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April 2019

Transfusion-related Non-conformances

Author: Terri Molloy MLT CQA (ASQ), Staff Technologist, IQMH, Centre for Accreditation

The Institute for Quality Management in Healthcare (IQMH) Centre for Accreditation Medical Laboratory Accreditation Requirements Version 7.1 came into effect in April 2017 and has been used as the basis for over 100 assessments. In 2018, 25 surveillance visits and 53 full assessment visits were completed.

The following is a review of the top non-conformances identified for hospital transfusion services from the visits completed in Ontario for 2018.

There were approximately 100 Transfusion medicine-specific requirements cited in 2018.

Collating the non-conformances into categories can help us to understand what issues present challenges for transfusion medicine laboratories.

The top issues are in order of citations noted:

Procedures/Processes – 15
There are hundreds of procedures written and followed for a transfusion service to function well. Gaps in understanding, compliance and consistency continue to be problematic. Several tools can help you identify gaps in procedure and process compliance.

  1. Adding a validation step to your process for writing and reviewing procedures where staff follow a procedure line by line when it is first drafted can avoid missing key steps down the road.
  2. Change up your internal audit process.
  • Revising the internal audit process to talk through a procedure with staff while they do it,
  • Ask key questions about a procedure and then look together to make sure those steps are where they should be

Temperature monitoring processes – 14
Lab staff are the gatekeepers to ensuring that blood and blood products are maintained appropriately and not wasted where at all possible.
In order to ensure that all products are handled according to the strict requirements set out by the CSA Z902-15 Standards for blood and blood components, laboratory staff should review and understand the parameters set for all products.

Competency assessments that include questions around storage and the measures required for the safety of the blood supply can help to ensure confidence in these processes and help staff to deal with problems before they occur.

Competency assessment of hospital staff – 13
Training and ongoing evaluation of competency is a challenge no matter where you work.
Communication with all staff involved in the transfusion process starts with the Transfusion Medicine Committee. A committee that is well represented and connects with educators within the facility can utilize support from the laboratory to improve these outcomes.
Follow up audits should be used to identify areas of weakness and help to update training to ensure it remains effective.

Procedures/Processes shared outside the lab – 10
When procedures are written and shared with users of a service, it can be difficult to know if they are accessed, used appropriately and still current for use.
As we suggested earlier, a validation step where the users are asked to provide feedback on the steps in the procedure may help to make the process more valuable for all concerned.
Follow up audits, using a pre-determined list of key steps will ensure that there has been effective uptake of the material.

Transport of products – 8
Many checks and balances are required when these precious products leave the safe confines of the laboratory.
Targeted training and well-written procedures are the first steps in creating a safe process. Audits can help to ensure that staff understand and follow the procedures as well as ensure that the supplies needed are always available.

Hopefully this compilation will assist Ontario transfusion services in assessing their own quality improvement, internal auditing and accreditation requirements. For more information about IQMH, please visit our website at: iqmh.org

Ontario AB Plasma Audit 2018

Author: Alison Wendt MLT, Regional Project Coordinator ORBCoN Central Region

The Ontario Regional Blood Coordinating Network (ORBCoN) conducted a provincial AB plasma audit in 2018 in order to gather more detailed information on the utilization of AB plasma in Ontario.

Nationally a downward trend in plasma utilization has been seen with an increase in the proportion of AB plasma requested by hospitals. Approximately 3% of the general population of Canada is group AB, however hospital requests for AB plasma represent 14% of the plasma demand1. AB plasma is considered to be the universal plasma donor group since it lacks anti-A and anti-B and can be given to patients of any ABO blood group. AB plasma is used for initial resuscitation of massively bleeding patients and in urgent situations where there is no blood group on file.

This was the first provincial AB plasma utilization audit performed and the goal was to determine: the disposition of AB plasma in Ontario, AB to AB recipients, AB to non-AB recipients with the primary objective to quantify the amount of AB plasma being transfused to non-AB recipients and to determine the reasons for this use.

All Ontario hospitals with a transfusion medicine laboratory (n=150) were invited to participate in the audit. As with all provincial audits conducted by ORBCoN, participation is not mandatory, however participating helps hospitals meet regulatory requirements for performing regular audits2,3. The data points surveyed were determined and collected over a three month period using LimeSurvey™ 3.13.1, a statistical web-based survey tool. Data capture points included:

  • AB plasma transfused to AB recipient
  • AB plasma transfused to non-AB recipient
    • due to massive hemorrhage protocol (MHP) with no blood group on file
    • thawed for another patient and/or for MHP – transfused to another patient to avoid outdating
    • frozen product near expiry – thawed and transfused to avoid outdating
    • due to only plasma group available in stock at the time of transfusion
    • for plasma exchange
    • with ABO incompatible renal transplant
    • who is a neonate
    • other reasons not listed
  • Disposition other than transfused
    • AB Plasma redistributed to another site
    • AB Plasma transferred with patient to another site
    • AB Plasma frozen and outdated
    • AB Plasma thawed for MHP, not used and outdated
    • AB Plasma ordered, thawed, not used and outdated
    • AB Plasma discarded, not outdated
    • broken in plasma thawer
    • other reasons not listed

Verification and validation procedures took place monthly during the data collection period and at the end of the final data entry period. As part of the verification process, all the data were reviewed for any duplicate, missing or discrepant entries. Audit data was exported for analysis by ORBCoN, both cumulatively (total provincial participants) and by region.

Eighty-two (82) hospitals participated, capturing 89.5% of the provincial AB plasma shipped by Canadian Blood Services during the audit period. Not all hospitals stock and/or transfuse plasma therefore not all hospitals in the province were able to participate in the audit. Audit results showed that 24.7% of AB plasma was transfused to an AB recipient and 75.3% to a non-AB recipient. A difference was seen between the three regions of the province (Central (CE), Northern and Eastern (NE), and South West (SW) Ontario).

The most common reasons for transfusing group AB plasma to patients of other ABO blood groups were: (1) for use in a MHP before the patient’s blood group was known (32.4%) and (2) to avoid outdate of plasma originally thawed for a MHP but not used (24.8%).

The disposition of AB plasma for reasons other than transfusion was relatively small, with the highest percentage being outdated due to being thawed for a MHP but not used and outdated (7.0%).

The disposition of AB plasma in Ontario, AB to AB recipients, AB to non-AB recipients was determined with a high percentage (75.3%) of AB plasma being transfused to non-AB recipients. A recent international survey by the BEST Collaborative showed that 73% of group AB plasma was transfused to non-AB recipients4, a finding similar to that shown by this Ontario audit. Knowing where AB plasma is being transfused will help to develop strategies to aid in the reduction of unnecessary AB plasma transfusions and lead to the sustainability of AB plasma supply.

Participating hospitals received a report with site specific data in April 2019.

The complete AB Plasma Audit Report will be posted April 2019 www.transfusionontario.org.


  1. Canadian Blood Services [Internet]. Toronto: Blood Brief;2018.An Update on AB Plasma;Aug.2018[cited 2019 March 11]; Available from: https://blood.ca/sites/default/files/2018-AB%20Plasma-Overview.pdf
  2. Canadian Standards Association. CSA-Z902-15 Blood and Blood Components. 2015 edition. Toronto (ON): Canadian Standards Association; 2015:,,
  3. Canadian Society for Transfusion Medicine. CSTM/SCTM Standards for Hospital Transfusion Services. 2017 edition. Markham(ON): Canadian Society for Transfusion Medicine; 2017: 1.9, 8.1.1, 8.1.2, 9.5
  4. Zeller MP, Barty R, Dunbar NM, et al, on behalf of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. An international investigation into AB plasma administration in hospitals: how many AB plasma units were infused? The HABSWIN study. Transfusion 2018;58:151-7