This policy is based on the 19/1/21 CBER document Updated Information for Blood Establishments Regarding COVID-19 Pandemic and Blood Donation.
- There is no COVID-19 laboratory testing requirement for routine blood donor screening.
- Donors must be in good health and meet all blood donor eligibility criteria on the day of donation.
- The blood establishment’s responsible physician must evaluate prospective donors and determine eligibility according to the blood donor criteria.
- Donors with a diagnosis of COVID-19 or who are suspected of having COVID-19 and who had symptomatic disease should refrain from blood donation for at least 14 days after COMPLETE resolution of symptoms.
- Donors who had a positive diagnostic test (RT-PCR SARS-CoV-2 or equivalent) but never developed symptoms, should refrain from blood donation for at least 14 days after the date of the positive test result.
- Donors who are positive for SARS-CoV-2 antibodies but did not have prior diagnostic testing and never developed symptoms can donate WITHOUT a waiting period and WITHOUT a diagnostic test (RT-PCR).
- Vaccination deferrals are as follows:
- Recipients of nonreplicating, inactivated, or mRNA-based COVID-19 vaccines can donate blood WITHOUT a waiting period if #2 above applies.
- Recipients of live attenuated viral COVID-19 vaccines should be deferred for 14 days after receipt of the vaccine.
- Recipients who are uncertain which COVID-19 vaccine was administered, should wait 14 days.
Note that these rules do not address the special case of COVID-19 convalescent plasma donors.
Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Transfusion, CBER, US FDA, 19/1/21
As part of good manufacturing process, we must trace everything in Transfusion Medicine, from registration through release of components. The adoption of the Medinfo Hematos IIG computer system allows us to document anyone and everyone who “touches” the blood components and all processes.
- Each staff member must use his/her personal log-in to sign into Medinfo Hematos IIG HIIG). Each transaction is recorded with the User ID.
- Through the Medinfo Hematos IIG computer system, we can trace:
- Each staff member who handled every step of every process.
- Which equipment was used in processing
- Which materials were used, including serial number of blood bags and selected reagents
- For each component, the donor is identified, including review of all test results, physical examinations, and questionnaire
- For each patient, all components received (from which each donor can be traced) and all testing results including transfusion reactions and any applicable protocols
- For each reagent lot numbers, expiration dates
- For each blood component, test results, serial numbers of blood, transfer, and pathogen-inactivation bags, dates and types of all modifications, including any changes in component outdates, disposition of unit (transfused, discarded, quarantined, etc.)
- Units can be quarantined based on each of the above parameters to block release to and/or usage at all blood transfusion services/hospital blood banks.
- Upon request of the Division Head, Transfusion Medicine/LIS, designated Transfusion Medicine and HIIG staff have access to trace any of the above.
- All traceability incidents will be reported as variances and documented according to standard procedures.
- Workflow processes for Medinfo HIIG, Current Versions
- Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
When I started my COVID-19 convalescent plasma CCP collection in early March, 2020, there were few antibody tests available. However, I anticipated that eventually we would want to include antibody results with the donor record. Antibody results were not used originally at all in the criteria for CCP acceptability for release.
There are many assays by type of antibody (total, IgG, IgA, IgM) and quantitation by titer and/or signal-cutoff ration S/CO. Any of these parameters may be used to define rules for acceptability to complete production and/or allocate to patients. Instrumentation used for titering/quantitation may be interfaced to the blood bank software.
Here is my generic approach to including these results with the donation record. In Medinfo HIIG, it is possible enter test results retrospectively and these can be used set rules for acceptability. Please consult with my detailed post on using rules against parameters.
All of this is easily implemented since all test information will be stored as parameters. From these parameters we can construct rules for:
- Low titer CCP
- High titer CCP
- Acceptability for patient allocation
Also, one can override the rules if the clinician and the transfusion medicine physician agree. For example, there is a severe shortage of group B CCP so use of low-COVID-antibody titer group B CCP could be allowed.
The key is to build whatever test methodology you use and include the manufacturer’s cutoff for low versus high titer interpretation. These results can be printed on the ISBT label as well. One can easily build multiple methodologies and acceptability criteria if different tests are used at different testing sites in your system—just as can be done for other tests (ABO/D, antibody screen, etc.) If one changes methodologies in the future, Medinfo will still use the same rules that applied for the day of production.
Here are some sample test rules:
Example 1: Total COVID antibody > 160 is high titer:
- If antibody >= 160, label as high-titer CCP and use for patient allocation.
- If antibody < 160, label as low-titer, physician must override for patient allocation
Example 2: IgG antibody with S/CO ratio > 12 is high-titer:
- If S/CO >= 12 label as high-titer CCP and use for patient allocation.
- If S/CO < 12, label as low-titer and discard.
Example 3: IgG and IgM antibodies must have S/CO > 12:
- If BOTH IgG and IgM antibody measurements have S/CO >12, use for patient allocation.
- Otherwise, discard unit.
Another option would be just to record the quantitation for each antibody type and list this on the ISBT label and permit its release regardless of the value. One could also permit low-anti-B titer group A plasma with whatever rules you set up.
This is the early Qatar experience of treating severe COVID-19 using locally produced Covid convalescent plasma CCP. At that time, the plasma was not tested for SARS-CoV-2 antibody levels.
This is the conclusion of a continuing series of posts on the actual Medinfo design of the CCP donation and release processes and covers the transfer of completed units to the hospital blood banks. It highlights specific changes made for the parallel CCP system I developed at HMC Doha.
A blood component is either located at a production site, a destination hospital blood bank site, or in transit. Here a quarantine production site is specified. The actual release process is documented in this post.
In summary, with the exception of the donor marker testing and immunohematology testing, all other CCP processes are handled by special quarantine processes. There are abbreviated marker testing specific for plasma and a special Predonation screening to minimize wastage of the expensive apheresis kits.
This is a part of a continuing series of posts on the actual Medinfo design of the CCP donation and release processes and covers the transfer of completed units to the hospital blood banks. It highlights specific changes made for the parallel CCP system I developed at HMC Doha.
A blood component is either located at a production site, a destination hospital blood bank site, or in transit. Here a quarantine production site is specified. The actual transfer protocols and allowable destination sites are listed for this product.
This is a part of a continuing series of posts on the actual Medinfo design of the CCP donation and release processes and covers CCP plasma thawing/labelling and donor marker testing. It highlights specific changes made for the parallel CCP system.
Thus, the machine interfaces for testing are the same as for regular testing and are not included in this document. Likewise, donor immunohematology testing is the same as for regular donors and is not addressed here
This is a part of a series of posts on the actual Medinfo design of the CCP donation and release processes. The registration of the donor and site, donor questionnaire/collection, and receipt/division of the product were covered in recent previous posts.