26-007445 - JOFOC.docx

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

b. Sponsoring organization. NIH/CC/MMES

c. Project Officer Information.

· Project Officer Name. David Ram

· Mailing address. NIH, CC, Bldg. 10/B2S245 9000 Rockville Pike, Bethesda Md 20892

· E-mail address. dram@cc.nih.gov

· Telephone number. 301-496-1311

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

a. Acquisition purpose and objectives.

The purpose of this requirement is to provide a fixed-price contract to buy MRI Infusion pumps for the activation of the new CC PICU.

An MRI infusion pump is a medical device designed to administer intravenous (IV) fluids, medications, or anesthetics at a controlled rate while a patient undergoes an MRI scan. Unlike standard infusion pumps, MRI infusion pumps are non-magnetic, allowing them to operate safely in the strong magnetic field

b. Project background.

· Usage in the Clinical Center:

The CC has been using MRI compatible pumps for decades. The CC and several other ICs have separate management of the MRI pumps, but pumps have always been standardized.

· MRI pumps have historically had very little competition amongst manufacturers

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

a. Project title. CC PICU MRI Infusion Pumps

b. Project description. Please refer to the SOW

c. Requirement type.

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 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 Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

· Acquisition identification number Total estimated dollar value and performance/delivery period. This will be a one time purchase totaling: $ 980,137.69. The Clinical Center anticipates delivery of items and services stated in the SOW to occur 8 weeks after award.

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

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_.

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).

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

· Iradimed is the sole proprietor for the only FDA approved MRI pump. There are not other manufacturers of MRI pumps.

· The CC has the old generations of Iradimed pumps and supplies

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.

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

IGCE is derived from previous contract pricing; Researched sources include ECRI equipment comparison and guidance charts. https://www.ecri.org/components/BiomedicalbenchMark, equipment managers, AAMI Technology Conference and Expositions attendance, industry review, Government-wide database of contracts and Internet searches, equipment age, and technology difference as compared with current technology. History of use in the CC and an FSS comparison

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.

Based on Market Research conducted by the Government through a Google search; review of the Association for the Advancement of Medical Instrumentation literature and on-site seminars; review of NIH license ECRI product comparisons, product buying guide, Iradimed is the sole proprietor for the only FDA approved MRI pump. There are not other manufacturers of MRI pumps.

A presolicitatiom notice of intent will be posted in SAM.GOV to assess the market and give any viable vendors the opportunity to respond.

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

In addition to question 5, A key outcome of this collaboration is standardization of equipment and supplies. The NIH CC benefits include:

✓ One Service contract

✓ Decreased IT involvement with clinical interfaces

✓ Reduced training time for users

✓ Reduced training time for equipment maintainers

✓ Reduced amount of stock (supplies, parts, and manuals)

✓ Decreased safety risks with clinical intervention due to incompatible equipment and supplies

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

Iradimed is the sole proprietor for the only FDA approved MRI pump. There are not other manufacturers of MRI pumps. The CC is currently using the old generation Iradimed pumps and supplies

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.

· For future acquisitions, the Government will continue to assess the market for opportunities that remove or overcome any barriers for competition and meets the needs of the Government.

· This equipment has a life of 5 years. It is the anticipation that the industry will be evolved to include simpler interfaces and move towards plug and play for medical equipment to remove third party costs that contributes to proprietary equipment and equipment interfaces

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.

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.

Contracting Officer image1.emf