Enforcing Good Manufacturing Process Through A Dedicated Blood Bank Software
Blood components are a drug and like medications must be consistently produced and follow Good Manufacturing Practices GMP. The following system that I set up for HMC Doha Qatar blood collection and processing is an example of the impact of Medinfo donor software on enhancing our safety and GMP compliance. In earlier posts, I provided the Medinfo flowcharts for these processes.
This is an outline of the processes I built in conjunction with the Medinfo software engineers:
- Registration:
- Read the barcode on the specified picture ID (usually a Qatar Residency/Citizen card).
- Retrieve the prospective donor’s demographics in English and Arabic from the Ministry of Interior.
- Check the donor deferral database (Qatar has only one), defer if contraindicated according to the rules built into Medinfo.
- Choose the type of donation (apheresis or whole blood; volunteer, directed, or autologous).
- Print a consent form and ISBT specimen labels for the donation.
- Read the barcode on the specified picture ID (usually a Qatar Residency/Citizen card).
- Pre-Collection Screening:
- Perform the donor questionnaire on-line in English or Arabic: this has contingent fields and could exceed 60 questions depending on the answers provided.
- Proceed to donor physical exam (vital signs and arm check).
- Collection:
- Collect the whole blood or apheresis component and specimen tubes: determine if the collection meets the volume requirement and time limit.
- Send the specimens for donor marker and donor immunohematology testing.
- Send the raw components for processing.
- Donor Marker Testing:
- Perform NAT, EIA, and LIA marker testing according to algorithms defined in Medinfo.
- Perform follow-up reflex marker testing according to Medinfo criteria.
- Component Processing:
- Process the raw whole blood in the Reveos machine into PRBCs, leukodepleted plasma, and buffy coat platelets.
- Filter/leukodeplete the RBCs.
- If marker test results pass:
- Pool the buffy coat platelets according to the platelet yield index for a yield of 2.4E11/dose.
- Add platelet additive solution PAS and pathogen inactivate (Mirasol).
- Pathogen inactivate the whole-blood-derived plasma.
- Divide the apheresis plasma into 200-250 ml aliquots and pathogen inactivate.
- Divide the apheresis platelets to provide a yield of 2.4E11 in each dose, then pathogen-inactivate (PAS had been added at the time of the apheresis collection).
- Donor Immunohematology Testing:
- Perform ABO/D testing and antibody screen (identification if positive):
- If antibody screening positive, discard the component.
- If ABO discrepancy, send for manual review and approval, otherwise discard.
- Labelling, Storage, and Transfer:
- If all criteria were met, attach the final ISBT label (this can only be printed based on the acceptance of each component).
- Place the components into storage (37C, 1-6C, or <= minus 18C).
- Distribute to the hospital blood banks using Inter-Depot Transfer function.
I emphasize that only if all criteria across all areas pass is the final ISBT label printed. Medinfo is not a label printing program. It enforces the rules ruthlessly. My technical staff tell me that it is merciless—as it should be for patient safety.
Attachments: None—please refer to earlier posts regarding collection, processing, donor testing, and inter-depot transfer.
28/6/20