CLSI PRE06—Evaluation of External Transport Systems describes processes for evaluating an external transport system. Specimens are commonly transported from external, off-site locations to the laboratory, where they are eventually examined. The system is comprised of any number of distinct and interdependent processes encompassing numerous variables that affect the system in unpredictable ways. Taken as a whole, the sending site, receiving site, examining laboratory, and all of the transportation modes and the components used, including the specimen carriers, dataloggers, and the supporting quality management system, make up the external transport system. Each component, route, and mode of transport should be individually and collectively evaluated. To ensure the integrity of the specimens transported, the sending site, receiving site, and examining laboratories are collectively responsible for evaluating the entire transport process, including its individual parts if warranted. Means to mitigate adverse conditions, such as extreme weather, should be communicated between each facility in real time. CLSI PRE06 presents important considerations for each part of the transport process, as well as best practice recommendations for assessing the suitability of an existing system or when changes are made within that system.

CLSI PRE06 focuses on evaluation criteria for a laboratory’s external transport system, which can involve collective responsibilities with other entities such as physician offices, specimen collection sites, centralized laboratories, commercial courier services, or large referral laboratories. CLSI PRE06 covers external transport methodologies (courier systems, storage and transport containers, and portable incubators), routes and processes, as well as new modes of transport (eg, drones). 

CLSI PRE06 does not discuss the evaluation of an internal specimen delivery system, including a pneumatic tube system or internal autonomous robotic carriers. 

The intended users of CLSI PRE06 are health care providers, accrediting organizations, government and regulatory agencies, and in vitro diagnostic (IVD) industry manufacturers. Governmental agencies can use CLSI PRE06 to establish regulatory and accreditation requirements relevant to external transport systems. By defining performance expectations, CLSI PRE06 assists industry partners when they design the components used within these systems to develop their product or service to meet the needs of their medical laboratory customers. 

CLSI PRE06 will not discuss in-depth the requirements for Transportation of Dangerous and/or Hazardous Goods (TDG). Although some mention is necessary, regulations change and are often determined by national or local agencies. Each organization must adhere to the regulations under which it operates. 

CLSI PRE06 will not include specimen handling and transport as it pertains to human safety (eg, for virology specimens see CLSI M291).