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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 26, 2018 FBO #6181
SOLICITATION NOTICE

65 -- Siemens / Advia 120 Maintenance Agreement

Notice Date

10/24/2018
 

Notice Type

Presolicitation
 

NAICS

811219 — Other Electronic and Precision Equipment Repair and Maintenance
 

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

19-000563
 

Archive Date

11/18/2018
 

Point of Contact

Grace P. Wong-Darko, Phone: 3014961199
 

E-Mail Address

wongdarkogp@nih.gov
(wongdarkogp@nih.gov)
 

Small Business Set-Aside

N/A
 

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 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: SIEMENS HEALTHCARE DIAGNOSTICS INC. 221 Gregson Drive Cary, NC 27511 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) 2005-100, 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: Siemens / Advia 120 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: The DLM requires the delivery and installation of the instrument. The equipment shall support the processing of all CC bone marrow biopsy samples obtained for clinical diagnosis. The new analyzer must be compatible with the current system and reagents must be interchangeable. 4. Period of Performance: Base plus four (4) option years with an approximately start date on or around 11/30/18. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) The subject contract shall cover preventive maintenance, support and emergency servicing for the Advia120 located on 3rd floor of Cell Processing of building 10. The preventive maintenance is required to compliance with manufacturer and FDA 21 CFR 211.67. The Advia120 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. 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: 1.1.Equipment and Systems to be serviced The following types of equipment and containment system components shall be serviced under this contract: -1 Advia 120 1.2.Service performance -Perform two preventive maintenance per contract year for the Advia120 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 1.3.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 2.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. 3. Labor and Travel The contractor shall provide all labor and travel at no additional cost for the duration of the contract. 4. 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 Period of Performance: One year plus four (4) option years with an approximate start date on or around November 30, 2018. Base: 11/30/18 - 11/29/19 Option Year One: 11/30/19 - 11/29/20 Option Year Two: 11/30/20 - 11/29/21 Option Year Three: 11/30/21 - 11/29/22 Option Year Four: 11/30/22 - 11/29/23 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, 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 November 3rd, 2018, 12:00 PM Eastern time and must reference solicitation number 19-000563. 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

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/19-000563/listing.html)
 

Place of Performance

Address: National Institutes of Health, 10 Center Dr., Bldg 10, RM 2C306E, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN05133638-W 20181026/181024230726-a2f89b4c35603929559c1f1919f7774e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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