36C24121Q0842.docx

SUBJECT*

Leica PROVIDO M530 Microscope Surgical

GENERAL INFORMATION

SET-ASIDE

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

CONTACT INFORMATION

VAMC Providence

830 Chalkstone Avenue Providence RI 02908

POINT OF CONTACT*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

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THIS IS NOTICE OF INTENT TO SOLE SOURCE MELLING MEDICAL, LLC FOR THE LEICA PROVIDO M530 MICROSCOPE.

INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: 650-21-4-7821-0100: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available and telephone requests will not be honored.

The Department of Veterans Affairs VA Medical Center intends to award a purchase order, Firm Fixed Price, Sole Source contract for Leica PROVIDO M530 Microscope Surgical to Melling Medical, LLC. Leica is the Original Equipment Manufacturer (OEM) for the affiliated PROVIDO M530 Microscope Surgical.

An Authorization of Sole Source/Distributor/Dealer Letter has been provided by OEM Leica Microsystems Inc. stating SDVOSB Melling LLC dba MellingMedical is the Sole Source Authorized Distributor of Surgical Microscopes into the Federal Government. SDVOSB Melling LLC dba MellingMedical is a fully authorized distributor/dealer for all Leica Microsystems products. The products distributed to Melling LLC dba MellingMedical by Leica Microsystems are hereby guaranteed to be safe, are not counterfeit or adulterated devices, have been maintained in adequate storage conditions, and any warranties and services and/or preventative maintenance agreements are transferred and will be honored by Leica Microsystems.

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 339112: Other Commercial & Service Industry Machinery & Manufacturing. The most current Business Size Rating for this NAICS is 1,000 employees.

Capable parties may identify their interests and authorization to respond to this requirement by September 10th, 2021 at 13:00 PM (EDT).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

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STATEMENT OF WORK

SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following:

· Installation and implementation of a fully functional

LEICA PROVIDO M530 MICROSCOPE

· Clinical Training for Providence VA Medical Center staff.

· Technical Training for Providence VA Medical Center staff.

1. EQUIPMENT

The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable.

LEICA PROVIDO M530 MICROSCOPE which includes the following:

· Leica M530 Optics Carrier for ULT 530

· Leica Protectivce glass M50xx, M620

· Leica PROVIDO Stand (Standard)

· Leica Power cable, 5m, North America

· Leica Wireless Footswitch 14-functions Type B

· Leica ULT530

· Leica Certificate of installation

· Leica Binocular tube var. 30-150°T,Typ II L

· Leica Eyepiece f. spect. w´s 10x/21B, type II

· Leica Binoc.tube var.0-180°t,type II

· Leica Eyepiece f. spect. w´s 10x/21B, type II

· Leica XY- Coupling PROVIDO

· Leica HD C100 for ULT530

· Leica PROVIDO Docuset Holder Kit HD C100

· Leica 27" Medical HD Touch Monitor

· Leica FSN 27’ Power Cable

· Leica PROVIDO Monitorarm

· Leica Dust Cover

· Installation, Calibration & On-Site Training

The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation.

2. SALIENT CHARACTERISTICS

The Contractor shall provide a fully functional system that meets the following characteristics:

Salient Characteristics Leica PROVIDO M530 ULT Brilliant optics with extended depth of field

· PROvido is equipped with innovative FusionOptics technology, 300W bright Xenon light, and Small Angle Illumination (SAI). This provides an expanded area in full focus, avoiding constant refocusing. Paired with SAI surgeons can benefit from deeper views into cavities with more detail and less shadow.

Modular concept for large variety of applications

· Multiple configurations for different surgical applications like ENT, Spine, Plastic Reconstructive Surgery, and Neurosurgery.

· PROvido is available with a standard stand option featuring a 300 Xenon Watt main illumination system and a 75W LED as back up. The premium stand version is operating with two 300W Xenon lamps systems and is compatible with fluorescence modules from Leica.

· Other optional accessories for the PROvido are X/Y module, FL800 and FL560 fluorescence modules, Autofocus, integrated camera, EVO 4K documentation system, and monitors of 24” or 27” size. Further Leica Microsystems offers wide range of observation

SPECIFICATIONS

OPTICS AND ILLUMINATION

· Fusion Optics for increased depth of field and high resolution for main surgeon

· Fully apochromatic optics for high contrast and natural colors without chromatic aberrations

· Magnification 6:1 zoom, motorized Optional 1.4× magnification multiplier

· Focus Motorized via multifocal lens, with manual adjustment

· Objective / working distance 225–600 mm, motorized multifocal lens, continuously adjustable and manual adjustment option

· Eyepieces Wide-field eyepieces for persons wearing glasses 8.3×, 10× dioptric adjustment, ±5 diopter settings and adjustable eyecup

· Integrated 360° rotatable adapter for main surgeon binocular (IVA, ULT) and opposite assistant (ULT)

· Illumination

· Single Xenon 300-Watt arc-lamp as main illumination with LED lamp as back up or optional dual Xenon arclamp illumination system

· Continuously variable illumination field diameter

· Continuously adjustable brightness at constant color temperature

· SpeedSpot Laser focusing aid for fast and exact positioning of the microscope

· AutoIris Built-in automatic zoom-synchronized illumination field diameter, with manual override and reset feature

· BrightCare Plus Safety function through working distancedependent limitation of the brightness, controlled by built-in luxmeter

CONTROL

· Control unit

· Programmable touchscreen with user-friendly Graphical User Interface for control of the microscope and stand

· Built-in electronic auto-diagnosis and user support

· Software independent hard keys for illumination

· Indicator for main/backup illumination and fluorescence modes

· Control elements

· Pistol handle with 10 programmable functions

· Optional 12-function wireless footswitch

· IR sensor for remote control of the external Leica HD C100 camera

MANEUVERABILITY

· XY speed Zoom linked XY speed

· XY range 62 x 62 mm

· Balancing Manual balancing at microscope carrier and at swing arm

· Brakes Floor stand with 6 electromagnetic brakes

· Carrier for monitor 610 mm long and flexible arm with 180° rotation and inclination to carry optional video monitor

CONSTRUCTION

· Base 700 × 700 mm with four 360° rotating castors with a diameter of 126 mm each and integrated brakes

· Materials All solid metal construction Load Max. 8.5 kg from microscope dovetail ring interface

· Weight Approx. 350 kg without load

OPTIONS

· ULT530

· Full stereo view for main surgeon and opposite assistant, semi stereo view for 2 side assistants

· Optional integrated HD Camera (HD C100)

· FL800 ULT ULT with the Leica FL800 vascular fluorescence observation filter module

· FL560 Leica FL560 fluorescence observation filter module

· IVA530 - Full stereo view for main surgeon, semi stereo view for 2 side assistants and C-mount interface for camera (HD or SD)

· Integrated documentation Prepared for integration of video camera system and digital recording. Open architecture

· Digital Recording Record still pictures and videos in standard definition (SD) and high definition (HD) using a digital recording device (documentation system)

· Laser compatibility compatible with Lumenis AcuSpot 712L Laser Manipulator and Digital AcuBlade

2. AREAS TO BE SERVICED

Department of Veterans Affairs Providence VA Medical Center Operating Room 830 Chalkstone Ave Providence, RI 02908

3. INSTALLATION

a) The Contractor shall provide all labor, materials, tools, equipment and etc. to prepare for and complete the installation of the equipment in the space determined by the Government.

b) Project implementation meetings, if necessary, shall be coordinated with the COR.

c) Installation and implementation dates are to be coordinated in advance with the Contractor and the COR.

d) All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access.

e) All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government.

f) All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work.

g) The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing of LEICA PROVIDO M530 MICROSCOPE .If the Contractor is unable to install the equipment to its normal operational state within 24 hours the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment.

h) The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable.

i) The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation.

4. TRAINING

The Contractor shall provide a comprehensive onsite training program for the operating clinicians. This training program shall include at the minimum the following sessions: (i) Technical Training, (ii) Operational Training, (iii) Administrative Training, and (iv) Hardware and Software Troubleshooting. Training shall occur onsite during normal business hours, 7:00am-3:30pm, Monday through Friday. Competency assessments shall be provided with the training. Onsite training is to be scheduled in advance with the Providence VA Medical Center through the COR.

The Contractor shall provide onsite general overview technical training for Clinical Engineering personnel as requested. Training shall include a technical overview of the mechanics, electronics, and general operations of the system. Training shall cover detailed instruction regarding the preventative maintenance, troubleshooting, and general maintenance of the equipment.

5. INSPECTION AND ACCEPTANCE

a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.

b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

6. WARRANTY

a) The contractor shall provide a one-year manufacturer’s warranty on all parts and labor.

b) The warranty shall include all travel and shipping costs associated with any warranty repair.

7. TASK FREQUENCY AND INSTRUCTIONS

The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR.

Equipment delivery shall not preceed installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including “go live” support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award.

8. SPECIAL WORK REQUIREMENTS

The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work.

The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work.

9. PROPERTY DAMAGE

The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, cubs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer.

10. ATTACHMENTS

None.

11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS

The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD

The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall:

A. Have methods by which all employees are educated as to risks associated with blood borne pathogens.

B. Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens.

C. Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens.

D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, and mouthpieces for the employee during performance of the contract.

13. INFORMATION SECURITY LANGUAGE

N/A