crystalloid;  for low protein albumin;  for coagulopathy FFP, factor concentrates, cryoprecipitate;  for thrombocytopenia, platelets.

Most recent studies now mention the danger of giving too much crystalloid, etc.  It talks about using fresh whole blood to provide all of the above in less volume.  Results from trauma and military studies are encouraging and may be better than individual component therapy.

There are special considerations for whole blood:

  1. 21-day outdate for the RBCs
  2. Platelet functionality limited after 7 days
  3. Use of group O, low-ABO-titer

Pathogen-inactivation of whole blood is CE-approved by riboflavin (Mirasol).  Terumo BCT is developing an exciting technology to first use Mirasol and then make components using the Reveos automated component system—RBCs, plasma, and platelets.  This is an ongoing project so for now the only CE-approved project is use as whole blood.  Such Mirasol-treated whole blood has been shown to prevent malaria transmission in Ghana.

From my review of the literature, these are my specifications as of this date 18/8/20:

  1. Use/ordering restricted to trauma and selected ICU/surgery suites
  2. Only male donors
  3. 7 day outdate
  4. Group O, Anti-A and anti-B IgM titers, both <= 1/256
  5. Leukodepleted < 1E6 residual WBCs

What level of anti-A and anti-B titers is acceptable?  The titer was set as low as 1:32 but at recent THOR meeting 1:256 has been used.  In Qatar in a pilot study, I found that about 50% of our donors had titers < 1:256.  The issue is that each time the donor presents himself/herself, we must repeat the titer—it is not stable.

Of course, performing even just a saline-titer is time consuming.  The only practical way for us in Doha would have been to use an automated titration option on an immunohematology analyzer—in our case, the Ortho Vision MAX, which could perform 1 titration run in about 30 minutes, and the instrument cannot be used for any other testing during the process.

I personally would perform leukodepletion to conform to CE, but you need a special whole blood filter that removes WBCs but spares the platelets.  Terumo BCT has such a filter that achieves <1E6 residual WBCs.  Never use a standard RBC leukodepletion filter since it will remove BOTH platelets and WBCs—this would defeat the purpose of using whole blood.

At HMC Doha, female donors were only used for packed RBC production—all plasma and platelets were discarded.  Some centers do HLA antibody screens and allow negative females to donate.

Finally, many groups do not leukodeplete at all.  I am concerned about the risk of adverse reactions and TRALI so I would conform to CE and do it.

Whichever conditions you stipulate, it is easy to create the process in Medinfo.  The most important thing is to know what you want to specify.

19/8/20

My Opinion: Separate Transfusion Medicine from the Laboratory

drzeyd

Transfusion Medicine includes laboratory and non-laboratory functions.  The non-laboratory and purely clinical functions are unique and have no analogy within the general laboratory.

The transfusion service/hospital blood bank laboratory is the closest to a laboratory operation, but there is component modification and complex manual testing, especially for reference immunohematology testing.  The staff must make detailed manual decisions, the errors for which could be life-threatening for the patient.

The blood donor center manufactures a pharmaceutical, i.e. blood components with collection, donor qualification, donor abnormal results review, infectious disease marker testing, component production, and donor immunohematology testing—all subject to Good Manufacturing Practices.  Never forget:  Blood is a drug!!

No other laboratory section is directly responsible for treatment of critically ill patients.  Therapeutic apheresis is essential for organ and stem-cell transplants, nephrology, neurology, etc.  No other laboratory section is directly responsible for treatment of critically ill patients.  Transfusion Medicine physicians are functioning as intensivists.  There is no hiding in the laboratory from clinical medicine.

There may also be an industrial manufacturing plant to extract various blood derivatives (e.g. factor concentrates, albumin, Rh immune globulin, etc.)  This is pharmaceutical manufacturing on a large-scale basis.  There is medical, technical, and special administrative expertise.

Many functions may operate 24/7.  The transfusion medicine physician may be on-call for donor issues and review of complex immunohematology problems to acutely decide which blood component (and phenotype) should be given as well as review all adverse reactions to transfusion.

The unique blend of clinical skills is unlike anything else in the laboratory.  Also, those outside the blood bank rarely have the skills or judgments for the best course of action for transfusion medicine or for its operations.

The clinical transfusion medicine physician must make acute, life-threatening decisions unlike anyone else in the laboratory.  The blood bank technologist is at the cutting edge of the battle with his testing and interpretations.  No other area of the laboratory is at such risk for injuring or even killing the patient.  There is high stress and burn-out.

I have talked with many blood bankers and many seem to share the exasperation that the laboratory does not understand us.  The latter looks at blood bank testing like that coming off a hematology or chemistry analyzer—although patients rarely would have severe morbidity or mortality like the blood bank from errors in those analyzers.

No laboratory pathologist has the pressure of the blood bank physician on-call.  It really is 24/7 and requires a broad, clinical background to make the right decisions.  It is very stressful and does not permit a good night’s sleep.

Thus, I make my case to separate us from the laboratory.  We can form our own more effective administrative organization and optimize our own planning.  Regretfully, I have never worked in such an administrative structure.  I also am a realist that cost-containment nowadays makes it much less likely high administration would permit this change for a mere cost center.  This will probably never happen during my career.

Finally, Transfusion Medicine is an essential service.  Blood components are essential drugs.  The operations and staff must be free of political influences.  This is a service for the entire region or country like the fire department, civil defense, etc.

8/8/20