36C24922Q0600-CombinedSynopsis_Solicitation-ENT_Navigation-final.pdf

SUBJECT* 36C249-22-AP-3803 - ENT Surgical Navigation System -

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 37129

SOLICITATION NUMBER* 36C24922Q0600

RESPONSE DATE/TIME/ZONE 09-08-2022 10:00 CENTRAL TIME, CHICAGO, USA

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSBC

PRODUCT SERVICE CODE* 6515

NAICS CODE* 334510

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

POINT OF CONTACT* Contract Specialist Sascha Hertslet sascha.hertslet@va.gov 615-225-6664

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) c/o ENT Clinic 1310 24th Avenue South Nashville TN

POSTAL CODE 37212

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

36C24922Q0600 Page 1 of 11

DESCRIPTION

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

36C24922Q0600 Page 2 of 11

9 PATIENT TRACKER EM-D MINI 8000-040-001 2

10 REGISTRATION POINTER EM-D 8000-050-003 2

11 PRECISION POINTER EM 8000-050-001 4

12 SUCTION TUBE FRAZIER EM 8000-050-005 4

13 SUCTION TUBE EIKEN EM 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 In the next Fiscal Year, Government seeks to procure additional quantity of Line Items

1 through 16 that equals the base quantity given AT PRICES NO HIGHER THAN THE

INITIAL BASE 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:

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

B. Technical Breakdown:

a) 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

b) Imaging Processing capability

1. Image fusion/merge capability

2. Multiple combinable data sets capability

36C24922Q0600 Page 3 of 11 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 https://ent.stryker.com/sites/default/files/2022-07/Scopis_ENT_Software_with_TGS_TD8000020701_F_IFU_ML.pdf

3. Fusible data formats

4. Automatic fusion capability

5. HD documentation capability

c) 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

d) 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

e) Registration capabilities – included

1. Surface

2. Landmarks

3. Enhanced surface

4. Shift correction

5. Accuracy prediction system

f) Certification/Standards:

1. 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:

1. All equipment is installed and is operational during in-service

2. 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.

36C24922Q0600 Page 4 of 11

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

36C24922Q0600 Page 5 of 11

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:

(1) 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.

(2) 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.

(3) 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.

(4) 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).

36C24922Q0600 Page 6 of 11 https://www.sam.gov/portal https://www.acquisition.gov/far/part-52#FAR_52_203_6

• (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

36C24922Q0600 Page 7 of 11 file:///C:/Users/VHACIN~2/AppData/Local/Temp/1/MicrosoftEdgeDownloads/545bdcce-061a-45d3-936e-fbaf27eb5ad8/deviationFar-20200817.PDF

52.204-18

COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.217-5 EVALUATION OF OPTIONS JULY 1990

52.217-6 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, 36C24922Q0600 Page 8 of 11 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

36C24922Q0600 Page 9 of 11 https://www.fda.gov/about-fda/cdrh-offices/office-product-evaluation-and-quality https://www.fda.gov/about-fda/cdrh-offices/office-product-evaluation-and-quality mailto:dice@fda.hhs.gov

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).

36C24922Q0600 Page 10 of 11 mailto:Thelisia.miller@va.gov

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.

36C24922Q0600 Page 11 of 11 mailto:sascha.hertslet@va.gov mailto:sascha.hertslet@va.gov