SOLICITATION NOTICE
J -- Thermo Fisher Scientific/ Centrifuges' Preventative Maintenance and Total Care Service Agreement.
- Notice Date
- 2/11/2020 7:04:07 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
- 20-005847
- Response Due
- 2/26/2020 7:00:00 AM
- Archive Date
- 03/12/2020
- 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 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 (DTM), 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: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC. 28 SCHENCK PKWY STE 400 ASHEVILLE,�NC,�28803-5053 UNITED STATES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 with a Size Standard $20.5 REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-04, January 15, 2020. 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: Thermo Fisher Scientific /Centrifuges� Preventative Maintenance & Total Care Service Agreement. � 2. Background Information: �The Center Cellular Engineering (CCE), 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, CCE operates a core facility (Charles S. Carter Cellular Therapy Laboratory) for the manufacture, storage, and distribution of cellular therapy products.� CCE 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: Preventative Maintenance and Total Care Services for critical equipment used in the manufacturing of cell based therapies for clinical trials sponsored by NIH investigators. 4. Period of Performance: Base 4/1/20 � 3/31/21 Option Year 1: 4/1/21 � 3/31/22 Option Year 2: 4/1/22 � 3/31/23 Option Year 3: 4/1/23 � 3/31/24 Option Year 4: 4/1/24 � 3/31/25 CONTRACTOR REQUIREMENTS (SCOPE OF WORK) 1. The subject contract shall cover Total Care (TC) support plan that covers Parts, Labor, Travel and includes the annual preventative maintenance (PM), support, and emergency servicing for the centrifuges located in the Center for Cellular Engineering Section of the Department of Transfusion of the Clinical Center at NIH. The Preventive maintenance (PM) is required to compliance with manufacturer, DTM/CCE QA and FDA. The centrifuges are used for patient cell culturing, growing, separation and centrifugation, being essential part of cell therapy processes. Included in this contract will be one regular preventive maintenance visit. 2.�Work to be perform - Independently, and not as an agent of the government, the contractor shall provide all necessary personnel, supplies, and services to perform the work required by this contract as set forth in the sections. ����� 3.The Contractor shall perform the following services: The service will be scheduled by a qualified representative and 30 days in advance of the scheduled due date. Services will be performed on the following: Annual onsite preventive maintenance Priority onsite repair Priority depot repair Repair instruments identified which are not operating and restore them to product specifications Detailed Service documentation Performance assurance checks, functionality checks Safety inspections in accordance with all applicable regulations Cleaning of operational contaminations Testing of components is operating in accordance with its performance specifications. Allocation of parts and labor for all necessary repairs 4. Parts/Supplies: The contractors shall supply all parts and supplies needed for service and maintenance. 5. Emergency Services/ Repair: The contractor shall respond within 1 business day of the customer call or email for every attempt to triage instrument problems. The onsite response for emergency or repair should be within 3 business days after the 1st remote response diagnosis is completed. 6. Service Calls Request for service has no designated individuals. Any employee assigned to a specific work area, can report a malfunction to one of the devices by call the 800 number. 7. Labor and Travel The contractor shall provide all labor and travel at no additional cost for the duration of the contract. 8. Period of Performance: Base 4/1/20 � 3/31/21 Option Year 1: 4/1/21 � 3/31/22 Option Year 2: 4/1/22 � 3/31/23 Option Year 3: 4/1/23 � 3/31/24 Option Year 4: 4/1/24 � 3/31/25 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 Thermo Fisher Scientific (Asheville) LLC. �With the continuation of using the same system 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, 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 consider 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 February 26th 2020, 10:00 AM Eastern time and must reference solicitation number 20-005847. 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://beta.sam.gov/opp/d02dbc52aeee423cb5c4811065972d6d/view)
- Place of Performance
- Address: Bethesda, MD 20892, USA
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN05557566-F 20200213/200211230151 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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