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Developing Innovative Specimen Packaging Approaches to Improve Transit Success Rates

Description:

Phase I SBIR proposals will be accepted. Fast-Track proposals will not be accepted. Phase I clinical trials will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I: up to $243,500 for up to 6 months; Phase II of up to $1,000,000 and a Phase II duration of up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Maintaining the integrity of clinical and laboratory specimens from the collection (self-collected or collected by a healthcare professional) to analysis is critical. As such, the performance of any laboratory test is dependent on several pre-analytical phases, including using suitable containers and applying appropriate packaging methods to avoid any possible leakage. During specimen packaging, it is critical to account for various transit factors to ensure shipping personnel and laboratory staff are not exposed to hazardous material. Transit challenges that may result in leaky specimens may also result in rejection for testing, which would require the recollection of clinical specimens thereby delaying timely diagnosis and patient management. During emergencies, opportunities to re-collect specimens may not be available due to potential health risks, inaccessibility, or death among affected individuals. Though smaller leak-proof specimen containers utilize O-rings to prevent leakage, the COVID-19 pandemic has highlighted potential operational challenges with maintaining specimen integrity resulting from underlying environmental or human- related factors on larger specimen volumes. Some polypropylene specimen tubes (e.g. Viral Universal Transport Medium tubes used for swab collections) are not currently designed to withstand increased cabin pressure that may occur during transportation by air. As air cabin pressure changes, gases expand, including, the trapped air inside a specimen tube. The expanded air may result in the loosening of the screw cap that alleviates the internal pressure. This may result in specimen leakage. Currently, the United Nations packaging recommendations for Category A or B infectious materials suggest the use of parafilm as a layered barrier on screw caps to reduce the risk of leakage. However, for parafilm to serve as a leak-proof seal it must be stretched around the container cap in the same direction as it closes. This introduces the possibility of additional human error into the specimen processing workflow. Second, based on the principles of application torque the overtightening of a container cap may strip the threaded closure leading to unintended leaks. Similarly, loosely tightening a cap may render the same result. Currently, re-training healthcare staff on specimen handling is a traditional intervention method used to prevent packaging-related issues and improve quality assurance practices. However, constantly rotating staff (as experienced during emergencies) increases the prevalence of human error, further impacting aspects of the quality management cycle on preserving specimen integrity. As such, overcoming environmental and/or human-prone challenges are critical to facilitate timely patient care, enable a rapid public health response, prevent loss of valuable and sometimes irreplaceable specimens, and protect the handling personals from exposure to hazardous materials. Project Goals The primary goal of this proposal is to develop a technical capability that improves the integrity of specimen packaging through transit. Like a ‘tamper-proof’ cap on prescription pill bottles, the innovation must provide a physical or visual indication to the handling personnel, re-assuring that the specimen is secure from leakage. The innovation may also consider the principles of torque and develop approaches that prevent the handler from over-tightening or loosely tightening a cap for both small and large volume specimen collection containers. The innovation should not increase the physical efforts needed to close specimen containers. This innovation may offer a low-cost advanced safety capability to current specimen collection containers or provide new specimen container alternatives to promote safe packaging of various specimen types. Further, a successful proposal must take into consideration the dependability on supply chain processes to support commercialization potential. Phase I Activities and Expected Deliverables During the Phase I period, the activities can include, but are not limited to: 1. Conduct a technical assessment of currently used specimen collection containers in various transport environments to determine physical or functional properties that may result in leaks and other specimen challenges associated with containers (e.g., material of container, external pressure, external vibration, torque, temperature changes, etc.). 2. Identify functional gaps and provide specific technical improvements that may be applied to existing specimen collection containers or for the development of new specimen containers to promote safe packaging of different clinical and laboratory specimen types (e.g., cerebral spinal fluid, OP/NP wash, swabs, serum, whole blood, urine, culture) and prevent leakage and other challenges through various transport environments. 3. Develop a technical prototype for existing or new specimen collection containers that includes a safety feature to prevent leakage through various modes of transportation. Impact The Institute of Medicine report “To Err Is Human: Building a Safer Health System,” among others, highlights the impact logistical, laboratory, or medical errors may have on public health and patient care. Specimen leakages pose increased health risks to shipping and laboratory personnel, further raising public health concerns on the spread of disease. Improving safety measures on specimen collection containers may promote public health safety, ensure specimen integrity to enable accurate laboratory result reporting, and supports the timely diagnosis for critical patient management during emergencies. The impact of this innovation on public health may be evaluated both during non-emergent and emergency scenarios to measure its effectiveness in preventing disease spread and patient outcome. Commercialization Potential This innovation has the potential of commercialization as an ‘add-on’ custom packaging safety feature to existing specimen collection products or a new specimen container alternative. Like the development of the ‘tamper-proof’ safety cap on prescription pill bottles, this capability offers a mechanism to prevent specimen leakage and unintentional exposure during transit resulting from poor packaging practices or environmental factors.
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