6515--BNOE NX EQ Circulatory Assist Units: Intra-Aortic Balloon

Sources Sought Notice

Sources Sought Notice

Page 7 of 7

Sources Sought Notice

*= Required Field

Sources Sought Notice

Page 1 of 7

1.0 DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Circulatory Assist Units, Intra-Aortic Balloon product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

The Department of Veterans Affairs (DVA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources.

The SAC in conjunction with VHA is seeking a qualified source to provide Getinge® brand name or equal Circulatory Assist Units, Intra-Aortic Balloon on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Circulatory Assist Units, Intra-Aortic Balloon to VA medical centers and facilities throughout the United States.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 Surgical Appliance and Supplies Manufacturing and the associated size standard is 800 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM prior to submitting an offer or quotation. You may access the SAM website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of quote submission.

This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes.

2.0 SCOPE -

Circulatory Assist Units: Intra-Aortic Balloon produce mechanical counter pulsation to reduce the afterload to the heart and increase coronary and cerebral blood flow. These devices consist of an inflatable balloon catheter, which is placed in the aorta attached to an external unit that includes a pneumatic system, regulating the automated inflation and deflation of the balloon in synchronism with the cardiac cycle; they include monitors of the physiologic parameters of the patient (e.g., heart rate, arterial pressure) and also of balloon pressure and volume. The inflated intra-aortic balloon forces the blood toward the heart during each diastolic phase of the cardiac cycle. Intra-aortic balloon circulatory assist units are used to improve cardiovascular functioning during cardiac failures that constitute life-threatening emergencies.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Circulatory Assist Units: Intra-Aortic Balloon to be used by clinicians throughout the VA medical centers and facilities.

The following Contract Line Items are being considered:

Contract Line Item#

Part Number

Description

BASE YEAR

YEAR 1

YEAR 2

YEAR 3

YEAR 4

0001

0998-00-0800-53

Cardiosave Hybrid Intra-Aortic Balloon Pump includes accessory kit (D0020-00-0480-01), 2 Li-Ion battery pack (D146-00-0097), Helium Tanks (D075-00-0024-03) and CARDIOSAVE Li-Ion Single Battery Transport PART NUMBER (D202-00- 0206-01) (Protective transport case required by fed regs). MANUFACTURER PART NUMBER (D202-00- 0206-01) - charger integral to Cardiosave cart

23

26

28

12

10

0002

0998-00-0803

Cardiosave Trainer

10

12

14

6

5

0003

ZSUSBZCDSVPOSEW

CRDSVE - GCare Preventative - EW 1Y

5

5

9

4

3

0004

ZSUSSVCDSVPOSEW

CRDSVE - GCare Professional - EW 1Y

5

5

9

4

3

0005

ZSUSGDCDSVPOSEW

CRDSVE - GCare Premium - EW 1Y

5

5

9

4

3

The Department of Veterans Affairs (VA) is seeking vendors who can provide Getinge® brand name or equal Circulatory Assist Units, Intra-Aortic Balloon as listed above or equal commodities which meet all the following salient characteristics.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

APPLICABLE CLINS

VENDOR S PROVIDE PAGE # WHERE EACH SC IS MET IN YOUR TECHNICAL LITERATURE

SC 1

Automatic, semiautomatic or manual modes of operation

Literature Review

0001

SC 2

Multiple triggering modes

Literature Review

0001

SC 3

Event/History Log capable

Literature Review

0001

SC4

Maximum Pump Rate of 200 bpm

Literature Review

0001

SC 5

Auto condensation removal capable

Literature Review

0001

SC 6

Display with parameters (e.g., ECG, heart rate, arterial pressure)

Literature Review

0001

SC 7

QRS Indicator

Literature Review

0001

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics (SC) specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

Does vendor offer an annual service plan, Yes or No?

If Yes:

What does the plan cover?

Does plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

Vendor are requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

Full name and address of company

DUNS number/ CAGE Code/ SAM UIE

Business Size

Manufacturer or Distributor

If distributor provide full name, business size and address of manufacturer.

Country of Origin designation for all products

Ability to provide uninterrupted supply of products on a national scale.

Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met.

Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.

1.0 DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Circulatory Assist Units, Intra-Aortic Ballon product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

The Department of Veterans Affairs (DVA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources.

The SAC in conjunction with VHA is seeking a qualified source to provide Getinge® brand name or equal Circulatory Assist Units, Intra-Aortic Ballon on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Circulatory Assist Units, Intra-Aortic Ballon to VA medical centers and facilities throughout the United States.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 Surgical Appliance and Supplies Manufacturing and the associated size standard is 800 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM prior to submitting an offer or quotation. You may access the SAM website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of quote submission.

This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes.

2.0 SCOPE -

Circulatory Assist Units: Intra-Aortic Balloon produce mechanical counter pulsation to reduce the afterload to the heart and increase coronary and cerebral blood flow. These devices consist of an inflatable balloon catheter, which is placed in the aorta attached to an external unit that includes a pneumatic system, regulating the automated inflation and deflation of the balloon in synchronism with the cardiac cycle; they include monitors of the physiologic parameters of the patient (e.g., heart rate, arterial pressure) and also of balloon pressure and volume. The inflated intra-aortic balloon forces the blood toward the heart during each diastolic phase of the cardiac cycle. Intra-aortic balloon circulatory assist units are used to improve cardiovascular functioning during cardiac failures that constitute life-threatening emergencies.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Circulatory Assist Units: Intra-Aortic Balloon to be used by clinicians throughout the VA medical centers and facilities.

The following Contract Line Items are being considered:

Contract Line Item#

Part Number

Description

BASE YEAR

YEAR 1

YEAR 2

YEAR 3

YEAR 4

0001

0998-00-0800-53

Cardiosave Hybrid Intra-Aortic Balloon Pump includes accessory kit (D0020-00-0480-01), 2 Li-Ion battery pack (D146-00-0097), Helium Tanks (D075-00-0024-03) and CARDIOSAVE Li-Ion Single Battery Transport PART NUMBER (D202-00- 0206-01) (Protective transport case required by fed regs). MANUFACTURER PART NUMBER (D202-00- 0206-01) - charger integral to Cardiosave cart

23

26

28

12

10

0002

0998-00-0803

Cardiosave Trainer

10

12

14

6

5

0003

ZSUSBZCDSVPOSEW

CRDSVE - GCare Preventative - EW 1Y

5

5

9

4

3

0004

ZSUSSVCDSVPOSEW

CRDSVE - GCare Professional - EW 1Y

5

5

9

4

3

0005

ZSUSGDCDSVPOSEW

CRDSVE - GCare Premium - EW 1Y

5

5

9

4

3

The Department of Veterans Affairs (VA) is seeking vendors who can provide Getinge® brand name or equal Circulatory Assist Units, Intra-Aortic Ballon as listed above or equal commodities which meet all the following salient characteristics.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

APPLICABLE CLINS

VENDOR S PROVIDE PAGE # WHERE EACH SC IS MET IN YOUR TECHNICAL LITERATURE

SC 1

Must Eliminate (Kill) 99.99% Pathogens (Bacteria)

Literature Review

0001

SC 1

Automatic, semiautomatic or manual modes of operation

Literature Review

0001

SC 2

Multiple triggering modes

Literature Review

0001

SC 3

Event/History Log capable

Literature Review

0001

SC4

Maximum Pump Rate of 200 bpm

Literature Review

0001

SC 5

Auto condensation removal capable

Literature Review

0001

SC 6

Display with parameters (e.g., ECG, heart rate, arterial pressure)

Literature Review

0001

SC 7

QRS Indicator

Literature Review

0001

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics (SC) specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

Does vendor offer an annual service plan, Yes or No?

If Yes:

What does the plan cover?

Does plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

Vendor are requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

Full name and address of company

DUNS number/ CAGE Code/ SAM UIE

Business Size

Manufacturer or Distributor

If distributor provide full name, business size and address of manufacturer.

Country of Origin designation for all products

Ability to provide uninterrupted supply of products on a national scale.

Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met.

Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.