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Question 1: How can shipping containers be validated?

Question 2: How can the temperature of blood transported in shipping containers be monitored?

Monitoring is done by using temperature monitoring devices such as these and others:

• Safe-T-vue^{TM   (}non-reversible indicators)
• TempTale 4 Monitors (reusable monitors)

Question 3: List the standards that apply to inter-facility transportation of blood and blood components in your country. 

Canadian standards (Z902-04 and CSTM draft Standards) specify that

• Blood components and products be transported so as to maintain the storage temperature requirements specified by the supplier. 

• There be documented evidence that the temperature was maintained within the required range (validated containers would fulfill this requirement)

• Transportation time should not exceed 24 hours

• Packaging be sturdy and have a tamper-evident seal

• Other requirements relate to container labelling, issuing vouchers, responsibility for documenting final disposition, and training and internal assessment to ensure compliance

Note: There are also Standards for transportation within a single facility. These relate to having operating procedures that define individuals who may sign out blood products from the transfusion service and transport them to the recipient’s location; acceptable time frames for products to be in transit, and more.

Question 4: List the types of standards related to training and competency assessment in a quality system.

Standards for training and competency assessment specify the need to 

• Identify training needs for all staff and develop documented training programs for initial and ongoing training

• Develop, maintain, and document formal competency assessment programs

• Assess competency following training and regularly thereafter

• Assess effectiveness of training programs annually

• Implement SOPs and important changes only after staff training is complete

Training and competency assessment requirements are the same for all staff (fulltime, part-time, or casual) and relate to a staff member's ability to perform assigned tasks. For example, staff who perform pretransfusion testing are trained and assessed on the same required knowledge and skills regardless of job category and number of hours worked. 

1. In a quality system how are  errors of this type handled?

A quality system focuses on systems (not individuals). The event would be 

• Documented by collecting and analyzing data resulting in an objective description of what happened

• Investigated using root cause analysis to identify why it happened (causes and contributing factors)

A plan for how to improve the system and prevent further occurrences would be developed, implemented, and assessed at intervals thereafter. Lessons learned could and should be applied to other aspects of operations.

For more information on error management:

• Moore SB, Foss ML. Error management: Theory and application in transfusion medicine at a tertiary-care institution (Arch Pathol Lab Med 2003;127(11):1517–22)

1. What contributory factors led to this adverse event?

Based on the case report alone, contributory factors included

• absence of formal and documented training and competency assessment programs
• communication difficulties between staff

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