This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information only. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The Department of Veterans Affairs Olin E. Teague Veterans Medical Center in Temple, Texas intends to award a brand name or equal contract award for the purchase of OPTOS | California fa Retinal Imaging System. The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items.

The purpose of this notice is to gain knowledge of potential qualified sources and their size
classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 333314 with a size standard of 500 employees. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

Please advise if you carry the products for this requirement. Please submit all information to Matthew Lee via e-mail: matthew.lee5@va.gov by Monday, 5 April 2021 10AM CST.
ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
0001

1.00
EA

OPTOS F California fa: has incorporated new hardware and softwareF technology enabling practitioners to see more, discover more and e?ectively treat more ocular pathology thus promoting patient health. The California fa device offers a motorized head and chin rest to more easily assist those patients requiring additional assistance during imaging and guided eye steering to extend image capture beyond 200?. The California fa model provides simultaneous non-contact pole to periphery views of more than 80% or 200 degrees of retina in a single capture. Non-mydriatic high resolution images from the central pole to the periphery can be taken in under a second, through 2 mm pupils and many cataracts. The device produces: color images by using red and green lasers with each wavelength providing information for interpretation and diagnosis. (Green 532 nm), (Red 635 nm) Ultra-Widefield autofluorescence imaging (Green 532nm) Ultra – Widefield autofluorences. (fa -blue laser 488nm) California fa device comes with the OptosAdvanceT browser-based image review software, which allows for simple documentation, monitoring and referral processing to assist in patient management and improved patient flow; VistA compliant and DICOM compatible. 1 year of full service is included in the purchase price. ADA wheelchair accessible table included. California fa Imaging modalities: optomap and optomap af, optomap fa INCLUDES INSTALLATION AND TRAINING AND 1 YEAR SERVICE WARRANTY 1/EA
LOCAL STOCK NUMBER: A10650-FA

0002

1.00
EA

OPTOS F (Option) Per device ordered: Enables capture station to query forF and receive Modality Worklist (MWL) data from a suitable MWL server. DICOM C Stoe is included. This capability does not include the Modality Worklist as a “Sevice Content Provider” (SCP) but where the scanheads are “users of the worklist” (Service Content User) (Required for Forum integration) F 1/EAF
LOCAL STOCK NUMBER: FEATURE_A10650_05CALI

GRAND TOTAL

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
Optos (Surgical Service)
CTVHCS
2/23/2021
CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COR): CTVHCS will appoint one (1) COR for this contract. When service is requested, the contractor will always contact the COR, TBD at email TBD or phone TBD

SCHEDULING ARRANGEMENTS: Except by special alternative arrangement, scheduled delivery will be provided only during Government s normal working hours local site time. Upon acceptance of this contract, the Contractor shall immediately contact the COR TBD at email TBD or phone TBD, to schedule mutually agreeable delivery times.

SCOPE OF WORK: Delivery and set up of the Optos California ultra-widefield retinal imaging device for Surgical Service, 2901 Montopolis Drive Austin, TX 78741. Delivery activities shall consist of the following:

Set-up. All preparation necessarily required to ready the Optos California ultra-widefield retinal imaging device for operation (set-up and training).
Post installation inspection.

COR will verify that required specifications are met and testing will be performed as necessary to meet VA and vendor requirements.

Upon receiving a maintenance and repair call from CTVHCS, the Contractor shall make a return telephone call for within 2 hours. The Contractor will restore the equipment to FULL PERFORMANCE within forty-eight (48) hours of the original call. The Contractor shall notify the COTR of the existence or development of any defects in the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse). Training and support and preventative maintenance and educational courses to be provided on-site as indicated.

The vendor will provide all resources required to ensure a smooth transition, in accordance with the contract requirements.

DESCRIPTION OF OPTOS CALIFORNIA ULTRA-WIDEFIELD RETINAL IMAGING DEVICE, PROVIDED EQUIPMENT:

Equipment features:

The Essential Characteristics Unique to the System
Single image captures 82% of the retina (927 mm2)
Single capture covers 200° of the internal surface of the retina
Single capture image reaches beyond the equator showing vortex vessels and ampullae
Ultra-widefield (200°) image capture in less than ½ second
Montage image shows up to 97% of the retina (1166 mm2)
Ellipsoidal mirror with virtual point technology enables maximum imaging field of view
Clinically validated color imaging proven equivalent to color fundus photography for
pathology detection
Multiple wavelength color imaging provides: color, red-free, choroidal, and true-color
views with a single capture
Ease of use validated in multi-site clinical studies
Proven to enhance clinic flow
Proprietary software presents images in a consistent geometry that accurately represents
anatomical features across the retina and allows for accurate measurements across the
retina
Color imaging with red/green lasers to minimize exposure to blue light
Non-mydriatic imaging of the retina in less than ½ second
saves time and helps improve clinic flow.
cSlO technology images through most cataracts and
small pupils (2 mm).
3-in-1 color Depth imaging TM provides important clinical
data from the retinal surface through the choroid.
Green laser autofluorescence minimizes patient exposure
to blue light and shows macula and optic nerve head detail.
image overlay tool facilitates comparison of images in
different image modes and from visit to visit.
Distance (mm) and area (mm2) measurements provide objective assessment of change over time.
Interweaved angiography saves time by enabling capture of fa and icg in the same session.
Stereo disc imaging allows assessment of the optic nerve to diagnose and follow the progression of glaucoma

This equipment will be under manufactures warranty for 2 Years. Training and support will be provided on-site as indicated.

EXCLUSIONS (unless otherwise quoted) :

Modifications or corrections to the work scope dictated by concealed conditions encountered in the performance of the work and not indicated by the drawings, or specifications.
Modification or corrections to installation room or supplied power.

PERSONNEL CLEARANCES AND PRIVACY CONSIDERATIONS: The Contractor will ensure that their personnel and subcontractor personnel meet the privacy standards as set forth by HIPAA (Health Insurance Portability and Accountability Act of 1996) with respect personal and confidential information that they may come upon, while servicing medical equipment.

PATIENT HEALTH INFORMATION (PHI) AND INDIVIDUALLY IDENTIFIABLE INFORMATION (III):

This system does not contain Patient Health Information (PHI) and Individually Identifiable Information (III).   No VA data will leave the VA Facility.  If a hard drive or any other electronic storage device needs to be replaced, the device will be given to the ISO.  After destruction of the data by degaussing, the device may be returned to the vendor for inventory control if so requested.  The repair of this system will be supervised by a VA employee in BioMed to assure data does not leave the facility.  The COR is responsible to assure that no VA data leaves the facility and an employee supervises repair.  No Security & privacy training is needed by the vendor because the repair will be supervised.  No other security statement is needed.   

Information Technology Security requirements section

As prescribed in 839.201, insert the following clause:
The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and
information system security as delineated in this contract.

1. GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be
subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks
as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS
a. A contractor/subcontractor shall request logical (technical) or physical access to VA
information and VA information systems for their employees, subcontractors, and affiliates only
to the extent necessary to perform the services specified in the contract, agreement, or task
order.
b. All contractors, subcontractors, and third-party servicers and associates working with
VA information are subject to the same investigative requirements as those of VA appointees
or employees who have access to the same types of information. The level and process of
background security investigations for contractors must be in accordance with VA Directive
and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations,
Security, and Preparedness is responsible for these policies and procedures.
c. Contract personnel who require access to national security programs must have a valid
security clearance. National Industrial Security Program (NISP) was established by Executive
Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the
classified information in their possession while performing work on contracts, programs, bids,
or research and development efforts. The Department of Veterans Affairs does not have a
Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security
Clearance must be processed through the Special Security Officer located in the Planning and
National Security Service within the Office of Operations, Security, and Preparedness.
d. Custom software development and outsourced operations must be located in the U.S.
to the maximum extent practical. If such services are proposed to be performed abroad and
are not disallowed by other VA policy or mandates, the contractor/subcontractor must state
where all non-U.S. services are provided and detail a security plan, deemed to be acceptable
by VA, specifically to address mitigation of the resulting problems of communication, control,
data protection, and so forth. Location within the U.S. may be an evaluation factor.
e. The contractor or subcontractor must notify the Contracting Officer immediately when
an employee working on a VA system or with access to VA information is reassigned or leaves
the contractor or subcontractor s employ. The Contracting Officer must also be notified
immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance
or administration of this contract or information developed by the contractor/subcontractor in
performance or administration of the contract shall be used only for those purposes and shall
not be used in any other way without the prior written agreement of the VA. This clause
expressly limits the contractor/subcontractor’s rights to use data as described in Rights in Data
– General, FAR 52.227-14(d) (1).
b. VA information should not be co-mingled, if possible, with any other data on the
contractors/subcontractor s information systems or media storage systems in order to ensure
VA requirements related to data protection and media sanitization can be met. If co-mingling
must be allowed to meet the requirements of the business need, the contractor must ensure
that VA s information is returned to the VA or destroyed in accordance with VA s sanitization
requirements. VA reserves the right to conduct onsite inspections of contractor and
subcontractor IT resources to ensure data security controls, separation of data and job duties,
and destruction/media sanitization procedures are in compliance with VA directive
requirements.
c. Prior to termination or completion of this contract, contractor/subcontractor must not
destroy information received from VA, or gathered/created by the contractor in the course of
performing this contract without prior written approval by the VA. Any data destruction done on
behalf of VA by a contractor/subcontractor must be done in accordance with National Archives
and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records
and Information Management and its Handbook 6300.1 Records Management Procedures,
applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media
Sanitization. Self-certification by the contractor that the data destruction requirements above
have been met must be sent to the VA Contracting Officer within 30 days of termination of the
contract.
d. The contractor/subcontractor must receive, gather, store, back up, maintain, use,
disclose and dispose of VA information only in compliance with the terms of the contract and
applicable Federal and VA information confidentiality and security laws, regulations and
policies. If Federal or VA information confidentiality and security laws, regulations and policies
become applicable to the VA information or information systems after execution of the
contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after
execution of this contract, the parties agree to negotiate in good faith to implement the
information confidentiality and security laws, regulations and policies in this contract.
e. The contractor/subcontractor shall not make copies of VA information except as
authorized and necessary to perform the terms of the agreement or to preserve electronic
information stored on contractor/subcontractor electronic storage media for restoration in case
any electronic equipment or data used by the contractor/subcontractor needs to be restored to
an operating state. If copies are made for restoration purposes, after the restoration is
complete, the copies must be appropriately destroyed.
f. If VA determines that the contractor has violated any of the information confidentiality,
privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the
contractor or third party or terminate the contract for default or terminate for
cause under Federal Acquisition Regulation (FAR) part 12.
g. If a VHA contract is terminated for cause, the associated BAA must also be terminated
and appropriate actions taken in accordance with VHA Handbook 1600.01, Business
Associate Agreements. Absent an agreement to use or disclose protected health information,
there is no business associate relationship.
h. The contractor/subcontractor must store, transport, or transmit VA sensitive information
in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2
validated.
i. The contractor/subcontractor s firewall and Web services security controls, if applicable,
shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available
upon request.
j. Except for uses and disclosures of VA information authorized by this contract for
performance of the contract, the contractor/subcontractor may use and disclose VA information
only in two other situations: (i) in response to a qualifying order of a court of competent
jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all
requests for, demands for production of, or inquiries about, VA information and information
systems to the VA contracting officer for response.
k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA
records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records
and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug
addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human
immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other
requests for the above-mentioned information, that contractor/subcontractor shall immediately
refer such court orders or other requests to the VA contracting officer for response.
l. For service that involves the storage, generating, transmitting, or exchanging of VA
sensitive information but does not require C&A or an MOU-ISA for system interconnection, the
contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on
a yearly basis and provide it to the COTR.

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.

DOCUMENTATION: Contractor will provide the COTR with individual written reports which describe the maintenance and repair service performed on the equipment under warranty in sufficient detail so as to be acceptable by field inspectors of the Joint Commission and other inspecting bodies. This shall include a list of all parts replaced, all service performed as well as a statement that the equipment is operating per manufacturer s specifications after repair. The service report will be signed by the contractor s service technician, and by designated CTVHCS personnel.

Prior to award, bidder must have a facility to include personnel, test equipment, parts inventory, training certificates, licenses and technical documentation available for inspection by VA Medical Center personnel and be able to show written evidence to technical qualifications of personnel, test equipment (and calibration documentation) licenses and availability of parts. Parts availability must be written documentation from either the equipment manufacturer or authorized parts supplier. In either case, bidder must be able to show the availability of parts to him/her within 24 hours after initial call. For contracts for maintenance and repair services form other than the original manufacturer or a designated representative, the Contractor will be fully responsible for obtaining all technical documentation necessary to fulfill contractual obligations.

The Contractor warrants that the services to be performed under this contract will be performed in a good workmanship manner and shall conform to the standards of the industry. This warranty is given expressly and in place of all other warranties, expressed or implied, statutory or otherwise, and is the only warranty given by the Contractor.

Warranty items that expire during the contract period will be added to the contract as appropriate.

NEGLIGANCE CLAUSE: When services and parts are required as a result of accident, abuse, misuse or negligence by other than the Contractor or his representative, and are not included as a part of PM inspection or service calls, such needs will be reported to the Contracting Officer s representative along with estimates of charges. The Contracting Officer and Representative will evaluate these needs and authorize appropriate action. The parts will be installed under the terms of the contact and each invoice is to include a legible itemized list of labor charges and parts costs. The government will incur no charges for service and parts including glassware due to accident, abuse, misuse or negligence by the contractor or his representative.

RECORDS MANAGEMENT:

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 

4. CTVHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of CTVHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to CTVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to CTVHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer’s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and CTVHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with CTVHCS policy. 

8. The Contractor shall not create or maintain any records containing any non-public CTVHCS information that are not specifically tied to or authorized by the contract. 

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 

10. The CTVHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which CTVHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training.  All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. 

END OF CONTRACT: Contractor guarantees that all equipment covered in this contract shall meet or exceed manufacturer s performance specifications at the contract expiration date.