Case A7: Inter-facility Transportation of RBCs
Based on an idea from Dynacare Kasper Medical Laboratories
Upon completion of this exercise, participants should be able to:
- Discuss the concept of validation as applied in the clinical laboratory
- Explain why blood shipping containers need to be validated
- Outline what validation of a shipping container involves
- Describe devices for monitoring the temperature of blood shipping containers
- Describe standards for inter-facility transportation of blood in Canada (or your country)
- Describe standards that apply to training and competency assessment in a quality system
At midnight on Saturday a nurse from the Emergency Department in Hospital B brings to the transfusion service a blood supplier shipping container with 3 units of crossmatched RBCs. (The blood supplier also operates a centralized transfusion service and performs compatibility testing for some of its customers, including Hospitals A and B.) The blood arrived with a patient who had been transferred from an outlying small hospital (Hospital A).
The supplier container still has an intact tamper-evident seal but no temperature indicator. All inter-facility transportation in the region is based on shipping with containers validated to maintain acceptable temperatures at defined ambient temperatures for specified time periods.
When the sole laboratory technologist on duty phones the originating hospital, she is told that:
The RBC units had been shipped by the supplier via Greyhound bus and had just arrived at the hospital when the patient was about to be transferred.
As a result the box was not opened on-site and was given to the air ambulance staff for transport with the patient to the larger facility.
The supplier's issue record indicated that the units were packed 25 hours ago (11 pm Friday).
When the RBC left the supplier, the temperature was 15o C (59o F) but had soared to 35o C (95o F) on Saturday.
Transportation from both supplier to Hospital A and from Hospital A to Hospital B took much longer than expected. The Greyhound bus suffered an engine breakdown en route and had to be replaced with another bus. As well, the air ambulance had experienced a long delay on the runway due to severe thunderstorms in the area.
The technologist at Hospital B is unsure about whether the blood is acceptable to use. She remembers that the recommended transport time is no more than 24 hours but it is only one hour past that and is only a recommended maximum. She does not notice that the shipment has no temperature monitor and is unaware there are maximum shipping times for specific ambient temperatures.
The technologist decides to place the RBCs in inventory for possible transfusion to the patient. On her last two shifts this month she had had to telephone the on-call supervisor, who had been terse in her responses and indicated that she did not appreciate being called over such routine matters.
The patient did not require transfusion overnight and the next day the supervisor removed the RBCs from inventory. She placed a report in the technologist's personnel file documenting the incident and made an appointment to discuss the issue with the technologist prior to her next shift.
The technologist is a part-time employee who typically works evening or midnight shifts a few times each month. After being on holidays, this is her first shift back to work in over a month. She had not received training or competency assessment related to inter-facility blood shipments, which had been implemented last month to combat shortages in the region. Her initial training, including receiving blood shipments and entering it into inventory, had occurred over two years ago, but she had not undergone formal competency assessment then or since.
The transfusion service orients new employees by assigning them to a technologist who concurrently works on the bench and trains them for two weeks. Competency is assessed informally and based on observation and completion of whatever assigned tasks happen to occur during the training period and varies according to whatever the individual trainer deems important. There are no formal assessment tools such as observational checklists or sign-off sheets for each SOP, standardized written or oral questions, etc. Training and competency assessment are not documented except by a note in the personnel file when the two weeks of training ends.
Supplier Shipping SOP
The shipping policies and procedures used by both the blood supplier and hospitals throughout the region have the following criteria in common (pertinent to this case):
Monitoring of every shipment is not mandatory when the temperature is 1-20 o C (34-68o F). Monitors are mandatory when the outdoor temperature is <1 o C (34o F) and > 20o C (68o F)
Transportation should not exceed 24 hours.
The containers had been validated to maintain a temperature of 1-10o C (34-50o F) for 24 hours in ambient temperatures of 15-30o C (59-86oF).
To test your knowledge and as an advance organizer for the discussion section, read and consider these questions:
- What does validation of equipment or a method mean in practice?
- Why do containers used to ship blood components need to be validated?
- What is typically involved in validating equipment such as shipping containers?
How can the temperature of blood transported in shipping containers be monitored?
- Which standards apply to inter-facility transportation of blood and blood components in your country? (e.g., describe applicable standards in Canada's new blood safety standards, CSA Z902-04)
- Which standards apply to training and competency assessment in a quality system?
Proceed to the case discussion, which includes interactive questions with feedback.
This quiz is offered as a self assessment.
- How can shipping containers be validated?
- How can the temperature of blood transported in shipping containers be monitored?
- List the standards that apply to inter-facility transportation of blood and blood components in your country.
- List the types of standards related to training and competency assessment in a quality system.
- Compared to fulltime staff, are training and competency assessment requirements different for part-time and casual employees in the transfusion service and elsewhere?
- The technologist at hospital B entered potentially unsafe blood into inventory and a report was placed in the technologist 's file documenting the incident.
- In a quality system how are errors of this type handled?
- What contributory factors led to this adverse event?
- George VM, Pringle TC, Kline L, Friedman LI. Development and evaluation of a shipping system for platelet components. Transfusion 1996 Apr;36(4):335-8.
- Rentas FJ, Macdonald VW, Houchens DM, Hmel PJ, Reid TJ. New insulation technology provides next-generation containers for "iceless" and lightweight transport of RBCs at 1 to 10 degrees C in extreme temperatures for over 78 hours. Transfusion 2004 Feb;44(2):210-6.
- Sharley PH, Williams I, Hague S. Blood transportation for medical retrieval services. Air Med J 2003 Nov-Dec;22(6):24-7. (validation of blood transport containers in Australia)