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 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:

Siemens Healthcare Diagnostics, Inc.

115 Norwood Park S.

Norwood, MA, 02062-4633

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) 2021-03, February 16, 2021. 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: Siemens/ Maintenance service agreement for Advia 2120i System.

2. Background Information:  The Center for Cellular Engineering (CCE), DTM, and 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 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: 5 years services agreement for Advia 2120i System is needed for the continuation of the maintenance agreement to be provided for clinical research and development testing.

4. Period of Performance will be a Base plus four option years from 9/8/21 to 9/7/2026.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

The subject contract shall cover preventive maintenance, support and emergency servicing for the Advia2120i located on 3rd floor, CCE of building 10. The preventive maintenance is required to compliance with manufacturer and FDA 21 CFR 211.67. The Advia2120i Complete Blood Count (CBC) Instrument to test over 15,000 samples per year. The instrument is used to perform blood count on patient serum for both licensed blood products and cellular therapy products. The CBC is strongly regulated by the FDA, without accurate blood counts, patients cannot be treated; no blood products can be licensed.

The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner 21 CFR 211.67.

1. Performance Requirements/Work Areas

The contractor shall be responsible for, independently, and not as an agent of the government, the contractor shall provide all necessary personnel, supplies, materials and services to provide required technical support and expertise for on-site preventive maintenance, inspection, certification and repair of Government owned instruments and equipment identified herein. The service will be scheduled by a qualified representative and 30 days in advance of the scheduled due date.

The contractor shall perform the following:

1. Equipment and Systems to be serviced

The following types of equipment and containment system components shall be serviced under this contract:

• 1 Advia2120i

2. Service performance

• Perform two preventive maintenance per contract year for the Advia2120i to manufacturer’s specifications
• Unlimited service visits including labor and travel for emergency and repair
• Unlimited replacement parts, excluding disposables and operating supplies
• Preventive maintenance and mandatory update visits at the manufacturer’s recommended intervals
• Detailed service documentation

3. Emergency Service/repair

• Required services other than the scheduled annual certifications
• Certifications for new equipment
• Emergency requests shall be responded to, on-site, within one working days after receipt of request
• 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

4. Work Manner and Time

• • The contractor shall be responsible for scheduling annual certification and emergency work with the principal user with coordination through the COR.
  • The contractor shall determine whether decontamination of equipment is necessary prior to commencement of work.
  • The contractor shall comply with the appropriate laboratory practices and policies.
  • The contractor shall observe the necessary safety precautions throughout the performance of this contract. Any additional personal protective equipment required for the safe performance of work shall be determined and provided by the contractor.
  • Services shall be performed during normal working hours, 8:00AM to 5:00PM, Monday through Friday, local time, excluding Federal Holidays, except as specifically approved by the COR.

5. Labor and Travel

The contractor shall provide all labor and travel at no additional cost for the duration of the contract.

6. IT Security Concerns

• Will the vendor install and/or maintain the equipment/software/hardware on site at NIH?

No

• How long will the vendor need to be on site?  Depends on the complexity of the problem, 6-8 hours
• 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
• Will the vendor have access (even inadvertently) to PII/PHI data on any NIH systems?  NO
• Will the vendor develop a system or hold NIH data off site (at vendor facility)?  NO

7. Contract duration:

• Base Year               09/08/2021 – 09/07/2022
• Option Year 1         09/08/2022 – 09/07/2023
• Option Year 2         09/08/2023 – 09/07/2024
• Option Year 3         09/08/2024 – 09/07/2025
• Option Year 4         09/08/2025 – 09/07/2026

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 Siemens Healthcare Diagnostics, Inc.  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 May 27th, 2020, 11:00 AM Eastern time and must reference solicitation number 21-006609. 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."