Brand Name Justification - Ortho Equipment_CO.pdf

Justification for Other than Full and Open Competition

Brand Name Justification

Program Office/Service Unit: Pine Ridge Comprehensive Health Care Facility Requisition: IHS1502870

1. Nature and/or Description of action being approved:

The Pine Ridge Service unit conducts orthopedic and podiatric surgical procedures for direct patient care. These cases require specialty hardware that is manufactured and produced under approved FDA (Food and Drug Administration) and//or ASTM (American Society for Testing and Materials) guidelines for implants within the human body. This is a new requirement at the PRSU to be able to perform orthopedic surgeries. Items are sterilized and must be transported and maintained after receipt in a sterile environment. Environment is temperature and humidity controlled. Must be newly manufactured items cannot be recycled or refurbished. Pine Ridge Service Unit is fully capable of sterilizing and storing these instruments according to manufacturer’s instructions for use.

PRSU is located in a remote setting, with the nearest higher level of care at 90-150 miles away. In order to get patients, the level of care they need, we often have to rely on air transport. However, this can get tricky with any inclement weather, when all flights are grounded.

These instruments would provide the hospital with the ability to fix many of the fractures in house and prevent patients from having to be air-lifted to other facilities. We have current orthopedic providers who are willing and able to complete these surgeries.

2. Description of Product, Supplies or Services required to meet the agency’s need

Orthopedic instrument sets are necessary to be able to complete orthopedic surgeries at PRSU.

Surgical intervention at PRSU will create revenue for the hospital due to patient insurance and Medicaid/Medicare. This would also reduce the hospital’s PRC spending by not having to transfer and airlift these patients out to higher levels of care. Inclement weather is often capable of delaying patient transfers by hours or days. These instruments would also benefit in instances of Plan D or natural disasters, we would have these instruments on hand to care for a wide-selection of patients.

3. Estimated Value of Procurement (to include options): $650,000.00

4. Recommended Source:

a. Contractor Name: Zimmer

b. UEI Number:

c. Address:

d. POC:

5. Reason for Sole Source/Limited Sources/Expedited Processing: Check one

☐ Brand Name essential to the Government’s needs. FAR 11.104 (b) Brand name or equal purchase descriptions must include, in addition to the brand name, a general description of those salient physical, functional, or performance characteristics of the brand name item that an "equal" item must meet to be acceptable for award. Use brand name or equal descriptions when the salient characteristics are firm requirements.

☐ Items peculiar to one manufacture. FAR 11.105 (a) The particular brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs

6. Justification Narrative:

The Pine Ridge Service unit conducts orthopedic and podiatric surgical procedures for direct patient care. These cases require specialty hardware that is manufactured and produced under approved FDA (Food and Drug Administration) and//or ASTM (American Society for Testing and Materials) guidelines for implants within the human body. This is a new requirement at the PRSU to be able to perform orthopedic surgeries. Items are sterilized and must be transported and maintained after receipt in a sterile environment. Environment is temperature and humidity controlled. Must be newly manufactured items cannot be recycled or refurbished. Pine Ridge Service Unit is fully capable of sterilizing and storing these instruments according to manufacturer’s instructions for use.

PRSU is located in a rural setting, with the nearest higher level of care at 90-150 miles away. In order to get patients, the level of care they need, we often have to rely on air transport. However, this can get tricky with any inclement weather, when all flights are grounded.

These instruments would provide the hospital with the ability to fix many of the fractures in house and prevent patients from having to be air-lifted to other facilities. We have current orthopedic providers who are willing and able to complete these surgeries.

7. Impact to the Government if not awarded in accordance with above:

Without these instruments, the hospital will be missing out on this revenue and increasing the cost of PRC spending by having to transfer these patients out to higher levels of care. Without these instruments, it is difficult to retain orthopedic surgeons who come here to operate. Lack of instruments would increase the cost of care to the patient with having to find transportation back home after being transferred to higher levels of care. Lack of these instruments would prevent the hospital from building patient relationships and reassurance that the is capable of caring for them and their needs.

8. Synopses of proposed contract action (SAM.gov): Yes ☒ No ☐ In the case of a brand name justification under 6.302-1(c), the justification shall be posted with the solicitation (see 5.102(a)(6)). Yes ☒ No ☐

9. A determination the anticipated cost to the Government will be fair and reasonable:

Administrative CO will determine fair and reasonable based on market research findings. (I.E.

Catalog pricing with individual suppliers, past performance with recommended awarded vendors and lastly the IGCE determined to fair and reasonable.

https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-5#FAR_5_102

Program/Project Manager:

Name, Title Date

Acquisition: Prepared by

Name, Contract Specialist/Purchasing Agent Date

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.

Name, Contracting Officer Date

Competition Advocate Approval: Competition Advocate Approval: over $750,000 but not exceeding $15 million 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.

IAW FAR 13.501(a) (2)(ii)

Name, Competition Advocate Date

*See Attached Applicable FAR References 11.104, 11.105, 6.302-1, 6.303-1 & 6.303-2

*6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

(a) Authority.

(1) Citations: 10 U.S.C. 2304(c) (1) or 41 U.S.C. 253(c) (1).

(2) When the supplies or services required by the agency are available from only one responsible source, or, for DOD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

(i) Supplies or services may be considered to be available from only one source if the source has submitted an unsolicited research proposal that-

(A) Demonstrates a unique and innovative concept (see definition at 2.101), or, demonstrates a unique capability of the source to provide the particular research services proposed;

(B) Offers a concept or services not otherwise available to the Government; and

(C) Does not resemble the substance of a pending competitive acquisition. (See 10 U.S.C.

2304(d)(1)(A) and 41 U.S.C. 253(d)(1)(A).)

(ii) Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C.

2304(d)(1)(B) or 41 U.S.C. 253 (d)(1)(B).)

(iii) For DOD, NASA, and the Coast Guard, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C. 2304(d)(1)(B).)

(b) Application. This authority shall be used, if appropriate, in preference to the authority in 6.302-7; it shall not be used when any of the other circumstances is applicable. Use of this authority may be appropriate in situations such as the following (these examples are not intended to be all inclusive and do not constitute authority in and of themselves):

(1) When there is a reasonable basis to conclude that the agency's minimum needs can only be satisfied by-

(i) Unique supplies or services available from only one source or only one supplier with unique capabilities; or

(ii) For DOD, NASA, and the Coast Guard, unique supplies or services available from only one or a limited number of sources or from only one or a limited number of suppliers with unique capabilities.

(2) The existence of limited rights in data, patent rights, copyrights, or secret processes; the control of basic raw material; or similar circumstances, make the supplies and services available from only one source (however, the mere existence of such rights or circumstances does not in and of itself justify the use of these authorities) (see Part 27).

(3) When acquiring utility services (see 41.101), circumstances may dictate that only one supplier can furnish the service (see 41.202); or when the contemplated contract is for construction of a part of a utility system and the utility company itself is the only source available to work on the system.

(4) When the agency head has determined in accordance with the agency's standardization program that only specified makes and models of technical equipment and parts will satisfy the agency's needs for additional units or replacement items, and only one source is available.

(c) Application for brand name descriptions. An acquisition that uses a brand name description or other purchase description to specify a particular brand name, product, or feature of a product, peculiar to one manufacturer does not provide for full and open competition regardless of the number of sources solicited. It shall be justified and approved in accordance with FAR 6.303 and 6.304. The justification should indicate that the use of such descriptions in the acquisition is essential to the Government's requirements, thereby precluding consideration of a product manufactured by another company. (Brand-name or equal descriptions, and other purchase descriptions that permit prospective contractors to offer products other than those specifically referenced by brand name, provide for full and open competition and do not require justifications and approvals to support their use.)

(d) Limitations.

(1) Contracts awarded using this authority shall be supported by the written justifications and approvals described in 6.303 and 6.304.

(2) For contracts awarded using this authority, the notices required by 5.201 shall have been published and any bids and proposals must have been considered.