Category: Donor

Includes registration, questionnaire, physical exam and arm check, collection, marker testing, component separation, donor immunohematology testing

Blood Component Inventory Management

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Principle:

Levels of blood inventory must be maintained to meet usual and unexpected needs and yet still minimize component wastage.  The HMC Blood Donor Center is the only source of blood components in Qatar.  Because Qatar’s demand for blood components is rapidly increasing, we must assess our desirable and critical inventory levels at frequent intervals.

Definitions:

HGHBB:  HGH Transfusion Service/Blood Bank

HIIG:  Hematos IIG dedicated blood bank computer software by Medinfo (Nice, France)

TMP:  Transfusion Medicine Physician

Policy:

  1. Establishing desirable and critical inventory levels:
    1. At least once per year, a review of blood component usage must be made to determine both desirable and minimal (critical) inventory levels for all blood components by group.
    2. Determine the maximal daily usage of each component in this period.
    3. Add 10% as a buffer to the maximal usage to determine the critical inventory level.
    4. Add 50% as a buffer to the maximal usage to determine the desirable inventory level.
    5. After each disaster and after every period of “critical” shortage, reassess the critical and desirable inventory levels.
    6. Minimally, even if there are no disasters or critical shortages, the recalculation of critical and desirable inventory levels must still occur at least once per year.
    7. Contact the HIIG software engineer to change the desirable and critical inventory levels in the computer (cumulative stock entry screen).
  2. Preventing shortages:
    1. Maintain adequate stocks of blood bags, Mirasol, and platelet additive solution,  reagents, functioning equipment with backup site (at least two of EIA and NAT analyzers, two Reveos and two Mirasol machines)
    2. Request additional resources (space and staffing) as far as possible in advance.
    3. Develop an additional testing/processing site for blood components (requested but not effected)
  3. During shortages:
    1. Inventory depot (currently HGHBB) technical staff will contact the Senior Consultant/Division Head, Transfusion Medicine or designate on-call whenever there is a critical shortage of any blood component:
    2. Depending on the severity of the shortage in consultation with the Division Head/Senior Consultant, Transfusion Medicine or TMP on-call will liaise with the key technical, nursing, and recruitment staff.
      1. Donor Recruitment:  Medical Manager, Recruitment/Logistics
      2. Nursing/Apheresis:  Head Nurse, Blood Donor Center
      3. Donor Marker Testing:  Supervisor, Donor Marker Testing
      4. Blood Component Processing:  Supervisor or Senior Technologist, Processing
      5. Hospital Transfusion Services:  Supervisor of Blood Depot (currently at HGHBB) and supervisors of all other hospital transfusion services/blood banks
      6. Medinfo HIIG Software Support/VHT Services:
    3. Depending on the severity of the shortage various actions may be approved by the Senior Consultant/Division Head, Transfusion Medicine:
      1. Transfusion Physician/Medical:
        1. Refer to Medical Director to review all requests for the critically short component(s) and provide initial triage usage
        2. Maintain close contact with clinical team(s) about request, emphasize need to minimize ordering if possible
        3. Refer cases of catastrophic blood use to a multidisciplinary ad-hoc team of physicians as designated by the Corporate Transfusion Committee and Medical Director (appointment of ad-hoc team currently under consideration by Medical Director)

As of this date (23/9/19), the Medical Director has not yet appointed a triage team for severe blood shortages.  The Transfusion Medicine physicians DO NOT serve as gatekeeper at these times.  It must be a committee including clinical medical staff who are the principal end-users of blood components

  • Recruitment:
    1. Mobilize recruitment/registration/aide staff
    2. Generate SMS lists to contact donors of the affected component type
    3. Contact media (radio, TV) and hospital intranet to put out messages to recruit donors
    4. Prepare mobile blood donor vehicles for emergency donor campaigns
    5. Arrange emergency transport of prepared units to affected site
    6. Extend Blood Donor Center hours of operation
    7. Nursing:
      1. Mobilize nursing/phlebotomy staff
      2. Extend staff working hours as needed
      3. Reschedule therapeutic apheresis cases as determined by the TMP
    8. Marker Testing:
      1. Mobilize staff to perform extra infectious marker testing run
    9. Component Processing:
      1. Mobilize staff for component processing (including filtration, pathogen-inactivation, and use of platelet-additive solution)
    10. Inventory Depot/Hospital Transfusion Services/Blood Banks:
      1. Maintain critical inventory level monitoring
      2. Report to Senior Consultant/Division Head, Transfusion Medicine or TMP on acute inventory levels
      3. Cancel non-emergency requests for critically short components
      4. Release components on expedited basis (MTP, emergency release, immediate-spin crossmatch, etc.)
    11. Computer:
      1. Medinfo/VHT software engineers to monitor system, provide support as needed
  • Notifications:
    1. Contact the Chairperson, DPLM, and/or the HMC Medical Director as needed, especially if stocks are in danger of depletion.
    2. Any alterations in the blood orders must be communicated to the patient’s most responsible physician by TM technical staff, TMP, or Senior Consultant/Division Head Transfusion Medicine
  • Post-Event Analysis
    1. Review effectiveness of all actions taken
    2. Modify process based on review
    3. Update Interim Policy
    4. Request additional resources as required

Attachment:

Current inventory calculation (follows)

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), 17th Edition, 2013

Abnormal Marker Testing Algorithm

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At the time this was written, West Nile Virus WNV, Chikungunya, Dengue, and Zika virus were not considered as high-risk and no testing was done on the blood supply for them. There were policies to check donor history and ask questions about each of these agents.

Note that we used a linear immunoblot assay for HIV 1/2, HCV, HTLV 1/2, and syphilis.

Definitions:

Positive result for EIA means S/CO ratio >= 1.0

Positive result for LIA (linear immunoblot assay) means particular pattern of bands as defined by the manufacturer

Indeterminate result for LIA means presence of bands not meeting positive criteria

  • Hepatitis B:
    1. HBsAg non-negative, then:
      1. HBsAg positive with HBsAg confirmatory positive, regardless of other results:  permanent deferral, refer to Infectious Disease clinic
      2. HBsAg positive with HBsAg confirmatory borderline or negative, repeat all HBV testing after 8 weeks
      3. HBsAg borderline:  repeat all HBV testing after 8 weeks
      4. HBV-DNA positive confirmed, regardless of other results:  permanent deferral, refer to Infectious Disease clinic
    2. If HBcAb positive, repeat after 8 weeks
    3. Repeat Hepatitis B Testing After 8 weeks:
      1. HBsAg positive with HBsAg confirmatory positive:  permanent deferral, refer to Infectious Disease clinic
      2. HBsAg positive with HBsAg confirmatory borderline or negative:  permanent deferral, refer to Infectious Disease clinic
      3. HBsAg borderline, permanent deferral, refer to Infectious Disease clinic
      4. HBV-DNA positive confirmed:  permanent deferral, refer to Infectious Disease clinic
      5. HBcAb positive or borderline with negative HBsAg and negative HBV-DNA:  review HBsAb level:
        1. If HBsAb level >= 100 mIU/mL (100 IU/L), donor may be reentered
        2. If HBsAb level < 100, then recommend to donor to receive booster HBV vaccine
          1. After HBV vaccine administration, retest after 30 days:
            1. If HBsAb level >= 100, donor may be reentered
            2. If HBsAb level < 100, donor is indefinitely deferred
      6. HBsAg, HBcAb, HBsAb all negative:  reenter into donor pool
  • Hepatitis C:
    1. HCV-RNA positive confirmed, regardless of other HCV results:  permanent deferral, refer to Infectious Disease clinic
    2. HCV-RNA borderline:  repeat all HCV testing after 6 months
    3. HCV-InnoLIA positive, regardless of other HCV results:  permanent deferral, refer to Infectious Disease clinic
    4. HCV-InnoLIA indeterminate:  repeat all HCV testing after 6 months
    5. HCV-Ab positive, HCV-RNA negative, do HCV-InnoLIA:
      1. If HCV-InnoLIA positive, permanent deferral, refer to Infectious Disease clinic
      2. If HCV-InnoLIA indeterminate or negative, repeat all HCV testing after 6 months
    6. Repeat Hepatitis C Testing After 6 months:
      1. HCV-RNA or HCV-InnoLIA positive:  permanent deferral, refer to Infectious Disease clinic
      2. HCV-RNA or HCV-InnoLIA borderline:  permanent deferral, HCV infection not confirmed
      3. HCV-Ab positive or borderline without positive HCV-RNA or positive HCV-InnoLIA:  permanent deferral, HCV infection not confirmed
      4. HCV-Ab negative, HCV-RNA negative, HCV-InnoLIA negative:  reenter donor into donor pool
  • HIV Testing:
    1. HIV-RNA positive confirmed, regardless of other HIV results:  permanent deferral and do HIV-InnoLIA, refer to Infectious Disease clinic
    2. HIV-RNA borderline:  do HIV-InnoLIA
    3. HIV-InnoLIA positive, regardless of other HIV results:  refer to Infectious Disease clinic
    4. HIV-InnoLIA indeterminate:  repeat all HIV testing after 8 weeks
    5. HIV Ab positive with negative HIV-RNA and/or borderline/negative HIV-InnoLIA:  repeat testing after 8 weeks
    6. Repeat HIV Testing After 8 Weeks:
      1. HIV RNA positive and/or HIV-InnoLIA positive, regardless of other HIV results:  refer to Infectious Disease clinic
      2. HIV-InnoLIA and/or HIV antibodies indeterminate:  permanent deferral, HIV infection not confirmed
      3. HIV Ab negative and HIV-RNA negative and HIV-InnoLIA negative:  reenter into donor pool
  • HTLV 1/2 Testing:
    1. HTLV Antibodies positive, then do HTLV-InnoLIA:
      1. HTLV InnoLIA positive for HTLV-1 and/or HTLV-2:  refer to Infectious Disease clinic
      2. HTLV InnoLIA indeterminate or negative, repeat HTLV Ab and HTLV InnoLIA testing after 6 months
    2. Repeat HTLV Testing After 6 Months:
      1. HTLV 1/2 antibodies positive, permanent deferral and do HTLV InnoLIA
      2. HTLV 1/2 antibodies indeterminate,  permanent deferral and do HTLV InnoLIA
      3. HTLV InnoLIA positive for HTLV-1 or HTLV-2: refer to Infectious Disease clinic
      4. HTLV InnoLIA indeterminate, donor permanently deferred.
        • Issue letter HTLV-Not Confirmed
      5. HTLV 1/2 Ab negative and HTLV InnoLIA negative, reenter donor.
  • Malaria Testing:
    1. Defer donor if he has been in malarial endemic zone within the past 4 months
    2. If travel to malarial zone > 4 months, do malarial antibody testing:
      1. Malaria antibody negative:  no deferral
      2. Malaria antibody positive, perform malarial antigen test:
        1. Malaria antigen test positive, refer to Infectious Disease clinic—defer until 3 years after cessation of treatment
        2. Malaria antigen test negative:
          1. Plasma may be collected
          2. RBCs and platelets must be destroyed.
        3. Repeat malarial antibodies after 3 years:
          1. If malarial antibody test positive, donor must not be used for RBC components but may be used for plasma production
          2. If malarial antibody test negative, reenter donor for all components
    3. Defer donor if he has received malarial treatment (not prophylaxis) for 3 years
      1. Perform both malarial antibody and antigen testing:
        1. Defer based on section 5.2
  • Syphilis Testing:
    1. Syphilis Ab test positive or indeterminate:  do InnoLIA-Syphilis test
      1. InnoLIA-Syphilis test positive:  permanent deferral, refer to Infectious Disease clinic
      2. InnoLIA-Syphilis test borderline or negative:  defer for 1 year, then repeat all syphilis testing.
    2. Repeat Syphilis Testing after 1 Year:
      1. Syphilis antibody testing negative, reenter into donor pool
      2. Syphilis antibody positive or borderline:  do InnoLIA-Syphilis test
        1. InnoLIA-Syphilis test positive:  permanent deferral, refer to Infectious Disease clinic
        2. If InnoLIA-Syphilis borderline or negative:  permanent deferral, syphilis not confirmed, Guidance for Industry, February 2020

References:

  1. Use of Serologic Tests to Reduce the Risk of Transfusion-Transmitted Human T-Cell Lymphotropic Viruses Types I and II, Final Guidance for Industry, February 2020
  2. Draft Guidance for Industry:  Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II), CBER, September 2018
  3. Guidance for Industry:  Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry, US Department of Health and Human Services, Center for Biologics Evaluation and Research CBER, May 2010
  4. Guidance for Industry:  Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc), US Department of Health and Human Services, Center for Biologics Evaluation and Research CBER, May 2010
  5. Product inserts, InnoLIA-Syphilis/HCV/HIV/HTLV

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

Blood Donation Process Overview

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This is a sample Medinfo overview document for the blood collection process for HMC Doha that I designed in conjunction with Medinfo France and Medinfo Doha. This includes, registration, donor consent, questionnaire, physical examination, and collection.

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.