Summary of Accomplishments at Hamad Medical Corporation 2011-2020

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

Operational Effects of the COVID Pandemic–My Experience in Qatar

The COVID-19 pandemic imposed new challenges to our system.  In general, these could be divided into:

  1. Decreased donors
  2. COVID vaccine effects
  3. Decreased available staff
  4. Shortages of supplies
  5. More demands on donor apheresis staff—CCP
  6. More demands on donor processing staff—CCP
  7. More demands on hospital transfusion service/blood bank staff—CCP

There were fewer donors in the early phase and the nurses also had to add a large number of donor plasmapheresis collections for COVID convalescent plasma CCP.  Still they had to maintain all donor and therapeutic apheresis services with no increase in staff.  Although elective procedures had been cancelled, there were still obstetrical, oncologic, and trauma services in full action.

Many of our staff were on leave when the borders were closed.  Some had to wait months before they could return to work.  Others had COVID-19 infection and were quarantined for several weeks.  This further reduced staffing.  We could not just hire outside staff since considerable training is involved in these processes.

I dedicated a separate donor collection space for the CCP program away from the regular donors as well as a quarantine processing area.  Similarly, the CCP plasma was kept segregated from the regular plasma supply and a specially designed location was identified for release of this product.  Working for this program diverted resources from blood collection to this special project, again without increasing resources.

With disruptions to shipments of supplies, including the Reveos whole blood kits and Trima donor apheresis sets, we had to rely on our large in-home inventory until the situation stabilized.  We prescreened the CCP donor candidates before we would collect them to avoid wastage of kits.

Fortunately, our throughput was minimally affected because our equipment and processes had always stressed speed.  We used single-well NAT testing to minimize the need of additional runs.  Also, we used Reveos automated component processing to greatly speed production (one Reveos can process four whole blood units in about 23 minutes or about 12 units in 75 minutes.)  One technologist could operate all 4 of our machines simultaneously and perform other tasks while the machines were working.

In the system I developed in Qatar, we could complete processing into components (RBCs, buffy coat platelet pools, leukodepleted plasma), all marker and immunohematology testing, leukoreduction of the pools and RBCs, Mirasol pathogen inactivation, and platelet additive solution in as little as five hours.

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.

I had built parallel separate donor collection, donor processing, and transfusion service/hospital blood bank processes specifically for CCP and had to staff them with available personnel, limited our capability to process regular donors.  The blood bank computer software restricted CCP use to designated physicians and transfusing locations.  For those interested, there is a separate series of posts about the CCP project and its implementation in the dedicated blood bank Medinfo HIIG.

COVID-19 vaccinations should have minimal effect in donor qualification since mRNA or antigen-based ones do not cause donor deferral.  Live attenuated COVID vaccines will defer donors for 2 weeks by current rules—the same as other live vaccines.  Donors who had previously received CCP will be deferred for three (3) months after last receiving this product.

In summary, the COVID pandemic reduced staffing and affected donor recruitment.  We had production mitigations to maximize throughput.  The system was stressed by the reduced staffing and special demands to produce CCP.  However, the extent of our automation allowed us to maintain throughput throughout the crisis.

Teaching Document: Validation Process

This is a teaching document for medical technology and transfusion fellows to explain the general structure of a validation.

Principle:

All validations must be planned.  A validation protocol must be prepared with specific criteria for acceptance.  All validations with attached evidence must approved by the Head, Transfusion Medicine.

Policy:

  1. A written validation protocol must be prepared in the advance and at least including the following:
    1. Specific parameters and number of iterations to be performed
    1. Designated staff to perform validation
    1. Documentary evidence of the testing
    1. Specific acceptability criteria
  2. The completed validation protocol must be submitted to the Division Head, Transfusion Medicine, or designee for review.
  3. Once the validation plan has been reviewed, it must be performed by the designated staff.
    1. Software validations will be performed in a specific test environment, not in the live, production system.
  4. The completed validation document, including screenshots of the software functionality if applicable, must be submitted to the Division Head, Transfusion Medicine for review.
  5. The equipment or software may only be used if the acceptability are met AND the validation is approved by the Division Head, Transfusion Medicine or designee.
  6. The completed validation protocol will be stored in the document control system.

Reference:

Standards for Blood Banks and Transfusion Services, Current Edition, Bethesda, MD, USA

COVID-19 Convalescent Plasma CCP Donor Questionnaire and Collection

This is a part of a series of posts on the actual Medinfo design of the CCP donation and release processes.  The site and donor registrations were covered in a recent previous post.

Donor Questionnaire and Physical Examination:

After registration, there is the online CCP donor questionnaire and vital signs entry.

Note that the CCP donor will automatically be excluded from other types of donation.  All other types will appear as contraindications in RED below.

Donor Apheresis Collection:

The actual donation process is the same as for plasmapheresis donors: