36C25521Q0490.docx

Optical Coherence Tomography (OCT) Machine (KCVA Lenexa CBOC Location)

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Denise Maynard denise.maynard@va.gov 913-946-1978

PLACE OF PERFORMANCE

4801 East Linwood Blvd.

Kansas City, MO 64128-2226

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does no obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified businesses.

Responses to this notice shall include:

1. Company Name

2. Address

3. Point of Contact

4. Phone, Fax, and Email

5. DUNS number

6. Must provide a capability statement that addresses the organizations qualifications and ability to perform the work in the Statement of Requirements.

See Attached:

1. Statement of Requirements

2. Gray Market

Please respond whether you can or cannot provide.

All responses due by 10:00 am CST, Tuesday, July 20, 2021.

Denise Maynard Contract Specialist denise.maynard@va.gov 913-946-1978 Network Contracting Office 15

See attached documents: Statement of Work, Gray Market

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

A. GENERAL INFORMATION

1. The Kansas City VA Lenexa CBOC, requires the purchase of the following equipment in support of the Kansas VA Medical Center’s mission:

· One (1) optical coherence tomography (OCT) with high definition (HD) and OCT angiography (OCTA) capability, wheelchair accessible table w/top.

· One (1) FORUM-DICOM Interface License to CZM Instrument (Vx.xx)

2. Scope of Work: The vendor/contractor shall deliver, assist with install, and provide appropriate user level training for

· One (1) optical coherence tomography (OCT) with HD and OCTA capability, wheelchair accessible table w/top that uses the same normative database and algorithms and

· One (1) FORUM-DICOM Interface License to CZM Instrument (Vx.xx). The vendor/contractor shall provide the requested equipment to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified, and meeting all applicable codes and regulations, drawings, and is subject to the terms and condition of the contract.

3. Background: The Kansas City VA has a requirement for

· One (1) optical coherence tomography (OCT) with HD and OCTA capability, wheelchair accessible table w/top that uses the same normative database and algorithms as current existing Eye Clinic diagnostic equipment and will connect to Zeiss Forum, the Kansas City VAHCS image management system.

· One (1) FORUM-DICOM Interface License to CZM Instrument (Vx.xx)

This highly specialized equipment is needed for the expansion of the Optometry Clinic a new location at the Lenexa CBOC, as part of the Kansas City VA Healthcare System.

4. Performance Period: The contractor shall complete the work required under this SOW in 90 calendar days or less from date of award, unless otherwise directed by the Contracting Officer (CO). If the contractor proposes an earlier completion date, and the Government accepts the contractor’s proposal, the contractor’s proposed completion date shall prevail. Work at the Government site shall not take place on Federal holidays or weekends unless directed by the CO.

5. Type of Contract: Firm-Fixed-Price

6. Power/control

· System shall connect to AC 100 to 240 V +- 10% 50/60 Hz

7. System mechanical:

· OCT machine shall be mounted on the automatic wheelchair accessible table.

8. Installation

· System will be installed by VA BioMed/IT department with the assistance of the vendor.

9. Maintenance:

· System shall require minimum maintenance.

· Systems shall be field serviceable and routinely maintainable by VA Biomedical engineering personnel.

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting or has advised the contractor that a kick off meeting is waived.

C. GENERAL REQUIREMENTS

For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, and along with associated sub-milestone dates. The contractor's subtask structure shall be reflected in the technical proposal and detailed work plan.

All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

Where a written milestone deliverable is required in draft form, the VA will complete their review of the draft deliverable within _90__ calendar days from the date of receipt. The contractor shall have _90__ calendar days to deliver the final deliverable from date of receipt of the Government’s comments.

Delivery address:

TBD by BIOMED and Chief - Optometry

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW.

OCT Machine:

Task One: Deliver

· One (1) optical coherence tomography (OCT) with HD and OCTA capability, wheelchair accessible table w/top that uses the same normative database and algorithms and

· One (1) FORUM-DICOM Interface License to CZM Instrument (Vxx.x) Deliverable One: Verification of one (1) proper, fully functional and installed optical coherence tomography (OCT) with HD and OCTA capability, wheelchair accessible table w/top that uses the same normative database and algorithms. System shall be mounted on the automatic wheelchair accessible table.

Task Two: Provide clinical training and configuration on the installed optical coherence tomography (OCT) and HD/OCTA capable machine.

Deliverable Two: Verification of on-site training for clinical users as specified in agreement.

Task Three: Provide full service literature, preferably in electronic format, including as-built drawings and installation data to Kansas City VAMC Biomedical Engineering department.

Deliverable Three: Verification of receipt of full-service literature (Operator and Service Manuals), preferably in electronic format, including as-built drawings and installation data.

Task Four: Provide the appropriate DICOM and one (1) FORUM-DICOM Interface License to CZM Instrument (Vx.xx) to connect OCT to VA Vista Imaging and the Eye Clinic’s middleware, pre-existing (Zeiss Forum), an image management system.

Deliverable Four: Verification of receipt of DICOM and one (1) FORUM-DICOM Interface License to CZM Instrument (Vx.xx) so the OCT can connect and transfer images to VA Vista Imaging and the Eye Clinic’s middleware, pre-existing (Zeiss Forum), an image management system.

E. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

F. INFORMATION TECHOLOGY (IT)

· The contractor does not require IT access.

· The contractor shall not be granted access to VA sensitive information.

· The C&A requirements do not apply.

· The Security Accreditation Package is not required.

· The contractor will be required to sign the Contractor ROB before conducting training at/in the VA.

G. ESCORT REQUIRED

· The vendor will be escorted by the COR or TECS clinic staff during the training of the non-mydriatic/mydriatic fundus camera with simultaneous optical coherence tomography (OCT).

H. DESCRIPTION

One (1) FORUM-DICOM Interface License to CZM Instrument (Vx.xx)

Table, computer, printer, DICOM licenses Includes 12 months warranty on all products and 24 months warranty on lasers

I. SALIENT CHARACTERISTICS

All equipment:

a. Must be DICOM compliant as per the DICOM Conformance Statement

b. The image must be captured using a DICOM interface for transfer into VistA Imaging

c. Should be on approved VA list: a listing of teleretinal image acquisition systems that have been validated by the VA is located at below website link on page 21 (ophthalmic photography) http://www.va.gov/HEALTH/imaging/docs/VistA_Imaging_DICOM_Modality_Interfaces.pdf

d. Should be able to connect to Kansas City main eye clinic’s existing software management system “middleware” (Zeiss Forum).

a. Mydriatic and non-mydriatic OCT

b. Able to take ocular coherence tomography images of nerve, macula, and corneal thickness

c. Able to perform HD scans

d. Able to perform OCT Angiography

e. Use of advanced algorithms to measure and display layers

f. Uses accurate centering software to ensure that pictures are taken in the same place each time.

g. Ability to automatically register data cubes with prior patient visit data

h. Precise registration and display of OCT scans

i. Macular Thickness and Change Analysis

j. Macular Thickness Normative Data

k. ONH & RNFL OU Analysis with normative data

l. Can perform a guided progression analysis after a set number of scans.

m. Efficient cross-modality analysis to switch between images registered with OCT scans and maps.

n. Connects to Zeiss Forum and allows Zeiss Forum to perform a high-level manipulation of data at the raw data level.

o. FORUM-DICOM Interface License to connect OCT to VA DICOM

CONTRACTOR RULES OF BEHAVIOR

This User Agreement contains rights and authorizations regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the Department of Veterans Affairs (VA). This User Agreement covers my access to all VA data whether electronic or hard copy ("Data"), VA information systems and resources ("Systems"), and VA sites ("Sites"). This User Agreement incorporates Rules of Behavior for using VA, and other information systems and resources under the contract.

1. GENERAL TERMS AND CONDITIONS FOR ALL ACTIONS AND ACTIVITIES UNDER THE CONTRACT:

a. I understand and agree that I have no reasonable expectation of privacy in accessing or using any VA, or other Federal Government information systems.

b. I consent to reviews and actions by the Office of Information & Technology (OI&T) staff designated and authorized by the VA Chief Information Officer (CIO) and to the VA OIG regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA. These actions may include monitoring, recording, copying, inspecting, restricting access, blocking, tracking, and disclosing to all authorized OI&T, VA, and law enforcement personnel as directed by the VA CIO without my prior consent or notification.

c. I consent to reviews and actions by authorized VA systems administrators and Information Security Officers solely for protection of the VA infrastructure, including, but not limited to monitoring, recording, auditing, inspecting, investigating, restricting access, blocking, tracking, disclosing to authorized personnel, or any other authorized actions by all authorized OI&T, VA, and law enforcement personnel.

d. I understand and accept that unauthorized attempts or acts to access, upload, change, or delete information on Federal Government systems; modify Federal government systems; deny access to Federal government systems; accrue resources for unauthorized use on Federal government systems; or otherwise misuse Federal government systems or resources are prohibited.

e. I understand that such unauthorized attempts or acts are subject to action that may result in criminal, civil, or administrative penalties. This includes penalties for violations of Federal laws including, but not limited to, 18 U.S.C. §1030 (fraud and related activity in connection with computers) and 18 U.S.C. §2701 (unlawful access to stored communications).

f. I agree that OI&T staff, in the course of obtaining access to information or systems on my behalf for performance under the contract, may provide information about me including, but not limited to, appropriate unique personal identifiers such as date of birth and social security number to other system administrators, Information Security Officers (ISOs), or other authorized staff without further notifying me or obtaining additional written or verbal permission from me.

g. I understand I must comply with VA’s security and data privacy directives and handbooks. I understand that copies of those directives and handbooks can be obtained from the Contracting Officer's Technical Representative (COTR). If the contractor believes the policies and guidance provided by the COTR is a material unilateral change to the contract, the contractor must elevate such concerns to the Contracting Officer for resolution.

h. I will report suspected or identified information security/privacy incidents to the COTR and to the local ISO or Privacy Officer as appropriate

2. GENERAL RULES OF BEHAVIOR

a. Rules of Behavior are part of a comprehensive program to provide complete information security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job.

b. The following rules apply to all VA contractors. I agree to:

(1) Follow established procedures for requesting, accessing, and closing user accounts and access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract.

(2) Use only systems, software, databases, and data which I am authorized to use, including any copyright restrictions.

(3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer, or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract. If authorized to use OE IT equipment, I must ensure that the system meets all applicable 6500 Handbook requirements for OE.

(4) Not use my position of trust and access rights to exploit system controls or access information for any reason other than in the performance of the contract.

(5) Not attempt to override or disable security, technical, or management controls unless expressly permitted to do so as an explicit requirement under the contract or at the direction of the COTR or ISO. If I am allowed or required to have a local administrator account on a government-owned computer, that local administrative account does not confer me unrestricted access or use, nor the authority to bypass security or other controls except as expressly permitted by the VA CIO or CIO's designee.

(6) Contractors’ use of systems, information, or sites is strictly limited to fulfill the terms of the contract. I understand no personal use is authorized. I will only use other Federal government information systems as expressly authorized by the terms of those systems. I accept that the restrictions under ethics regulations and criminal law still apply.

(7) Grant access to systems and information only to those who have an official need to know.

(8) Protect passwords from access by other individuals.

(9) Create and change passwords in accordance with VA Handbook 6500 on systems and any devices protecting VA information as well as the rules of behavior and security settings for the particular system in question.

(10) Protect information and systems from unauthorized disclosure, use, modification, or destruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive information, both safeguarding VA sensitive information in storage and in transit regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA.

(11) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VA information. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders.

(12) Ensure that the COTR has previously approved VA information for public dissemination, including e-mail communications outside of the VA as appropriate. I will not make any unauthorized disclosure of any VA sensitive information through the use of any means of communication including but not limited to e-mail, instant messaging, online chat, and web bulletin boards or logs.

(13) Not host, set up, administer, or run an Internet server related to my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA unless explicitly authorized under the contract or in writing by the COTR.

(14) Protect government property from theft, destruction, or misuse. I will follow VA directives and handbooks on handling Federal government IT equipment, information, and systems. I will not take VA sensitive information from the workplace without authorization from the COTR.

(15) Only use anti-virus software, antispyware, and firewall/intrusion detection software authorized by VA. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with VA.

(16) Not disable or degrade the standard anti-virus software, antispyware, and/or firewall/intrusion detection software on the computer I use to access and use information assets or resources associated with my performance of services under the contract terms with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or significant alert messages to the COTR.

(17) Understand that restoration of service of any VA system is a concern of all users of the system.

(18) Complete required information security and privacy training, and complete required training for the particular systems to which I require access.

3. ADDITIONAL CONDITIONS FOR USE OF NON- VA INFORMATION TECHNOLOGY RESOURCES

a. When required to complete work under the contract, I will directly connect to the VA network whenever possible. If a direct connection to the VA network is not possible, then I will use VA approved remote access software and services.

b. Remote access to non-public VA information technology resources is prohibited from publicly-available IT computers, such as remotely connecting to the internal VA network from computers in a public library.

c. I will not have both a VA network line and any kind of non-VA network line including a wireless network card, modem with phone line, or other network device physically connected to my computer at the same time, unless the dual connection is explicitly authorized by the COTR.

d. I understand that I may not obviate or evade my responsibility to adhere to VA security requirements by subcontracting any work under any given contract or agreement with VA, and that any subcontractor(s) I engage shall likewise be bound by the same security requirements and penalties for violating the same.

4. STATEMENT ON LITIGATION

This User Agreement does not and should not be relied upon to create any other right or benefit, substantive or procedural, enforceable by law, by a party to litigation with the United States Government.

5. ACKNOWLEDGEMENT AND ACCEPTANCE

This acknowledgement and acceptance will be conducted with the awardee after award is made.

I acknowledge receipt of this User Agreement. I understand and accept all terms and conditions of this User Agreement, and I will comply with the terms and conditions of this agreement and any additional VA warning banners, directives, handbooks, notices, or directions regarding access to or use of information systems or information. The terms and conditions of this document do not supersede the terms and conditions of the signatory’s employer and VA.

Print or type your full name Signature

Last 4 digits of SSN Date

Office Phone Position Title

Contractor’s Company Name Please complete and return the original signed document to the COTR within the timeframe stated in the terms of the contract

*Contractors providing equal products shall provide descriptive literature describing equal characteristics and must be compatible with current system.

GRAY MARKET LANGUAGE

The Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The vendor shall provide new items ONLY; no remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty.