This case concerns practices related to inter-facility transportation of blood (blood monitors and shipping times) and to training and competency assessment policies and procedures. To recap, the pertinent events include
Staff did not include a temperature monitor with the shipment, even though their SOP specified that one was required for ambient temperatures >20o C (68o F). When the blood was initially shipped at 11 pm Friday, the temperature was 15o C (54o F).
Temperatures in the range of 35o C (95o F) were forecast for Saturday, but staff thought that the blood would reach Hospital A by early Saturday morning when the temperature would not have exceeded the validated maximum of 30o C (86o F).
When the RBCs arrived at Hospital A at 7 pm on Saturday, it was 28o C (82o F) after a daytime high of 35o C (95o F). In the rush to ship the blood with the patient, staff
- did not notice the absence of the required blood monitor
- did not recall that the shipping boxes were validated for a maximum temperature of 30o C (86o F)
- thought that the blood would reach Hospital B within the maximum 24 hour shipping time (even though 20 hours had elapsed since the blood was packed)
When the RBCs finally arrived at Hospital B at midnight, the sole technologist at Hospital B
- noticed the 25-hour shipping time
- did not notice the absence of a blood monitor
- was unaware that shipping boxes were validated for specific temperature ranges
- did not consult anyone before deciding to enter the blood into inventory.
The technologist at Hospital B had not been trained in the new inter-hospital transport procedures and had not undergone competency assessment in more than 2 years. She was intimidated by the supervisor, whose approach to being phoned when on-call was perceived as non-supportive on the last two occasions. The transfusion service at Hospital B lacked formal, documented training and competency assessment programs.
The case will be discussed as follows:
- Validation in the clinical laboratory
- Validation of shipping containers
- Requirements for inter-facility transportation of blood
- Training and competency assessment standards
Validation is a concept long known in chemistry and hematology laboratories, and in blood centres, but has come to transfusion services relatively recently. In brief, validation is a documented process to demonstrate that any process or procedure will consistently provide the expected results. The validation documents that a process will consistently produce a result that meets pre-established quality and performance specifications.
The purpose of method validation is to demonstrate that the method is " fit for the purpose," i.e., will provide valid and reliable data for the purpose for which it is intended. Similarly, the purpose of equipment validation, including computer systems, is to show that the equipment will work as expected.
Before methods and equipment are implemented, the laboratory must ensure that they meet specified performance requirements by validating criteria such as accuracy, sensitivity, specificity, and reproducibility. Validation is typically performed before implementing new methods and equipment. Revalidation is done after equipment repairs, and if the method or equipment is suspected of malfunctioning.
How to validate?
There is no single accepted procedure for conducting validations. Regulatory guidance, published literature, and educational tools are consulted, if available. From an operational perspective, the validation process may include these or similar steps:
- identifying process variables
- developing normal, abnormal, and worst case scenarios
- developing the validation protocol
- identifying functional requirements (how the method or equipment will be used in the lab and the expected performance)
- determining acceptance criteria
- approving the validation protocol
- training staff on the validation
- executing the protocol
- reviewing the collected data
- approving the validation
Once validated, the new method can be implemented with appropriate staff training and competency assessment, along with post-implementation error management and a comprehensive review of effectiveness.
The idea is to validate that the instrument works as expected according to defined requirements for the complete spectrum of samples that may be encountered in the lab.
What does validation of equipment or a method mean in practice ? Explain using using an example of validating a semi-automated instrument to determine ABO groups.
It is only recently that inter-hospital transportation of blood has been implemented in Canada, driven by regionalization of transfusion services and the desire to conserve scarce blood resources.
In general, blood shipping containers are tested using various
- types of blood components and products
- numbers of components
- configurations of ice packs, gel, and dry ice (see example)
- ambient temperatures, including extremes
- transportation times
See these examples of validation studies for blood shipping containers:
- 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)
Why do containers used to ship blood components need to be validated?
What is typically involved in validating equipment such as shipping containers?
Many countries have standards that apply to inter-facility transportation of blood and blood components. For example, in Canada CSA Z902-15 includes standards for transporting blood and blood components between (and within) facilities related to
- required temperature ranges
- maximum shipping times
- shipping containers (validated or with evidence of temperature compliance)
- tamper-evident security fasteners
- container packaging
- container labelling
- release (issuing) vouchers
- responsibility for documenting final disposition (inter-facility shipments)
- training and internal assessment to ensure compliance
Maintaining proper storage temperatures during transportation is critical. This can be accomplished by using validated shipping containers (as described above) or by using temperature monitoring devices (or a combination of both).
Temperature monitoring devices
How can the temperature of blood transported in shipping containers be monitored? Various devices exist to monitor that temperatures within the shipping containers are maintained within required ranges. Below are two examples and inclusion here does not constitute endorsement. Other devices are available.
- Safe-T-vueTM (non-reversible indicators that change colour when temperature reaches 10o C)
- TempTale 4 Monitors from Sensitech Inc.
- Monitors are the size of a small calculator with a display screen and start/ stop buttons. Users can set parameters such as the measurement interval, alarm settings, and start up delay.
For Canadian regulatory requirements for inter-facility transportation of blood, refer to
In this case study, the shipping containers had been validated to maintain a temperature of 1– 10o (34–50o F) for 24 hours for ambient temperatures of 15–30o C (59–86o F). What errors or poor practices, if any, related specifically to transporting blood, were made by staff at the
Which standards apply to training and competency assessment in a quality system? Elements of quality systems that relate to training and competency assessment generally include requirements to
Identify training needs for all staff and develop documented training programs, including initial and ongoing training
Develop, maintain, and document formal competency assessment programs
Assess competency following training and at regular intervals thereafter
Assess effectiveness of training programs at least annually
Implement SOPs and important changes only after staff training is complete
Such requirements are included in Canada's new blood safety standards, Z902-15. Blood & blood components (see Personnel)
In this case study, the transfusion service at Hospital B lacked formal, documented training and competency assessment programs. The part-time technologist on duty had not been trained in the new inter-hospital transport procedures and had never undergone formal, documented competency assessment.
- What changes to the training and competency assessment system at Hospital B's transfusion service would you recommend?
- Do part-time staff need the same training as full-time staff?
- Do staff have a responsibility to refuse to perform duties for which they have not been trained?
The technologist did not ask for assistance despite being unsure of what to do. Her decision not to contact the on-call supervisor was influenced by the supervisor having been perceived as non-supportive in the past. Which of the following possibly contributed to the technologist not asking for help?
Technologist is shy and needs to be more assertive
Technologist feels intimidated and makes poor decisions
Supervisor suffers from stress that adversely affects her interpersonal skills
Supervisor lacks patience with those she perceives as less capable than herself
Communication between supervisor and staff is faulty
In a quality system how are errors handled?