Summary
A new CLSI document on external laboratory transport, expected in December 2025, will provide a risk-based framework for evaluating specimen transport systems, including emerging technologies like drones. The document will emphasize assessment over validation, considering factors like temperature, humidity, and vibration, and will offer recommendations for implementing data loggers and mitigating adverse environmental effects.
CLSI guidance on external lab transport due out in ’26
December 2025—A new Clinical and Laboratory Standards Institute document on external laboratory transport is expected to be released early next year.
“It’s the first comprehensive framework for evaluating external specimen transport systems,” says Joe Wiencek, PhD, D(ABCC), document development chair and medical director and associate professor of pathology, microbiology, and immunology at Vanderbilt University Medical Center.
The emphasis will be on assessment over validation or verification, he says. “That’s because in the general external specimen transport process, there’s a lot of complexity and variables, and there are limited to no specified or standardized performance criteria to verify or validate against.”
The document, titled “Evaluation of External Transport Systems (PRE06),” will delve into the characteristics and monitoring tools for storage and transport devices, including a brief discussion on emerging technologies like drones. It will cover the effects of external conditions, such as temperature, humidity, and vibration, across a variety of specimen types, and including guidance for assessing accuracy-related factors.
“The utility is it’s a risk-based approach to map site-specific transport challenges and ensure specimen stability from collection to laboratory arrival,” Dr. Wiencek says. It’s the first document to set forth recommendations to mitigate adverse environmental effects, including seasonal, regional, and microclimate variability.
Also included will be recommendations for implementing data loggers to monitor new transport systems and to maintain specimen stability and quality.
“The document’s significance lies in its flexible risk-based evaluation strategy, which allows laboratories to tailor their assessments to their specific needs and ensure reliable specimen transport under a wide range of conditions,” Dr. Wiencek says.
He expects the new document will also apply to evaluating the use of drones for laboratory specimens and blood products (see story, page 3). “Drones are basically flying courier lockboxes, and they need to be assessed for their ability to maintain specimen stability under varying conditions, which is something that courier lockboxes themselves don’t necessarily go through,” Dr. Wiencek says. Institutions would have to factor in not only specimen integrity and safety issues with drones but also privacy and security, among many others, including cost.
Still, there’s no question, he says, that drones are “transforming transport options in medicine, enabling faster and potentially more reliable transport, especially in congested or hard-to-pass areas of land with no roads or limited road access.”
“We should all be open to looking at efficient and sustainable transport processes,” he says. And all such processes should be evaluated using a risk-based approach.
As one of those processes, “drones are positioned to enhance patient and institutional satisfaction, while creating opportunities for improved outcomes,” Dr. Wiencek says. “The sky is truly the limit.”
CAP supports prehospital blood transfusion
There is sufficient medical oversight to allow prehospital emergency medicine personnel to initiate blood transfusions in the field, and to do so according to specific clinical indications and protocols while under the supervision of the EMS physician medical director, the CAP said in a position statement released in November.
Most states have updated their scope of practice to allow blood transfusions by EMS personnel to be initiated. Six states (Hawaii, Wyoming, Arkansas, Vermont, Maine, and Illinois) have scope-of-practice prohibitions on EMS personnel initiating and/or administering blood transfusions. In its position statement, the CAP encourages the states in which EMS scope of practice relative to prehospital transfusion is limited (for example, where transfusion cannot be initiated but can be monitored by EMS clinicians in the field) or disallowed to update the scope of practice toward a uniform national practice model.
The CAP also supports ongoing efforts to systematize data collection and support research to evaluate best practices and better refine interventions. The Agency for Healthcare Research and Quality is currently conducting a systematic review of the feasibility, effectiveness, and safety of prehospital transfusion.
The CAP notes the operational challenges blood suppliers face. Among them are adequate donor recruitment, manufacturing limitations, supply chain vulnerabilities, and the need to balance overall demand to supply prehospital programs while ensuring adequate inventory for hospitals. More research and data analysis are needed, the statement says, “to define the additive impact of supplying blood to EMS agencies to the overall blood supply and suggest strategies to accommodate this growth.”
“CAP is committed,” it said, “to supporting the EMS community and working with CMS and others to advance policies that will increase patient access to lifesaving prehospital blood transfusions.”
The full statement is at https://bit.ly/CAP_111825.
Abbott to acquire Exact Sciences
Abbott and Exact Sciences announced Nov. 20 a definitive agreement for Abbott to acquire Exact. Under the terms of the agreement, Exact shareholders will receive $105 per common share, representing a total equity value of about $21 billion.
Exact’s tests include Cologuard for colorectal cancer screening, Oncotype DX for breast cancer, Oncodetect for residual disease, and Cancerguard for multicancer early detection.