Tag: Donor Processing

Automated and manual component processing including Reveos, Mirasol, PAS

Teaching Document: Validation Process

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This is a teaching document for medical technology and transfusion fellows to explain the general structure of a validation.

Principle:

All validations must be planned.  A validation protocol must be prepared with specific criteria for acceptance.  All validations with attached evidence must approved by the Head, Transfusion Medicine.

Policy:

  1. A written validation protocol must be prepared in the advance and at least including the following:
    1. Specific parameters and number of iterations to be performed
    1. Designated staff to perform validation
    1. Documentary evidence of the testing
    1. Specific acceptability criteria
  2. The completed validation protocol must be submitted to the Division Head, Transfusion Medicine, or designee for review.
  3. Once the validation plan has been reviewed, it must be performed by the designated staff.
    1. Software validations will be performed in a specific test environment, not in the live, production system.
  4. The completed validation document, including screenshots of the software functionality if applicable, must be submitted to the Division Head, Transfusion Medicine for review.
  5. The equipment or software may only be used if the acceptability are met AND the validation is approved by the Division Head, Transfusion Medicine or designee.
  6. The completed validation protocol will be stored in the document control system.

Reference:

Standards for Blood Banks and Transfusion Services, Current Edition, Bethesda, MD, USA

Blood Component Variances

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Principle:

AABB Standards requires that all variances are documented and investigated and corrective actions taken when necessary.  Any time a blood component is found to be defective (e.g. broken seal, leaking, discoloration, clots, etc.), mislabeled, or testing results incomplete or not documented,  the cause should be investigated by the Donor Center and reported back to the initiator of the report in writing.

Policy:

  1. All transfusion services must inspect all blood components upon receipt (e.g. for leakage, broken seals, improper temperature, clots, discoloration, gas, etc.).
  2. Labels must be compared to the consignment sheet for complete concordance.
  3. If units are found that are not listed or mislabeled, they must be reported in writing to the Donor Center and returned as-is for investigations.
    1. If the unit is leaking or broken, ensure standard/universal precautions are taking to minimize contact with the fluids.
    2. Damaged blood components must not be used.  Units with mislabelings or other discrepancies between the labels and the consignment sheets may be used when such errors are corrected and officially reported by the Donor Center.
  4. Use the standard incident (occurrence variance) report form (OVA) for each and every variance.
  5. The submitting location should keep a copy of the OVA and immediately forward the original to the Transfusion Quality Section.
  6. The Donor Center should investigate the variance and prepare a written investigative report and submit to the Division Head, Transfusion Medicine.
    1. Donor Center investigations should be completed within one calendar week.
  7. The Donor Center should forward a copy of the completed written investigation to the transfusion service which initiated the investigation.
  8. The copy of the investigation report should be attached to the OVA and kept at the local site.
  9. Transfusion Quality shall include these variances in its monthly reports.

References:

Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

COVID-19 Convalescent Plasma CCP Thawing and Marker Testing

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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

Washed RBCs

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Note:  This is an updated version of a previous post.

Principle:

Washing RBCs removes plasma and reduces the leukocyte count only by 1 log.  For leukodepletion, we must rely on filtration to reduce the WBCs to less than 1 x 106 per unit according to CE rules.  Red cells or platelets in additive solution contain only minimal plasma (about 35 ml).  There are few definite indications for washing RBCs and it should be rarely necessary.

Policy:

Washing RBCs should only be done in the following circumstances:

  1. Deglycerolization of frozen RBCs.
  2. Severe allergic or anaphylactic reactions to plasma proteins
  3. IgA deficiency with anti-IgA
  4. Paroxysmal nocturnal hemoglobinuria PNH—relative indication (often these patients receive RBCs before the diagnosis of PNH is confirmed)
  5. Transfusing a previously irradiated RBC unit for pediatric use if more than 24 hours has passed since it was irradiated.
  6. Any other time when so designated by a transfusion medicine consultant.

Note:

  1. If anyone requests washed RBCs and it does not fit into one of the above categories, contact the transfusion medicine consultant.
  2. Washed RBCs are NO substitute for leukodepleting RBCs by filtration NOR can they be used in place of irradiation for prophylaxis against transfusion-associated-graft-versus-host disease TAGVHD.  Using the Reveos automated component processing system, all components are leukodepleted—RBCs are released in SAGM.

Reference:

Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

COVID-19 Convalescent Plasma CCP Donor Questionnaire and Collection

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This is a part of a series of posts on the actual Medinfo design of the CCP donation and release processes.  The site and donor registrations were covered in a recent previous post.

Donor Questionnaire and Physical Examination:

After registration, there is the online CCP donor questionnaire and vital signs entry.

Note that the CCP donor will automatically be excluded from other types of donation.  All other types will appear as contraindications in RED below.

Donor Apheresis Collection:

The actual donation process is the same as for plasmapheresis donors: