SOLICITATION NOTICE
65 -- Intra-Aortic Balloon Pump System [CARDIOSAVE Hybrid], Training, Care Plan including Remote Support and one (1) year warranty - Notice of Intent to Sole Source
- Notice Date
- 9/2/2016
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 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
- ZIP Code
- 20892-5480
- Solicitation Number
- 16-011045
- Archive Date
- 10/1/2016
- Point of Contact
- Christopher D. Lauver, Phone: 3014969427
- E-Mail Address
-
christopher.lauver@nih.gov
(christopher.lauver@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent (NOI) to Sole Source 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 Nursing Department, 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 ¬¬¬¬¬¬¬¬¬¬¬Maquet Cardiovascular US Sales, LLC. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 334516 with a Size Standard of 1000 employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-89-1, August 15, 2016. 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-Simplifeid Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Intra-Aortic Balloon Pump System [CARDIOSAVE Hybrid], Training, and Care Plan including Remote Support and one (1) year warranty 2. Background Information: The Clinical Center at the National Institutes of Health (NIH) in Bethesda, Maryland, is the nation's largest hospital devoted entirely clinical research. It is a national resource that makes it possible to rapidly translate scientific observations and laboratory discoveries into new approaches for diagnosing, treating, and preventing disease. Approximately 1,500 studies are in progress at the NIH Clinical Center. Approximately, half of the studies are the first tests of new drugs or medical treatments in humans. The rest are natural history studies which include many rare diseases. These long-term studies lead to a better understanding of how diseases develop and result in improvements in prevention and treatment. 3. Purpose or Objective: Current Intra-Aortic Balloon Pumps (IABP) are assigned to the ICU (Datascope CS-100) and National Heart Lung and Blood Institute's Catheterization Lab (Datascope CS-300). The CS 100 device is obsolete and no longer supported. This life critical medical equipment no longer meets The Joint Commission Standards and requires replacement. 4. Delivery Date: 30 Days A.R.O. for supplies (12 Months A.R.O for warranty, training, support, etc.). CONTRACTOR REQUIREMENTS (SCOPE OF WORK) The contractor must be headquartered or have service locations within the United States of America. The contractor must be certified by the manufacturer to provide sales. The following are required during the period of warrantee: 1. The contractor must be able to provide on-site technical service and repairs within 48 hours of trouble call. 2. Contractor is to provide 24/7 emergency call center contact for clinical and technical troubleshooting 3. Contractor must have the ability to provide a rental unit with-in four hours of request 4. The contractor must be able to facilitate software support and address any FDA recalls or manufacturer alerts IABP Requirements NIH, CC, Nursing needs to support patients undergoing cardiac procedures in the Cath Lab if a patient decompensates and needs to come to the ICU. The IABP will require these specifications: • Total weight not to exceed 114 lbs. or 53 lbs. in transport mode (ambulance or helicopter) • Not to exceed 53" height X 27" deep X 22" wide • Batteries are hot swappable with a minimum of 3 hours runtime with low battery alarm • Retractable AC cord no less than 15ft • Internal and external Helium Tank • Color LCD with no less than 12.1" diagonal and no less than 1024 X768 resolution • Waveform trace no less than 7 sec • Font size no less than 15mm • ECG lead fault management • Color coded cable connectors (ECG, Pressure) • Condensation removal system • Pressure Fill - calculate fill pressure based on catheter and tubing volume • Diffusion replacement cycle • No exposed drain or fill tubing • Pneumatic speed not to exceed 229 msec for 80 HR and 226 msec for 150 HR • Manual and automatic lock screen features • External monitor interface (1/4" phono jack) • Automatic and semi-automatic operating modes • Manual pacer setting capability • Technical, high, and medium priority alarms • IAB Catheter must be compatible with existing IABP • IAB catheter must be as large as 50CC • IAB catheter must be as small as 25CC with no step down is shaft diameter 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 medical 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 16, 2016, 4:30 PM Eastern time and must reference solicitation number 16-011045. 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."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/16-011045 /listing.html)
- Place of Performance
- Address: 10 Center Drive, BLDG 10, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04254180-W 20160904/160902235214-109051b0dbd69002ee8049846b639b45 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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