JOFOC.docx

Justification for Other than Full and Open Competition (Under the SAT) Open Market FAR 13.106-1

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

The Department of Health and Human Services.

National Institutes of Health

OD OALM OLAO

Hospital and Laboratory Support Medical & Patient Care Bethesda, MD 20892

POTS: 26-003977

NAICS Code: 811210

PSC/FSC: J066

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

The National Institutes of Health MPC on behalf of Clinical Center (CC), Center for Cellular Engineering (CCE) has a need to approve a purchase order of this BD 5-Year service contract for the mentioned devices, so the continuation of the maintenance agreement can be provided after current warranties expire.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY’S NEEDS

This is a 5-year service contract for two sets of BD FACSLyric flow cytometers (S/N: Z662383000114, Z662383000115) with Universal Loaders (S/N: Z662462000213, Z662462000214) as well as two sets of BD Lyse/Wash Assistants (LWAs) (S/N: RR337146001216, RR337146001208). These instruments are used to process patient samples including both licensed blood products and cellular therapy products, and to identify cell population from blood and cell products for clinical research and cell therapeutic product development. It can also provide guidance in test of our gene modification efficiencies, and QC our cell selection methods.

4. THE TOTAL ESTIMATE FOR THIS PROJECT:

The total estimate for this 5-year service contract is $318,511.20 with the rate for annual renewal of $63,702.24.

5. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPENCOMPETITION. Check the applicable below.

_X_ FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g. urgency, inclusive licensing agreements, brand name, or industrial mobilization).

___FAR 13.501 (a) (1) (ii) &2(i): For actions for commercial supplies or services greater than the SAT but not exceeding $6.5M, the citation is: Test Program for commercial Items, Section 4202 of the Clinger-Cohen Act of 1996.

6. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS ORTHE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED BD Biosciences has been the leading provider of innovative technology and advanced solutions in flow cytometry systems since 1974 when the first fluorescent activated cell sorter was introduced. Workflow automation, standardization across instruments and sites, and connectivity are all critical for a successful clinical lab like us at CCE, NIH. As a latest advanced clinical cell analyzer from BD, the FACSLyric System streamlines processes and reduces hands-on time for operators but still provides accurate, reliable and repeatable results, which provide a perfect solution for our clinical lab at CCE, NIH.

The features of the BD FACSLyric Flow Cytometer:

· Up to 12-color configurations. Onsite upgradeable to adapt to your lab's changing needs

· 3 lasers (blue, red and violet), 12 fluorescence channels and 14 parameters

· 35,000 events per second maximum acquisition rate; no limit on number of events acquired

· Automated single-tube QC with BD CS&T Beads

· Fluorescence compensation required only every 60 days, improving efficiency and productivity

· 21 different loading options: plates or tubes; built-in flexibility with BD FACS Universal Loader

· Powered by the BD FACSuite™ Acquisition and Analysis Application, whose password protection, audit trail, electronic signatures and IQ/OQ procedures assist in supporting U.S, FDA 21 CFR Part 11 compliance

· BD FACSLink Laboratory Information System (LIS) Interface and BD Assurity Linc Remote Systems Management Software streamline your workflow and help improve productivity through seamless integration.

Meanwhile, the BD Lyse Wash Assistant (LWA) automates sample preparation for flow cytometry applications, thus provides an efficient workflow for increased performance.

The features of LWA system:

· Automates sample preparation for flow cytometry applications with its patented cell wash technology

· Lyses, mixes, washes and fixes to streamline your workflow

· Processes up to 40 samples each time

· Offers an easy-to-use, touch-screen interface

· Is compatible with our BD FACSLyric Flow Cytometers That said, the instruments mentioned above can 1) help us automatically identify cell population of clinical engineered cell products for research and development to guide and improve cell product administrated to the patient, 2) generate data that is required for providing guidance to improve immunotherapy efficiency of the cellular therapy product. Most importantly, the preventive maintenance is required to compliance with manufacturer and FDA 21 CFR 211.67.

7. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE

At this current time, it is not practicable to solicit offers for the reasons due to 1) only BD can cover preventive maintenance and support emergency servicing; 2) the quality of product required (per FDA) for ongoing protocols and 3) the urgency of the requirement.

8. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE.

The Government anticipates that the proposed cost will be fair and reasonable in accordance with FAR 15.404-1(b)(ii) and (v).

9. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OFTHE REASON MARKET RESEARCH WAS NOT CONDUCTED

With the Quality of product necessary and Proprietary nature of this requirement, market research will be conducted to the extent the Ofc. of Purchasing and Contracts deems necessary.

10. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPENCOMPETITION.

In accordance with FAR 6.303-2(iii), the nature of harm that would be brought to NIH CC is that if NIH does not have this in place, NIH CC patients could expire (die). Many of these patients are here at the NIH/CC on research/testing due to their unique conditions/diseases.

11. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THEACQUISITION.

BD is the sole vendor to provide the periodic Preventive Maintenance (PM) for the mentioned devices.

12. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY REMOVE OROVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITIONFOR THE REQUIRED SUPPLIES OR SERVICES.

All other vendors are either unable to provide material component reagent and consumables or high-quality service on this instrument that meets FDA requirement.

13. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Brenda Jimenez Administrative Officer

14. Contracting Officer Certification “I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Susan Nsangou Contracting Officer