Heska Element HT5+ Veterinary Hematology Analyzer
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/15/2023
Procurement Summary
The Element HT5+ Veterinary Hematology Analyzer, manufactured by Heska in China. The Laboratory of Malaria Immunology and Vaccinology (LMIV) conducts basic research on malaria pathogenesis and immunology, with an emphasis on studies in humans who are naturally or experimentally infected with malaria parasites. Specialists in each step of the development process, from antigen selection to clinical trials, contribute their expertise as the candidate moves along the development pathway. This allows multiple vaccine candidates to move from concept to clinical trials efficiently and rapidly. This Element HT5+ Veterinary Hematology Analyzer is a blood chemistry analyzer and is being requested by the Laboratory of Malaria Immunology and Vaccinology (LMIV) as we need an additional blood chemistry analyzer to analyze blood collected from animal studies looking at various malaria vaccine candidates in pre-clinical trials. This analyzer will provide important information about the condition of the animal in real time which will be an improvement over waiting for a contract company to read and provide the results. This is a new machine model not yet released but is near market. The technology is based on the old HT5 system that has been in production for many years and used by our collaborators in the Vaccine Research. Center (VRC). The ability to study anemia is important to our work as many people in Africa suffer from anemia with malaria parasites in their blood. The ability to accurately measure reticulocytes is a critical component of our research and this machine has a 95% accuracy rate for that measurement. This blood chemistry analyzer will replace one that is beginning to fail. LMIV has been contracting out blood chemistry assays with Antech Diagnostics (a local veterinary diagnostic company) who can perform Complete Blood Counts (CBC) and other requested animal blood work at a fee for service, and we’ve spent thousands of dollars with Antech having them perform the blood chemistry analysis, because one blood chemistry analyzer in the lab can’t keep up with the current workload. Procuring a second blood chemistry analyzer will save time and government funds and eliminate the need for an outside source to perform blood chemistry assays for us, which will also allow us to make quicker and more informed decisions regarding our preclinical studies. Since we’re currently using an older version of the requested blood chemistry analyzer, same as Antech Diagnostics uses, and our collaborators in the NIAID/VRC currently owns one and uses the HT5 which is the previous generation model, we need to maintain continuity protocols and use the same instrument. The Element HT5+ instrument can be integrated with our current protocols for studying reticulocytes accurately, which is a critical component to our mission related work using Non-Human Primate’s (NHP) in preclinical studies. Other major required parameters include total red blood cell count, hemoglobin, hematocrit, Mean cell volume, mean corpuscular Hemoglobin, white blood cell distribution in a scatter plot, white blood cell distribution in a histogram, RBC size distribution as a histogram and platelet size distribution as a histogram.
Waiver Rationale Summary
Conclusion: Based on the above market research findings and results from previous brand name or equal combines synopsis and solicitations posted on SAM.gov, no domestic products that meet the requirements were identified. No domestically manufactured items that meet the Government’s need that are mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of satisfactory quality could be identified. Historically, only one quote for foreign equipment had been received when reviewing previous solicitations for blood chemistry analyzers, no domestic quotes were received. The feasibility of foregoing the requirement or providing a United States-manufactured substitute has been considered, and no substitutes were found. Authority is requested to acquire the above-described Element HT5+ Veterinary Hematology Analyzer that is manufactured in China by Heska. Sources Sought Notice SS-NIAID-23-2183277 was posted on SAM.gov from 08/07/2023 to 08/09/2023 and received no responses for domestic products. Based on the findings detailed above, the Element HT5+ Veterinary Hematology Analyzer, manufactured by Heska are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Therefore, it is hereby determined by NIAID, consistent with FAR 25.103(b)(2), that these items are not domestically available.
Yes
Yes
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
08/15/2023
N/A
Pre-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH