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CATH LAB BPA-ABIOMED-Impella Catheters


Mississippi, United States
Government : Federal
RFP
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SOURCES SOUGHT NOTICE

This is not a request for proposals. A solicitation will not be issued at this time. The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 16 South Central VA Health Care System, 2002 Holcombe Blvd, Houston, TX 77030 has a requirement for Catheters. The South Central VA Health Care System requires catheters in order to utilize on patients that require emergency catheterization surgeries. The catheters must be compatible with the Abiomed Inc. Impella Catheters that is owned by Abiomed Inc. The catheter shall be minimally invasive. The intent of the procurement is to award an BPA (Blank Purchase Agreement) contract.

The type of products to be purchased are specific and must be compatible for use with the existing equipment. The applicable NAICS code is 339112 Surgical and Medical Instrument Manufacturing. Small Business manufacturers for this NAICS code have a size standard of 500 employees or less.B The resulting contract will have fixed unit costs for the catheters. The terms of the BPA is intended to be a one year Base Period from date of award, with three (3) one (1) year options.

It is anticipated that a Request for Proposals will be issued in December, 2017. Award of an BPA contract is contemplated by April, 2018. This notice is published to conduct market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Businesses (SB), or Large Business capable of performing the requirements to warrant a socio-economic set-aside or full & open competition. It is strongly recommended that interested parties register in the US Department of Veterans Affairs Vet Biz database and the Small Business Administration (SBA) database. Registration may be accomplished at http://www.vip.vetbiz.gov/ and www.sba.gov/, respectively. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) documentation relating to capability of performance of residential renovation projects (including references); (3) intentions of subcontracting program to include set-asides; (4) proof of registration in the VA Vet Biz or SBA websites or intention of registration prior to submission of offers to a solicitation; (5) documentation on company s bonding capacity and limitations; and (6) any other pertinent company documentation.

The response date to this Sources Sought notice is October 31, 2017 at 4:00 pm CTS. This market research is for informational and planning purposes only to determine if a socio-economic set-aside, or full & open competition, or sole-source procurement is appropriate. The Government will not pay any costs for responses submitted. Electronic submissions are acceptable via diyonne.williams@va.gov. Hard copy submissions are acceptable to VISN 16 Network Contracting Office; 715 South Pear Orchard Road, Suite A, 4th Floor, Ridgeland, MS 39157.

NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN. ALL FIRMS ARE INSTRUCTED NOT TO CALL THE INDIVIDUAL VA MEDICAL CENTERS REQUESTING MORE INFORMATION.


STATEMENT OF WORK
Abiomed-Impella
Introduction/Background
This transaction is for the setup of a Blanket Purchase Agreement (BPA) with the vendor Abiomed for the ongoing purchase of Impella Catheters for one base year and 3 option years. This contract will provide more timely accessibility of supplies and materials needed for High Risk/Life-Threatening diagnostic and interventional cardiac procedures. It will reduce procurement lead times and simplify the ordering process. Impella Catheters have been used in the lab for approximately 3 years. This product has been previously ordered as an EMERGENCY and the estimated quarterly par levels are used to determine the amount ordered as an EMERGENCY.
The Impella Catheter replaces the Tandem Heart machine and is used in the Cath Lab during emergency catheterization surgeries. It is the world s smallest heart pump that provides cardiac support by pumping blood through the heart during a procedure. In high risk patients for whom surgery is not an option, interventional cardiac procedures utilize this ventricular assist device to assist the heart. This device can successfully save lives during high risk procedures when other options are no longer available. Below is an overview of each type of Impella catheter.
The Impella CP Circulatory Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella CP Circulatory Support System also provides pressure measurements which are useful in determining intravascular pressure.
The Impella 2.5 System (Impella 2.5) is a temporary (< 6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined that high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned, temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
The Impella RP System is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
The Impella 5.0 is a micro axial, catheter-mounted pump that works on the principle of Archimedes screw. It is able to generate a total output of 4.0-5.0 L/min at an RPM of 33,000, a step up from its predecessor, the Impella 2.5, which generates a maximum of 2.0-2.5 L/min. The Impella 5.0 sits with its distal end inside the ventricle, across the aortic valve, with its outlet in the proximal aorta (Figure 2). The distal end consists of a 7 French (Fr) pigtail that helps anchor the device inside the left ventricle (LV) and an inlet (proximal to the pigtail) with up to 5 openings, connected to a nitinol-based 21 Fr catheter that houses the motor at the proximal end. Distal to the encapsulated motor housing is the outlet where blood is ejected into the aorta, while distal to the outlet is the differential pressure sensor that assists with positioning the Impella across the aortic valve. The Impella is then connected to a controller system (outside of the body) that helps regulate its function, including manual adjustments of up to 9 different iterations of rotational speed, with commensurate changes in flow and resultant change in cardiac output. The controller system also houses the purge system that infuses dextrose and heparin through the Impella, preventing the blood from contaminating the motor and also preventing clotting. In addition, it has also been successfully implemented as bridge in-between treatments, i.e., transition from one form of support to another, such as ECMO to Impella, Impella 2.5 to 5.0, intra-aortic balloon pump to Impella, etc.
Scope of Work
This Blanket Purchase Agreement (BPA) will provide services to the Cardiology/Cath Lab Section of the Michael E. DeBakey VA Medical Center (MEDVAMC). The MEDVAMC intends, through this procurement, to expedite care to critically ill patients, reduce waste by eliminating the use of less effective devices, have on demand the resources available to provide required services, and to enhance the best possible patient outcomes and patient satisfaction.
Through the duration of the contract, the contractor(s) will provide the delivery of Impella CP, 2.5, RP, and 5.0 Catheters. The contractor shall have subject matter expertise and provide all resources necessary to perform the specific requirements as defined in the Task Orders. All products ordered under this BPA and placed against the Awarded Contract are subject to the terms and conditions of the executed contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.
Individual Task Orders will be awarded on a firm-fixed price basis. The Contracting Officer may waive the dollar limit and the period of performance ceilings for individual task orders. Solely the Contracting Officer, on a case-by-case basis, shall determine deviations from the dollar limitation and the period of performance ceilings. VISN 16 will provide an estimated volume by catheter as reflected in schedule of supplies for the medical center. Pricing is based on the AVERAGE daily volume per instrument. The Government estimates the volumes of usage as listed in the schedule of supplies, but does not guarantee volumes as listed; they are estimates ONLY.
Period of Performance
The period of performance for this BPA is for the duration of the contract, beginning on the date of award, with annual reviews by the Contracting Officer. This will be a single award, firm-fixed price BPA with one base year and three, one year options (or the duration of the contract) and shall be effective for the term of the Contract including additional extensions. BPA s generally should not exceed 5 years in length, but may do so to meet program requirements. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor s contract. In addition, where a new contract replaces Contractor s current contract, the resulting BPA may be reassigned under the new contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VAMC Houston intends to establish the base year of the agreement for to be determined upon award.
Place of Performance
The supplies delivered under the Blanket Purchase Agreement (BPA) with the vendor Abiomed will be used in the Cardiology/Cath Lab Section of the Michael E. DeBakey VA Medical Center (MEDVAMC).
Work Requirements
As part of the Blanket Purchase Agreement (BPA) agreement with the contractor Abiomed, the contractor will be responsible for performing tasks throughout various stages of this contract. The following is a list of these tasks which will result in the successful implementation of this device:
Training Phase:
Contractor will provide continuous clinical and education support to the Cardiology/Cath Lab Section of the Michael E. DeBakey VA Medical Center (MEDVAMC).
Schedule


Base yr.





Stock #
Item Description
Unit of Measure
Quantity
Price
Total

74716
Impella 2.5
EACH
2
$25,000.00
$50,000.00

5062
Impella 5.0
EACH
7
$32,000.00
$224,000.00

4334
Impella RP
EACH
7
$25,000.00
$175,000.00
B
75209
Impella CP
EACH
32
$25,125.63
$804,020.16

B
B
B
B
B
$1,253,020.16

B
B
B
B
B
B

B
Option Year 1
B
B
B
B
B
74716
Impella 2.5
EACH
2
$25,000.00
$50,000.00
B
5062
Impella 5.0
EACH
10
$32,000.00
$320,000.00
B
4334
Impella RP
EACH
10
$25,000.00
$250,000.00
B
75209
Impella CP
EACH
48
$25,125.63
$1,206,030.24
B
B
B
B
B
B
$1,826,030.24
B
B
B
B
B
B
B
B
B
Option Year 2
B
B
B
B
B
74716
Impella 2.5
EACH
2
$25,000.00
$50,000.00
B
5062
Impella 5.0
EACH
10
$32,000.00
$320,000.00
B
4334
Impella RP
EACH
10
$25,000.00
$250,000.00
B
75209
Impella CP
EACH
48
$25,125.63
$1,206,030.24
B
B
B
B
B
B
$1,826,030.24

B
B
B
B
B
B

B
Option Year 3
B
B
B
B

74716
Impella 2.5
EACH
2
$25,000.00
$50,000.00

5062
Impella 5.0
EACH
10
$32,000.00
$320,000.00

4334
Impella RP
EACH
10
$25,000.00
$250,000.00

75209
Impella CP
EACH
48
$25,125.63
$1,206,030.24

B
B
B
B
B
$1,826,030.24

B
B
B
B
B Total Estimated Cost
$6,731,110.88





















B

Ordering Method/Acceptance Criteria/Delivery
Delivery Orders issued will be identified by BPA Number and Contract Number. The participating facility may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. If a Purchase Card is used, do not use EDI, as this will result in a duplicate charge.
All warranted MEDVAMC personnel are authorized to place delivery orders against this BPA consistent with their warranted authority.
Unless otherwise agreed to, all delivers under this BPA must be accompanied by delivery tickets or sales slips that must contain the following information as a minimum:
Name of contractor
BPA number
Purchase order number
Date of purchase
Quantity, unit price, product, or catalog number, description; and
Date of shipment

Products will be delivered strictly in accordance with the requirement of the Cardiac Catheterization Laboratory at Michael E. DeBakey VA Medical Center M S 08:00am 05:00pm, unless otherwise specified, with the exception of the following Federal holidays:
New Year s Day
Martin Luther King s Birthday
Presidents Day
Memorial Day
Independence Day
Labor Day
Columbus Day
Veterans Day
Thanksgiving Day
Christmas AND any other day specifically declared by the President of the United States to a national holiday.

Deliveries will incorporate sufficient packing to comply with all applicable federal and/or state standards related to shipment of these products. Shipping containers must comply with all federal and state regulations. This will include, but is not limited to, DOT, DOE, regulations and standards.
Final inspection and acceptance of all deliverables will occur at the place of delivery by the Cardiology/Cath Lab Nurse Manager or COR. Final approval and acceptance of documentation required here in shall be by letter of approval and acceptance by Cardiology/Cath Lab Nurse Manager or COR. The Government will monitor performance and review deliverables utilizing solicited and unsolicited feedback.
The Contractor will invoice each delivery order as directed by authorized personnel of the Cardiology/Cath Lab Section of the Michael E. DeBakey VA Medical Center (MEDVAMC). The Government is obligated only to the extent of authorized orders actually issued under the BPA by Authorized Users, who are Government Contracting Officers and Purchasing Agents representing the South Central VA Health Care Network (VISN 16).
Other Requirements
N/A

Diyonne Williams
Contract Specialist
601-206-6956

diyonne.williams@va.gov

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