Updated COVID-19 Donor Eligibility Requirements

Principle:

This policy is based on the 19/1/21 CBER document Updated Information for Blood Establishments Regarding COVID-19 Pandemic and Blood Donation.

Policy:

  1. There is no COVID-19 laboratory testing requirement for routine blood donor screening.
  2. Donors must be in good health and meet all blood donor eligibility criteria on the day of donation.
  3. The blood establishment’s responsible physician must evaluate prospective donors and determine eligibility according to the blood donor criteria.
  4. 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.
  5. 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.
  6. 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).
  7. Vaccination deferrals are as follows:
    1. Recipients of nonreplicating, inactivated, or mRNA-based COVID-19 vaccines can donate blood WITHOUT a waiting period if #2 above applies.
    2. Recipients of live attenuated viral COVID-19 vaccines should be deferred for 14 days after receipt of the vaccine.
    3. 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.

References:

Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Transfusion, CBER, US FDA, 19/1/21

Physician Comments in Medinfo

Principle:

There are several different types of comments in HIIG:

  • Donor Global
  • Patient Global
  • Analytical Comments
  • Result Comments

Physicians may enter any of these comment types.  Comments may be entered before or after a test is authorized/verified.  If entered after authorization, the test must be modified to accept the comment.  Only result comments are visible in the patient’s medical record.

Policy:

  1. Physicians should use comments in the following situations:
    1. Interpretations of DAT, antibody identification, ABO discrepancies
    2. Instructions for the selection of specific and/or modified blood components
    3. Donor eligibility issues (e.g. donor marker testing abnormalities and disposition)
    4. Donor reactions
    5. Telephone call documentation
    6. Donor counseling documentation
    7. Any special instructions to staff
    8. Any other situation where the transfusion physician determines it is desirable to enter a comment
  2. Copy all result-comments and also enter then as global comments against the patient or donor record as applicable.

Procedure—Patient Result Comments After Results are Authorized/Verified:

Sign into HIIG and select Patient module, Patient Consultation, and enter the patient hospital HC number.

Comments in Medinfo Hematos IIG

This post is the policy for using comments in Medinfo software.  A subsequent post will show the process of entering comments.

Principle:

There are several different types of comments in HIIG:

  • Donor Global
  • Patient Global
  • Analytical Comments
  • Result Comments
  • Contraindication Comments

Global Comments appear on the first main screen of either the donor or patient record.  The presence of comments is indicated by a bar at the bottom of the screen (in yellow or blue saying Presence of Comments.  Double-clicking opens the list of entered comments.

Examination/Results Comments appear only when you open the result to which it is attached.  You must know in advance to which result they are linked to find them.

Contraindication Comments appear when entering a donor deferral code

At HMC, we will enter examination/results comments again as global comments (donor or patient) so it is easy for staff to retrieve them and see them with all other comments.  You can do this by cut and paste.

Physicians may enter any of these comment types.  Comments may be entered before or after a test is authorized/verified.  If entered after authorization, the test must be modified to accept the comment and require a special password (not the user sign-into HIIG).  Only results/examination comments are visible in the patient’s medical record.  Global, analysis, and contraindication comments are visible only in HIIG!  Donor comments are only visible in HIIG.

The presence of comments documents physician review of abnormal results as required by the various accreditation standards.

Policy:

  1. Only designated staff may enter comments.
  2. Comments entered after authorization/verification of results will modify the donor/patient record and require a special, high-level password distinctly different from the normal user password.
  3. Enter comments in the following situations:
    1. Telephone call documentation (e.g. critical values).
    2. Interpretations of donor or patient test results, transfusion reactions, etc.
    3. Instructions for the selection of specific and/or modified blood components
    4. Donor eligibility issues (e.g. donor marker testing abnormalities and disposition)
    5. Donor reactions
    6. Donor counseling documentation (e.g. donor counseled at 0930 on 24/3/14 about his abnormal result).
    7. Any special instructions to staff
    8. Any other situation where the transfusion physician/supervisor or designate determines it is desirable to enter a comment
  4. Copy all results/examination-comments and also enter then as global comments against the patient or donor record as applicable.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Workflows 1001-1005, Medinfo Hematos IIG, 2013-2014.

Documenting Physician Review of Abnormal Results

International accreditation standards require physician review of certain abnormal results such as transfusion reaction and antibody workups.  This post describes how such review is documented in Medinfo Hematos IIG dedicated blood bank software.

In general there are three main ways to do this:

  1. User ID associated with each transaction
  2. Comments against results, analysis, or globally
  3. Physician direct entry of results (e.g. transfusion reactions)

This applies to all modules of Medinfo, including donor and patient.

User ID:

The system records the User ID of the staff member who performed an action—this includes the authorized transfusion physicians  This covers everything in the system, donor or patient.  However, it may require a specific query by user ID to list all of that person’s transactions.  This is not easy to show an external assessor/inspector unless the query is performed in advance.

Comments:

For those cases requiring review, comments can be placed with the results, which will be visible to anyone viewing that record.  Additionally, internal comments can be added to the analysis and globally within the record.

Direct Physician Entry of Results and Interpretations:

For transfusion reaction workups, physicians may directly enter their interpretations and results in the system.

Subsequent posts will show how comments and direct physician entry of results are performed in the system.

Transfusion Medicine Lectures for Pediatric Fellows

In my time at the Saudi National Guard Health Affairs and at HMC Qatar, I offered the pediatric fellows a series of lectures of 1-2 hours duration.  The following list has been updated to cover current topics of interest, including COVID-19 convalescent plasma.

  1. Transfusing blood components for physicians—what do you need to know
  2. Recognizing and treating adverse effects of transfusion
  3. Blood components and derivatives—what you need to know
  4. Blood filters, irradiation, aliquoting, and washing blood components
  5. Pathogen inactivation and platelet additive solutions
  6. COVID-19 and the blood supply, COVID-19 convalescent plasma
  7. Indications for blood components and monitoring efficacy
  8. Patient blood management:  minimizing transfusions
  9. Blood group serology and compatibility—what you need to know
  10. Adult vs. pediatric transfusion medicine:  special considerations for the pediatrics
  11. Hemolytic disease of the fetus and newborn
  12. Rh immunoprophylaxis:  RhIG, fetomaternal hemorrhage
  13. Platelet refractoriness:  prevention and treatment
  14. Hemoglobinopathy:  component selection for pediatric patients
  15. Therapeutic apheresis, focused on pediatric age group
  16. Stem cell transplantation
  17. Transfusion-transmitted diseases
  18. Emerging pathogens:  ZIKA, Chikungunya, Dengue

25/2/21

Traceability of Processes in Transfusion Medicine using Medinfo Hematos IIG

Principle:

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.

Policy:

  1. 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.
  2. Through the Medinfo Hematos IIG  computer system, we can trace:
    1. Each staff member who handled every step of every process.
    2. Which equipment was used in processing
    3. Which materials were used, including serial number of blood bags and selected reagents
    4. For each component, the donor is identified, including review of all test results, physical examinations, and questionnaire
    5. For each patient, all components received (from which each donor can be traced) and all testing results including transfusion reactions and any applicable protocols
    6. For each reagent lot numbers, expiration dates
    7. 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.)
  3. 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.
  4. Upon request of the Division Head, Transfusion Medicine/LIS, designated Transfusion Medicine and HIIG staff have access to trace any of the above.
  5. All traceability incidents will be reported as variances and documented according to standard procedures.

References:

  1. Workflow processes for Medinfo HIIG, Current Versions
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA