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One (1) year of regular preventive maintenance visits(one or more), emergency servicing, spare /replacement parts, and support for existing Rees Monitoring system

General Information

Document Type:PRESOL
Posted Date:Sep 07, 2017
Category: Maintenance, Repair and Rebuilding of Equipment
Set Aside:N/A

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480

Description

INTRODUCTION 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 Department of Transfusion Medicine, 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: REES SCIENTIFIC CORPORATION 1007 WHITEHEAD ROAD EXT STE 1 EWING, NJ, 08638-2405, UNITED STATES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 with a Size Standard $20.5 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-95, January 13, 2017. 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 ($150,000). 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: One (1) year of regular preventive maintenance visits(one or more), emergency servicing, spare /replacement parts, and support for each listed device [Nodes: 3 and 5, service contract on existing Rees Monitoring system is required to comply with 21CFR 211.67 (Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart Equipment Cleaning and Maintenance)]. 2. Background Information: The National Institutes of Health (NIH) is the nations 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 Cell Processing Section (CPS), 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. 3. Purpose or Objective: This requirement shall cover the extension of our current environmental monitoring system that will allow us to ensure that all blood component storage areas (fridges, freezers etc) across the CPS area that are monitored 24/7 in the Cell Processing Section of the Department of Transfusion Medicine in the Clinical Center at NIH. The purpose of this Statement of Work (SOW) is to detail the tasks and responsibilities of (hereinafter, the Vendor) in relation to providing a services that will perform or cover maintenance, preventive maintenance, support, and emergency servicing Instruments. The instruments are located in in the Cell Processing Section/2J area of the Department of Transfusion Medicine at the Clinical Center at NIH. Nodes: 3 and 5, service contract on existing Rees Monitoring system is required to comply with 21CFR 211.67 (Current Good Manufacturing Practice for Finished Pharmaceuticals Subpart Equipment Cleaning and Maintenance). Included in this service agreement will be one or more regular preventive maintenance visits, emergency servicing, spare /replacement parts, and support for each listed devices. 4. Period of Performance: 1 year with an anticipated award date on or around 9/26/2017. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) 1. Coverage. Included in this service agreement will be one or more regular preventive maintenance visits emergency servicing, spare /replacement parts, and support for each listed devices. 2. Work to be performed. Independently, and not as an agent of the government, the contractor will provide all necessary personnel, supplies, and services to perform the work required by this service agreement as set forth in the sections. 3. The contractor will perform the following: a. 2J Project - Adding Room DPs (Differential Pressure Sensors) (16). Room Humidity, & (17) Room Temp to 2J area 4. The contractor will provide the following parts:1 MPX-RMT-RJ-24;16 CUSTOMER-SENS,16 CAL-DIFF-PRES,16 MOD-45-CORD,17 Z3-T/H-WF, 17 WEATHER-COVER 5. Technical Support and warranty. Tech Support 24/7 and warranty will follow the terms of the existing contract for the rest of the system. 6. Labor and Travel. The contractor shall provide all labor and travel at no additional cost for the duration of the contract for all items covered as per existing service agreement. 7. Period of Performance (POP). Service will be performed MON-FRI 8am to 5 pm. Anticipated award on or around September 26th, 2017 for a period of one year. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The intended sole source is the only known source to meet the technical needs of the scientific equipment. 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, 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 September 22, 2017, 3:00 PM Eastern time and must reference solicitation number 17-016374. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@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."

Original Point of Contact

POC Christopher D. Lauver, Phone: 301-594-5914, Barbara Taylor, Phone: 301-594-5915

Place of Performance

Address:
9000 Rockville, BLDG 10, Bethesda, Maryland, 20892, United States
20892,
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