The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Laboratory Medicine (DLM), 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:

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) 2005-100, August 22, 2018. 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: 5x LOVO Cell Washer instruments Maintenance Agreement

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 200 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: Cell washing and concentration is needed to remove supernatant from target cells. The LOVO is an automated system, using spinning membrane technology, which produces at a higher volume, has a faster flow rate and closed system. The instrument allows for processing volume from 50ml to 15 liters, up to 10 billion cells or more. The LOVO specifically designed to wash and concentrate cells in a closed system. It used spinning membrane technology to help reduce cell loss and damage and reduces platelets in the final product. The LOVO also be equipped with software which documents the identification of the product processed and the washing parameters.

4. Period of Performance: Base plus four (4) option years with an approximately start date on or around 12/31/18.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

The subject contract shall cover maintenance, support, and emergency servicing for the automatic cell washing instrument located in the Cell Processing Section of the Department of Transfusion of the Clinical Center at NIH. The Preventive maintenance (PM) is required for compliance with manufacturer specifications and the FDA. The instruments processes large quantities of cells up to 10 billion cells or more. The instrument is an automated system for cell concentration and cell washing. It also has an auto dilution feature that help reduce errors could occur during processing and saves staff time. Included in this contract will be one regular preventive maintenance visit(s).

1. Performance Requirements/Work Areas
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.
The contractor shall preform the following:
Preventive Maintenance (PM)
The contractor shall provide scheduled preventive maintenance one in the 12 month period. The PM will be scheduled by a qualified representative and 30 days in advance of the scheduled due date. The contractors shall supply all parts and supplies needed for the service.
Services will be performed on the following:

Instrument checks as specified in the Operator's Manual
Repair any non-functioning parts due to normal wear and tear
Inspect and test the device to make sure it is function accordance with its specifications, included, but not limited to:
-Clamp, pump, spinner verification
-Air detector and Pressure Sensor verification
-Calibrate the weight sets
-Performance assurance checks
-Functionality and safety checks
-Safety inspections in accordance with all applicable regulations
-Cleaning and greasing of mechanical parts
-Repair of defects, if found
-Allocation of parts and labor for installation and setup
-Detailed service documentation

Parts/Supplies
The contractors 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.

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.

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.

IT Security Concerns
1. Will the vendor install and/or maintain the equipment/software/hardware on site at NIH? NO
2. How long will the vendor need to be on site? Depends on the complexity of the problem 4-6 hours
3. Will the vendor have remote access to any system on site at NIH (e.g. patch management/trouble shooting, etc.)? If so, what remote access technology will the vendor use? NO
4. Will the vendor have access (even inadvertently) to PII/PHI data on any NIH systems? NO
5. Will the vendor develop a system or hold NIH data off site (at vendor facility)? NO

Contract duration:
December 31, 2018 thru December 30, 2019, Base with 4 option years.

Period of Performance: One year plus four (4) option years with an approximate start date on or around December 31, 2018.

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 Roche. 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, 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 December 11th, 2018, 12:00 PM Eastern time and must reference solicitation number 19-002100. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at [email protected]. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."