Contributory factors

Notes

1. QLD data is unavailable for 2012–13.
2. Contributory factors are not identified for most of the adverse events reported by QLD and SA.
3. Contributory factor data is unavailable for WA.
4. * refers to human errors.

The National Haemovigilance Program requests that states and territories report data on factors contributing to each adverse event where applicable. The contributory factor categories defined seek to mirror key stages of the transfusion chain. Definitions for contributory factors can be found in Table 39 in Appendix II: Definitions in haemovigilance. It should be noted that:

• These categories are not mutually exclusive and more than one contributory factor may be associated with an adverse event.
• Most factors are related to human errors which could have been avoided.
• Contributory factors are not identified for most of the adverse events reported by QLD and SA.
• Near miss data is not presented in the report. However, some states and territories, such as VIC, SA, ACT, NT and NSW, have collected near miss events in their systems. All states and territories will be required to collect and report near miss data through the implementation of NSQHS Standard 7.^[33]

The data in this report shows:

• The most frequent contributory factor was 'product characteristic', accounting for 186 adverse events in 2011–12 and 191 in 2012–13. A blood component may contribute to an adverse reaction due to an inherent but not necessarily faulty characteristic, such as an allergic or immunological reaction to a component. Individual patient characteristics play an important role in this factor. Patients with previous transfusions and pregnancies are at increased risk of FNHTR, allergic and anaphylactic reactions. Since this factor is related to both individual patient characteristics and component characteristics, the current terminology and definition may not be appropriate and could lead to confusion for data collectors and users.
• There were 67 adverse event reports (10.9%) that cited one or more preventable contributory factors other than 'product characteristic' for 2011–12 and 85 reports (19.8%) for 2012–13. The most common contributory factors cited were 'administration of product', 'laboratory (testing/dispensing)', and 'procedure did not adhere to hospital transfusion guidelines'.
• Despite the unavailability of QLD data for 2012–13, 'administration of product' remained a factor in 2012–13 and the number of reports increased to 46 from 16 in 2011–12.
• Table 16 and Table 17 show that 'administration of product' impacted:
  • 25 severe allergic reactions with 5 in 2011–12 and 20 in 2012–13
  • 19 FNHTRs with 3 in 2011–12 and 16 in 2012–13
  • 14 IBCT adverse events with 5 in 2011–12 and 9 in 2012–13
  • 2 anaphylactic or anaphylactoid reactions in 2011–12
  • 2 TACOs with 1 in 2011–12 and 1 in 2012–13.
• The clinical outcome severities related to 'administration of product' included:
  • 6 cases reporting severe morbidity with 3 in 2011–12 and 3 in 2012–13
  • 52 cases reporting minor morbidity with 11 in 2011–12 and 41 in 2012–13
  • 2 cases reporting no morbidity in 2012–13.
• 'Laboratory (testing/dispensing) contributed to 46 events with 24 in 2011–12 and 22 in 2012–13 and was related to 5 severe morbidity cases with 3 in 2011–12 and 2 in 2012–13.
• 'Procedure did not adhere to hospital transfusion guidelines' was related to one severe morbidity case in 2011–12 and one life threatening case and one severe morbidity case in 2012–13.

A key observation from the data is the need for clinical staff to conform to their local facility guidelines for transfusing. NSQHS Standard 7 recommends that the facility guidelines should be consistent with the following national evidence‑based guidelines:

• ANZSBT Guidelines for the Administration of Blood Products 2nd ed
• ANZSBT Guidelines for Pre‑Transfusion Laboratory Practice
• Australian Red Cross Blood Service Blood Component Information Circular
• Australian Red Cross Blood Service Blood Components and Products
• Australian Standard for Medical Refrigeration Equipment—For the Storage of Blood and Blood Products
• BloodSafe eLearning Australia module on Transporting Blood
• National Pathology Accreditation Advisory Council Requirement for Transfusion Laboratory Practice
• NBA PBM Guidelines.

Despite the improvement of national and local facility guidelines for transfusing, human errors continue to contribute significantly to transfusion-related risks to patients in Australia and other developed countries. The VIC STIR program reported^[34] that human error related adverse events, including IBCT, WBIT and near miss events, accounted for 46% of all reports (404) during 2009–11. The SHOT Annual Report 2011^[23] reported that procedural or human errors, including IBCT, inappropriate and unnecessary transfusion, handling and storage errors and ABO incompatible red cell transfusions, represented 51% (5,031) of the cumulative number of cases (9,925) reviewed from 1996–97 to 2010–11.

NSQHS Standard 7 (Action 7.2.1) recommended the following strategies to reduce the risk of human error:

• Identify the risks associated with transfusion, particularly risks relating to human errors.
• Redesign the system to reduce the potential for patient harm.
• Regularly and comprehensively review systems for effective and appropriate prescribing, sample collection, cross‑matching, transport and storage, and product administration to identify and address weaknesses that create the potential for error and patient harm.

This Australian Haemovigilance Report 2013 delivered a recommendation to reconsider the definitions in the ANHDD, including those for contributory factors.

Notes

1. Contributory factors are not identified for most of the adverse events reported by QLD and SA for 2011–12.
2. Contributory factor data is unavailable for WA for 2011–12.

Notes

1. Contributory factors are not identified for most of the adverse events reported by SA for 2012–13.
2. Contributory factor data is unavailable for QLD and WA for 2012–13.