36C25619Q0711-001.pdf

Page 1 of

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Specific Brand Name Supply

Contracting Activity: The US Department of Veterans Affairs, Network Contracting Office 16, Michael E DeBakey Veterans Affairs Medical Center (MEDVAMC) located in Houston, TX

Nature and/or Description of the Action Being Processed:

Description of Supplies/Services Required to Meet the Agency’s Needs:

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Brand Name Supply Justification Format >SAT

Page 2 of

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable due to the expectation of competition the CO determines the cost to the Government fair and reasonable.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Page 3 of

Any Other Facts Supporting the Use of Other than Full and Open Competition:

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Firm 1: JLS Medical Products Group, VOSB Firm 2: Aspen Scientific, VOSB Firm 3: C3 Solutions, VOSB Firm 4: Medtronic CVG, Cardiac Surgery, Large Business

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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

Page of

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date

L. S

Network Contracting Office 16 - HOUSTON

b. : I certify the justification meets requirements for other than full and open competition.

Date

c. VHA HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Date

Randy Hays Acting

8/8/2019

KEVER SWAFFORD 409487 Digitally signed by KEVER SWAFFORD 409487 Date: 2019.08.08 06:03:52 -05'00'

AARON VILLALPANDO

178014

Digitally signed by AARON

VILLALPANDO 178014

Date: 2019.08.08 12:08:51 -05'00'

*Check block(s) below that describe the basis for the IGCE:

Please Explain

POC NAME: Cassonya Johnson Phone: 713-794-7927 Email: cassonya.johnson@va.gov Date: 6/13/2019

ACQUISITION PLAN

36C256-19-AP-0649

MEDTRONIC PERFUSION PACKS MEDTRONIC PERFUSION PACKS

Department of Veterans Affairs 07-19-2019

MEDTRONIC PERFUSION PACKS

BACKGROUND INFORMATION: The Michael E. DeBakey performs 325 heart procedures yearly. Every Heart Surgery utilizes a specialized, highly technical and customized “Perfusion Pack”. This perfusion Pack consists of several, specific components such as Oxygenator, Venous Reservoir, Cardioplegia circuit and bio- Active coated tubing. The Oxygenator and the Venous Reservoir are the most critical components. The oxygenator must have proactive venous air handling capacity with 25 micron integrated arterial filter. In addition, all the blood ports must be orienting on the same side of the device with separate CPG and Recirc ports. The Venous Reservoir must have capacity of at least 4500ml with Cardiotomy Filtration of 30 microns. The positive pressure relief valve pressure must be less than 5 mmHg. The Perfusion Packs are custom made using the Oxygenator, Venous Reservoir, Cardioplegia circuit and with biocompatible tubing and connectors as per the requirements of the CV Surgeons, the Perfusionists and the type of the procedures anticipated.

1. DATE PREPARED: 07-19-2019 2. PREPARED BY: KEVER L. SWAFFORD

3. DESCRIPTION OF REQUIREMENT:

4. PRODUCT OR SERVICE? Product 5.NAICS/FSC/PSC: 339112 / 6565

6. REQUESTOR: Cassonya Johnson 7. PHONE NO: 713-794-7927

8. PLANNED/ACTUAL DATE SUBMITTED:

01-14-2019

9. PLANNED AWARD DATE: 08-15-2019

10. ESTIMATED TOTAL COST: $1,571,352.25 11. ESTIMATED BASE PERIOD COST: $284,375.00

12. RISKS: There aren’t any inherent risks regarding these service requirements. Risks have been minimized by conducting market research. Furthermore, as commercial item procurement, there is very little design, no developmental, or technical requirements that pose any risks to the Government. Each requested perfusion pack consist of commercial items combined to meet the needs of the particular cardiac surgery being performed.

13. OTHER CONSIDERATIONS: None.

14. COMPETITIVE?

YES NO

15. REASON FOR OTHER THAN FULL AND OPEN

COMPETITION: Market Research indicate this action will be a SB Set aside.

16. POTENTIAL SOURCES:

Firm 1: JLS Medical Products Group, VOSB

Firm 2: Aspen Scientific, VOSB

Firm 3: C3 Solutions, VOSB

Firm 4: Medtronic CVG, Cardiac Surgery, Large Business

17. DESCRIPTION OF MARKET RESEARCH EFFORTS CONDUCTED OR TO BE CONDUCTED:

18. SMALL BUSINESS

PROGRAMS

Service-Disabled Veteran- Owned Business Set-aside

Veteran-Owned Business Set-aside

8(a) Set-Aside

HUBZone Set-Aside Small Business Set-Aside

Women- Owned Small Business Set Aside

19. PLANNED CONTRACT TYPE: Firm Fixed Price

20a. COMMERCIAL ITEM OR SERVICE?

YES NO

20b. If NO, could the requirement be changed to provide for commercial item or service?

YES NO

21. IF SERVICES, ARE INHERENTLY GOVERNMENTAL FUNCTIONS INVOLVED?

YES NO N/A

22a. SUITABLE FOR PERFORMANCE-

BASED?

YES NO N/A

22b. If performance-based unacceptable, provide explanation:

23a. OPTIONS:

YES NO

23b. If YES, number and type: This action consist of one (1) Base Period of 12 months and (4) Option Periods of 12 Months each.

24a. GOVERNMENT PROPERTY TO BE

FURNISHED?

YES NO

24b. If YES, describe (attach additional sheets, if necessary):

25a. GOVERNMENT INFORMATION TO

BE PROVIDED?

YES NO

25b. If YES, describe:

26. ENVIRONMENTAL AND ENERGY CONSERVATION OBJECTIVES: Facilities have been inspected for compliance with Occupational Safety and Health Act (OSHA), and no hazards have been identified for which any special precautions shall be taken.

27. SECURITY CONSIDERATIONS:

28. SOURCE SELECTION PROCEDURES TO BE USED: Lowest Price Technical Acceptable (LPTA).

29. EVALUATION FACTORS:

30. MILESTONES

MILESTONE PLANNED DATE

1) Completion of acquisition package -Market Research -6500 Security Checklist -Purchase Request (VA Form 2237) -Statement of Need/ Statement of Work/Statement of Objectives

-IGE

Completed Completed Completed Completed Received Received

2) Acquisition plan approvals 0 - -2019

3) QA review completed 07-31-2019

4) Legal review completed 08- -2019

5) Issuance of solicitation 08- -2019

6) Quotes Due 08- 3-2019

7) Evaluation of Quotes 08- -2019

8) Contract preparation, reviews, and clearances obtained: 08- -2019

9) Contract Award 0 - -2019

SIGNATURES OF APPROVAL In Accordance With VHAPM AP SOP, Vol. 6, Chapter II Kever L. Swafford Contracting Officer

Signature:

Date:

KEVER SWAFFORD 409487 Digitally signed by KEVER SWAFFORD 409487 Date: 2019.08.08 06:05:07 -05'00'

Reuben A. Zepeda Chief, Network Contracting Office

Date:

Network Contracting Office

Signature:

Date:

Reuben A.

Zepeda 194112

Digitally signed by Reuben A.

Zepeda 194112 Date: 2019.08.07 12:12:29 -05'00'

SUSAN E HAYS

1046805

Digitally signed by SUSAN E

HAYS 1046805

Date: 2019.08.08 08:53:06 -05'00'

Attachment 2: Simplified Market Research Template

VHAPM Part 810 Market Research SOP Page 1 of 4 Revision: 02, Effective Date: 07/11/18

Requirement Title: MEDTRONICS PERFUSION PACKS

In accordance with FAR 7.102, contracting officers and acquisition planners are required to perform acquisition planning and conduct market research. The following information is a summary of the acquisition planning: In submitting this request for procurement, the customer considered available sources within the agency, any government furnished information/property, and security considerations IAW VA Directive/Handbook 6500. The contract type for this procurement is firm fixed price and the milestone schedule will be accomplished and documented in the Electronic Contract Management System (eCMS). The information below summarizes the market research results for this requirement.

1. Objective: Per FAR 10.001(a)(2) and VAAR 810.001-70, this report is in support of (check as many as apply):

A new requirement

An acquisition with an estimated value in excess of the simplified acquisition threshold (see FAR subpart 2.1 for current threshold)

An acquisition with an estimated value less than the simplified acquisition threshold where adequate information is not available to develop the requirements package and the circumstances justify the cost of performing the market research;

An acquisition that could lead to a bundled contract (15 U.S.C.

644(e)(2)(A)) (see FAR subpart 2.1 for bundled contract definition);

Other:

2. Background:

a. Title: Medtronic’s Perfusion Packs

b. Product or Service Code: 6515

c. NAICS Code: 339112

d. Size Standard for NAICS: 1000 EMPLOYEES

Vendor Information Pages https://www.vip.vetbiz.va.gov/Home/BasicSearchResult[3/25/2019 9:05:08 AM]

Find Veteran Business

YOUR SEARCH

Export Print

NAICS: 339112

Sort By:

-Change Sorting-

Change Search Criteria

DBA:

Location:

Chesapeake, Virginia Last Verified:

1/8/2018 Expiration Date:

1/8/2021

DUNS:

080791677 Phone:

7574775582 Email:

info@1acquisitions.com Web:

http://www.1Acquisitions.com

1 Acquisitions LLC

Search Results

Organizations Found: 303

Records Per Page

Search

Verification

Login

Register

-Change Sorting-

65-- MEDTRONIC PERFUSION PACKS - Federal Business Opportunities: Opportunities https://www.fbo.gov/index?s=opportunity&mode=form&id=d54a8d15990d60230930610bc84515c7&tab=core&_cview=0[2/12/2019 6:42:23 AM]

Solicitation Number:

36C25619Q0430

Notice Type:

Sources Sought

Buyers: Login | Register Vendors: Login | Register Accessibility

Original Synopsis Feb 11, 2019 12:13 pm

Synopsis:

Added: Feb 11, 2019 12:13 pm

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE (NCO) 16

MICHAEL E. DEBAKEY VA MEDICAL CENTER (VAMC), HOUSTON,

TEXAS

REQUEST FOR INFORMATION

36C25619Q0430

BACKGROUND:

The Houston VAMC has a requirement for the following brand name supplies: MEDTRONIC PERFUSION PACKS

Â

Â

Â

Â

Products (including software, licenses)

Item #

Description/Part Number*

Qty

Price

Extended Amount

Â

BASE PERIOD

Â

Â

ALL FILES

Attachment

Feb 11, 2019

36C25619Q0430 36C256...

GENERAL INFORMATION

Notice Type:

Sources Sought

Posted Date:

February 11, 2019

Response Date:

February 15, 2019

Archiving Policy:

Automatic, on specified date

Archive Date:

March 17, 2019

Original Set Aside:

N/A

Set Aside:

N/A

Classification Code:

65 -- Medical, dental & veterinary equipment & supplies

NAICS Code:

339 -- Miscellaneous Manufacturing/339112 -- Surgical and Medical Instrument Manufacturing

65-- MEDTRONIC PERFUSION PACKS

Solicitation Number: 36C25619Q0430 Agency: Department of Veterans Affairs Office: Houston VAMC Location: Department of Veterans Affairs Medical Center

Notice Details Packages Interested Vendors List Print Link

Return To Opportunities List Watch This Opportunity

Add Me To Interested Vendors