6515--36C249-22-AP-3803 - ENT Navigation System

This amendment corrects an administrative error found related to the solicitation response due date.

The incorrect Response Date/Time/Zone in the General Information section is 09-08-2022 10:00 Central Time, Chicago, USA.

The CORRECT Response Date/Time/Zone in the General Information section of the combined synopsis solicitation post is 09-01-2022 10:00 Central Time, Chicago, USA. This aligns with the RFQ close date given on page 11 of 11 in the solicitation document.

I. This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice and conducted under FAR part 13 procedures. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation document will not be issued.

II. The combined synopsis/solicitation number is 36C24922Q0600. It is issued as a request for quotation (RFQ).

III. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-06, effective 5/26/2022; VA Acquisition Regulation (VAAR) update 2008-32, effective 11/1/2021; and VA Acquisition Policy Flash 22-19, effective 5/19/2022.

IV. The combined synopsis/solicitation is 100% set-aside for Service-Disabled Veteran-Owned Small Businesses (SDVOSB). Offeror must be registered in System for Award Management (SAM) www.SAM.gov and must be VIP-certified in vip.vetbiz.va.gov before considered for award.

The NAICS is 334510 with a small business size standard of 1250 employees for manufacturers. Nonmanufacturing business size standard is 500 employees. A nonmanufacturer class waiver is in effect for the given NAICS and requirement description. The FSC/PSC is 6515.

V. & VI. This combined synopsis solicitation is for the following:

DESCRIPTION OF REQUIREMENT: The Department of Veterans Affair s NCO-9 is seeking the Supplies and/or Services under the Table below:

SUPPLIES/SERVICES TABLE: Brand: Stryker Medical

Item No.

(CLIN)

PRODUCTS

Model Number

Qty

1

HYBRID NAVIGATION UNIT, EM

8000-010-003

1

2

FIELD GENERATOR PLANAR

8000-010-004

1

3

FIELD GENERATOR MOUNTING ARM

8000-010-005

1

4

SCOPIS ENT W TGS

8000-020-002

1

5

MOUSE, WIRED

8000-030-020

1

6

MEDICAL KEYBOARD US/INTL

8000-030-010

1

7

TGS GUIDEWIRE, FINAL PAC

8000-060-009

1

8

PATIENT TRACKER TABS (PU 100)

8000-100-001

1

9

PATIENT TRACKER EM-D MINIÂ

8000-040-001

2

10

REGISTRATION POINTER EM-DÂ

8000-050-003

2

11

PRECISION POINTER EM

8000-050-001

4

12

SUCTION TUBE FRAZIER EMÂ

8000-050-005

4

13

SUCTION TUBE EIKEN EMÂ

8000-050-006

4

14

INSTRUMENT CLAMP ELECTROMAGNETIC SPHERE

8000-060-020

4

15

INSTRUMENT CLAMP ELECTROMAGNETIC UNIVERSAL

8000-060-021

4

SERVICES

16

Installation, Calibration & On-Site Training

OPTION(S)

OPT1

Government seeks to procure one additional quantity each of Line Items 1 through 16 in the next Fiscal Year AT PRICES NO HIGHER THAN THE INITIAL REQUIREMENT.

Intended Use: Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of Eye/Nose/Throat (ENT) surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

Product Specification Sources:

https://ent.stryker.com/medical-devices/navigation

https://ent.stryker.com/physician-resources/instructions-for-use

https://ent.stryker.com/sites/default/files/2022-07/Scopis_ENT_Software_with_TGS_TD8000020701_F_IFU_ML.pdf

SALIENT CHARACTERISTICS:

General: ENT Navigation System with Electromagnetic (EM) Tracking Technology.

Technical Breakdown:

Endoscope integration

1. HD Video Capability

2. Augmented Reality (AR) in Endoscopy Capability

3. Target Guided Surgery (TGS) capability

4. Unit integration into Endoscope tower capability

Imaging Processing capability

1. Image fusion/merge capability

2. Multiple combinable data sets capability

3. Fusible data formats

4. Automatic fusion capability

5. HD documentation capability

Instruments Capabilities

1. Multiple instrument ports

2. Universal adapters

3. Balloon catheter tracking capability

4. EM-sensors in instrument tip

5. Malleable instruments

6. Multiple RME/disposable reusability (sterilization) required with usage tracking capability

Product Software features ENT

1. Tumor segmentation

2. Targets

3. Target Guided Surgery (TGS)

4. Capability to Set multiple targets

5. Tracking sound notification capability

Registration capabilities included

1. Surface

2. Landmarks

3. Enhanced surface

4. Shift correction

5. Accuracy prediction system

Certification/Standards:

Must meet FDA regulated standards as a Class II Stereotaxic Instrument; under FDA Product Code: PGW

Delivery / Installation Schedule:

Items will be delivered and installed in one trip to TVHS, Nashville Campus, ENT clinic during the weekdays of Monday through Friday from 8:00am to 4:00pm.

Offeror shall be responsible to contact and coordinate a proper date and time for delivery and installation with the Government s designated point-of-contact (POC).

Training is expected on-site, same date, after installation is completed.

Project Completion Will be Determined Successful When:

All equipment is installed and is operational during in-service

Vendor Representative has adequately trained to the stakeholder s expectations

Warranty: Free from defects in material and workmanship based on manufacturer s commercial warranty.

Payment Information:

Payment will be administered to vendor upon project completion in one full payment (total cost outlined in the quote) after submission of a proper invoice via Tungsten.

VII. FOB Destination, Delivery and Acceptance will be:

Department of Veterans Affairs

Tennessee Valley Healthcare System (TVHS)

1310 24th Avenue South,

c/o ENT Clinic

Nashville, TN 37212

DELIVERY SCHEDULE & Period of Performance (POP):

Base Contract Period of Performance shall be no later than 22 weeks after receipt of order (ARO).

The period in which the option may be exercised is anytime within the base contract period.

All provisions and clauses applicable to this solicitation can be viewed in full text using the following web addresses:

http://www.acquisition.gov/far/index.html (FAR)

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

VIII. Provision 52.212-1, Instructions to Offerors Commercial Products and Commercial Services (NOV 2021), applies to this acquisition.

Addendum to FAR 52.212-1 Instructions to Offerors Commercial Items:

(c): Period for acceptance of Quote is a minimum of 60 calendar days.

(End of Addendum)

IX. Provision 52.212-2, Evaluation - Commercial Products and Services (NOV 2021), applies to this acquisition.

Addendum to FAR 52.212-2 Evaluation Commercial Items:

(a) Basis for Award. The Government will issue a purchase order to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

(b) The following factors shall be used to evaluate quotations: Technical Specification, Delivery Time, Authorized Distributor/Reseller status, and Price.

(c) 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. Quote is for all quantities or none. No piecemeal allowed.

The evaluation will consider the following:

Technical Specification: 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. Offeror must provide details of extent of service provided.

Delivery Time: Quote should have an estimated delivery time of when items are ready for delivery to the Government. If no delivery time is stated in the quote then it is presumed that the offeror accepts the Government s delivery/period of performance given in previous section VII.

Authorized Distributor/Reseller status: Offeror must provide on the original equipment manufacturer (OEM) letterhead that they are an authorized distributor and/or reseller and that all warranties associated under the OEM pass to the Government for the product/services procured.

Price: The Government will evaluate the price by adding the total of all line item prices, including all options. The Total Evaluated Price will be that sum.

(d) Options - The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement.

(End of Addendum)

X. Provision 52.212-3 Offeror Representations and Certifications Commercial Products and Commercial Services (MAY 2022) 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. Paragraph (j) of the provision is applicable, a written submission is required.

XI. Clause 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (NOV 2021), applies to this acquisition.

XII. Clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders Commercial Products and Commercial Services (MAY 2022), applies to this acquisition including, if any, additional FAR clauses cited in the clause are applicable to the acquisition.

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021)

(4) 52.204 10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109 282) (31 U.S.C. 6101 note).

(8) 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).

(22) (i) 52.219-28, Post Award Small Business Program Representation (SEP 2021) (15 U.S.C. 632(a)(2))

(26) 52.219-33 Nonmanufacturer Rule (SEP 2021) (15 U.S.C. 637(a)(17)).

(27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

(28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2022) (E.O. 13126).

(29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(30)(i) 52.222 26, Equal Opportunity (SEP 2016) (E.O. 11246).

(31)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212)

(35)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

(44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513)

(50) 52.225-5, Trade Agreements [JUL 2020] [DEVIATION ]

(51) 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).

(58) 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) (31 U.S.C. 3332).

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html (FAR)

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

FAR Number

Title

Date

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

52.217-5

EVALUATION OF OPTIONS

JULY 1990

52.217-6Â OPTION FOR INCREASED QUANTITY MAR 1989:

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor anytime within the base contract period. Delivery of the added items shall continue at the same rate as the like items called for under the contract unless the parties otherwise agree.

FAR Number

Title

Date

52.227-19

COMMERCIAL COMPUTER SOFTWARE-RESTRICTED RIGHTS

DEC 2007

52.232-19 AVAILABILITY OF FUNDS FOR NEXT FISCAL YEAR APR 1984

Funds are not presently available for performance under this contract beyond Fiscal Year 2022 (FY22). The Government s obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond FY22, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

FAR Number

Title

Date

52.232-8

DISCOUNTS FOR PROMPT PAYMENT

FEB 2002

(End of Clause)

VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020):

VAAR Number

Title

Date

852.203-70

COMMERCIAL ADVERTISING

MAY 2018

852.211-70 EQUPMENT OPERATION AND MAINTENANCE NOV 2018

MANUALS

The Contractor shall follow standard commercial practices to furnish manual(s), handbook(s) or brochure(s) containing operation, installation, and maintenance instructions, including pictures or illustrations, schematics, and complete repair/test guides, as necessary, for technical medical equipment and devices, and/or other technical and mechanical equipment provided per CLIN(s) 1 through 15. The manuals, handbooks or brochures shall be provided in hard copy, soft copy or with electronic access instructions, consistent with standard industry practices for the equipment or device. Where applicable, the manuals, handbooks or brochures will include electrical data and connection diagrams for all utilities. The documentation shall also contain a complete list of all replaceable parts showing part number, name, and quantity required.

852.211-72 TECHNICAL INDUSTRY STANDARDS NOV 2018

(a) The Contractor shall conform to the standards established by the Food and Drug Administration (FDA) as a Class II Stereotaxic Instrument; under FDA Product Code: PGWas to CLIN 1-15.

(b) The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement. Proof may also be furnished by the organization listed above certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards.

(c) Offerors may obtain the standards cited in this provision by submitting a request, including the solicitation number, title, and number of the publication to: [Organization] FDA s Office of Health Technology 1 within CDRH's Office of Product Evaluation and Quality (OPEQ) at dice@fda.hhs.gov.

(d) The offeror shall contact the Contracting Officer if response is not received within two weeks of the request.

VAAR Number

Title

Date

852.212-71

GRAY MARKET ITEMS

APR 2020

852.219-10

VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE

DEC 2009

852.232-72

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

NOV 2018

852.233-70

PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

SEP 2018

852.233-71

ALTERNATE PROTEST PROCEDURE

SEP 2018

852.246-71

REJECTED GOODS

OCT 2018

852.247-72 MARKING DELIVERABLES OCT 2018

(a) The contract number & IFCAP PO number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract.

(b) Mark deliverables, except reports, for Thelisia Miller, Surgical Services.

852.247-74 ADVANCE NOTICE OF SHIPMENT OCT 2018

The Contractor shall give 5-work days of advance notice prior to shipping item(s)

For items 1-5, the Contractor shall furnish the anticipated shipment date, bill of lading number (if applicable), and carrier identity to Thelisia Miller, Thelisia.miller@va.gov and to the Contracting Officer.

VAAR Number

Title

Date

852.270-1

REPRESENTATIVES OF CONTRACTING OFFICERS

JAN 2008

852.273-70

LATE OFFERS

NOV 2021

852.273-71

ALTERNATIVE NEGOTIATION TECHNIQUES

NOV 2021

852.273-74

AWARD WITHOUT EXCHANGES

NOV 2021

(End of Clause)

VAAR 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.

FAR Number

Title

Date

52.212-3

Offeror Representations and Certifications - Commercial Products and Commercial Services

MAY 2022

(End of Provision)

XIII. Additional Solicitation Terms and Conditions.

This is a Brand Name only solicitation. See attached Brand Name Justification.

Quote must include offer s sam.gov unique entity identifier (UEI).

Quote/Offeror response must include a written statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

XIV. Intentionally Left Blank.

XV. This RFQ closes Thursday, September 1, 2022, 10:00am, Central Time (CT). Submit all quotes and applicable attachments by e-mail to sascha.hertslet@va.gov with subject line 36C24922Q0600-ENT_SurgicalNavigationSystem.

Final Offer package will be put into one .pdf-formatted attachment and emailed to the person listed in paragraph XVI. Multiple emails will not be accepted.

Our email server has a size limitation of 30 GB. Zip files will be removed and therefore, will not be considered.

Email attachment must be in .pdf format and in the English language. Font type & size must be appropriate for easy and quick viewing, 10 point or greater. Only acceptable font types are Calibri, Times New Roman, Courier, or Arial. Documents must only be 8 ½ x 10 inches in size, with one-inch margins all around.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

XVI. Phone calls and fax will not be accepted, all questions or concerns must be submitted in writing via email to sascha.hertslet@va.gov, with subject line Questions- RFQ 36C24922Q0600 no later than two business days before the close of the solicitation.

The Government reserves the right to make no award at all.