Month: Jul 2021

Process: Donor Notification of Abnormal Results

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Enumeration:  5.8.2

Principle:

AABB requires that all donors be notified and counseled of abnormal test results in a timely manner.  Notifications should be done based on required AABB and/or CE protocols including the requirements for follow-up testing at specified intervals.

Process:

  1. Blood components prepared from donors with abnormal blood results will be discarded according to current SOPs unless a variance is approved by a transfusion medicine physician.
  2. Abnormal results will be handled according to the current Abnormal Marker Testing Algorithm in effect.
    1. Additional testing after specified time intervals may be necessary depending on the initial results.
  3. Medinfo Hematos IIG will automatically follow the donor marker testing abnormal result algorithm and quarantine the affected units.
  4. All abnormal test results will be reviewed by the Division Head, Transfusion Medicine or other Transfusion Medicine Physician in a timely manner upon completion of the testing algorithm and any other additional testing that has been ordered.
  5. A Transfusion Medicine physician will counsel the affected donor.
  6. Counseling will only be performed when the ALL specified test results are available.
  7. Donors will be counseled as soon as possible but within 8 weeks of completion of the test algorithm.
    1. All counselling must be done confidentially.
    1. A letter for the donor explaining the contraindication will be prepared and given to the donor at the time of the counselling session.
    1. Positive identification of the donor must be confirmed before counselling or releasing any results.
    1. If the donor cannot be contacted, details of the contact attempts will be added to the donor’s records in Medinfo Hematos IIG.
  8. Donors will be offered referral to the appropriate clinic (e.g. Infectious Disease) for treatment and/or further assessment.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition
  3. Guidance for Industry, Donors of Blood and Blood Components, Small Entity Compliance Guide, US Department of Health and Human Services, Food and Drug Administration,  Center for Biologics Evaluation and Research, June 2011
  4. Interim Policy Abnormal Marker Testing Algorithm, Current Edition

Policy: Donor Notification of Abnormal Results

drzeyd

Enumeration:  5.8

Principle:

AABB requires that all donors be notified and counseled of abnormal test results in a timely manner.  Notifications should be done based on required AABB and/or CE protocols including the requirements for follow-up testing at specified intervals.

Policy:

  1. All policies and processes must meet applicable local and national standards and laws as well as international accreditation standards (e.g. JCI, CAP, AABB, CE, ISO).
  2. Donors with abnormal results will be counselled after the completion of the testing algorithm.
  3. Testing algorithm built with Medinfo Hematos IIG blood bank donor software will be used.
  4. All abnormal test results will be reviewed by the Division Head, Transfusion Medicine or other Transfusion Medicine Physician in a timely manner upon completion of the testing algorithm and any other additional testing.
  5. A Transfusion Medicine physician will counsel the affected donor confidentially in a timely manner.
  6. If the donor cannot be contacted, details of the contact attempts will be added to the donor’s records in Medinfo.
  7. Donors will be offered referral to the appropriate clinic (e.g. Infectious Disease) for treatment and/or further assessment.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition
  3. Guidance for Industry, Donors of Blood and Blood Components, Small Entity Compliance Guide, US Department of Health and Human Services, Food and Drug Administration,  Center for Biologics Evaluation and Research, June 2011
  4. Interim Policy Abnormal Marker Testing Algorithm, Current Edition

Process: Donor Marker Testing

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5.7.1 PROCESS:  Donor Marker Testing

Process:

  1. Specimens will be received from the collection areas.
  2. Specimens will be processed (e.g. centrifuging, aliquoting if required) by marker testing personnel.
  3. The mandated tests will be performed on the designated equipment by marker testing personnel.
  4. The results will be sent by computer interface into Hematos IIG whenever possible.
  5. Appropriate reflex and other algorithm-mandated testing will be performed.
  6. Abnormal results will be reviewed by a transfusion medicine physician.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Policy: Donor Marker Testing

drzeyd

Enumeration:  5.7

Policy:

  1. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, and JCI).
  2. All donors will have samples tested for infectious disease marker testing according to the applicable international standards.
  3. All testing will follow manufacturer’s recommended testing methods.
  4. The specific algorithms will be programmed into the Hematos IIG software.
  5. Whenever possible, tests performed on automated equipment will sent to Hematos IIG by validated software interfaces.
  6. All abnormal results will be reviewed by a transfusion medicine physician.
  7. Donors will be deferred based on specific algorithms which will be programmed into Hematos IIG software.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Anecdote: Serial Panels Reactivity

drzeyd

When I review nonspecific reactions on an antibody panel, I always check the outdate of the reagents and the age of the specimen.  Outdating reagents may show weak reactivity.  Old specimens may get contaminated and bacteria may alter the RBC surfaces (e.g. T-activation).

Here is an example of weakened reactions with an outdating antibody panel.  This panel was used one-week before its expiration:

Here is the same patient with the new panel with 5 weeks before its expiration:

Building Donor Center Software Processes: Donor Physical Examination and Adverse Reactions

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Donor physical examination, along with the donor questionnaire, are important both for donor and patient safety.  In general:

Is it safe for the donor to donate?

Is it safe for the patient to receive the blood even if it is safe for the donor to donate.

Any donor who does not feel well must not donate.  This may be the single most important step in ensuring a safe blood supply.

The donor physical examination includes the vital signs (blood pressure, pulse, temperature, heart rate, and temperature).  I have attached a sample set of criteria for review.  All are user-definable.  Note how the arm examination is also included (looking for scarring, skin lesions, etc.)

For all types of donations, there may be adverse reactions.  These must be documented in the record along with the disposition of the donation.  Will the donor need an extended deferral if the RBCs in the apheresis run are not returned?  This can be built from the reaction documentation.  Note the following sample table of reactions.

To Be Continued

Building Donor Center Processes: Setting Deferral Intervals between Donation Types

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Donation can be whole blood or apheresis-based.  The sex and age for each donation type is specified.  At HMC, we did not accept females for platelet or plasma donations, so the starting age is listed as 99 years.  Otherwise, in accordance with Qatari law, the starting age for donation is 18.  All these parameters are user-definable, and a transfusion medicine physician can override the rules if necessary.

For each and every combination of donations, the deferral interval must be specified.  Examples follow.  The temporary deferral period is in days:

Previous donation whole blood, current donation whole blood:  56

Previous donor platelets, current donation whole blood:  2

Previous donation whole blood, current donation platelets:  56

Also note how for each possible combination there is an entry for male AND female.  Females are restricted to whole blood donation and only RBCs will be made from the collection.

If there is a collection incident and the apheresis procedure is not completed, the interval will be set to 56 days.  This will be covered in the post on donor adverse effect reporting.

To Be Continued: