Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF OCTOBER 18, 2020 SAM #6898
SOLICITATION NOTICE

65 -- Kinevo 900 surgical Microscope

Notice Date

10/16/2020 8:54:15 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
 

ZIP Code

76006
 

Solicitation Number

36C25721Q0031
 

Response Due

10/26/2020 9:00:00 AM
 

Archive Date

11/25/2020
 

Point of Contact

Danise Burt, Contract Specialist, Phone: 972-708-0809
 

E-Mail Address

DANISED.BURT@va.gov
(DANISED.BURT@va.gov)
 

Small Business Set-Aside

SDVOSBC Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)
 

Awardee

null
 

Description

This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 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.  Solicitation number 36C25721Q0031 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular. SET-ASIDE:  This requirement is a Service Disable Veteran Owned Small Business and Veteran Owned Small Business Set-Aside, the NAICS is 339113 and the small business size standard is 750 Employees. In order to be eligible an offeror must be small for the applicable NAICS code at the time of the quote submission and at the time of award. Only qualified offerors may submit bids. Introduction:  A Firm Fixed Price award will be made to the lowest priced quote which conforms to the requirements within this solicitation and represents the best price to the Government. Description of Services:  The Contractor shall provide all personnel, supervision, transportation, equipment as outlined in the Statement of Work. See the Statement of Work for full details. Place of Performance: Department of Veterans Affairs Medical, North Dallas VA Healthcare System, 4500 S Lancaster Road, Dallas TX 75216 Type of Contract: A Firm Fixed Price Statement of Work The system must offer four intraoperative fluorescence options as well as fluorescence-based video angiography. It is important that the system provide blood flow assessment and it be integrated into the host system not an adjunct to the system. QEVO2 (Integrated Micro-Inspection Tool). The system must include a stand integrated Micro-Inspection Tool for endogenous visualization of tissue out of the line of sight of the microscope. The integrated Micro-Inspection Tool must simultaneously provide a straight look and a 90° view without changing optics. The integrated Micro-Inspection Tool must feature a HD resolution. The integrated Micro-Inspection Tool must not require additional footprint in the OR. The Central Computing Unit, Recorder, User Interface and Monitor of the integrated Micro-Inspection Tool must be integrated into the system. The recording system must be able to capture the microscopic and integrated Micro-Inspection Tool view into a single stream. The integrated Micro-Inspection Tool must be fully autoclavable and machine washable. The integrated Micro-Inspection Tool must use an angled design to ensure a free line of sight through the microscope on the situs. The integrated Micro-Inspection Tool must use a working distance between 5 mm and 30 mm for Neuro and Spine applications without the need to refocus. Items: KINEVO 900 Premium package for use in Surgical Service. 1 each EYEPIECE 10X, 2 PCS. - KINEVO 900 SYSTEM 1 each BLUE 400 MODULE - KINEVO 900 SYSTEM 1 each Source Considerations: -Power source: Voltage requirements: single, 110V/60Hz, Biomedical Tech Considerations: -Operator Training requirements- Staff trained by local support -Consumable/Spare/Repair parts inventory considerations- Kinevo Smartdrape required. Certifications: Attached 510K certificate: DEVICE: QEVO System with KINEVO 900 Carl Zeiss Meditec AG 510(k) NO: K170667(Traditional) 510(k) SUMMARY AVAILABLE FROM FDA movement modes using his handgrip and FCP. This is again workflow and technology to maximize outcomes Leica can NOT offer the desired capability that includes a stand integrated Micro-Inspection Tool for endogenous visualization of tissue out of the line of sight of the microscope. The integrated Micro-Inspection Tool must simultaneously   Must have a light source that is able to be as low as 300 watts Navigation included: The system should provide fast and easy connection to all leading navigation systems without external components and irritating wiring. The system should provide binocular, color injection and superimposition of navigation data. The system should be able to track for viewing every point in the working and tilting range of the OPMI. The system must have laser-guided, high-speed auto focus system that delivers precise navigation by focusing to a fraction of a millimeter and precisely identifying the displayed point. The system has ability to function as surgical microscope, but also Exoscope (ie be able to use system without looking thru binoculars) Support in case of an emergency: The system is covered by a 24/7 service and are supported by a help-desk database as well as a remote service function. Magnification System: The system must have a motorized zoom, apochromatic, 1:6 ratio The system must have a magnification displayed on touch screen and in the ocular The system must have user specific start position Focusing System: The system must have motorized focus varioskop with working distance 200 -625mm Autofocus with 2 visible laser dots It must have an internal, motorized, continuous adjustment The system must have a magnification linked adjustment of focus speed The high-speed laser autofocus, must be accurate to +/- 0.5 mm (Class II Laser) The system must have a visual focusing aid with two converging laser spots The system must have a working distance displayed on touch screen and in the ocular (on demand) The system must have a user specific start position Multi Vision System Integrated data display with shutter function SVGA 800 x 600, color, 50-60 Hz, or better Color, binocular, injection and superimposition of contours and data Supported external data signals Computer data (VGA Signal) i.e. data from navigation systems Y/C video data (NTSC) i.e. data from endoscopy systems Superimposition of system information (focus, zoom, light) Injection of the touch screen user interface into the eyepiece for sterile control of the system Tubes and Co-Observation Main tube: 0-180° rotatable & foldable with 2x mag available with the turn of a knob on the binocular Eyepieces 10x/21B, 12.5x/18B Integrated beam splitter for lateral and face-to-face co-observation Stereo co-observation tube* remains fixed when tilting Spine adapter for symmetric face-to-face configurations Integrated rotary tube adapters Automatic Balancing The system must be able to auto balance the microscope, suspension system or entire system by pushing a button or using an attachment for handsfree movement/balancing The microscope auto balance is independent of position or accessories Draping The system must have an integrated vacuum system to remove air from sterile drape for fast and easy draping One touch auto drape Integrated Digital Video 2 ea integrated attached HD monitors on integrated swivel arms Video camera operates in HD 1080p HD Video output on touch screen Digital video outputs: Fire wire/DV and Progressive Scan (VGA) or better Analog video outputs: FBAS (BNC), Y/C, RGB Stereo camera Image capture Image freeze function Image capture as TIFF, JPG, BMP Integrated Image annotation Still image archiving via CD/DVD/USB and optional DICOM interface Digital video recording system HD recording Parallel HC/DVD recording Editing function Video clip archiving Hospital Workflow Integration Must be able to integrate using: LAN interface and modem DICOM data interface Microphone and speaker Dictation, telephone and voice control functions Patient data management allowing archival of image, video and audio data Service file Remote service interface Illumination System The system must have: Superlux 330 light source with two 300 W Xenon daylight character lamps Integrated light source and light guide Integrated two-way illumination brightens shadows Variable spot illumination, minimum diameter 10 mm Semi-automatic lamp exchange Display of remaining lamp life on Touch screen Brightness regulation via handgrips Magnification dependant automatic brightness adjustment Synchronized camera flash system Electrical Data Voltage supply: 115/230 V ± 10% Voltage consumption: 115 V: max. 12A; 230 V: max 6A Frequency: 50-60 Hz Line protection: automatic circuit breaker Standards Compliance The system must be compliant with: IEC 60601-1 IN 60601-1, protection class I, type B UL 60601-1 CSA C 22.2 No. 601.1 93/42/EWG, class I system Florescence option: class 11a Training Requirements The purchase of this product includes in-house training of staff RNs, PAs, and surgical technologists by an applications specialist (certified technologist) from the manufacturer. The following clauses and provisions apply to this solicitation: 52.209-5, Certification Regarding Responsibility Matters 52.212-3, Offeror Representations and Certifications-Commercial Items 52.212-4, Contract Terms and Conditions-Commercial Items 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items 52.217-8, Option to Extend Services The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days. Evaluations of Options (July 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation.  Evaluation of options under FAR 52.217-8 will be accomplished by using the prices offered for the last option period to determine the price for a 6-month option period, which will be added to the base and other option years to arrive at the total price.  Evaluation of options will not obligate the Government to exercise the option(s). (End of Clause) 52.217-9, Option to Extend the Term of the Contract a) The Government may extend the term of this contract by written notice to the Contractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 (five) years. The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days. 52.203-17 Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Right 52.203-99 Prohibition of Contracting with Entities That Require Certain Internal Confidentiality Agreements 52.219-14, Limitations on Subcontracting 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C. 637(d)(2) and (3). 52.222-3, Convict Labor 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving 52.228-5 Insurance-Work on a Government Installation (JAN 1997) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management 52.237-3 Continuity of Services (JAN 1991) 52.232-39, Unenforceability of Unauthorized Obligations (In the FAR https://www.acquisition.gov/far/html/52_232.html#wp1160005) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) 52.233-3, Protest after Award (In the FAR https://www.acquisition.gov/far/html/52_233_240.html) 852.203-70, Commercial Advertising (JAN 2008) 852.232-72, Electronic Submission of Payment Requests 852.237-70, Contractor Responsibilities 52.252-1, Solicitation Provisions Incorporated by Reference: This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es). 52.252-2, Clauses Incorporated by Reference: 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). Full text can be obtained at http://www.acquisition.gov/far/index.html 852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (JUL 2018) LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (a) This solicitation includes far 52.219-6, Notice of Total Small Business Set-Aside. (b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement. (c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. (d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement. (End of clause) 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE. AS PRESCRIBED IN 819.7203(C) INSERT THE FOLLOWING CLAUSE: SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018) (a) This contract includes FAR 52.219-9, Small Business Subcontracting Plan, and VAAR 852.219-9, VA Small Business Subcontracting Plan Minimum Requirement. (b) Accordingly, any contract resulting from this solicitation will include these clauses, unless the contract is awarded to a small business concern. The Contractor is advised in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing the Contractor's compliance with the plan, including reviewing the Contractor's accomplishments in achieving the subcontracting goals in the plan. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding the Contractor's compliance with this requirement. (c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. (d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting plan. (End of clause) SUBMISSION OF QUOTE (FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS): The Offeror shall submit their quote on company letterhead and shall include unit price, overall total price, name, address, and telephone number of the offeror, firm's DUNS# and ORCA document in SAM at www.sam.gov.  Complete copy of 52.212-3 Offerors Representations and Certifications- Commercial Items, and ORCA document. The offeror shall provide sufficient evidence that they possess adequate resources, capability, experience, responsibility and integrity to meet the technical capabilities to comply with the requirements of the resulting contract. All quotes received without this documentation will not be considered. Quotes must be received no later than Monday, October 26, 2020, 11:00 am CST. Email your quote to danised.burt@va.gov . The subject line must specify 36C25721Q0031. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered. These services are subject to the Service Contract Act and Wage and Determination (WD 15-5227 Rev.-7) which was first posted on www.wdol.gov on 01/01/2019 and can be assessed at https://www.wdol.gov/wdol/scafiles/std/15-5227.txt?v=6. End of Document
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/626a7171988948c39dab822a3c1052ec/view)
 

Place of Performance

Address: Department of Veterans Affairs North Dallas VA Healthcare System 4500 S Lancaster Road, Dallas TX 75216, USA

Zip Code: 75216

Country: USA
 

Record

SN05829807-F 20201018/201016230136 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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