Tag: Donor Collection

Recruitment and Collection

Active Inventory Management: Further Discussion

drzeyd

Yesterday’s post showed my active blood inventory management scheme for my previous position in Qatar.  I thought today I would elaborate on how I adjust the inventory based on critical shortages and planning for disasters and other major events.

I always review the critical shortages to check for atypical usage (e.g. a disaster situation) or production issues (equipment breakdown, shortage of donors during holiday period).

If it is due to increased utilization, I try to adjust the critical and desirable inventories upward to cover the shortfall for future events.  However, it is not always possible if the event is a one-of-a-kind situation unlikely to recur.  Also, I must take into account the available resources (supplies, kits, manpower, equipment) to see if I can cope with the increase.

If it is due to resource issues, I see if I can bolster those by recommending increases or improving utilization of what is available.

Very important is through-put:  How quickly can I produce components from whole blood or apheresis components?  This was one of the major reasons we shifted away from PCR to other NAT testing with single-well processes since to minimize the need to make additional runs (Grifols Panther System).  Also, automated component processing can greatly speed production (one Reveos can process four whole blood units in about 23 minutes or about 12 units in 75 minutes.)  Those staff can be busy with other tasks while the machines are working.

In the system I developed in Qatar, we could complete processing into components (RBCs, buffy coat platelet pools, leukodepleted plasma)–Reveos 3C Program, all marker and immunohematology testing, leukoreduction of the pools and RBCs, Mirasol pathogen inactivation, and platelet additive solution in as little as five hours!!  There is great need for speed in a place that must be 100% self-sufficient in all blood components. We could even further reduce the total processing time if we only made RBCs and plasma, Reveos 2C Program

In rapid turn-around events, it is most helpful to have a robust blood bank computer system that can scale to the challenge.  Also, it must mercilessly enforce all the rules starting with donor qualification, screening, collection through testing and production.  At times of emergency, it is difficult to meet Good Manufacturing Processes manually.

After each major shortage, I recommend a “post-mortem” analysis of the situation with senior donor and quality staff to analyze our processes and see if we can further optimize them for the future.  A report is prepared and reviewed by me as the Division Head/Medical Director of the Blood Bank.  If possible, we implement our recommendations.  If not, I request additional resources from the Administration.

As regards Disaster Planning, I always asked Administration how many victims did they want to save?  When I got the response, I always try to adjust inventory by two extra RBCs and one adult platelet dose (> 2E11) per salvageable victim.  This may come at the expense of increased wastage, especially in a region that cannot export the excess, unused stock.

The exasperating issue is that I didn’t get a clear answer on this last point.  What number should I use?  I made a spreadsheet showing calculations for a variety of endpoints, e.g. 100, 500, 1000 treatable victims and sent this to Administration to consider.

Blood Component Inventory Management

drzeyd

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

Blood Donation Process Overview

drzeyd

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:

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.