P03_PM_Part808.405-6_Atch2_Limiting_Sources_Justification_OVER_SAT_FINAL.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: VA258-18-AP-1272

1. Contracting Activity: Department of Veterans Affairs, VISN 22, NCO 22-G, Southern Arizona

VA Medical Center - 678-18-3-030-2944.

2. Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). The Southern Arizona VA Health Care System (SAVAHCS) located at 3601 S. 6th Ave, Tucson, AZ 85723, has a continuing requirement to procure Acera Surgical Inc., specialized disposable products for specialized veteran care procedures that the SAVAHCS provides. Acera Surgical Inc., provides a Restrata Wound Matrix that would be a Sole Source, firm fixed price contract. This proposed contract would be a new contract with a base plus four option years.

Order against: FSS Contract Number: 36F79718D0525

Name of Proposed Contractor: ACERA SURGICAL INC

Street Address: 10880 BAUR BLVD

City, State, Zip: ST LOUIS, MO 63132

Phone: 844-879-2237 X702

3. Description of Supplies or Services:

The estimated value of the proposed action is $450,306.00

The Southern Arizona VA Health Care System (SAVAHCS) has a continuing requirement to procure the Restrata Wound Matrix which is manufactured and proprietary to Acera Surgical Inc. The quantities listed below are currently the Governments best estimate and may change (up or down) based upon the number of future Veteran procedures being completed.

Product Name

Stock # Product Size Unit Price Est Annual Usage

Vendor Total Cost

Restrata Wound Matrix

RWM1-

1x1

2.5 cm x 2.5 cm

$ 990.00 60 Acera Surgical $ 59,400.00

Restrata Wound Matrix

RWM1-

1x3

2.5 cm x 7.5 cm

$ 2,151.00 60 Acera Surgical $ 129,060.00 https://www.gpo.gov/fdsys/pkg/USCODE-2009-title41/pdf/USCODE-2009-title41-chap4-subchapIV-sec251.pdf https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

Restrata Wound Matrix

RWM1-

2x2

5 cm x 5 cm $ 2,799.00 60 Acera Surgical $ 167,940.00

Restrata Wound Matrix

RWM1-

3x3

7.5 cmx 7.5 cm

$ 4,275.00 12 Acera Surgical $ 51,300.00

Restrata Wound Matrix

RWM1-

4x5

10.0 cm x 12.5 cm

$ 7,101.00 6 Acera Surgical $ 42,606.00

Estimated Cost $ 450,306.00

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

(CHECK ALL THAT APPLY AND COMPLETE)

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data.

Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH

FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: This is a brand name justification in support of FAR 6.302-1 (2) (ii) Supplies may be deemed to be available only from the original source. The specific Restrata Wound Matrix products are unique and specific to the procedures SAVAHCS providers complete to include the training the providers have been given. Additionally, the Restrata Wound Matrix is manufactured and proprietary to Acera Surgical Inc. Acera Surgical Inc., is the only provider for the Restrata Wound Matrix.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

Market research has been completed on a previous Acera Surgical Inc., purchase back in February 2018 and to date there is no other known vendors found that can provide the Restrata Wound Matrix. Based upon this market research and the fact that SAVAHCS personnel are trained to use these specific products for the highly specialized procedures these products are used for; However, since February 2018, Acera Surgical has obtained a Federal Supply Schedule and has agreed upon lower costs when purchasing in bulk.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: See information provided above.

(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY

SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: None.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

VHAPM Part 808.405-6 Limiting Sources Page 4 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Tina Kennedy, Contracting Officer NCO 22-G Mesa

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Jeremy J. Parker Contracting Officer Supply Branch 2 – Branch Chief

HIGHER LEVEL APPROVAL (Required for orders over $700,000):

c. VHA SAO HCA REVIEW AND APPROVAL (over $700,000 to $68 million): 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 restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

NAME DATE

VHA Head of Contracting Activity (HCA)

d. VHA Senior Procurement Executive Approval (over $68 million): 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.

JAN R. FRYE DATE

Deputy Assistant Secretary Office of Acquisition and Logistics Senior Procurement Executive (SPE)