JOFOC.pdf

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

HHS, National Institutes of Health, NHLBI, DIR.

b. Sponsoring organization.

National Heart, Lung and Blood Institute

Division of Intramural Research

c. Project Officer information.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The primary purpose of the proposed renewal is to award a follow-on contract to the existing cardiothoracic surgery and research contract program at Suburban Hospital. An essential component of a successful, integrated program is the proximity of the basic cardiothoracic research laboratory at the NHLBI to acute patient care. Close proximity of the basic research laboratory to patient care is critical for academic surgeons and fellows to move quickly between the research environment at the

NHLBI/NIH and the cardiothoracic surgery facility.

This project offers a unique link between basic science and clinical investigations, relative swiftness in translating basic science to clinical usage, presence of multidisciplinary research teams, capability to focus on selected science and health problems, support of a centralized coordinating facility, organization of a center of excellence in clinical research, and ability to provide timely integrated service delivery.

b. Project background.

NHLBI has made many contributions to cardiovascular research and the practice of cardiothoracic surgery. After a long absence from NHLBI’s portfolio, NHLBI re-established a Cardiothoracic Surgery Research

Program and awarded a contract to Suburban Hospital on September 30, The goals of the Cardiothoracic Surgery Branch (CTSB) in the NHLBI are to conduct innovative basic, translational, and clinical research that will advance the field of cardiovascular science and medicine and to train the next generation of academic cardiothoracic surgeons in leadership skills, research methodologies and techniques, and publication generation. To accomplish these goals, the NHLBI seeks a combination of clinical excellence and mutually beneficial research within the setting of an academic research environment led by an academically established cardiothoracic surgeon from the hospital.

In its pursuit of this combination, the NIH offers links between basic science and clinical investigations, relative swiftness in translating basic science to clinical usage, presence of multidisciplinary research teams, capability to focus on selected science and health problems, support of a centralized coordinating facility, organization of a center of excellence n clinical research, and ability to provide timely integrated service delivery.

NIHLBI intends to award a contract to a hospital able to provide access to acute care, along with a leading academic cardiovascular surgeon who has experience in developing and leading a basic science and clinical research team. This academic cardiovascular surgeon should have prior experience with NIH funding and research. The cardiovascular surgeon must be a recognized leader in academic cardiothoracic surgery with sufficient basic and clinical research experience such that the basic and clinical research as well as the training and education components of the program are ongoing, integrated activities useful not only to the participating partners, but to the long-term goal of stimulating full participation of the national and international cardiothoracic surgery community.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Cardiothoracic Surgery and Research Program

b. Project description.

The establishment of a cardiothoracic surgery research program. The goal of the program is to provide a world-class basic science and clinical research program that links basic laboratory research and clinical investigation. The program will include conducting research protocols designed by NHLBI and recruiting of patients.

Requirement type.

X Research & development (R&D) R & D support services

Support services (non-R&D)

Supplies/equipment

Information technology (IT)

Construction

Architect-engineer (A & E) services

Design-build

Other (specify): ____________________

Type of action.

New requirement X Follow-on

Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee X Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): __Cost_________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

Other (specify): ___________

Completion Form Term form

Acquisition identification number. NHLBI-CSB-HL-12-13

c. Total estimated dollar value and performance/delivery period.

Total estimated cost is . The contract will have a base year with four options estimated to begin 11/1/12 through 10/31/17.

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1(a)(2).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Suburban Hospital, Inc.

8600 Old Georgetown Road

Bethesda, Maryland 20814

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The primary purpose of the proposed renewal is to award a follow-on contract to the existing cardiothoracic surgery and research contract program at Suburban Hospital. An essential component of a successful, integrated program is the proximity of the basic cardiothoracic research laboratory at the NHLBI to acute patient care. Close proximity of the basic research laboratory to patient care is critical for academic surgeons and fellows to move quickly between the research environment at the

NHLBI/NIH and the cardiothoracic surgery facility. Close proximity is required to permit NHLBI clinical and technical staff the ability to respond quickly to acute patient issues in a timely fashion from the NIH campus and is critical to the success of the program. This fundamental principle of proximity is the basis for the configuration of the Clinical

Research Center at the NIH where basic scientists, clinical investigators, clinicians and patients are co-located in the same building or in close proximity. Meetings with other investigators, collaborators, and staff occur daily and require the surgeon to move from the clinical arena to the research facility in a timely fashion. This fundamental principle of close proximity is also the basis for the design of academic cardiothoracic research units where academic cardiothoracic surgeons conduct basic research in close proximity to the operating rooms, recovery rooms, and patient care units. As examples, the University of Maryland, Johns

Hopkins University, the University of Virginia, the University of

Michigan, Brigham and Women’s Hospital at Harvard University, Stanford University, and other outstanding cardiothoracic programs have the cardiothoracic basic research laboratory, the operating rooms, and patient care units within the same building, in adjacent buildings, or nearby on campus and in any event located no more than 10 minutes walking distance apart. These models have been used to define the requirement for close proximity of the NHLBI basic research laboratory to the operating rooms and patient care units as less than 5 minutes driving time or 10 minutes by foot.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A 15 day intent notice was issued in FedBizOps on September 2, 2011 as required by FAR subpart 5.2. No responses were received indicating a desire to undertake the work described in the notice that expired on the September 19, 2011.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research in the form of a small business sources sought (SBSS) notice was issued in the FedBizOpps on August 17, 2011 to assess the availability of small businesses to perform the requirement. At the same time, a sources sought notice was also issued to the general public on FedBizOpps to assess the availability of all qualified sources to perform the requirement. Upon the September 2, 2011 expiration date of these notices no capability statements were received.

9. Any other facts supporting the use of other than full and open competition.

Increasing distance from the NIH campus exponentially increases the difficulty of conducting the translational work that is at the core of NHLBI research in cardiac surgery and percutaneous coronary intervention. The importance of collocation of laboratory scientists and their clinical brethren was built into the structure of the original Clinical Center with adjoining corridors, one with laboratories and the second with patient care rooms. This structure reduces the barriers to testing interesting hypotheses developed in the laboratory in patients housed in rooms that are steps away from the laboratory. The structure also encourages closure of the loop with results from patient intervention fed back to the laboratory.

Cardiothoracic surgeons, cardiologists and laboratory scientists working in this setting will constitute an academic community much like those at the best US

University Hospitals that also house these workers in adjacent laboratories and hospital beds. Continuation of this academic community would be much more difficult with hospitals that are not in close proximity as defined above. This difficulty would put at risk the substantial investment that has already been developed with is needed to sustain the current clinical research center environment.

NHLBI DIR must have access to a fully equipped cardiothoracic surgery facility with operating rooms and cardiovascular intensive care beds to conduct research in cardiothoracic surgery and procedures designed to assess new approaches in the treatment of heart disease. In addition, office space for non-contractor staff collaborating on study protocols shall be provided in the hospital in order for them to see patients and conduct other research and training activities.

Suburban Hospital is the only responsible source and no other supplies or services will satisfy agency requirements. Maryland state law requires that any state hospital that provides cardiothoracic surgery must be issued a Certificate of Need

(CON) by the Maryland Health Care Commission. Suburban Hospital is the only hospital with a CON within the required distance to the NIH campus authorized to perform cardiothoracic surgery. Their location satisfies the Academic Model where the basic research laboratory is in close proximity to patient care to allow academic surgeons and fellows to move quickly between the research environment and the cardiothoracic surgical facility. Suburban Hospital's location gives NHLBI clinical and technical staff the ability to respond quickly to acute patient issues in a timely fashion from the NIH campus and is critical to the on-going success of this program. This fundamental principle of proximity is the basis for the configuration of the Clinical Research Center at the NIH where basic scientists, clinical investigators, clinicians and patients are co-located in the same building. Suburban Hospital fits into that operational construct. Proximity also is critical to the research effort. Interactions with other investigators, collaborators and staff occur daily and require the surgeon to move from the clinical arena to the research facility in a timely fashion. This fundamental principle of close proximity is also the basis for the design of academic cardiothoracic research units where academic cardiothoracic surgeons conduct basic research in close proximity to the operating rooms, recovery rooms, and patient care units. Again, Suburban Hospital offers the proximity to go from bench to bedside and back without concern for the limitations and contingencies that can arise in a large metropolitan area. No other hospital authorized to perform cardiothoracic surgery satisfies the need for close proximity. Suburban also has a leading academic cardiovascular surgeon, , who has experience in developing and leading a basic science and clinical research team. He has prior research experience with NIH and he is a recognized leader in academic cardiothoracic surgery. He has extensive experience in basic and clinical research, as well as training and education of other surgeons, completely cover all components of the program. He has the necessary skills and research experience to insure that the research and clinical activities are integrated and useful to the participating partners, and serve the long-term goal of stimulating full participation of the national and international cardiothoracic surgery community.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Market research was conducted in the form of both a small business and a general sources sought notice. No capability statements were received. A 15 day intent notice was issued in FedBizOps on September 2, 2011 as required by FAR subpart 5.2. No responses were received indicating a desire to undertake the work described after the expiration of the notice.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is anticipated that this will be an ongoing requirement. For any follow on acquisitions, market research will be conducted to survey the market place for offerors with the appropriate expertise. It is likely that this requirement will be non-competitive for the following reasons: 1) Limited access to a certified cardiothoracic surgical facility with a collaborative research and training program,

2) a lead cardiothoracic surgeon with the academic and research qualifications required and 3) a hospital with close proximity to the NIH.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Project Officer’s

Immediate Supervisor

Head of the Sponsoring

Program

Office

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

15. Competition Advocate signature.

Competition Advocate

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement

Executive