36C10G24R0012.docx

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6515--Orthopedic Surgical Robotic Systems (VA-23-00059232)
Solicitation number
36C10G24R0012
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This document is a Combined Synopsis/Solicitation for a federal contract opportunity to provide Orthopedic Surgical Robotic Systems to the Department of Veterans Affairs (VA). The VA seeks to award a single Requirements contract for these products, which are used for minimally invasive partial knee, total knee, and total hip replacement procedures. The contract will have a 12-month base period and four 12-month option periods. The VA is looking for vendors that can provide products meeting specified salient characteristics, such as FDA approval, the ability to pre-plan procedures, and constraining robotic cutting tools. Offers are due by June 21, 2024 and the Government reserves the right to award without discussions. The contract will be awarded under NAICS code 339113 with a size standard of 800 employees.

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Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

SUBJECT*
Orthopedic Surgical Robotic Systems (VA-23-00059232)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
22408-2697
SOLICITATION NUMBER*
36C10G24R0012
RESPONSE DATE/TIME/ZONE
06-21-2024 12:00 EASTERN TIME, NEW YORK, USA
ARCHIVE
90 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N

SET-ASIDE

PRODUCT SERVICE CODE*
6515
NAICS CODE*
339113
CONTRACTING OFFICE ADDRESS
U.S. Department of Veterans Affairs

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Michael Andrews michael.andrews6@va.gov 678-428-5319

PLACE OF PERFORMANCE

ADDRESS
USA and all of its territories

POSTAL CODE

COUNTRY
United States

ADDITIONAL INFORMATION

AGENCY’S URL
https://www.va.gov/opal/sac/index.asp
URL DESCRIPTION
VA | OALC | OPAL | SAC
AGENCY CONTACT’S EMAIL ADDRESS
michael.andrews6@va.gov
EMAIL DESCRIPTION
michael.andrews6@va.gov

DESCRIPTION

Number:

36C10G24R0012 Notice Type:

Combined Synopsis/Solicitation Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial products prepared in accordance with (IAW) the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This notice constitutes the only solicitation, offers are being requested.

Solicitation number 36C10G24R0012 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2024-03, dated 23 February 2024.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable Equipment (NX) National Program has identified the Orthopedic Surgical Robotic Systems product line as a candidate for inclusion in the National Equipment Catalog (NEC). This will be accomplished via the awarding of a single award Requirements contract.

Orthopedic Surgical Robotic Systems were developed to facilitate minimally invasive surgery to ultimately help surgeons perform procedures more consistently and accurately than with manual techniques. The first robot intended for orthopedic surgery was developed in the early 1990's to aid hip replacements. Current orthopedic surgical robots are used for knee and/or hip replacements.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Offers shall contain the terms for cost/price and technical capabilities of the equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 – Surgical and Medical Instrument Manufacturing, Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies. and the associated size standard is 800 employees. This procurement action is issued as full and open unrestricted competition.

This acquisition is for a single award Requirements contract in accordance with FAR Subpart 16.5 for NX EQ ORTHOPEDIC SURGICAL ROBOTIC SYSTEMS. All interested companies shall provide an offer for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A – PRICE COST SCHEDULE - NX EQ ORTHOPEDIC SURGICAL ROBOTIC SYSTEMS.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda also applies to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Products and Commercial Services, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting an offer. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 12:00 PM ET on May 29, 2024 to Contract Specialist, Michael Andrews at michael.andrews6@va.gov and Contracting Officer, Kristal Hall at kristal.hall@va.gov. No calls will be accepted.

Offers are due via email by 12:00PM ET on June 21, 2024 to Contract Specialist, Michael Andrews at michael.andrews6@va.gov and Contracting Officer, Kristal Hall at kristal.hall@va.gov.

1. BACKGROUND:

The VHA Non-Expendable Equipment National Program has identified the Orthopedic Surgical Robotic Systems product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirement contract award.

Orthopedic Surgical Robotic Systems were developed to facilitate minimally invasive surgery to ultimately help surgeons perform procedures more consistently and accurately than with manual techniques. The first robot intended for orthopedic surgery was developed in the early 1990's to aid hip replacements. Current orthopedic surgical robots are used for knee and/or hip replacements.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Orthopedic Surgical Robotic Systems to be used by clinicians throughout the Department of Veterans Affairs (VA) medical centers and facilities.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal, which requires the offeror indicate that each product being offered as an “equal” product to the Stryker® Mako Orthopedic Surgical Robotic Systems. For each equal product, the offeror must include a description reflecting the salient characteristics (SCs) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

The following line items comprise the Orthopedic Surgical Robotic Systems product line:

Table 1. Product Description and Estimated Quantities

CONTRACT LINE ITEMS
DESCRIPTION
ESTIMATED QUANTITIES

BASE YEAR

ESTIMATED QUANTITIES

YEAR 1

ESTIMATED QUANTITIES

YEAR 2

ESTIMATED QUANTITIES

YEAR 3

ESTIMATED QUANTITIES

YEAR 4

0001
Mako Robotic Arm System (3 APP) Kitted Part Number (Includes: Stryker Robotic Arm System (Part #220000); Mako Partial Knee Application (Part #211845); Mako Total hip Application (Part #211846); Mako Total Knee Application (Part #212183); Mako Service (1-Year Standard Warranty)
3
4
4
6
6
0002
Mako Robotic Arm System (2 APP) Kitted Part Number (Includes: Stryker Robotic Arm System (Part #220000); Select Combination of Two Applications -- Mako Partial Knee Application (Part #211845), Mako Total hip Application (Part #211846), Mako Total Knee Application (Part #212183); Mako Service (1-Year Standard Warranty)
2
2
2
2
2
0003
Mako Robotic Arm System (2 APP) Kitted Part Number (Includes: Stryker Robotic Arm System (Part #220000); Select Combination of Two Applications -- Mako Partial Knee Application (Part #211845), Mako Total hip Application (Part #211846), Mako Total Knee Application (Part #212183); Mako Service (1-Year Standard Warranty)
2
2
2
2
2
0004
Mako Annual Service Agreement 3 APP
2
3
3
3
3
0005
Mako Annual Service Agreement 2 APP
2
3
3
3
3
0006
Mako Annual Service Agreement 1 APP
2
3
3
3
3

The Department of VA is seeking vendors who can provide Orthopedic Surgical Robotic Systems identified above which meet all the following SCs. Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs.

The following SCs apply to CLIN’s 0001-0006 Table 2. Salient Characteristics

SC #
SALIENT CHARACTERISTICS
METHOD OF EVALUATION
SC – LITERATURE MAP
DOCUMENT TITLE
PAGE #
SC 1
Perform robotic partial knee replacement procedures
Literature Review
SC 2
Perform robotic total knee replacement procedures
Literature Review
SC 3
Perform robotic total hip replacement procedures
Literature Review
SC 4
FDA approved for indicated robotic procedures
Literature Review
SC 5
Provide the surgeon with the ability to pre-plan the procedure within defined cutting boundaries and surface
Literature Review
SC 6
Provide the surgeon with the ability to constrain the movement of the robotic cutting tool to minimize bone and tissue damage
Literature Review
SC 7
Product must have at least a one (1) year written warranty
Literature Review

Products offered in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may offer any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero. The following SC applies to Ancillary Products:

SC #
SALIENT CHARACTERISTICS
METHOD OF EVALUATION
SC – LITERATURE MAP
DOCUMENT TITLE
PAGE #
SC 8
Ancillary product(s) compatible with CLIN 0001, 0002, or 0003
Literature Review

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ ORTHOPEDIC SURGICAL ROBOTIC SYSTEMS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ ORTHOPEDIC SURGICAL ROBOTIC SYSTEMS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ ORTHOPEDIC SURGICAL ROBOTIC SYSTEMS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ ORTHOPEDIC SURGICAL ROBOTIC SYSTEMS.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ ORTHOPEDIC SURGICAL ROBOTIC SYSTEMS.

See attached document: ATTACHMENT F – PAST PERFORMANCE QUESTIONNAIRE

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - BNOE - NX EQ ORTHOPEDIC SURGICAL ROBOTICS SYSTEMS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - BNOE - NX EQ ORTHOPEDIC SURGICAL ROBOTICS SYSTEMS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - ORTHOPEDIC SURGICAL ROBOTICS SYSTEMS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - BNOE - NX EQ ORTHOPEDIC SURGICAL ROBOTICS SYSTEMS.

See attached document: ATTACHMENT E - REPORTING TOOL - BNOE - NX EQ ORTHOPEDIC SURGICAL ROBOTICS SYSTEMS.

See attached document: ATTACHMENT F - PAST PERFORMANCE QUESTIONNAIRE.

*= Required Field
Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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