Title: QuidelOrtho Reagents and Supplies Standing Order – FY 2027
\n\nAgency: Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center (CC)
\n\nDepartment: Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL)
\n\nNAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing
\n\nPSC: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
\n\nPlace of Performance:
\nNIH Clinical Center
\n10 Center Drive
\nBethesda, MD 20892
Estimated Period of Performance: October 1, 2026 through September 30, 2027
\n\nResponse Deadline: October 5, 2026, at 1:00 PM Eastern Time (ET)
\n\nDESCRIPTION
\n\nThe National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL), has a requirement for a FY 2027 standing order for QuidelOrtho reagents and supplies used in patient and blood-product testing.
\n\nThe Transfusion Services Laboratory operates 24 hours a day, seven days a week, providing blood products and testing in support of transfusion needs for patients at the NIH Clinical Center. The required reagents are essential for patient and donor testing and are used to identify potentially harmful antibodies directed against transfused red blood cells. The use of these reagents supports the provision of compatible blood products and helps prevent severe or potentially fatal hemolytic transfusion reactions.
\n\nThe required QuidelOrtho reagents have unique red-cell antigen compositions and donor panels and have undergone validation for clinical testing within the TSL. These products are incorporated into the laboratory's standard operating procedures and are currently validated as the test of record.
\n\nThe requirement includes, but is not limited to, QuidelOrtho blood-bank reagents, gel cards, antisera, quality-control kits, reagent red blood cells, diluents, and associated supplies necessary to support patient care and blood-product manufacturing activities.
\n\nDue to the short expiration dates of certain reagents, the products are manufactured based on customer standing orders. Supplies will therefore be manufactured and shipped throughout the period of performance according to the manufacturer's production schedule to ensure that the TSL receives in-date reagents as required.
\n\nINTENDED SOURCE
\n\nThe Government intends to procure these supplies from:
\n\nQuidelOrtho Sales Company, LLC
\n\nThe Government's market research indicates that QuidelOrtho is the only source capable of providing the required proprietary reagents and supplies. QuidelOrtho does not authorize third-party resellers or distributors for these products.
\n\nThe required reagents have already undergone large-scale validation studies and are currently validated for clinical use within the NIH Clinical Center's Transfusion Services Laboratory. Use of alternative reagents would require additional validation studies before they could be introduced into clinical testing and could result in delays to essential transfusion services and patient care.
\n\nRESPONSE REQUIREMENTS
\n\nThis notice is not a request for competitive quotations. However, all responsible sources that believe they can provide the required products may submit a capability statement demonstrating their ability to satisfy the Government's requirement.
\n\nCapability statements must provide sufficient information demonstrating the respondent's ability to provide all required reagents and supplies, including documentation establishing authorization to provide the required QuidelOrtho products, if applicable.
\n\nResponses must include:
\n\nCompany name, address, UEI, and point of contact;
\n\tBusiness size and socioeconomic status under NAICS 325413;
\n\tDocumentation demonstrating the ability to provide the required QuidelOrtho reagents and supplies;
\n\tEvidence that the proposed products meet the Government's requirements and are compatible with the NIH Clinical Center's existing validated testing processes; and
\n\tAny other information demonstrating the respondent's capability to satisfy the complete requirement.
\n\tAll capability statements must be received no later than October 5, 2026, at 1:00 PM Eastern Time (ET) and sent to shasheshe.goolsby@nih.gov. Telephone calls are not acceptable.
\n\nResponses received by the stated deadline will be considered by the Government solely for the purpose of determining whether conducting a competitive procurement is appropriate.
\n\nA determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government.
","text":"Title: QuidelOrtho Reagents and Supplies Standing Order – FY 2027\n\nAgency: Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center (CC)\n\nDepartment: Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL)\n\nNAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing\n\nPSC: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets\n\nPlace of Performance:\n\nNIH Clinical Center\n\n10 Center Drive\n\nBethesda, MD 20892\n\nEstimated Period of Performance: October 1, 2026 through September 30, 2027\n\nResponse Deadline: October 5, 2026, at 1:00 PM Eastern Time (ET)\n\nDESCRIPTION\n\nThe National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL), has a requirement for a FY 2027 standing order for QuidelOrtho reagents and supplies used in patient and blood-product testing.\n\nThe Transfusion Services Laboratory operates 24 hours a day, seven days a week, providing blood products and testing in support of transfusion needs for patients at the NIH Clinical Center. The required reagents are essential for patient and donor testing and are used to identify potentially harmful antibodies directed against transfused red blood cells. The use of these reagents supports the provision of compatible blood products and helps prevent severe or potentially fatal hemolytic transfusion reactions.\n\nThe required QuidelOrtho reagents have unique red-cell antigen compositions and donor panels and have undergone validation for clinical testing within the TSL. These products are incorporated into the laboratory's standard operating procedures and are currently validated as the test of record.\n\nThe requirement includes, but is not limited to, QuidelOrtho blood-bank reagents, gel cards, antisera, quality-control kits, reagent red blood cells, diluents, and associated supplies necessary to support patient care and blood-product manufacturing activities.\n\nDue to the short expiration dates of certain reagents, the products are manufactured based on customer standing orders. Supplies will therefore be manufactured and shipped throughout the period of performance according to the manufacturer's production schedule to ensure that the TSL receives in-date reagents as required.\n\nINTENDED SOURCE\n\nThe Government intends to procure these supplies from:\n\nQuidelOrtho Sales Company, LLC\n\nThe Government's market research indicates that QuidelOrtho is the only source capable of providing the required proprietary reagents and supplies. QuidelOrtho does not authorize third-party resellers or distributors for these products.\n\nThe required reagents have already undergone large-scale validation studies and are currently validated for clinical use within the NIH Clinical Center's Transfusion Services Laboratory. Use of alternative reagents would require additional validation studies before they could be introduced into clinical testing and could result in delays to essential transfusion services and patient care.\n\nRESPONSE REQUIREMENTS\n\nThis notice is not a request for competitive quotations. However, all responsible sources that believe they can provide the required products may submit a capability statement demonstrating their ability to satisfy the Government's requirement.\n\nCapability statements must provide sufficient information demonstrating the respondent's ability to provide all required reagents and supplies, including documentation establishing authorization to provide the required QuidelOrtho products, if applicable.\n\nResponses must include:\n\n•\nCompany name, address, UEI, and point of contact;\n\n•\nBusiness size and socioeconomic status under NAICS 325413;\n\n•\nDocumentation demonstrating the ability to provide the required QuidelOrtho reagents and supplies;\n\n•\nEvidence that the proposed products meet the Government's requirements and are compatible with the NIH Clinical Center's existing validated testing processes; and\n\n•\nAny other information demonstrating the respondent's capability to satisfy the complete requirement.\n\nAll capability statements must be received no later than October 5, 2026, at 1:00 PM Eastern Time (ET) and sent to shasheshe.goolsby@nih.gov. Telephone calls are not acceptable.\n\nResponses received by the stated deadline will be considered by the Government solely for the purpose of determining whether conducting a competitive procurement is appropriate.\n\nA determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government.","origin":"detail"},"notice_type":{"code":"p","label":"Presolicitation"},"schema_version":1,"solicitation_number":"27-000138","place_of_performance":{"zip":"20892","city":{"name":"Bethesda"},"state":{"code":"MD"},"country":{"code":"USA"}},"product_service_code":"6550"}],"due_at":"2026-10-05T17:00:00Z","due_date":"2026-10-05","closes_at":"2026-10-05T17:00:00Z","awardable":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7529","sub_name":"NATIONAL INSTITUTES OF HEALTH","office_key":"o-75N980","office_name":"NATIONAL INSTITUTES OF HEALTH OLAO","state":"MD","county":"24031","county_name":"Montgomery County","city":"2407125","city_name":"Bethesda","country":"USA","state_source":null,"state_evidence":null,"site_key":null,"winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-30T04:14:25.251125Z","principal_notice_id":"3a933738f9e14014924df0b4f5c3d371","description":{"text":"Title: QuidelOrtho Reagents and Supplies Standing Order – FY 2027\n\nAgency: Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center (CC)\n\nDepartment: Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL)\n\nNAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing\n\nPSC: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets\n\nPlace of Performance:\n\nNIH Clinical Center\n\n10 Center Drive\n\nBethesda, MD 20892\n\nEstimated Period of Performance: October 1, 2026 through September 30, 2027\n\nResponse Deadline: October 5, 2026, at 1:00 PM Eastern Time (ET)\n\nDESCRIPTION\n\nThe National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL), has a requirement for a FY 2027 standing order for QuidelOrtho reagents and supplies used in patient and blood-product testing.\n\nThe Transfusion Services Laboratory operates 24 hours a day, seven days a week, providing blood products and testing in support of transfusion needs for patients at the NIH Clinical Center. The required reagents are essential for patient and donor testing and are used to identify potentially harmful antibodies directed against transfused red blood cells. The use of these reagents supports the provision of compatible blood products and helps prevent severe or potentially fatal hemolytic transfusion reactions.\n\nThe required QuidelOrtho reagents have unique red-cell antigen compositions and donor panels and have undergone validation for clinical testing within the TSL. These products are incorporated into the laboratory's standard operating procedures and are currently validated as the test of record.\n\nThe requirement includes, but is not limited to, QuidelOrtho blood-bank reagents, gel cards, antisera, quality-control kits, reagent red blood cells, diluents, and associated supplies necessary to support patient care and blood-product manufacturing activities.\n\nDue to the short expiration dates of certain reagents, the products are manufactured based on customer standing orders. Supplies will therefore be manufactured and shipped throughout the period of performance according to the manufacturer's production schedule to ensure that the TSL receives in-date reagents as required.\n\nINTENDED SOURCE\n\nThe Government intends to procure these supplies from:\n\nQuidelOrtho Sales Company, LLC\n\nThe Government's market research indicates that QuidelOrtho is the only source capable of providing the required proprietary reagents and supplies. QuidelOrtho does not authorize third-party resellers or distributors for these products.\n\nThe required reagents have already undergone large-scale validation studies and are currently validated for clinical use within the NIH Clinical Center's Transfusion Services Laboratory. Use of alternative reagents would require additional validation studies before they could be introduced into clinical testing and could result in delays to essential transfusion services and patient care.\n\nRESPONSE REQUIREMENTS\n\nThis notice is not a request for competitive quotations. However, all responsible sources that believe they can provide the required products may submit a capability statement demonstrating their ability to satisfy the Government's requirement.\n\nCapability statements must provide sufficient information demonstrating the respondent's ability to provide all required reagents and supplies, including documentation establishing authorization to provide the required QuidelOrtho products, if applicable.\n\nResponses must include:\n\n•\nCompany name, address, UEI, and point of contact;\n\n•\nBusiness size and socioeconomic status under NAICS 325413;\n\n•\nDocumentation demonstrating the ability to provide the required QuidelOrtho reagents and supplies;\n\n•\nEvidence that the proposed products meet the Government's requirements and are compatible with the NIH Clinical Center's existing validated testing processes; and\n\n•\nAny other information demonstrating the respondent's capability to satisfy the complete requirement.\n\nAll capability statements must be received no later than October 5, 2026, at 1:00 PM Eastern Time (ET) and sent to shasheshe.goolsby@nih.gov. Telephone calls are not acceptable.\n\nResponses received by the stated deadline will be considered by the Government solely for the purpose of determining whether conducting a competitive procurement is appropriate.\n\nA determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government.","html":"Title: QuidelOrtho Reagents and Supplies Standing Order – FY 2027
\n\nAgency: Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center (CC)
\n\nDepartment: Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL)
\n\nNAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing
\n\nPSC: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
\n\nPlace of Performance:
\nNIH Clinical Center
\n10 Center Drive
\nBethesda, MD 20892
Estimated Period of Performance: October 1, 2026 through September 30, 2027
\n\nResponse Deadline: October 5, 2026, at 1:00 PM Eastern Time (ET)
\n\nDESCRIPTION
\n\nThe National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL), has a requirement for a FY 2027 standing order for QuidelOrtho reagents and supplies used in patient and blood-product testing.
\n\nThe Transfusion Services Laboratory operates 24 hours a day, seven days a week, providing blood products and testing in support of transfusion needs for patients at the NIH Clinical Center. The required reagents are essential for patient and donor testing and are used to identify potentially harmful antibodies directed against transfused red blood cells. The use of these reagents supports the provision of compatible blood products and helps prevent severe or potentially fatal hemolytic transfusion reactions.
\n\nThe required QuidelOrtho reagents have unique red-cell antigen compositions and donor panels and have undergone validation for clinical testing within the TSL. These products are incorporated into the laboratory's standard operating procedures and are currently validated as the test of record.
\n\nThe requirement includes, but is not limited to, QuidelOrtho blood-bank reagents, gel cards, antisera, quality-control kits, reagent red blood cells, diluents, and associated supplies necessary to support patient care and blood-product manufacturing activities.
\n\nDue to the short expiration dates of certain reagents, the products are manufactured based on customer standing orders. Supplies will therefore be manufactured and shipped throughout the period of performance according to the manufacturer's production schedule to ensure that the TSL receives in-date reagents as required.
\n\nINTENDED SOURCE
\n\nThe Government intends to procure these supplies from:
\n\nQuidelOrtho Sales Company, LLC
\n\nThe Government's market research indicates that QuidelOrtho is the only source capable of providing the required proprietary reagents and supplies. QuidelOrtho does not authorize third-party resellers or distributors for these products.
\n\nThe required reagents have already undergone large-scale validation studies and are currently validated for clinical use within the NIH Clinical Center's Transfusion Services Laboratory. Use of alternative reagents would require additional validation studies before they could be introduced into clinical testing and could result in delays to essential transfusion services and patient care.
\n\nRESPONSE REQUIREMENTS
\n\nThis notice is not a request for competitive quotations. However, all responsible sources that believe they can provide the required products may submit a capability statement demonstrating their ability to satisfy the Government's requirement.
\n\nCapability statements must provide sufficient information demonstrating the respondent's ability to provide all required reagents and supplies, including documentation establishing authorization to provide the required QuidelOrtho products, if applicable.
\n\nResponses must include:
\n\nCompany name, address, UEI, and point of contact;
\n\tBusiness size and socioeconomic status under NAICS 325413;
\n\tDocumentation demonstrating the ability to provide the required QuidelOrtho reagents and supplies;
\n\tEvidence that the proposed products meet the Government's requirements and are compatible with the NIH Clinical Center's existing validated testing processes; and
\n\tAny other information demonstrating the respondent's capability to satisfy the complete requirement.
\n\tAll capability statements must be received no later than October 5, 2026, at 1:00 PM Eastern Time (ET) and sent to shasheshe.goolsby@nih.gov. Telephone calls are not acceptable.
\n\nResponses received by the stated deadline will be considered by the Government solely for the purpose of determining whether conducting a competitive procurement is appropriate.
\n\nA determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government.
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