JA_Memo.pdf

Control Number: 17-RHCO-P-219

For Official Use Only (See FAR 2.101 and 3.104)

(25 February 2016)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: This acquisition is for Madigan Army Medical Center (MAMC) the contracting activity is Joint Base Lewis-McChord Health Contracting Cell (JBLM- HCC).

2. Description of Action: Madigan (MAMC) Army Medical Center, Department of Anesthesia and Operative Service, (DOAS), Joint Base Lewis-McChord, Tacoma, WA is requesting a Blanket Purchasing Agreement.

3. Description of Supplies/Services: Various FDA approved-Consumable Supplies to be used with the Constellation and Infinity Vision Systems for the outlying medical treatment facilities (MTF). All items must be 100% compatible with the Government-owned Constellation Vision System and Infiniti Vision System (both are Alcon Laboratories, Inc. systems). The equipment is considered mission critical and imperative to maintaining patient care. These systems are made by Alcon Laboratories, Inc. as well as the appropriate disposables for use with these machines. No other company makes the consumable supplies that work specifically with the currently owned Alcon equipment. The surgeon is trained on the surgical procedures for using these consumable supplies with the existing equipment. Reduced liability risk, administrative and training time represent a cost savings to the Government. Increased likelihood of successful surgery, recovery, and quality of life derived from the most appropriate implants and supplies based on the surgeon’s diagnosis is a significant intangible benefit to the Government consistent with the mission of the US Army Medical Command. Estimated value is $7,000,000.00 which is five year total.

4. Authority: Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: Madigan Army Medical Center currently owns several of the following systems for operating room surgeons to utilize for specific ophthalmologic surgeries: Constellation Vision system (purchased in October 2010 and June 2013) and Infiniti Vision system (purchased in October 2008). The equipment is considered mission critical and imperative to maintaining patient care. These systems are made by Alcon Laboratories, Inc. as well as the appropriate disposables for use with these machines. No other company makes the disposable accessories that work specifically with the currently owned Alcon equipment. As Alcon makes improvements to its surgical systems, they also update their disposables. Reduced liability risk, administrative and training time represent a cost savings to the Government. Increased likelihood of successful surgery, recovery, and quality of life derived from the most appropriate implants and supplies based on the surgeon’s diagnosis is a significant intangible benefit to the Government consistent with the mission of the US Army Medical Command.

6. Efforts to Obtain Competition: Market research will be conducted on a continual basis for new technologies that will provide the best value and the most benefit to both surgeons and patients. In addition, the intended contractor is the only source capable of meeting the surgeon’s requirements prescribed for the patient.

a. Effective Competition: Yes, the lack of an in place agreement limits the ability of the MTF and JBLM- HCC to respond to patient surgical requirements, particularly trauma resolution in potential unauthorized commitments to meet emergent patient needs

(See FAR 2.101 and 3.104)

(25 February 2016)

Control Number: 17-RHCO-P-219

Various FDA-Consumable Supplies to be used with the Constellation and Infinity Vision Systems for the outlying medical treatment facilities (MTF)

b. Subcontracting Competition. None

7. Actions to Increase Competition: There is currently no effort to increase competition as there is only one source capable of meeting the requirement. The manufacturer is the only company that is capable of providing the disposables that are compatible for use with the Government-owned equipment. Based on this information, there is no effort to increase competition at this time.

8. Market Research: This requirement is for surgical supplies (Class VIII). Detail, including key work searches described in the Market Research report which supports this J & A can be found in PCF A.01.01_Market Research. Market Research has been conducted by searching the Dynamic Small Business search using NAICS Code: 339112. Market Research has been conducted on the open market to determine if there were any available sources readily available that could provide the requested supplies.

Market Research has shown that Alcon Laboratories, Inc. is the only company that can provide the specific products required by the surgeons and that work with the Alcon equipment currently owned by Madigan Army Medical Center. The Surgeon is to ensure that they meet FDA guidance, safety and overall for the patient.

9. Interested Sources: A notice of intent to sole source as required by FAR 5.201 will be published on FedBizOpps and any proposals received will be considered. The Special Notice with J & A will be posted to FBO.

10. Other Fact: The surgeon is trained on the surgical procedures for using these to be used with the existing equipment Constellation and Infinity Vision Systems at the MTF’s. Reduced liability risk, administrative and training time represent a cost savings to the Government. Increased likelihood of successful surgery, recovery, and quality of life derived from the most appropriate implants and supplies based on the surgeon’s diagnosis is a significant intangible benefit to the Government consistent with the mission of the US Army Medical Command.

a. Previous Procurement History.

(1) W91YU0-11-D-0011, awarded on 8 Jun 2011 (POP - 16 Jun 2011 to 30 Sep 2013; total contract value-$1,250,000.00.

(2) The competitive status of these actions. N/A

(3) IAW FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy the agency requirement.

(4).The previous contracts state that there was no effort at that time to increase the competition as there was only one source capable of meeting the requirement. The manufacturer on each of this contract, Alcon Laboratories, Inc was the only company capable of providing the disposables that are compatible with the Government-owned equipment at MAMC.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A

(25 February 2016)

Control Number: 17-RHCO-P-219

Various FDA-Consumable Supplies to be used with the Constellation and Infinity Vision Systems for the outlying medical treatment facilities (MTF)

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

7) Each of the previous buys was justified through the use of FAR 6.302-1. This was used due to the fact that there was only one source capable of meeting the requirement. In each of these contracts, the manufacturer, Alcon Laboratories, Inc., was the only company capable of providing the disposables that are compatible with the Government-owned equipment at MAMC.

b. Acquisition Data Availability: The Constellation Vision system and Infiniti Vision system are made by Alcon Laboratories, Inc as well as the appropriate disposables for use with these machines. No other company makes the consumable disposable accessories that work specifically with the currently owned Alcon equipment.

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Digitally signed by

HAYNES.DEBBIE.YVETTE.1104954819

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, Signature:ETTE.1104954819 ou=USA, cn=HAYNES.DEBBIE.YVETTE.1104954819 Date: 2017.02.08 10:51:28 -08'00' Date:

Typed Name: Title:

12. RequirementsCertification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Digitally signed by ANGELILLI.SYLVIA.A.1228644761 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, Signature: 44761 ou=USA, cn=ANGELILLI.SYLVIA.A.1228644761 Date: 2017.02.08 11:29:25 -08'00' Date:

Typed Name: Title:

Only the most senior persons within the organization responsible for acquiring the supplies or services described in the justification (e.g. program manager, depot commander, or senior program engineer) and with specific knowledge of the individual requirement (commodity, technology, and/or function) shall sign the technical and requirements certifications.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

ANGELILLI.SYLVIA.

Signature: A.1228644761 Digitally signed by ANGELILLI.SYLVIA.A.1228644761 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=ANGELILLI.SYLVIA.A.1228644761 Date: 2017.02.08 11:30:01 -08'00'

Date:

HAYNES.DEBBIE.YV

ANGELILLI.SYLVIA.A.12286

(25 February 2016)

Control Number: 17-RHCO-P-219

Various FDA-Consumable Supplies to be used with the Constellation and Infinity Vision Systems for the outlying medical treatment facilities (MTF)

Typed Name: Title:

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Digitally signed by

BRADBURY BRADBURY.LARRY.A.11642419

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=BRADBURY.LARRY.A.11642

Date:

41951 Date: 2017.02.09 11:15:00 -08'00'

Title:

.LARRY.A.1

Typed Name: 164241951

(25 February 2016)

Control Number: 17-RHCO-P-219

Various FDA-Consumable Supplies to be used with the Constellation and Infinity Vision Systems for the outlying medical treatment facilities (MTF)

Approval

Based on the foregoing justification, I hereby approve the procurement of Various FDA approved- Consumable Supplies to be used with the Constellation and Infinity Vision Systems being procured with a total dollar of $7,000,000.00 not to exceed five years (The single purchase limit when using the Government Purchase Card will be $25,000, or call limit will be $350,000 when issued by a contracting officer),on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date:

Typed Name: Title:Joseph S. Peck Special Advocate for Competition

10 Feb 17

PECK.JOSEPH.SAMU

EL.1165787150

Digitally signed by

PECK.JOSEPH.SAMUEL.1165787150

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=PECK.JOSEPH.SAMUEL.1165787150 Date: 2017.02.10 15:07:20 -06'00'