Tag: Donor Collection

Recruitment and Collection

Process Donor Medical Questionnaire

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5.2.1 PROCESS:  DONOR QUESTIONNAIRE

Process:

  1. Donor passes donor deferral database screening.
  2. Donor is taken to a private area for the interview.
  3. The donor is positively identified by a designated picture ID and Hematos donor consent form with specimen/encounter number and barcode.
  4. Donor is asked ALL questions by trained Donor Center staff using the Medinfo Hematos IIG questionnaire.
  5. Hematos IIG determines if any contraindications apply.
  6. Donor responses are reviewed by the transfusion medicine physician as indicated in the questionnaire.
  7. Donors without contraindication are sent for donor physical examination.
  8. Donors passing transfusion medicine physician review are sent for donor physicial examination.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo, Nice, France
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Policy Donor Medical Questionnaire

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Policy Donor Medical Questionnaire

5.2 POLICY:  DONOR MEDICAL QUESTIONNAIRE

Policy:

  1. All policies, processes, and procedures must comply with local, national, and applicable accreditation standards (i.e. AABB, CAP, and JCI).
  2. All donors will be positively identified with a picture ID and by their Medinfo Hematos software identifiers (donor ID and session registration/specimen number).
  3. Donors will be assessed confidentially in a private area.
  4. Donors will be asked questions based on the latest Uniform Donor Questionnaire with additional localization questions for Qatar.
  5. Donor must understand either English or Arabic.
    1. Otherwise, they cannot be accepted for donation.
  6. Donors passing the donor questionnaire will be processed for the donor physical examination.

References:

  1. HMC 1001 Setting Specifications, Version 1.5, Hematos IIG, Medinfo, Nice France
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Donor Registration Process

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5.1.1 PROCESS:  Donor Registration

Process:

  1. Donor presents acceptable picture ID with a unique alphanumeric identifier.
  2. Donors without Qatari ID must be approved by the Coordinator, Donor Recruitment, a donor center physician, or Head, Transfusion Medicine.
  3. Donor ID is scanned into Hematos IIG.
  4. Donor is assigned Hematos IIG Donor ID if not already in the system.
    1. Donors with previous ID will be given a Hematos ID
    1. All donors are registered only using the Hematos ID
  5. Medinfo Hematos IIG software checks donor deferral database
  6. Donor is accepted for medical questionnaire only if he has no contraindications.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Donor Registration Policy

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Number:  5.1

Policy:

  1. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, ISO, and JCI).
  2. All prospective donors must show an approved identity document with picture (e.g., Qatari ID, other GCC ID, passport) that confirms their identity with a unique alphanumeric identifier.
  3. All positively identified candidates will be assigned a Hematos donor ID if they do not already have one.
  4. All donors with the previous old donor ID will be assigned a Hematos donor ID.  All future donations will be done using the Hematos ID.
  5. All positively identified candidates must be checked in the donor deferral database.
    1. Only those without contraindications may be accepted for further processing.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Donor Recruitment and Campaigns Process

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5.0.1 PROCESS:  Donor Recruitment and Campaigns

Process:

  1. Company or organization contacts Coordinator, Donor Recruitment to schedule donation OR:
  2. Coordinator, Donor Recruitment contacts companies or organizations to schedule donations.
  3. The Coordinator, Donor Affairs, is responsible for all recruitment activities:
    1. Serves as initial contact point for organizations and companies desiring to have a donor campaign.
    2. Schedules donor campaigns in advance, arranges for emergency collections as needed.
    3. Assigns donor recruitment staff to visit and inspect prospective donation sites.
    4. Arranges logistics of resources for donor campaigns (personnel, equipment, vehicles, supplies)
    5. Coordinates with HMC Public Relations and the media
    6. Prepares news media to encourage donation
  4. All contacts and schedules are entered into Hematos IIG.
  5. Donor recruitment materials are left at donation site to encourage donation and provide means for donors to schedule their donations during the campaign.
  6. Donor recruitment staff prepare the donation site at time of donation.
  7. Donation processes are conducted in accordance to policies, processes, and procedures for registration, donor questionnaire, physical examination, and collection.
  8. Hematos IIG is accessed by either wireless connection (VPN) or off-line data dump to check donor against donor deferral database.
  9. Blood is stored at suitable temperatures at collection site and in transit back to Donor Center.
  10. Campaign blood components and specimens are received in Donor Center and transferred for further processing and testing.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Donor Recruitment and Campaigns Policy

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5.0 Donor Recruitment and Campaigns Policy

Policy:

  1. All policies, processes, and procedures must comply with local, national, and applicable international accreditation standards (i.e. AABB, CAP, ISO, and JCI).
  2. All recruitment information must be entered into Hematos IIG.
  3. The Coordinator, Donor Affairs, is responsible for all recruitment activities.
  4. Donor recruitment staff will visit scheduled donation sites in advance and assess their suitability and prepare them for use before the start of each campaign.
  5. Donor recruitment materials and announcements will be left at each location during the inspection visit.
  6. Collected blood will be stored at room temperature during the collection on-site and transported back to the Donor Center in suitable validated containers to maintain storage at desirable temperature.
  7. The processes and procedures for normal donation, e.g. registration, donor questionnaire, physical examination, and collection apply.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Summary of Accomplishments at Hamad Medical Corporation 2011-2020

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2011

Established automated component production using Atreus technology, plasma and platelet pathogen inactivation (Mirasol)—made HMC component production Good Manufacturing System GMP compliant

2011

Qatar is the first to adopt non-PCR-based NAT technology (Grifols/Novartis Tigress) and becomes world reference site for this

2011

Based on the above, Qatar can now completely process all whole blood into blood components (red cells, platelets, and plasma) in as little as 5 hours from collection!

2011-2020:

I established policies and procedures for the hospital blood banks/transfusion services, blood donor center, therapeutic apheresis, and laboratory information systems to bring HMC in compliance with the Council of Europe, international AABB, and other standards.  I customized our own standards for our local needs based on them.

2012-2013

Implemented custom build of the multilingual blood bank computer system (Medinfo) for both patient and donor services, including development of interfaces to all production equipment including Atreus and Mirasol (world’s first) and a direct link to Ministry of the Interior to obtain patient demographics in English and Arabic—Qatar became the world’s first site to combine fully-interfaced, automated component production with pathogen inactivation:  Qatar becomes world reference site for this.

2013-2014

Built, validated, and implemented laboratory build of hospital information system, Cerner Millennium

2015

Replaced and updated Atreus with Reveos automated component production to allow faster throughput and capacity with a full bidirectional interface (world’s first), introduced platelet

additive solution PAS with pathogen inactivation (Mirasol)—Medinfo interfaces updated to Reveos for all equipment:  this doubles the capacity to process whole blood into components using the same physical space

2015-2019

Updated dedicated blood bank software Medinfo Hematos IIG by several versions using Division Head, LIS, and internally trained Super Users—at great cost savings to HMC by not using outside consultants (e.g. Dell Consulting)

2019

Established column absorption technology using Terumo Optia therapeutic apheresis machine for treatment of ABO-incompatible renal transplants:  I validated using the Ortho Vision MAX to perform ABO antibody titers for this system and correlated it with the reference method at Karolinska Institutet in Stockholm (manual gel) to bring rapid throughput and labor savings—Qatar being the first-site in the world to do this.  We saved money by using the same apheresis machine to use this column absorption technology (no need for second machine to use the columns)

2020

Expedited setup (two weeks total) of COVID-19 convalescent plasma production, initially manual and then fully integrated into the Medinfo computer system as a customized module with separate quarantine collection, production, and transfusion service functions

Other:

I was awarded two HMC Star of Excellence Awards:

2013—Liver Transplantation Transfusion Support

2019—ABO-Incompatible Renal Transplantation Support

Updated Donor Questions for Ebola Virus Screening

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The AABB just updated its Ebola Toolkit and made proposed changes to the Uniform Donor Questionnaire UDQ to reflect this.  Up to five (5) questions should be included in your questionnaire.  What question(s) to use depends on:

  • Are you in an area with NO widespread transmission?—1 question (#1)
  • Are you in an area with widespread transmission?—5 questions (#1-5)
  • Are you in an area post-widespread (> 4 weeks) transmission?—1 question (#1)
 YesNo
Ebola Question 1: Have you ever had Ebola virus disease or infection?qq
Ebola Question 2: In the past 8 weeks, have you lived in, or traveled to, a country with widespread transmission of Ebola virus disease or infection? (Review list of affected areas, as classified by CDC) *qq
Ebola Question 3: In the past 8 weeks, have you had sexual contact with a person who has EVER had Ebola virus disease or infection?qq
Ebola Question 4: In the past 8 weeks, have you had direct exposure to body fluids (blood, urine, stool, saliva, semen, vaginal fluids or vomit) from a person who may have Ebola virus disease or infection, including a person under investigation?qq
Ebola Question 5: In the past 8 weeks, have you been notified by a public health authority that you may have been exposed to a person with Ebola virus disease or infection?qq

If the response to question #1 is YES, then the donor is indefinitely deferred.

For questions 2-5, there is an 8-week deferral.

In areas with no widespread transmission, self-deferral of donors with a history of Ebola infection should be adequate, only question #1 is required.  If there is widespread transmission, questions #2-5 should be added.  Four (4) weeks after widespread transmission stops, revert back to using question #1 only.

These can be easily added to the donor questionnaire in Medinfo blood donor module.

References:

  1. AABB v2.1 DHQ and Flowcharts Modified for Ebola Risk, March 2021, AABB, Bethesda, MD, USA
  2. AABB Ebola Toolkit, Revised May 2020, Bethesda, MD, USA
  3. Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus, Guidance for Industry,  U.S. Department of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research, January 2017

Plasma Project Considerations for Middle East

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This is an update of a previous post.

I have been involved with planning for several plasma fractionation projects in the Middle East.

Many clients expressed the interest in using local plasma to make plasma derivatives (e.g. factor concentrates, intravenous gamma globulin, albumin), feeling that local plasma was safer than using imported plasma.  Some of these are in short supply in the world market so the only way to ensure their uninterrupted availability is to consider to manufacture them for local consumption.

Still, the major issue today is that it is difficult for any country in the region to collect enough plasma to make such a project feasible.  When I first considered such planning, we were looking for as much as 250,000 raw liters of plasma annually.  Since then, there are newer technologies that allow much smaller batches to be cost-effective.  Alternatively, one could charge higher prices for using smaller batches from local plasma.

Still, it is likely that plasma must be imported to sustain a plant.  There are different regulations for plasma donor qualification country-to-country.  Many of these jurisdictions may do less screening and testing than is done for normal blood and apheresis donors.  Other countries use their blood donors with the same requirement for both commercial plasma and blood donations.

In this era of emerging infectious diseases, I personally favor using the stringent blood donor criteria—same as routine collections.  It is not what we know, but the unknown pathogens that are potentially the most dangerous.

In addition to building a fractionation plant, one must train staff for this highly technical operation.  This may require developing a special curriculum to prepare students for these jobs.

To export the plasma to certain regions, one may have to use plasma quarantine.  In this protocol, plasma is held or quarantined until the next donation is collected and passes screening.  This requires a robust blood bank production software such as Medinfo to track serial donations.

There are other processes to consider:  how to develop a transport network to keep plasma frozen at minus 80C viable in a region that reaches very high ambient temperatures.

I would recommend a graded approach to develop such an industry.  First I would negotiate a plasma self-sufficiency arrangement.  We would collect local plasma in the country and export it to a manufacturing plant in another country and the derivatives would be returned to us.  This may require inspection by the accreditation agency of the processing country to allow importation of the raw plasma for manufacture.

Since it is unlikely any one country has enough plasma for manufacture, recruiting neighboring countries to participate in a manufacturing plant is important.  Technology for such a plant is complex so establishing a joint venture with one of the plasma industry companies is essential.  Some manufacturers are very keen to develop extra capacity since there is a world-wide shortage of plasma fractionation and are even willing to help obtain external plasma sources for such a plant.

Such a plant is an excellent way to develop local talent to run such a plant, including training of local staff to be the industrial engineers in the plasma fractionation process.  It would take approximately two years of training to prepare engineers on-site at a plasma fractionation site if they have studied the necessary science and mathematics subjects.

Such a program would take several years of planning and development.  Some of the major steps needed include:

  1. Acquiring software for a blood center with plasma brokering capabilities.
  2. Passing accreditations such as international AABB and CE for transfusion medicine to allow export of our plasma to the external manufacturing site in the initial plasma self-sufficiency phase
  3. Identifying extended sources of plasma to feed a manufacturing plant.
  4. Preparing a curriculum suitable for training as staff for the plant.
  5. Establishing a joint venture to share technology with a major plasma company to design, build, and operate a plasma fractionation plant.

Overextending Oneself—Two Case Studies in the Blood Bank

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One has to learn when enough is enough.  There are times when there are staff shortages but the conscientious staff wants to be the Super-Tech and handle all the work, whether or not there are sufficient resources.  This is a big gamble, and there may be serious consequences for the over-achiever and for the patient.

Anecdote #1:  Chicago Blizzard of 1979 (13-14 January):

When I was in my residency training in Chicago, I was in the blood bank during the blizzard of January, 1979.  The following tragedy occurred.

Suse was one of the best blood bank technologists that I have ever known, extremely conscientious and very meticulous—and very fast at doing things.  She was a workaholic.  Suse’s whole life centered on her job at our academic medical center—so much so that she had an apartment near the hospital complex.  In mid-January, a snow storm was predicted with an estimated snowfall of about 5 cm. total.  Actually, that night a blizzard developed and around a meter of snow fell with white-out conditions and zero visibility.  Preoperative patients had been admitted the night before based on the low snowfall prediction.

The next day was chaos.  Essentially only staff who lived near the hospital complex could report to work.  Suse came in and saw all the pending preoperative blood requests.  She decided to “double-up” and work on two cases at one time.  In the rush, she mixed up test tubes and issued ABO-incompatible blood for a surgical case.  The surgeon noted the abnormal oozing of blood at the operative site and stopped the transfusion.  Hematuria developed, but the patient survived.

Suse was suspended pending investigation.  Based on her excellent work record, she was offered to return to work.  Unfortunately, she became very depressed and was afraid to return since she feared she would make another mistake.  She never worked in the blood bank again.

Anecdote #2:  Shortage of Blood at Major Hospital:

1991 in another country, a large hospital complex was suffering a shortage of blood.  A large number of donors were called and the available staff were overwhelmed with work.  One donor phlebotomist decided to collect whole blood from two different donors simultaneously and in the confusion, mixed up the sample tubes for donor marker testing.

Unfortunately, one of those donors was HBsAg positive, but with the specimen mix-up was marked as negative.  The unit of blood was transfused, and the recipient developed fulminant hepatitis B and died.

Analysis:

In both these systems, there were processes in effect not to work on two patient specimens or collect two donors at one time, but the staff took short-cuts.

No one is super-human.  Don’t try to cut corners and handle more than one patient at a time.  Your intention may be good, but you will be judged by the consequences.  No one will care about the extenuating circumstances.  You will be blamed.  I tell my staff that if they cannot handle the workload, they should contact me as the Division Head, Transfusion Medicine, to triage the cases for them.  My role is to bring these events to the higher authorities to get the resources we need to do the work properly and safely.