Sole_Source_JA_DRAFT_Redacted.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. CONTRACTING AGENCY

673d Contracting Squadron, Joint Base Elmendorf-Richardson (JBER), AK 99506

2. DESCRIPTION OF THE ACTION

2.1. A new, firm-fixed-price, single award indefinitely delivery indefinite quantity (IDIQ) contract award is anticipated for the delivery of Medical Grade Liquid Oxygen (LOX) to the 673d Medical Group JBER, AK.

3. DESCRIPTION OF SUPPLIES

3.1. Under the contemplated contract, Air Liquide shall deliver medical grade liquid oxygen to the 673 MDG bulk storage tank once every two weeks. All LOX provided must meet the following standards:

3.1.1. All medical oxygen will follow regulations stated in the FDA's Current Good

Manufacturing Practices (CGMP), and will be produced, processed, packaged, distributed, and stored in accordance to the CGMP, and will be labeled in accordance to FDA standards (21 CFR Part 201; Part 211). Liquid Oxygen will be

United States Pharmacopeia (USP) oxygen, and will conform to the requirements of the United States Pharmacopeia. Oxygen must have a purity of no less than 99.0 percent by volume of oxygen to be labeled USP grade medical gas and to meet FDA requirements. The vendor shall make deliveries once every two weeks.

3.2. This requirement is for a one year base period plus four one year option periods. The total estimated cost of this requirement is

4. STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN

COMPETITION

4.1. 41 U.S.C. 1901 as implemented by FAR 13.501(a)(1)(ii)

4.2. 10 U.S.C. 2304(c) as implemented by FAR 6.302-1 “Only One Responsible Source and

No Other Supplies or Services Will Satisfy Agency Requirements.”

Note: Part 6 references in this document are used as guidance IAW FAR 6.001(a).

5. DEMONSTRATION THAT THE CONTRACTOR’S UNIQUE QUALIFICATIONS

OR NATURE OF THE ACQUISITION REQUIRES THE USE OF AUTHORITY

CITED

5.1. The geographically separated nature of Alaska from the lower contiguous 48 states limits competition of this requirement as it is not financially beneficial for another contractor to make delivery every two weeks as required and Air Liquide is the only vendor with a liquid oxygen generation plant in state. Furthermore, this requirement does not increase the net quantity of LOX that is used in the state of Alaska and doesn’t provide enough incentive for another contractor to open a generation plant prior to 1 Oct

2014.

5.2. Alternatives were contemplated for this requirement however none were found that could be modified as Medical Grade Oxygen must meet approved federal healthcare standards that no other products could be modified to meet.

5.3. Justification: Air Liquide currently has the only Liquid Oxygen generation plant in the state of Alaska and do not provide LOX by means of resale through any other vendor.

This makes them the only one responsible source and no other supplies or services will satisfy agency requirements.

6. EFFORTS TO OBTAIN COMPETITION

6.1. Multiple attempts to promote competition in this field have been made. Local hospitals that use Medical Grade LOX were contacted in efforts to obtain other potential sources.

All contacted stated that they receive LOX from Air Liquide. The Defense Logistics

Agency (DLA) was also contacted as they currently have a contract for Liquid Aviators

Oxygen, a product that closely resembles but doesn’t meet the stringent USP requirements of Medical Grade LOX. During discussions with DLA it was discovered that during their solicitation process only Air Liquide submitted a proposal. This is furthermore supported as the recent Purchase Order FA5000-14-P-0051 for Medical

Grade LOX was solicited via the Government Point of Entry GPE and only one source, Air Liquide, responded to the solicitation at that time.

6.2. Further research was preformed to as to the feasibility of adjusting this requirement to promote competition by contacting DLA, Local Hospitals, and other local vendors to obtain additional sources for Medical Grade LOX. The scope of the requirement was also reviewed to ensure that it could not be modified or rephrased in a way that would allow for greater competition. This was not possible as Medical Grade Oxygen must meet approved federal healthcare standards that no other products could be modified to meet.

6.3. This Justification and Approval will be posted to the Government Point of Entry at

Fbo.gov within 14 days of contract award IAW FAR 13.501(a)(1)(iii).

7. FAIR AND REASONABLE COST DETERMINATION

7.1. The Contracting Officer hereby determines that the anticipated cost for this contract action will be fair and reasonable. To ensure this a cost realism analysis will be conducted to evaluate the reasonableness of the offer. Pricing received will also be compared to the Department of Labor Producer Price Index for Oxygen Manufacturing, and preferred government rates on GSA schedules and DLA contracts.

8. MARKET RESEARCH

8.1. The commercial market was surveyed for commercial standards, practices and procedures. Market research indicates that the Liquid Oxygen required is not available through any of the mandatory sources. It was found that the Defense Logistics Agency

(DLA) currently has an established IDIQ with Air Liquide that provides liquid oxygen throughout the state of Alaska. However, it only provides for the purchase of Aviators liquid oxygen not Medical Grade Liquid Oxygen. DLA stated that it would be out of the scope of the original contract to complete a modification to add the medical grade liquid oxygen to the contract. While discussing with DLA it was discovered that only one offer was received for the solicitation. The single offer received was from Air Liquide.

8.2. The local sources in Alaska were surveyed and found that there is only one contractor in the state, Air Liquide, which is currently capable of producing liquid oxygen. This is furthermore supported as PO FA5000-14-P-0051 was solicited as full and open competition on the GPE and only one source, Air Liquide, responded to the solicitation at that time. Local hospitals, Alaska Regional Hospital and Providence Alaska Medical

Center were surveyed via telephone on 6 May 2014 and both stated that they receive liquid oxygen from Air Liquide.

9. OTHER INFORMATION

9.1. No other additional information is required.

10. INTERESTED SOURCES

10.1. To date, no other sources have expressed an interest in writing.

11. ACTIONS TO INCREASE COMPETITION

11.1. IAW FAR 13.501(a)(1)(iii) this Justification and Approval will be posted to the

Government Point of Entry at FBO.gov within 14 days of contract award for a period of

30 days.

11.2. There are no further actions within the government’s control that can increase competition in the local area. All requirements, including the subject requirement, are thoroughly reviewed to ensure that competition is not unnecessarily restricted. The scope of the requirement was reviewed to ensure that it could not be modified or rephrased in a way that would allow for greater competition, but Medical Grade Oxygen must meet approved federal healthcare standards and cannot be modified.

12. CONTRACTING OFFICER CERTIFICATION

The Contracting Officer’s signature on the Coordination and Approval Document evidences that he has determined this document to be both accurate and complete to the best of their knowledge and belief.

13. TECHNICAL CERTIFICATION

As evidenced by their signatures on the Coordination and Approval Document, the technical and/or requirements personnel have certified that any supporting data contained herein, which is their responsibility, is both accurate and complete.