6515--Brand Name Penumbra Catheters and Accessories

Closed Solicitation Posted

Solicitation number
36C25924Q0482
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Department of Veterans Affairs Eastern Colorado Health Care System Aurora CO 80045

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs (VA) is seeking quotes for brand name Penumbra catheters and accessories, including Lightning Flash Procedure Packs, Aspiration Catheters, and Thrombectomy System Catheters. This is an unrestricted, brand name only solicitation under NAICS code 339113. The VA will evaluate quotes based on technical capability and price, and anticipates awarding a firm-fixed price contract. Quotes are due by 4:00 PM MT on May 24, 2024, and the deadline for questions is 4:00 PM MT on May 22, 2024. The VA will not accept gray market or remanufactured items, and offerors must be the Original Equipment Manufacturer (OEM), authorized dealers, distributors, or resellers.

This procurement is not set-aside. The estimated value is not provided, but the items are intended for use at the VA's Eastern Colorado Health Care System Rocky Mountain Regional VAMC in Aurora, CO. The solicitation lists specific part numbers for the required Penumbra brand catheters and accessories, with quantities needed for each line item.

Notice text

2 versions

Update #2 · Latest ·

Amendment 0001

The following changes have been made to this solicitation:

Lighting Flash Procedure Pack P/N USVS- LITNGFHT100BERPPS currently includes the following:

Flash aspiration catheter 100cm

Separator 12 P/N SEP12

Penumbra engine P/N PMXENGN not part of this procedure pack. (This is now removed)

Penumbra cannister P/N IAPS3

Lighting flash aspiration tubing

CORRECT Items to be Included - Lighting Flash Procedure Pack P/N USVS- LITNGFHT100BERPPS includes following:

Flash Catheter, 100cm

Separator 12, P/N SEP12

Penumbra ENGINE Canister P/N IAPS3

6 F Select Catheter 135 BER

Lightning Flash Aspiration Tubing

Update #1 ·

Request for Quote (RFQ) #: 36C25924Q0482

BRAND NAME ONLY PENUMBRA CATHETERS AND ACCESSORIES

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation.

* The deadline for all questions is 4:00pm MT, 05/22/2024

All questions must be submitted in writing no later than the question cut-off date marked above. All questions will be answered officially through an amendment to the solicitation.

** Quotes are to be provided to Lindsey.Zwaagstra@va.gov no later than 4:00pm MT, 05/24/2024.

Quotes shall not be hand carried. Faxed quotes shall not be accepted. Emailed quotes are the only method of submitted quotes (4MB email limit). The Government reserves the right to make award solely on initial Quotes received. Offerors bear the burden of ensuring that all portions of the offer (and any authorized amendments) reach the designated office before the deadline specified in the solicitation. This RFQ shall be completed in its entirety, and signed and dated, failure shall not be considered for award.

This is a Request for Quote (RFQ) and the solicitation number is 36C25924Q0482. The government anticipates awarding a firm-fixed price contract resulting from this solicitation.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-04 effective May 01, 2024.

The North American Industrial Classification System (NAICS) code for this procurement is 339113 with a small business size standard of 800 employees. This solicitation is brand name, unrestricted.

List of Line Items;

Line Item

Description

Quantity

Unit of Measure

Unit Price

Total Price

0001

USVS-LITNGFHT100BERPPS

LIGHTNING FLASH PROCEDURE PACK 100CM CATHETER

Brand Name Only

EA

1

$

$

0002

USVS-LITNGFHT115BER

FLASH ASPIRATION CATHETER

Brand Name Only

EA

1

0003

USVS-LITNG12HTORQ100

THROMBECTOMY SYSTEM PENUMBRA 100CM

Brand Name Only

EA

1

0004

USVS-LITNG12HTORQ115

SYS THRMB 115CM INDG LGHT CAT12 HTORQ

Brand Name Only

EA

1

Grand Total

$

Description of Requirements for the items to be acquired (insert salient characteristics or Statement of Work);

Penumbra P/N s USVS-LITNGFHT100BERPPS, USVS-LITNGFHT115BER,

USVS-LITNH12HHTORQ100, and USVSLITNG12HTORQ1115

Technical Specifications/Salient Characteristics:

Lightning Flash Specs

Intelligent aspiration

Dual clot detection algorithms

Quicker clot detection

Quicker patent flow detection

Flash mode most advanced thrombectomy alogo rith designed for expedited VTE clot removal

Enables operator to identify thrombus location

18:1 fluid loss detection with lightning vs dynamic tubing

Microprocessor with proprietary thrombus removal algorithm

Automatic valve control

Dual pressure sensors for real time flow monitoring

Powered by Penumbra engine

Lightning on/off switch

Lighting Flash Procedure Pack P/N USVS- LITNGFHTT100BERPPS includes following

Flash aspiration catheter 100cm

Separator 12 P/N SEP12

Penumbra engine P/N PMXENGN

Penumbra cannister P/N IAPS3

Lighting flash aspiration tubing

Lightning Flash Catheter 115cm HTORQ P/N USVS-LITNGFHT115BER

Lightning Flash aspiration tubing

6F select catheter 135 BER

Indigo Specs

Maximized thrombus engagement

Size and sweep enables operator to engage and remove thrombus

Multi pitch laser cut stainless steel hypertube

Proprietary separator technology

Lightning Indigo catheter 100cm HTORQ P/N USVS-LITN12HTORQ100

Lightning Flash aspiration tubing

Lightning Indigo catheter 115cm HTORQ P/N USVS-LITN12HTORQ115

Lightning Flash aspiration tubing

Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the Veterans Affairs Medical Center, located at

Department of Veterans Affairs

Eastern Colorado Health Care System

Rocky Mountain Regional VAMC

1700 N. Wheeling Street

Aurora, CO., 80045

52.212-1, Instructions to Offerors--Commercial Items applies to this acquisition

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL

Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

Any award made as a result of this solicitation will be made on an All or Nothing Basis.

State if quoted items are available and priced through offerors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract.

Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations.

All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below.

All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote.

Submission of quote shall include the following volumes: (I) Technical capability or quality of the item offered to meet the Government requirement; and (II) Price

Volume I - Technical Capability Brand Name Only

Volume II Price

Price - The offeror shall complete the pricing schedule provided in Section (v) above: Price/Cost Schedule.

(End of Addendum to 52.212-1)

52.212-2, Evaluation--Commercial Items applies to this acquisition

ADDENDUM to FAR 52.212-2 EVALUATION COMMERCIAL ITEMS:

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government considering price and other factors.

The following factors shall be used to evaluate quotations:

Factor 1. Technical Capability Brand Name Only

Factor 2. Price

Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2(b)(3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following:

Factor 1. Technical capability or quality of the item offered to meet the Government requirement: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

Factor 2. Price: The Government will evaluate the price by adding the total of all line item prices. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet or exceed the technical capability or quality of the item offered to the Government requirement shall not be selected regardless of price.

(End of Addendum to 52.212-2)

52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. Offerors must be registered in SAM at time of offer submission.

52.212-4, Contract Terms and Conditions--Commercial Items applies to this acquisition

52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (JUL 2020) applies to this acquisition

FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference;

FAR 52.204-10

Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020)

FAR 52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

FAR 52.204-24

Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (OCT 2020)

FAR 52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020)

FAR 52.219-28

Post Award Small Business Program Representation (NOV 2020)

FAR 52.222-3

Convict Labor (JUN 2003)

FAR 52.222-19

Child Labor Cooperation with Authorities and Remedies (JUL 2020)

FAR 52.222-21

Prohibition of Segregated Facilities (APR 2015)

FAR 52.222-26

Equal Opportunity (SEP 2016)

FAR 52.222-35

Equal Opportunity for Veterans (JUN 2020)

FAR 52.222-36

Equal Opportunity for Workers with Disabilities (JUN 2020)

FAR 52.222-37

Employment Reports on Veterans (JUN 2020)

FAR 52.222-40

Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

FAR 52.222-50

Combating Trafficking in Persons (OCT 2020)

FAR 52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020)

FAR 52.225-3

Buy American--Free Trade Agreements--Israeli Trade Act (JUL 2020)

FAR 52.225-13

Restrictions on Certain Foreign Purchases (JUN 2008)

FAR 52.232-33

Payment by Electronic Funds Transfer System for Award Management (Oct 2018)

Additional contract requirements or terms and conditions:

852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items (Apr 2020)

VAAR 852.203-70

Commercial Advertising (MAY 2018)

VAAR 852.232-72

Electronic Submission of Payment Requests (NOV 2018)

VAAR 852.233-70

Protest Content/Alternative Dispute Resolution (OCT 2018)

VAAR 852.233-71

Alternate Protest Procedure (OCT 2018)

VAAR 852.246-71

Rejected Goods (OCT 2018)

852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (Jan 2008)

The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer. Copies of these provisions or clauses are available on the Internet at the web sites provided in the provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference, or the clause at FAR 52.252-2, Clauses Incorporated by Reference. Copies may also be obtained from the contracting officer.

http://www.acquisition.gov/far/index.html

https://www.acquisition.gov/vaar

The following FAR provisions are to be incorporated by reference:

FAR 52.204-7

System for Award Management (OCT 2018)

FAR 52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

FAR 52.229-11

Tax on Certain Foreign Procurements Notice and Representation (JUN 2020)

The following VAAR provisions are to be incorporated by reference:

None

The following FAR clauses are incorporated by reference:

FAR 52.203-17

Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (JUN 2020)

FAR 52.204-13

System for Award Management Maintenance (OCT 2018)

FAR 52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

FAR 52.232-40

Providing Accelerated Payments to Small Business Subcontractors (NOV 2021)

The following VAAR clauses are to be incorporated by reference:

VAAR 852.212-71

Gray Market Items (APR 2020)

The Defense Priorities and Allocations System (DPAS) does not apply.

Date and Time offers are due to Lindsey.Zwaagstra@va.gov by 4:00pm MT, 05/24/2024.

Name and email of the individual to contact for information regarding the solicitation:

Lindsey Zwaagstra

Lindsey.Zwaagstra@va.gov

Files

File Type Posted
36C25924Q0482 0001.docx DOCX document
P03 Attachment 1 Single Source Justification 36C259-24-AP-3131 Contract Opportunities.pdf PDF
36C25924Q0482.docx DOCX document

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