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Stryker Power Tools for OR


Iowa, United States
Government : Federal
RFQ
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Solicitation Number: 36C26318Q9816

1a. DESCRIPTION OF SOLICITATION
In accordance with FAR Part 13 this a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

This Solicitation issued as a Request for Quotation (RFQ) for the following Commercial Items:

Power Tools for Operating Room, Brand-Name Only, Set-Aside 100% for SDVOSB

Responses shall be on an all or none basis, no partial submission. The Government reserves the right to make no award at all.

Respond by: Please see INSTRUCTIONS TO OFFERORS below.

Small Business Set-Aside:
This solicitation is Set-aside 100% for Service Disabled Veteran Owned Small Business. Quotations from other Small Businesses and Large Business offerors will be considered non-responsive, will not be evaluated and will not be eligible for award.

Brand-Name Only solicitation:
This is a Brand-Name Only solicitation.

NAICS code/Size Standard/PSC or FSC:
NAICS code (North American Industrial Classification system: 339112
Size Standard for this NAICS code: 1000 employees
PSC/FSC (Product Service Code/Federal Supply Code): 6515

Type of Contract/Award:
The type of contract/award the government intends to make/enter into for this solicitation is a single award, firm-fixed price purchase order.

Delivery: FOB Destination, 30 Calendar Days or Less ARO. See Delivery below.

Contract Period: Delivery Date of 30 Calendar Days or Less ARO.

Method of Payment:
Payment will be made electronically to:

Department of Veterans Affairs FMS-VA-2(101), Financial Services Center, PO Box 149971, Austin
TX 78714-9971 through the Tungsten Network Client Services. For help call: 1-866-340-4980, E-mail: va.registration@tungsten-network.com.

Provisions and Clauses:
All provisions and clauses applicable to this solicitation can be viewed in full text using the following web addresses: https://www.acquisition.gov/browsefar -or- https://www.va.gov/oal/library/vaar/
1b. DESCRIPTION OF SUPPLIES/SERVICES being solicited:
Description & Salient Characteristics: Stryker Malis Bipolar Generator and irrigator system provides a method to use electrical current through the device, which cuts through tissue and/or seals bleeding vessels. Surgeons often combine this type of surgical instrument simultaneously with some type of fluid irrigation that to controls the amount of tissue damage occurring during surgery. Compared to other cauterization methods, bipolar cautery allows surgeons to accurately and delicately move and remove diseased areas without causing extensive damage to adjacent or deeper tissue. By immediately searing affected blood vessels, surgeons usually spend less time performing the procedure, and patients generally experience tissue damage and blood loss.
The system must meet the following characteristics:
Offer both cut and coagulation settings
Smart console that as tissue resistance increases, the generator dramatically decreases electrical output
Irrigation capable
Oversized color touchscreen that provides easy recognition of settings and easy adjustment of settings
Has quick knobs that allow for rapid adjustment of settings
Allows user to set up surgeon specific profiles for quick recovery of preferred setting
Have Aperiodic Waveform technology that helps eliminate popping during electrosurgery. This reduces charring and unwanted collateral damage to surrounding tissue
Waveform minimizes risk of undesired cutting while in COAG mode as well as undesired sparking at the tips
Have one attachable foot pedal that has two separate controls, one section for output that delivers cutting power and one section that delivers coagulation power
Audible signal when coagulation or cut mode in activated
Small footprint that can fit on surgical boom approximate sizes of 8 height, 13 wide, 16 deep but portable enough to move from OR to OR
Foot pedal cord length of at least 15 feet
Ability to be cleaned by a hospital disinfectant
Meets or exceeds ANSI/AAMI ES 60601-1 2006, CAN/CSA-C22.2 No. 60 1-1-08 Medical electrical equipment general requirement for safety and essential performance
Provides high priority alarms and error messages
Stryker Core Console 2.0 supplies power to a variety of small and large bone drills, saw, drivers and bone mills. It is an upgrade from our current Core system that is 4-7 years old. It is a power system that is used daily during orthopedic, neurosurgical and podiatric procedures. It is our desire to have compatible equipment as Stryker power is what all our surgical power is currently.
The power system must meet the following characteristics:
Must be capable to power Stryker micro electric powered handpieces including wire drivers, sagittal saws, oscillating saw, reciprocating saw, and high speed microdrill
Must be able to operate two handpieces simultaneously
Console must detect power device when attached to console and display options and setting appropriate for that device
Have a touch screen that provides visual output
Ability to store user presets and surgeon preferences
Supports irrigation use, ability to adjust irrigation flow reate
Ability to rotate in a forward or reverse direction
Foot pedal with various pressure on the pedal will cause the motor speed to vary or be set at a constant speed as set on the home screen
Able to provide colored illumination to match drills with foot pedals
Software can adjust torque, tactile feel and drill precision and performance
Provides audio output that distinguishes actuation, motor rotating in reverse and error messages
Small footprint that can fit on surgical boom approximate sizes of 5 height, 13 wide, 16.5 deep but portable enough to move from OR to OR. Weight under 20 lbs
Ability to be cleaned by a hospital disinfectant
Meets or exceeds ANSI/AAMI ES 60601-1:14 2005/B. 2012, Medical electrical equipment part 1 general requirement for basic safety and essential performance

Required Individual Line Items & Quantity of Items
Stryker Malis Bipolar Generator Model 6700-313-500 2 each
Stryker Core Console 2.0 Model 5400-052-000 7 each

(1 each) Maintenance Manuals (CD, PDF or Word)
(1 each) User Manuals
(1 each) Cleaning Instructions for all equipment, supplies and accessories
1.c MANUALS, CARE/CLEANING INSTRUCTIONS:
Appropriate user manuals, service manuals, and instructions for cleaning/sterilization.

1.d DELIVERY Needed:
Delivery Terms: 30 Calendar Days or Less ARO, FOB Destination.
Deliver to: Department of Veteran Affairs
Iowa City VA Health Care System, Warehouse
601 Highway 6 West
Iowa City, IA 52246

2. INSTRUCTIONS TO OFFERORS
The Provision FAR 52.212-1, Instructions to Offerors Commercial Items (Jan 2017) applies to this acquisition.

Addendum to 52.212-1 Instructions to Offerors Commercial Items:

Respond by:
Offerors are to email complete offers to Harry.gramboiii@va.gov
Offers must be received no later than 02:30pm CST Friday August 31, 2018.
Please include in the subject line: Solicitation 36C26318Q9816, Laryngoscopes

Letter of Authorization to Distribute for the Original Equipment Manufacturer:
In accordance with the Original Equipment/No Gray Market Goods language under TERMS & CONDITIONS stated below, a letter of Authorization to Distribute shall be included with the offer and received before the closing time and date of this solicitation.

(End of Provision 52.212-1)

3. EVALUATION OF OFFERS
The Provision FAR 52.212-2, Evaluation Commercial Items (Oct 2014) applies to this acquisition and the following two lines are to be used and inserted into paragraph (a) of the that provision:

(i) LPTA The basis for award will be Lowest Price Technically Acceptable - evaluated on technical capability of the item offered to meet the Government requirement. The government will award a contract resulting from this solicitation to the responsible offeror who offers the Lowest Price Technically Acceptable quote. The government shall evaluate the lowest quote first and if found technically acceptable will not evaluate other quotes.

(ii) Past performance IAW 9.104-3(b). The government will consider past performance
when making a contractor responsibility determination IAW 9.104-3(b).

(End of Provision 52.212-2)
4. OFFEROR REPRESENTATION AND CERTIFICATIONS

The Provision 52.212-3, Offeror Representation and Certifications Commercial Items applies to this acquisition. The offeror is required to include a completed copy of this provision with their offer if indicated as instructed by the language of the provision.

(End of Provision 52.212-3)

5. TERMS & CONDITIONS
The Clause 52.212-4, Contract Terms and Conditions Commercial Items (Jan 2017), applies to this acquisition.

Addendum to FAR 52.212-4, Contract Terms and Conditions - Commercial Items (Jan 2017):

52.252-2 Clauses Incorporated by Reference (FEB 1998)
52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)
852.203-70 Commercial advertising (Jan 2008)
852.232-72 Electronic submission of payment requests (NOV 2012).
Addendum to FAR 52.212-4 Contract Terms and Conditions Commercial Items (Jan 2017) continued:

Original Equipment/No Gray Market Goods

(a) 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 remanufactured, used, expired, outdated (old edition or old model) or gray market items will be acceptable. Gray market items are Original Equipment Manufacturer (OEM) goods sold through unauthorized channels in direct competition with authorized distributors.

(b) Offeror shall be a distributor that is authorized directly by the manufacturer (OEM) of the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter from the manufacturer. The OEM s warranty and service shall be provided and maintained by the OEM and pass through to the VA. 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 and shall pass through to the VA.

(c) The delivery of remanufactured, used, expired, outdated (old edition or old model) or gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to 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.

(End of addendum to 52.212-4)

(Endo of Clause 52.212-4)

6. CONTRACT TERMS & CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS

The Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items applies to this acquisition. The FAR clauses listed below are the clauses chosen from paragraph (b) of this provision that apply to this acquisition and are incorporated by reference:
52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).
52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013)
52.222 19, Child Labor Cooperation with Authorities and Remedies (OCT 2016) (E.O. 13126).
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 (JUL 2014) (29 U.S.C. 793).
52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627).
52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)
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 2013)
(31 U.S.C. 3332).
52.232-40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)
(End Clause 52.212-5)
852.219-10 VA Notice of Total Service Disabled Veteran-Owned Small Business Set-Aside.
** end solicitation**

Harry R Grambo III
Contract Specialist
319-688-3614

harry.gramboIII@va.gov

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