6515--Power Assisted Liposuction (PAL) Handpiece and Accessories CS: Maureen Sundstrom

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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Combined Synopsis/Solicitation Notice

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DESCRIPTION

Combined Synopsis/Solicitation Notice

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This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This is a Brand Name or Equal To Request for Quote (RFQ), and the solicitation number is 36C26024Q0174. The Government anticipates awarding a firm-fixed price supply order from this solicitation.

This is a solicitation for Power Assisted Liposuction (PAL) Handpiece and Accessories. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-01 Effective November 14, 2023.

This solicitation is 100% set-aside for Small Business. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1000 employees and the PSC is 6515.

All interested companies shall provide quotations that are Brand Name or Equal To for the following:

Equipment Needed:

Brand Name MicroAire

PART

Description

UOM

Quantity

PAL-750

Power Assisted Liposuction (PAL) Handpiece Blue

EA

3

5006-PAL

PAL instrument Cable (for 5020 Console)

EA

3

5020

PAL Electric Console

EA

1

CAP-600E

PAL Washer Disinfector Cap

EA

3

PAL 500

PAL Sterilization Case

EA

3

ASP-1021

Lipo Tower Tumescent Liposuction Device w/ Surgical Cart

1 PK

1

ASP-CBL-5020

5020-to-Lipo Tower Integration Cable

1 PK

1

ASP-TB-VAC

Vacuum Tubing

4 PK

1

ASP-FLTR

Lipo Tower Bio Filter Assembly

EA

1

PAL-1200

PAL Aspiration Tubing

5 PK

1

INF-KIT

PAL Infiltration Kit

EA

1

PAL-INF-1600

Infiltration Tubing (5 PK)

5 PK

1

ASP-CAN-2S

LipoFilter Canister w/Toomey Syringe

1 PK

1

ASP-CAN-2R

LipoFilter Stand

EA

1

ASP-CAN-2C

LipoFilter Clamp

EA

1

ASP-ADP-2

Toomey-to-Luer Syringe Adapter

EA

1

ASP-ADP-3

Toomey-to-Luer Needle Adapter

EA

1

PAL-504LL

Mercedes 5.0mm x 30cm, 10mm Port, Single Use Cannula

EA

2

PAL-504LS

Mercedes 5.0mm x 22cm, 10mm Port, Singe Use Cannula

EA

2

PAL-404LL

Mercedes 4.0mm x 30cm, 10mm Port, Singe Use Cannula

EA

2

PAL-404LS

Mercedes 4.0mm x 22cm, 10mm Port, Singe Use Cannula

EA

2

PAL-304LL

Mercedes 3.0mm x 30cm, 8mm Port, Singe Use Cannula

EA

2

PAL-304LS

Mercedes 3.0mm x 22cm, 8mm Port, Singe Use Cannula

EA

2

PAL-244LM

Mercedes 2.4mm x 15cm, 7.5mm Port, Single Use Cannula

EA

2

PAL-INF-30MLL

Multi-Hole Infiltration 3mm x 30cm, Single Use Infiltration Cannula

EA

2

PAL-INF-30MLS

Multi-Hole, 3mm x 22cm, Single Use Infiltration Cannula

EA

2

PAL-INF-30MLM

Multi-Hole, 3mm x 15cm, Single Use Infiltration Cannula

EA

2

Salient Characteristics: Electroretinogram

Must meet all required federal mandates for medical use

Must be able to perform liposuction for breast, belly, and amputations.

Must be able to have two footswitches for operating with an attending and resident surgeon.

For O.R. efficiency and infection reduction, the tube set must be separate from the cannula and be capable of being removed and changed intraoperatively.

Must offer disposable and reusable cannulas for use

Disposables must include sterile suction tubing at least 3 meters long with both single and double funnel options

Containers for fat storage must be included

Containers for fat storage must be able to store at least 6L total

Needs to instill tumescence and provide fat injection. this is performed by removing the patients fat and temporarily storing the specimen in a holding container, before being placed back into the patients body.

The machine needs to regulate the suction to a safe level to prevent harm to the patient.

Must regulate temperature of the tumescence to maintain patients body temperature

Needs to have overflow protection and a hydrophobic filter to maximize the amount of tissue able to be reimplanted.

Must be on wheels for easy movement

Bacteria Filter must be included

Vacuum must meet -90kPA on normal null setting

Suction power must meet or exceed 55L/min +/-6 l/min at 50 Hz

Stroke length and frequency- 3,000-6,000/min approx. 3mm

Pumping rate 50-300 ml/min

Accuracy +/- 15%

Acoustic volume not to exceed 55 dB(A)

Must have digital display with touch screen capabilities

All modules must safely mount to single cart

Must meet the following dimensions

Utilize 115/120V 50-60hz, 1.1A

Cart dimensions not to exceed 1050mmx550mmx600mm

Weight not to exceed 40 kg

Delivery shall be FOB: Destination: 30-60 days after receipt of order is preferred. All deliveries will be coordinated with the Portland VAMC Point of Contact.

Place of Delivery:

Department of Veterans Affairs

Portland VA Medical Center

Warehouse

3710 SW Veterans Hospital Road

Portland, OR 97239

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, Instructions to Offerors Commercial Products

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL

52.204-7

System for Award Management (OCT 2018)

52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

52.211-6

Brand Name or Equal (AUG 1999)

52.225-2

Buy American Certificate (Oct 2022) (41 U.S.C. chapter 83)

52.252-1

Provisions Incorporated by Reference (FEB 1998)

VAAR Provisions:

852.252-70

Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008)

(a) Gray market items are Original Equipment Manufacturers (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.

(b) 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.

(c) 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.

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

(e) 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 contractors, the offeror making such contact may be excluded from award considerations.

(f) 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.

(g) 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.

(End of Addendum to 52.212-1)

2. FAR 52.212-2, Evaluation-Commercial Items : The Government may award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In accordance with FAR 9.104-2, the special standards of responsibility described below apply to this procurement. Offerors who fail to meet any special standards of responsibility will not be eligible to receive contract award. The following factors shall be used to evaluate offers:

Special Standards of Responsibility: (Per FAR 9.104-2) The following special standards of responsibility apply to this procurement:

SP1: Offeror must be a manufacturer authorized provider for the items provided. A letter from the manufacturer stating such must be included with any response to this solicitation.

Technical compliance

Price

*Adherence to the technical characteristics and meeting the special standard is more important than price.

(a) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offeror's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

3. Offerors must complete annual representation and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with 52.212-3, Offerors Representations and Certifications -- Commercial Products. If paragraph (j) of the provision is applicable, a written submission is required.

4. Any Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered/certified with the U.S Small Business Administration at Veteran Small Business Certification (https://www.sba.gov).

The following contract clauses apply to this acquisition:

5. FAR 52.212-4, Contract Terms and Conditions Commercial Products (OCT 2018)

ADDENDUM to FAR 52.212-4 The following clauses are included as a part of the addendum:

52.204-13

System for Award Management Maintenance (OCT 2018)

52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

52.219-6

Notice of Total Small Business Set-Aside (NOV 2020)

52.222-19

Child Labor Cooperation with Authorities and Remedies (DEC 2022)

52.232-40

Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

52.252-2

Clauses Incorporated by Reference (FEB 1998)

VAAR Clauses:

852.203-70

Commercial Advertising (MAY 2018)

852.212-71

Gray Market Items (NOV 2018)

852.232-72

Electronic Submission of Payment Requests (NOV 2018)

852.242-71

Administrative Contracting Officer (OCT 2020)

852.246-71

Rejected Goods (OCT 2018)

852.247-71

Delivery Location (OCT 2018)

852.247-73

Packing for Domestic Shipment (OCT 2018)

6. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products (MAR 2023)

The following subparagraphs of FAR 52.212-5 are applicable and incorporated by reference:

52.204-10

Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note)

52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) (31 U.S.C. 6101 note)

52.219-28

Post Award Small Business Program Representation (MAR 2023) (15 U.S.C 632(a)(2))

52.222-3

Convict Labor (JUN 2003) (E.O. 11755)

52.222-21

Prohibition of Segregated Facilities (APR 2015)

52.222-26

Equal Opportunity (SEP 2016) (E.O. 11246)

52.222-36

Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793)

52.222-37

Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212)

52.222-50

Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627)

52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513)

52.225-1

Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83)

52.225-13

Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury)

52.232-33

Payment by Electronic Funds Transfer System for Award Management (Jul 2018) (31 U.S.C. 3332)

7. All quoters shall submit according to the following:

Quotes must be emailed to Maureen.Sundstrom@va.gov and received no later than 3:00 PM PST on 12/21/2023. Quotes may be submitted on this document or the vendor s own form and must include the completed Buy American Certificate 52.225-2, and if not the manufacturer, an authorized distributor letter. Any offer that does not provide the supporting documentation may be considered non-responsive.

Required Supporting Documentation:

Buy American Certificate

Authorized Distributor Letter if not the manufacturer

Certification that equipment meets/exceeds the salient characteristics of the desired brand above

Delivery date

Warranty

The Government intends to make award without discussions.

For information regarding the solicitation, please contact Maureen Sundstrom at Maureen.Sundstrom@va.gov.

See attached document: 52.225-2 BUY AMERICAN CERTIFICATE.