Tag: Quality Assurance

Quality Asssurance in Transfusion Medicine

Policy: Division Head Transfusion Medicine Role in Policy Making

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Principle:

The Division Head, Transfusion Medicine and Blood Banks, is responsible for all aspects of transfusion medicine at HMC for the State of Qatar.  The following policy documents some of those roles.

Policy:

  1. The Division Head, Transfusion Medicine HTM, serves as a member of the Corporate Transfusion Committee
  2. The HTM through the CTC establishes criteria for transfusion of blood components and passes these through the HMC corporate process for establishing official guidelines.
  3. The HTM reviews blood component requests, especially in times of shortage to triage in conjunction with the Medical Director and Chairperson, DPLM
  4. The HTM establishes transfusion practices through the interim policies, which are in turn used to prepare processes and procedures through corporate transfusion medicine.
  5. The HTM serves as Project Manager for the Medinfo Hematos IIG computer system and prepares policies, processes, and procedures for Transfusion Laboratory Information Systems.

References:

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

Policy: Interdepot Transfer

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Enumeration:  5.9

Policy:

  1. All transfers of blood components will be done through the dedicated blood bank computer system Medinfo Hematos IIG.
  2. Only units passing all donation criteria including testing and processing will be eligible for transfer.
  3. Each unit must have a final ISBT label attached.
  4. Quarantined units will be discarded through Medinfo at the blood processing site.
  5. Units will be transferred in temperature controlled and monitored, validated containers.
  6. Upon receipt, the ABO forward and D type of the transferred RBC units will be repeated at the first hospital blood bank.
  7. Subsequent transfers between hospital blood banks do not require repeat ABO/D typings.
  8. Each unit will be inspected for leaks and physical appearance (e.g. clots, leaks, discoloration).
  9. Only units whose temperature monitoring passes criteria for transit shall be used.
  10. The specific transfer algorithms will be programmed into the Hematos IIG software.
  11. All variances will be reviewed by the supervisor and a transfusion medicine physician.
  12. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, and JCI).

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

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