36C24524C0122_1.pdf

Justification and Approval Notice

*= Required Field Justification and Approval Notice

SUBJECT* Cardiac Intra-Aortic Balloon Pumps

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 26301-4199

SOLICITATION NUMBER*

DELIVERY/TASK ORDER NUMBER 36C24524C0122

BASE NOTICE TYPE

ARCHIVE 10 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

PRODUCT SERVICE CODE* 6515

NAICS CODE* 334510

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Louis A Johnson, VAMC

Contracting Office (90C)

1 Med Center DR

Clarksburg WV 26301-4199

POINT OF CONTACT*

CONTRACTING SPECIALIST

ALISON KLEIN

ALISON.KLEIN@VA.GOV

304-623-3461 X 4143

AWARD INFORMATION

STATUTORY AUTHORITY* FAR 6.302-5 - Authorized or required by statute

AWARD NUMBER* 36C24524C0122

MODIFICATION NUMBER

AWARD AMOUNT* $738,769.17

LINE ITEM NUMBER 7

AWARD DATE (MM-DD-YYYY)* 08-19-2024

AWARDEE NAME*

CONTRACTOR’S UEI

MARATHON MEDICAL CORPORATION

YNGKKQWQLKC9

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 3* 3251 LEWISTON ST

AWARDEE ADDRESS LINE 4* STE 16

AWARDEE CITY AURORA

AWARDEE STATE CO

AWARDEE ZIP CODE 80011

ADDITIONAL INFORMATION

AGENCY’S URL HTTPS://WWW.VA.GOV

URL DESCRIPTION DEPT OF VETERAN AFFAIRS

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

1. Contrac ng Ac vity: Department of Veterans Affairs, VISN 05, VA Maryland Health Care System, Hun ngton VA Medical Center, and Washington DC VA Medical Center. Purchase Request # 482‐24 4‐

9163‐0045.

2. Nature and/or Descrip on of the Ac on Being Processed: The purpose of this requirement is to replace the cardiac intraor c balloon pumps (IABPs) throughout VISN 5 that are end of life and are recommended to be replaced by the FDA. The requirement is for two units for Hun ngton, two units for Maryland, and five units for Washington DC. The equipment shall come with all parts and accessories needed for the systems to func on at these facili es. The procurement shall include setup of the machines and training for the users, and all necessary travel and labor to accomplish this. This shall be executed as a new firm‐fixed price contract.

3. Descrip on of Supplies/Services Required to Meet the Agency’s Needs: The requirement is for nine

(9) total AC3 OPTIMUS INTRA‐AORTIC BALLOON PUMPs, manufacturer part number IAP‐0700, for

VISN 5. Two units are required for Hun ngton VAMC, two units are required for VA Maryland Health

Care System, and five units are required for Washington DC VAMC. The IABP systems shall be portable for use in mul ple rooms. The IABPs shall have IV poles. The IABPs shall be currently approved by the FDA and without major recalls or alerts indica ng issues with this cri cal equipment. The equipment should be delivered within 90 days of contract award, and the extended warran es will proceed a er installa on.

4. Statutory Authority Permi ng Restricted Compe on: FAR 13.5 Simplified Procedures for Certain

Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106‐1(b)(2) for restric ng compe on on this procurement. Compe on is restricted on this procurement for the reason below:

() Only One Responsible Source and No Other Supplies or Services Will Sa sfy Agency Requirements

( ) Unusual and Compelling Urgency

( ) Industrial Mobiliza on, Engineering, Developmental or Research Capability or Expert Services

( ) Interna onal Agreement

(x) Authorized or Required by Statute

( ) Na onal Security

( ) Public Interest

5. Demonstra on that the Contractor’s Unique Qualifica ons or Nature of the Acquisi on Requires the Use of the Authority Cited Above (applicability of authority):

Per the FDA, any Maquet/Ge nge/Datascope Cardiosave equipment needs to be replaced and its use discon nued. VISN 5 has nine of these units’ requiring replacement.

Market research concluded there are only two manufacturers of IABP units: Maquet/Ge nge/Datascope and Teleflex. Thus, only the products of Teleflex are acceptable. The IAP‐0700 model IABP by Teleflex meets all requirements of the Government. Marathon Medical was the only Service‐Disabled Veteran Owned

Small Business able to provide an authorized distributor le er from the manufacturer. The CO is going to sole source under Public Law 109‐461.

6. Descrip on of Efforts Made to ensure that offers are solicited from as many poten al sources as deemed prac cable: Market research was completed to determine available products on the marketplace. Use of the Emergency Care Research Ins tute (ECRI) cost comparison tool showed only two manufacturers of IABPs that are sold in the United States: Ge nge USA and Teleflex Medical. Se arches of contract opportuni es on Sam.Gov were executed to determine other poten al sources. Searches of Google were accomplished to find any other available products and resulted in only Teleflex and Maquet/Datascope/Ge nge. The Defense Logis cs Agency Medical Product Data

Bank was searched to find available distributors or contracts for the acceptable Teleflex products. A

Sources Sought 36C24524Q0790 was issued on sam.gov. Three SDVOSB vendors replied, however two of the firms did not provide an authorized distributor le er from the manufacturer. The CO is going to sole source under Public Law 109‐461.

7. Determina on by the CO that the An cipated Cost to the Government will be Fair and Reasonable:

The es mated cost of 9 pumps to include training and service for a year is $738,763.17 for three loca ons within VISN 5. The Northport VAMC in NY purchased one system on 11/8/2023 and it cost $84,000. If you take the cost of 1 system, mul ple it by 9 and u lize the US Bureau of

Labor Sta s cs CPI Infla on Calulator the current cost of the units would be $773, 540.19, which is

4.5% higher than es mated costs.

8. Descrip on of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market Research was conducted in December 2023, July

2024 and August 2024. Market Research determined there were only two manufacturers who distribute their equipment in the United States. The items manufactured and distributed by

Maquet/Datascope/Ge nge are not endorsed by the FDA, as there have been significant recalls and nega ve pa ent outcomes. The FDA issued a le er sta ng there are “con nued safety and quality concerns” with he Ge nge/Maquet/Datascope Caridosave Hybrid system currently installed in VISN

5 facilites. The le er states, “The FDA recommends that health care facili es transi on away from use of these devices and seek alterna ves, if possible” due to many medical device reports, including 15 that reported issues resul ng in pa ent serioes injury or death. A Sources Sought

36C24524Q0790 was issued on sam.gov. Three SDVOSB vendors replied, however two of the firms did not provide an authorized distributor le er from the manufacturer. The items manufactured and distributed by Teleflex Medical/Marathon Medical are the only FDA cleared intra‐aor c balloon pumps per ECRI, a trusted source for medical equipment informa on.

9. Any Other Facts Suppor ng the Use of Other than Full and Open Compe on: None

10. Lis ng of Sources that Expressed, in Wri ng, an Interest in the Acquisi on:

11. Statement of the Ac ons, if any, the Agency May Take to Remove or Overcome any Barriers to

Compe on before Making subsequent acquisi ons for the supplies or services required: Future procurements of IABP systems will be researched again, as there may be new products on the market that are FDA approved.