Tag: Donor Collection

Recruitment and Collection

Donor Center Materials and Equipment Strategy

drzeyd

This is the policy I developed for HMC Doha Blood Donor Center:

Policy:

  1. This policy applies to all blood donor processing (including reagents, materials, equipment) in the Blood Donor Center.
    1. Immunohematology testing and donor infectious disease marker testing are not included.
  2. Equipment and reagents must be selected to meet/exceed productions standards set by the Council of Europe, International AABB, HMC policies and procedures, and Qatari law.
  3. Each equipment must have a fully functioning, reliable, bidirectional interface to Medinfo Hematos IIG and be fully interfaced
    1. Vendor is responsible to pay for the interface licensing for each piece of equipment.
  4. Materials/reagents/equipment must cover the following functionalities:
    1. Automated separation of whole blood and apheresis components into:
      1. Packed RBCs in additive solution
      2. Buffy coat derived platelet pools
      3. Apheresis-derived platelets, plasma, and/or RBCs
      4. Fresh frozen and FP24 plasma
    2. Pathogen inactivation of whole blood, platelets, plasma, RBCs
    3. Cryoprecipitate
    4. Cryo-poor plasma
    5. Frozen RBCs (high-glycerol method)
    6. Washed RBCs
    7. Thawed plasma
    8. Irradiated RBCs
    9. Reconstituted whole blood (PRBCs and thawed plasma)
    10. Leukodepletion of ALL components to current and future CE standards
  5. Equipment must have/meet:
    1. CE mark or equivalent (FDA, CSA, etc.)
    2. Sufficient throughput for the workload in the area assigned
    3. Scalability:  A path of upgrading to larger capacity/throughput equipment using the same reagent line of the vendor
    4. A minimum of two of each equipment type must be obtained to minimize disruption of blood supply.
  6. Vendors:
    1. Vendors must offer 24/7 service on critical equipment for donor blood component and patient compatibility testing
    2. Vendors who do not meet qualification standards must not be used.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guide to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), European Directorate for the Quality of Medicines and Healthcare, Current Edition, Strasbourg, France

Re-Entry of Donors with History of Hepatitis On/After Age 11

drzeyd

Principle:

Until this guidance, everyone with hepatitis at age ≥ 11 has been permanently deferred, regardless of the type of hepatitis.  Except for confirmed cases of HCV at any age, donors with other causes may be reassessed to determine if they may be re-entered into the donor pool.  I have also included assessing levels of anti-HBs as per my previous policy at HMC Doha.

Policy:

  1. All donors with a history of HBV (confirmed HBsAg and/or HBV-NAT positive) or HCV, regardless of the age it occurred, continue to be permanently/indefinitely deferred.
  2. Donors with anti-HBc with negative HBsAg and/or HBV-NAT may be further assessed by performing anti-HBs titering.
    1. If the level of anti-HBs >= 100 IU/L (mIU/ml), then the donor may be reentered.
    1. If the donor’s antibody titer < 100 IU/L, he may be offered HBV vaccination:
      1. If the post-vaccination HBV titer >= 100 IU/L, then he may be reentered.
      1. If the donor does not receive HBV vaccination, he remains deferred.
  3. Donors with a history of HAV, CMV, or Epstein-Barr hepatitis may be reentered into the donor pool without further testing.
  4. If the donor is uncertain what type of hepatitis he had, then perform:
    1. HBV testing (HBsAg, HBcAb, HBsAb, HBV DNA NAT)
    1. HCV testing (HCV Ab, HCV LIA, HCV RNA NAT
    1. Liver enzyme testing (ALT, AST)
  5. If there is evidence of current or past HBV and/or HCV, then the donor is still permanently deferred
  6. If there is evidence of ALT or AST elevation, the donor remains indefinitely deferred.

References:

Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday, FDA-2017-D-5152–Requalification for History of Hepatitis Guidance-Final, US FDA/CBER, September 2017

SARS-CoV-2 Vaccines and Donor Qualification

drzeyd

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.”

CMV Prophylaxis Policy

drzeyd

I developed this policy for HMC Doha where most of the local population are CMV-seropositive. Note that I used the CE definition of <1E6 instead of the American <5E6.

Principle:

Since most of the local population (>90%) are CMV-seropositive, it is impractical to rely on CMV-negative donors as our basis for CMV prophylaxis.  Instead, we perform universal leukodepletion and pathogen-inactivation to greatly reduce this risk:

  1. CMV transmission risk can be lowered to a level comparable to using CMV-seronegative components by universal leukodepletion to levels <1E6.
  2. Pathogen inactivation greatly reduces (at least 2 log10) the number of organisms with nucleic acid (DNA or RNA) and is used for all platelet (pools and apheresis) and plasma components.
  3. Platelet additive solution reduces the amount of original plasma to about 35 ml and further reduces donor exposure to foreign material.

Policy:

  1. All blood components (platelets, plasma, RBCs) are universally leukodepleted to residual levels below 1E6.
  2. All platelet and plasma components are pathogen-inactivated using the Mirasol system (riboflavin added and then exposed to ultraviolet light).
  3. All platelet components (pooled buffy coat and apheresis) are prepared in platelet additive solution PAS.

References:

  1. Technical Manual, AABB, Current Edition, Bethesda, Maryland, USA
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA
  3. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Donor Deferrals for Body Fluid Exposure

drzeyd

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

External Disaster Plan

drzeyd

Principle:

Maintaining an adequate blood supply and expedited compatibility testing are critical in disaster planning.  This plan is assuming that the Blood Donor Center is functional and can process donors and make components.

Medinfo Hematos IIG System is critical to monitoring inventory, preparing blood components expeditiously using Good Manufacturing Processes, and distributing blood components in a timely controlled manner.

Policy:

  1. Determinate total available blood supply across all locations by using the Cumulative Stock Display program in Medinfo Hematos IIG.
    1. Recheck stock at least every hour during the disaster.
  2. At each transfusion service site, in conjunction with the Transfusion Medicine Consultant:
    1. Cancel reservations for elective surgical and non-emergency medical cases of affected ABO/D types.
    2. Retain reservations for antigen-matched, oncology, NICU, and high-risk obstetrical cases.
  3. Inform Manager for Donor Recruitment/Logistics to send SMS, radio, and television messages for blood donors—all types.
  4. Contact ALL staff and have them report to duty.
    1. At Blood Donor Center, the Head Nurse, Recruitment Manager, Supervisor, Component Processing, and Supervisor, Marker Testing will contact their respective staff.
    2. At various hospital blood bank transfusion services, the site supervisor will contact all staff.
  5. Process blood components using automated component technology (Reveos).
  6. Perform all donor marker testing including single-well NAT.
    1. Abbreviation of donor testing is only at the discretion of the Head, Transfusion Medicine.
  7. Send blood components using Inter-Depot Transfer function of Medinfo.
  8. Transfusion Services:
    1. Release blood component according to the various protocols as needed:
      1. Massive transfusion protocol
      2. Emergency release
      3. STAT
      4. Priority
      5. Routine
  9. Compatibility testing will be electronic, immediate-spin, or full AHG as per our protocols.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition

Revised 10/9/20

Minimizing Iron Deficiency in Blood Donors

drzeyd

Principle:

HMC Blood Donor Center is implementing a policy to limit or help limit iron deficiency in its blood donors (whole blood and/or apheresis).  The reasons for this are:

  1. Development of iron deficiency in some donors
  2. Progression of iron deficiency that occurs with frequent blood donation
  3. Potential adverse effects of iron deficiency

Definition:

Donors high-risk for iron loss include:

  1. Females—all, regardless of age
  2. Males donating three or more times within a 12-month period
  3. Apheresis donors giving 5 sessions in an 8-week period
  4. Donors after one RBC apheresis dual-unit donation
  5. Males and females with borderline low hemoglobin levels:
    1. Males with hemoglobin <= 13.5 g/dl
    2. Females with hemoglobin <= 13.0 g/dl
  6. Donors with low ferritin level (below current lower limit of reference range)

Policy:

  1. Donors will be provided with information regarding iron-deficiency from donation.
  2. High risk donors (as defined above) will be offered a prescription for iron supplementation equivalent to 18 mg of elemental iron daily for 30 days.
  3. During the iron supplementation period, the donor will be deferred for donation.
  4. If a donor does not take the iron supplement, then he/she is limited to 2 donations/year.
  5. We will offer donors to test ferritin in the following categories:
    1. Apheresis donors after their fifth donation of plasma or platelets within 8 weeks
    2. Whole blood donors after three donations within a 12-month period
    3. Donors after dual-unit (2-unit) RBC apheresis donation
    4. All female donors otherwise meeting donor criteria before donation
  6. Donors with low ferritin levels will be deferred until ferritin levels are normal (based on reference range currently in effect)

References:

AABB Association Bulletin #17-02, Updated Strategies to Limit or Prevent Iron Deficiency in Blood Donors, 26/3/17

Updated 6/9/20

Processes and Software Building 41: Off-Line Medinfo Donor Transactions

drzeyd

Principle:

Normally, outside donor campaigns still connect to the main server via wireless 4G/5G with a VPN.  However, if there is a “dead” spot, Medinfo can provide a local area network using one of the PCs/laptops to serve as a server.  The local server receives an uploaded image of the donor database.  Upon return to the donor center, the local server’s data is uploaded and synchronized.

When you cannot establish a direct link to the live Medinfo program, you must arrange for Medinfo/VHT to create a local server that will have the current Medinfo donor database for use at outside campaigns where the internet connection cannot be used.  This can also be used if for some reason the Blood Donor Center link is down in order to register donors and check the donor deferral database.

Policy:

  1. For each outside campaign, there should be a pre-campaign visit to verify the availability of internet to connect to Medinfo.
    1. If the internet connection is working, use Medinfo using the 4G/5G access points.  Otherwise:
    2. If none, inform Medinfo/VHT to prepare a local server—at least ONE DAY in advance of the campaign.
      1. Provide Medinfo/VHT one of the portable computers to download the database and software.  This will be the offline server for the campaign.
      2. Link the offline server to the other portable computers for the campaign (see the corresponding Medinfo job aid).
      3. Use the local network (offline server and other portable computers) for registering donors.
      4. Upon return to the Blood Donor Center, upload the data as indicated in the Medinfo job aid.
      5. Continue the regular processes after uploading.

7/9/20

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