W065--Extracorporeal Shockwave Lithotripsy (ESWL) Treatment Commodities Lease Amendment to remove 4 Salient Characteristics not associated with Lithotripsy Treatment

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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Combined Synopsis/Solicitation Notice

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Combined Synopsis/Solicitation Notice

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1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, 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.

2. This is a Request for Quote (RFQ) and the solicitation number is 36C26022Q0901. The Government anticipates awarding a firm-fixed price purchase order contract resulting from this solicitation.

3. This is a solicitation for EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY (ESWL) TREATMENT (Commodities Lease). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-07 effective August 10, 2022.

4. This is a Full-and-Open solicitation Unrestricted by business size. The associated North American Industrial Classification System (NAICS) code for this procurement is 621999, with a small business size standard of $16.5 Million and the PSC is W065.

All interested companies shall provide quotations, including pricing, as a part of this solicitation. All information of this nature submitted to the government shall be made in accordance with the Statement of Work below. Responsive quotes shall include a price quote, past relevant performance, and item/task technical specifications outlining how they intend to meet the standards provided in Part (2) of Section (5) Special Tasks .

5. Statement of Work:

STATEMENT OF WORK (SOW)

1. Scope

The scale of work involved requires a representative the contractor to bring in the ESWL machine. This is accomplished each time the procedures are performed. This procedure will be provided in the MGVAMC Operating Room (OR).

2. Specific Tasks

The specific work that will be accomplished in the performance of the ESWL procedure for kidney stones. The following steps would be included in this contract:

Patients are seen in the Urology clinic and scheduled for the ESWL procedure.

Requests sent to the surgery scheduler for time in the Main Operating Room

OR Manager will stack cases for certain OR days, (example 3-5 patient per day), twice a month.

Contractor representative is contacted to alert him/her regarding upcoming cases. Machine is brought in day of surgery.

Set fee is established for per person (unilateral/bilateral) procedures.

Contractor will have 48-hour turn-around time for facilities in the Inland and Pacific Northwest region for surgical patients requiring ESWL.

3. Performance Monitoring (if applicable)

Contractor is required to provide OR Nurse Manager with accreditation and credentialling for use of the ESWL machine. This documentation will be kept on file in the manager s office. On the day(s) of surgical cases, the ESWL machine will be inspected and cleared for use by the Bio-Med staff prior to its use in the main Operating Room. This inspection will take place every separate time it is to be used.

4. Security Requirements

Per attachment 6500.

5. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI)

N/A

6. Other Pertinent Information or Special Considerations

N/A

7. Place of Performance.

This procedure will be performed in the Main Operating Room at MGVAMC only.

8. Period of Performance.

Base plus two-year option from time of award.

9. Delivery Schedule.

SOW Task#

Deliverable Title

Format

Number

Calendar Days After CO Start

1

Technician Certificates

Contractor determined service report, but must meet required credentialing

1 hard copy, 1 emailed copy

Provided on Date of Service

2

Invoice for work

Contractor determined format.

1 hard copy or 1 emailed copy

Within 30 days of completion of work.

10. Salient Characteristics:

For Urology Service

The dimensions/characteristics for this system are as follows:

Minimum penetration depth of 170 mm

Minimum focal depth of 175 mm

Integrated C-ARM with a -30 to 30 degree rotation range

15 kW X-Ray Generator

Electro Magnetic Shockwave Emitter coil up to 180 mm

An image intensifier 9-10 screen

Patient exam table with weight capacity of 400-500 lbs

Transportable

Capacity to store 400,000-500,000 images

The equipment also shall have the following features:

Customized Surgical Pack to fit existing surgical handpieces.

Intrepid Hybrid Tip

Alcon OVD s contain chondroitin sulfate, allowing slower viscosity loss during stress and improved endothelial cell protection

Intrepid Transformer I/A handpiece specific.

The above features are necessary to meet Joint Commission requirements in terms of patient safety and optimum performance.

6. Pricing Schedule

Item #

Unit

Description

Estimated Quantity

Unit

Unit Price

Total Amount

Base

0001

Lithotripsy Treatment

Regular Treatment

70

EA

Base 0002

Lithotripsy Treatment

Bilateral or Dual Treatment

5

EA

OY1 1001

Lithotripsy Treatment

Regular Treatment

74

EA

OY1 1002

Lithotripsy Treatment

Bilateral or Dual Treatment

6

EA

OY2 2001

Lithotripsy Treatment

Regular Treatment

78

EA

OY3 2002

Lithotripsy Treatment

Bilateral or Dual Treatment

7

EA

Grand Total

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

http://www.va.gov/oal/library/vaar/index.asp

The following solicitation provisions apply to this acquisition:

7. FAR 52.212-1, Instructions to Offerors Commercial Items , applies to this acquisition and the following clauses and instructions are added as addenda:

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL

52.252-1

Solicitation Provisions Incorporated by Reference (FEB 1998)

52.204-7

System for Award Management (OCT 2018)

52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

52.214-21

Descriptive Literature

(a) Gray market items are Original Equipment Manufacturers (OEM Ellex, Inc.) 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 contactors, 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)

8. FAR 52.212-2, Evaluation-Commercial Items , applies to this acquisition. The government intends to make a best value determination based on, but not limited to, the following evaluation factors when evaluating offers:

(a) Technical Compliance:

Quoted commodities and services/supplies shall be in accordance with the Statement of Work above.

(b) Price:

Price - The offeror shall complete the Pricing Schedule provided in Part (6) of Section (5) above.

(c) Proof of Meeting the Special Tasks and Salient Characteristics per the SOW:

The offeror shall provide either a statement or a brief synopsis of the process outlining how they intend to meet the standards provided in both Part (2) of Section (5) Special Tasks and in Part (10) of Section (5) Salient Characteristics order to be considered for award.

9. Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov.

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.

The following contract clauses apply to this acquisition:

10. FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018)

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

52.203-17

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

52.204-4

Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011)

52.204-13

System for Award Management Maintenance (OCT 2018)

52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

52.217-8

Option to Extend Services (NOV 1999)

52.217-9

Option to Extend the Term of the Contract (MAR 2000)

52.222-19

Child Labor Cooperation with Authorities and Remedies (JUL 2020)

52.232-40

Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020). The following clauses are incorporated by this clause:

852.203-70

Commercial Advertising

852.212-71

Gray Market Items (APR 2020)

852.232-72

Electronic Submission of Payment Requests.

852.242-71

Administrative Contracting Officer (OCT 2020)

11. The following subparagraphs of FAR 52.212-5 are applicable:

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

52.203-6

Restrictions on Subcontractor Sales to the Government (JUN 2020)

52.204-10

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

52.204-14

Service Contract Reporting Requirements (OCT 2016)

52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020) (31 U.S.C. 6101 note)

52.219-8

Utilization of Small Business Concerns (OCT 2018)

52.219-28

Post Award Small Business Program Representation (MAY 2020) (15 U.S.C 632(a)(2))

52.219-33

Nonmanufacturer Rule (MAR 2020)

52.222-3

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

52.222-19

Child Labor Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126)

52.222-21

Prohibition of Segregated Facilities (APR 2015)

52.222-26

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

52.222-35

Equal Opportunity for Veterans (JUN 2020)

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)

52.222-40

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

52.222-50

Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627)

52.222-54

Employment Eligibility Verification (OCT 2015)

52.223-18

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

52.225-13

Restrictions on Certain Foreign Purchases (JUN 2008) (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)

52.222-41

Service Contract Labor Standards (AUG 2018)

52.222-55

Minimum Wages Under Executive Order 13658 (NOV 2020)

52.222-62

Paid Sick Leave Under Executive Order 13706 (JAN 2017)

12. There are no additional contract requirements, terms or conditions.

13. The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.

14. Quotes must be emailed to dane.gift@va.gov and received no later than 17:00 PM EST on 09/22/2022. Quotes may be submitted on this document or the vendor s own form.

No late quotations will be accepted. The Government intends to make award without discussions.

15. For information regarding the solicitation, please contact Dane Gift at Dane.Gift@va.gov.

DEPARTMENT OF VETERANS AFFAIRS