36C25519Q0060-0002000.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

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6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

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10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

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1. CONTRACT ID CODE

FACILITY CODE

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

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STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

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ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 11-19-2018 589-19-1-4805-0004 n/a 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 To all Offerors/Bidders

36C25519Q0060

X X X

See CONTINUATION Page X The purpose of this amendment is to;

1) Post Questions and Answers

2) Update the Statement of Requirements and CLINS accordingly.

3) Extend the response date to Wednesday, November 28 th @ 10:00 am

*ALL CHANGES ARE HIGHLIGHTED IN RED*

Larry Zaritz

Questions and Answers for RFQ #36C25519Q0060:

1. Tables 3-5 indicate a requirement for a single universal port which is the current standard for connectivity to multiple sources, table 8 contradicts this requirement and requires individual connections to sources. Is a single universal port the requirement for this request?

3 universal laparoscopic images clownology images

1. Specific request is for HD camera requirement. The healthcare industry now provides 4K options to provide superior image clarity to improve clinical diagnoses. Would the government consider expanding the scope to include 4K throughput capabilities to align with the current technological evolution?

Yes 4k

1. There is no specific requirement for HL7 and DICOM connectivity in the RFQ, this is typically a requirement to meet to the VA CIO’s interoperability initiatives. Would the government consider expanding the scope to include HL7 and DICOM connectivity for the solution provided?

Yes

1. As outlined in the 2017 VA Medical Device Protection Program (MDPP) and subsequent implementation of a Medical Device Isolation Architecture (MDIA), it is our understanding that a VA Directive 6550, Pre-Procurement for Medical Device/Systems, is required to be completed for any medical device that is otherwise used to capture and store patient information. Can you confirm VA Form 6550 will need to be completed in our submission?

Yes

1. Related to VA Form 6550, it is our understanding that any projects in the VA involving the acquisition of medical device equipment that captures patient information should be listed and approved in the VA ONE-VA Technical Reference Model (TRM) and comply with the architectural guidance as outlined in the 2017 VA Medical Device Protection Program (MDPP). Can you confirm any proposed solution must be currently listed in the TRM?

Trm is outdated and unreliable

1. What is the current environment/integration system in place with the other ORs in the facility? (brand/installation date)

5. Is connectivity to any existing systems, such as imaging carts that support ENT, Urology, etc., a requirement for this request?

Olympus, Yes to laberscopic scopes, colorology scopes and GE c amrs

1. Would the government consider including a requirement for booms to support the ability to integrate patient lifts in alignment with VA Safe Patient Handling Mobility Directive 1611?

No

1. Table 6 request is for a 27” bracket with a smaller monitor requested in Table 9, would the government accept a 27” monitor and a 27” bracket?

Yes

1. The Statement of Requirements Introduction references installation of “two surgical lights, two equipment booms, and two anesthesia booms for expansion of surgery to accommodate two new operating rooms.” In contrast, the drawings indicate the need for the following ceiling mounted equipment (per OR):

-1 anesthesia boom -1 equipment boom -3 LED surgical lights -2 arms to support -2 19-26” monitors. (IAW Other Questions, Max Size changed to 27”, Table #9) Your CLINS/ Price Schedule request the following:

-6 LED Lights per each Operating Room (CLINS 2, 5, 8) -2 Monitor Arms -1 Equipment Boom -1 Anesthesia Boom

1. “II Booms” references “infrastructure.” We interpret that to mean an above-ceiling support structure. Please confirm if that support structure is to be quoted, as it is not listed in the CLIN.

General Contractor is putting the supports to mount lights

1. “II Booms” references a Perfusion hookup and Table 5 lists requirements for a perfusion hookup arm. Please confirm if that is to be quoted as it is not listed in the CLIN or called out on the drawings.

It should be capable if we need to add it later. But as of right now no.

1. The Description of Work, Statement of Requirements, and Table 8 states that an integration system is a requirement. Please confirm if that is to be quoted as it is not listed in the CLIN.

We do need the integration system

1. Table 8 states a requirement for a video capture device that “must capture video and images on screen.” Please confirm if that is to be quoted as it is not listed in the CLIN.

Yes

1. The Statement of Requirements states the head shall have the ability to power on/off the light. Where should prospective offerors include the required items under the current CLINS structure?

Mount in the OR room on wall

1. Please confirm the number and type of video inputs.

1. Does the facility require room-to-room or off-site connectivity?

No

1. Table 10 states the vendor shall mount and install all products supplied using union labor. Shall the union labor portion of the cost be separate from the installation line item?

We wont be using union labor

STATEMENT OF REQUIREMENTS (SOR)

*ALL ITEMS HEREIN THAT MENTION BRAND NAME PRODUCTS MAY BE SUBSTITUTED FOR A LIKE OR SIMILAR ITEM*

1. INTRODUCTION

This solicitation is to provide the Veterans Health Administration, Wichita Facilities Management with all labor, personnel, equipment, tools, materials, parts and services necessary install three surgical lights, one equipment boom, and one anesthesia boom per room for the expansion of surgery to accommodate two new operating rooms.

2. BACKGROUND

The Wichita Robert J. Dole Veterans Health Administration Facilities Management Each room will require new surgical lighting, ceiling-mounted equipment management system (booms), and a digital OR integration system to improve information access and modernize the surgery suites in Building 34.

3. SCOPE OF WORK

WORK TO BE PERFORMED:

Description of Work: The contractor shall provide surgical lights and ceiling-mounted equipment management system(booms), and a digital OR integration system. The single-phase project of two ORs (General OR Rooms) shall provide installation to include, labor, training, tools, documentation of performance, and perform all field modification needed to complete install. More details can be seen in the minimum technical requirements section and a table is available at the bottom of this document

1. Surgical Lights The term “surgical lights” is used to describe the light head, including the light bulbs, wiring and housing that provides direct illumination over the patient during surgery. Each surgical light head is affixed to an arm that is mounted to the ceiling.

1. Light head – surgical grade light

1. Camera-ready light head – light head that is capable of supporting a video camera. Light head is pre-wired for video capability and the camera can “plug and play” into the light head

1. Booms The term “booms” is used to describe the general ceiling-mounted equipment management system. The system is composed of the mounting hub and the arms. The arms are capable of multiple degrees of articulation and positioning within the operating room and terminate in a unique item, such as an equipment carrier, a surgical light, a monitor, an anesthesia hookup, or a perfusion hookup. Definition are as follows:

1. Mounting hub – Infrastructure located within the ceiling that safely supports the weight and articulation of the arms. Multiple mounting hubs may be required in each operating room and multiple arms can extend from a single hub.

1. Anesthesia Hookup Arm – provides the utilities and gases commonly used by an anesthesia machine. This arm is not a fixed column from the ceiling, but rather an arm to tether to the anesthesia machine.

1. Equipment Carrier Arm – Provides storage of the surgical equipment and utilities and gases commonly required during surgery. This usually consists of a column with multiple shelves, power outlets and medical gasses.

1. Perfusion Hookup Arm – Provides utilities and gases commonly used by a heart-lung machine. This arm is not a fixed column from the ceiling, but rather an arm to tether to the heart-lung machine, without lifting the machine off the floor.

1. Monitor Arm – An arm that supports a flat panel surgical display monitor of varying size. This does not include the monitor itself.

1. Surgical Light arm – Supports one surgical light head. Each arm terminates with one light head.

4. Minimum Technical Requirements of Equipment

1. Surgical Lights Surgical Lights are required in every operating room. The specific number of surgical lights per OR room will be specified at the time of ordering. There should be a standard surgical light line item and an in-light camera surgical light line item.

Table 1: Requirements for Surgical Lights Technical Requirements

Lights shall be capable of “pure white light”

Functionality

Usability

Lights shall be able to fully rotate 360° on all axes Lights shall have drift-free stability

Design Quality and Safety

Lights shall not have any contours or grooves that obstruct proper and efficient sanitation

Lights shall not contain any exposed fasteners that could compromise the effectiveness of medical gloves

1. Booms The booms should all have the same general requirements that all terminate with a unique item with additional requirements. All these requirements can be seen below.

Table 2: General Requirements for Arms Technical Requirements

Arms shall not require significant deconstruction to apply lubrication of parts

Usability

Reach and rotational capabilities permit positioning of equipment carrier around surgical table.

Arm reach and rotational capabilities allow placement of the utility arm in various locations for surgical use with rolling equipment carts.

Arm shall be capable of being positioned outside of surgical workspace in such a manner that it does not disrupt workflow when desired.

Lights shall be capable of vertical travel Arms shall have drift-free stability Adjustable rotational stops Column Height is adjustable

Raceway

Design Quality and Safety

Arms shall not have any contours or grooves that obstruct proper and efficient sanitation

Arms shall not contain any exposed fasteners that could compromise the effectiveness of medical gloves

Design renderings shall indicate clearance

Table 3: Requirements Specific to the Equipment Carrier Arm Functionality

Shelves shall be movable Shelves shall be at least 36” wide Shelves shall be at least 24” deep

Usability

Carrier shall be able to reach and rest adjacent to the surgical table Carrier shall be able to rotate around its Z axis

Utilities – Outlets and Ports

Table 4: Requirements to the Anesthesia Hookup Arm Functionality

Usability

Hookup shall be able to reach such that the anesthesia unit can be positioned adjacent to either side of the surgical table Hookup shall be able to rotate around its Z axis

Utilities – Outlets and Ports

Table 5: Requirements Specific to the Perfusion Hookup Arm Functionality

Usability

Hookup shall be able to rotate around its Z axis

Utilities – Outlets and Ports

Table 6: Requirements Specific to the Monitor Arm Functionality

Usability

Arm shall be able to reach such that the monitor can be positioned on either side of the surgical table Arm shall be capable of vertical travel Monitor shall be able to rotate around its Z axis Arm shall include handholds to allow movement of the monitor without touching the monitor

Table 7: Requirements Specific to the Light Arm Functionality

Usability

Arm shall be able to reach such that the light can be positioned on either side of the surgical table Arm shall be able to reach such that the light can be positioned directly over the surgical table Arm shall be capable of vertical travel Light head shall be able to rotate around its Y axis Light head shall include a handhold(s) to allow movement of the light head without touching the housing

1. Integration System The digital OR integration solution will provide integrated routing of the video, audio, and clinical information system signals in the operating room. The system will provide a graphical interface that allows clinical users to manipulate the routing of video and audio signals from a common in-room interface. This integration system should include a large monitor that will go on a wall in the OR room, monitors that can be attached to monitor arms, a computer that controls the entire integration system and an in-room camera. Additionally, the integration system should have the capability to turn on/off surgical lights, adjust the brightness of the lights, pick various sources to display on the various monitors, and connect to mobile equipment and computers to display those sources on the monitors.

Table 8 - Integration Solution Product Requirements:

Functionality Requirements

1. Must control surgical lights – turn on/off, intensity variation

1. Control entire video system – select video inputs, output video sources to the various monitors, power on/off the monitors

1. Control room camera that will be installed on one end of the room (see specs below)

1. Capture video and images displayed on screen

1. Store data on a drive on the VA network

1. Have the potential to communicate with the other ORs in the facility

Pan/Tilt/Zoom Camera Required

Control Station Required

Audio System Required

A/V Hub Required

Video Input Requirements

Video Output Requirements

Table 9 - Flat Panel Surgical Display Requirements:

The vendor shall provide medical grade LCD/LED monitors for use in the operating room. These monitors shall be capable of displaying in high resolution all video feeds from the integration solution. These monitors shall meet all necessary medical standards and be properly designed for the operating room environment. The product quoted shall meet or exceed with all specifications below.

Table 10 - Installation of Digital OR Integration Solution:

Following contract award vendor shall meet and coordinate with the Contracting Official Technical Representative (COTR) to review and finalize the installation schedule. The product installation services quoted shall meet or exceed with all specifications below.

SPECIAL WORK REQUIREMENTS:

Hours: The regular work hours for this facility is Monday through Friday, from 8:00 am to 4:30 pm (CST), excluding Federal Holidays. All maintenance shall be provided during the regular business hours of this facility. If work is required after hours prior approved will be made by department.

Response Time: None required

Preventive Maintenance Inspections: None required

Service Quality: All services provided in this contract must meet manufacturers’ performance and technical specifications, Federal Regulations, VA Regulations, and meet the requirements of The Joint Commission and Life Safety Code. The contractor shall document all maintenance and PMI actions and provide said documentation to the COR upon completion of each service action.

Noncontract Charges: The contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer.

4. DELIVERY & LOCATION INFORMATION

Wichita Kansas, 67218

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

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MANUFACTURER PART NUMBER (MPN): FD 2000

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MANUFACTURER PART NUMBER (MPN): CY 1008104

MANUFACTURER PART NUMBER (MPN): 83307

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