SOLICITATION NOTICE
J -- ProteinSimple / Maintenance Services for Milo and two-Color Scanner.
- Notice Date
- 4/5/2022 7:42:21 AM
- Notice Type
- Presolicitation
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 22-006624
- Response Due
- 4/20/2022 8:00:00 AM
- Point of Contact
- Grace Wong-Darko, Phone: 3014961199
- E-Mail Address
-
grace.wong-darko@nih.gov
(grace.wong-darko@nih.gov)
- Description
- INTRODUCTION This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Center for Cellular Engineering (CCE), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to: ProteinSimple 3001 Orchard PKWY San Jose, CA 95134-2017 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 with a Size Standard $6.5 MIL. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-04 January 30, 2022. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: ProteinSimple / Maintenance Services for Milo and two-Color Scanner. 2. Background Information:� The National Institutes of Health (NIH) is the nation�s foremost federally funded biomedical research institution.� It is comprised of twenty-seven Institutes and Centers.� The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings.� The NIH CC is an 870,000 square-foot facility with the capacity to serve 240 inpatient beds and 82 day-hospital stations. The Center for Cellular Engineering, Department of Transfusion Medicine, NIH CC is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials.� These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials.� The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product.� To provide these services, CPS operates a core facility (Charles S. Carter Cellular Therapy Laboratory) for the manufacture, storage, and distribution of cellular therapy products.� CPS manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year.� The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases.� All products are manufactured using good manufacturing practices (GMP).� The NIH protocols are institutional review board (IRB) approved and in the case of INDs approval by the US Food and Drug Administration (FDA) for treatment of human subjects.� Each subject must consent to participate in a NIH Clinical Research Study.� The proposed vendor, Protein Simple, the only company, which provides the clinically approved platform for reagents and cartridges, and the respective instruments that are used for patient care testing of clinical lot release assays at CCE for more than 30 FDA approved protocols and tracking immunotherapy efficiency and monitoring side effects on clinical and research cellular products.� The preventive maintenance is required to compliance with manufacturer and FDA 21 CFR 211.67. Both Milo single cell western system and two-color scanner are unique instrument that can help us identify specific biomarkers changes at single cell level from different CAR-T or Cellular Engineered product to guide and improve cell product administrated to the patient. This instrument is needed to generate data that is required for providing guidance to improve immunotherapy efficiency of the cellular therapy product. 3. Purpose or Objective: This is 4 years of service contract plan (one base year plus 3 option years) for the service coverage of Milo single cell western system, an automated protein detecting instrument that uses single cell western analysis at a single run and with its two-color scanner system. Using those system, CCE provides single cell protein detection and profiling on CAR-T cell product and therefore on lot release testing development to support the clinical cell processing laboratory and clinical research in clinical center. 4. Contract Duration:� Base year(year1):� 6/21/2022 to 6/20/2023 Note: After PM completion for bring Milo back on continued coverage for additional 3 years. Because Milo (ZB-0203) is currently off-contract. Option year 1(year 2):� 6/21/2023 to 6/20/2024 Option year 2(year 3):� 6/21/2024 to 6/20/2025 Option year 3(year32):� 6/21/2025 to 6/20/2026 5. CONTRACTOR REQUIREMENTS SCOPE: The subject contract shall cover maintenance, support and emergency servicing for Milo single cell western system with compatible two-color scanner system in the Center for Cellular Engineering (CCE) of the Clinical Center at NIH.� Milo Platinum Service Plan for 4 years (one base year plus additional three option years), is required to comply with 21CFR 211.67.� The Milo with its compatible two-color scanner perform single cell western analysis to measure proteins and biomarker changes at single cell level during cell manufacturing for clinical CAR-T cell products and other cell products of lot release assays in CCE. Work to be performed Independently, and not as an agent of the government, the contractor shall provide necessary personnel, supplies, and services to perform the work required by this contract as set forth in the sections. The contractor shall perform the following: The contractor shall provide the most popular full-service plan balancing performance, productivity, and cost to deliver confidence and peace of mind. Milo Platinum Service Plan Agreement includes: Provides unlimited service at a Bio-Techne depot repair facility. Provides all parts and labor required for repairs. Plan includes shipping/packaging coverage to and from factory. Loaner instrument provided upon request during repair. Includes one preventative maintenance visit for the Milo system. Parts/Supplies The contractor shall supply all parts and supplies needed for service and maintenance. Labor and Travel The contractor shall provide all labor and travel at no additional cost for the duration of the contract. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This system is on site and has been validated for use on CC patients.� It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by ProteinSimple.� With the continuation of using the same supplies will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, and the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. � A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by April 20th, 2022, 11:00 AM Eastern time and must reference solicitation number 22-006624. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted. ""All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.""
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/e0ae1a1a4e6b4ecfa410579bb809ff99/view)
- Place of Performance
- Address: Bethesda, MD 20892, USA
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN06289431-F 20220407/220405230055 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |