Includes all areas: Donor, patient, marker testing, component preparation
This was the HMC methodology for manual whole blood processing to prepare packed RBCs, plasma, cryoprecipitate, and cryo-poor plasma using blood bank centrifuges (not Reveos). It did not include preparing platelets since we did not have manual buffy coat processing equipment. In this algorithm we did not specifically release whole blood as a final product (although we did have the capability of activating this in emergency situations).
10/9/20
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:
References:
Revised 10/9/20
Outside the USA, platelet pools stored at room temperature may be valid for up to 7 days, especially if pathogen-inactivation is used. The following workflow shows both Mirasol pathogen-inactivated and standard platelets. The standard platelets are then irradiated. Both types can be aliquoted.
A major advantage in using a specific blood bank computer software is to enforce the Good Manufacturing Process. Medinfo is merciless: there are no exceptions without authorization and that is restricted by the security policies.
In the recent Reveos post, the upper and lower platelet volume specifications were discussed. The platelets are weighed and the volume is calculated. If a manual or another method for preparing platelets is used, then the according values can be specified.
To Be Continued: 8/9/20
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:
7/9/20
A major advantage in using a specific blood bank computer software is to enforce the Good Manufacturing Processes. Medinfo is merciless: there are no exceptions without authorization and that is restricted by the security policies.
The following tables show the values established at HMC Doha during my tenure. These values were recommended by the Terumo BCT Reveos engineer after his direct, hands-on set-up of the equipment.
The minimum and maximum volumes for platelets are specifically designed to work for pooling the buffy coats before Mirasol pathogen inactivation. There are different settings for platelets suspended in plasma versus those suspended in platelet additive solution PAS.
Similarly, there are specific volume ranges for plasma so that pathogen inactivation can be performed according to Terumo BCT recommendations.
To Be Continued: 4/9/20
Automated component processing is an almost hands-free separation of into packed RBCs (ready for leukodepletion), buffy coat platelets (ready for pooling), leukodepleted plasma, and a residual buffy coat. The older Atreus device takes about 10 minutes for one whole blood unit whereas the newer Reveos device needs slightly more than 20 minutes to process four whole blood units. At the end of processing:
The process in Medinfo is as follows:
At HMC Doha, Medinfo developed the first bidirectional interfaces to both Reveos and Atreus.
To Be Continued
2/9/20
As with each major area of Transfusion Medicine, a current state is captured. From this, a future state overview is then developed.
At this time, the client should study his current state and the future state and see how he can bolster the critical control points and build them into the processes.
In this series of posts, we will consider:
The example of current and future state shown is what Medinfo and I built for HMC Doha:
To Be Continued
1/9/20
This series of the processes for donor marker testing has demonstrated the complexity and flexibility of designing processes. In Medinfo, you can custom-design the criteria based on your local, national, and international requirements. The end-user client must specify what he wants, and I reiterate: Be careful what you ask for, you may get it. Seek assistance if you are uncertain of what to use.
My criteria were based on several international standards, e.g. AABB, US FDA, CE, and Australian. I strongly recommend you start with a set of standards and localize it for your needs.
For example, US FDA/AABB do not have a screening criteria for brucellosis since it is rare in their jurisdiction. However, it is relatively common in the Middle East so I added a donor screening question for it. International AABB does allow for variance with US FDA criteria so if you are outside the USA, embrace this. The advantage of customizable software allows you do localize it to your needs. A turnkey system, e.g. from the USA, may not allow such changes.
Finally, there are emerging pathogens that are constantly changing the donor criteria (e.g. SARS-CoV-2, MERS, SARS, Zika). The software must be robust and allow rapid alteration to meet new donor screening criteria. This is a constant uphill battle and requires a lot of time to keep up and validate any changes.
Complete Interim Policy on Marker Testing
For your reference, the following is the complete set of marker testing algorithms I used just before I left HMC Doha:
Definitions:
Positive result for EIA means S/CO ratio >= 1.0
Positive result for LIA means particular pattern of bands as defined by the manufacturer
Indeterminate result for LIA means presence of bands not meeting positive criteria
References:
25/8/20
In Medinfo, criteria for donor screening may be based on one test (e.g. Hgb), a group of tests taken together (HBsAg, HBcAb, HBsAb), or separate sets of donor testing criteria. Nucleic Acid Testing NAT is considered separate from the EIA, LIA, and Ag tests. In any case, when there is a combination of both acceptable and deferrable results, the longest deferral is applied as the deferral or contraindication, e.g. a temporary deferral is replaced by a permanent deferral.
Our NAT testing at HMC Doha consisted of a combination combo test. If this was non-negative, then individual HIV 1-2, HCV, and HBV NAT testing were performed. For speed, we used single-well testing for each donor. However, it is very easy to build pooling into the algorithm if that is preferred by the client:
To Be Continued:
24/8/20
Processes and Software Building—Part 35:
Malaria Testing Donor Screening Process
Zeyd Merenkov, MD, FCAP, FASCP
Independent Consultant in Transfusion Medicine and Information Technology
The malaria screening varies considerably by country. I chose for Qatar to follow a combination of WHO and Australian guidelines as per the attached criteria. We used a malaria antibody screen and malaria antigen test. There are many alternate approaches, including using a malaria NAT. The actual specification was:
The Medinfo testing algorithm follows:
To Be Continued:
22/8/20
Dr. Zeyd Merenkov 