36C25618U0049-000.docx

36C25618U0049 FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE

(MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Zeiss Mobile Humphrey Field Analyzer HFA3 71101 36C25618U0049 08-09-2018 N 333314 Department of Veterans Affairs Overton Brooks VA Medical Center (90C) 510 East Stoner Avenue Shreveport LA 71101

VERONICA MASKELL

Mobile VA Outpatient Clinic (new) 4444 Demetropolis Road Mobile, AL 36619

USA

veronica.maskell@va.gov This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with format in Subpart 12.6- Streamline Procedures for Evaluation and Solicitation for Commercial Item.

This procurement is being conducted under FAR Part 13- Simplified Procedures and the conduct of the procurement will be in accordance with FAR Parts 12 and 13 or some combination thereof.

The solicitation number is 36C25618U0049 and is issued as a Request for Quotation (RFQ).

The proposed contract action is for CARL ZEISS HFA3 MODEL 860 & ZEISS OS-CIRRUS HD-OCT Model 5000 or Equal for the Mobile VA Outpatient Clinic, located at Mobile, AL for which the Government intends to solicit competitive quotes. Interested persons may submit quotes, and all eligible quotes must be received prior to the response date listed on FBO to be considered by the Government. This solicitation is 100% SET-ASIDE FOR SERVICE DISABLED VETERAN OWN SMALL BUSINESS.

The NAICS code is 333314 and the size standard is 500 Employees.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC 2005-99A- 06/15/2018). Only emailed requests received directly from the requester will be accepted.

Delivery FOB Destination to the following locations:

Mobile VA Outpatient Clinic 4444 Demetropolis Rd Mobile, AL 36619

RESPONSES ARE DUE August 9, 2018, by 12:00 p.m. Central Standard Time (CST). Quotes are due electronically to veronica.maskell@va.gov no later than the response date listed on FBO. Only electronic quotes will be considered.

Phone calls will not be accepted, all question and or concerns must be submitted via email to veronica.maskell@va.gov by 12pm August 2, 2018!

Point of contact for this solicitation is Veronica Maskell at veronica.maskell@va.gov.

All Inquires must be submitted electronically.

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6.

SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a.

CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary) 25.

ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE O

RDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________

OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR

CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND

TITLE OF SIGNER (TYPE OR PRINT)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25618U0049 07-26-2018

VERONICA MASKELL

3189904090 08-09-2018

12 PM CST

Department of Veterans Affairs Overton Brooks VA Medical Center (90C) 510 East Stoner Avenue Shreveport LA 71101 X X 333314 500 Employees N/A X Department of Veterans Affairs

WHSE/INSIDE DELIVERY V.A. MEDICAL CENTER

Mobile VA Outpatient Clinic (new) 4444 Demetropolis Road Mobile AL 36619 Department of Veterans Affairs Overton Brooks VA Medical Center (90C) 510 East Stoner Avenue Shreveport LA 71101

Department of Veterans Affairs Financial Services Center (667) PO Box 149971 Austin TX 78714-9971 X See CONTINUATION Page

CARL ZEISS HFA3 MODEL 860 & ZEISS OS-CIRRUS

HD-OCT Model 5000 OR EQUAL

SEE LINE ITEM DETAILS AND SOW FOR FURTHER INFORMATION.

***Must be registered with Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. Contracting Officers are required to verify that all SDVOSBs and VOSBs who are interested parties are VIP Verified during entire acquisition process*** See CONTINUATION Page X X Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs Overton Brooks VA Medical Center (90C) 510 East Stoner Avenue Shreveport LA 71101

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center (667) PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Gulf Coast Veterans Health Care System (GCVHCS) 400 Veterans Avenue Biloxi, MS 39531

SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR CARL ZEISS HFA3 MODEL 860 & ZEISS OS-CIRRUS HD-OCT Model 5000 OR EQUAL

1. Background GCVHCS requires new medical equipment in support of the activation of a new project for Mobile CBOC. The Mobile Eye Clinic will require all new ophthalmologic equipment to accommodate the expanded services and increased access in space provided. Both Biomedical Engineering and Surgical-Eye Service encourage continued use and replacement of current facility wide Carl Zeiss Angiography/Scanner and Visual Fields Analyzer Or Equal. Additionally, this extension of Carl Zeiss equipment would connect to an existing Zeiss FORUM network server in place at the Biloxi VA Hospital covered with service/maintenance agreements under Carl Zeiss.

2. Project Scope GCVHCS requires purchase of (1) Carl Zeiss HFA3 Model 860 and necessary accessories, and (1) Zeiss OS|Cirrus HD-OCT Model 500 with AngioPlex OCT or Equal for timely activation of our Mobile CBOC Major Lease Replacement project. Product outlined in this Scope of Work shall be available for direct delivery to project site no later than December 2018 to meet current activation schedule. Delivery coordination with the COR may occur as early as two weeks following the contract award. Awarded vendor must follow delivery instructions outlined in Section 7 of this document. All requested items must meet the specifications included herein this document to meet technical acceptance by requestor. See noted specifications in Section 3.

3. Specifications for Carl Zeiss HFA3 Model 860 or Equal:

a. Technical Specifications

1. Unit dimensions must be 18.5” L x 20.5” W x 23” H or less.

2. Must conform to following electrical requirements: 100-120V – 50/60 Hz, 4.0A or less

3. Require an internal storage of at least 500GB

4. Require a Windows 7-64 bit operating system for VA compliance

5. Must provide a fixation control system that will include the following parameters: Video eye monitor, Heijl-Krakau blind spot monitor, gaze tracking, head tracking, vertex monitoring

b. Visual Field Index Requirements

1. Provides summary measurement of patient’s visual field status expressed as a percent of normal age adjusted visual field.

c. Liquid Trial Lens

1. Require trial lens using liquid pressure to deliver patient’s refractive correction

d. Smart Touch interface capability

1. Requires a touch screen interface to power the RelEye workflow program which allows the systematic and pin point fixation inspection.

2. Requires unit to capture and keep image of eye during testing and after prior to Result Review screen.

important data to future exams.

e. Guided Progression Analysis (GPA) capability

1. Requires GPA capability to allow provider to compare visual fields status and progression data collected from glaucoma subjects.

2. System must provide statistically significant change as well as rate of change, and predict future vision quality.

f. Glaucoma Hemifield Test (GHT) capability

1. Requires GHT capability to compare points in the superior and inferior hemifield to provide analysis of test results.

2. Must be capable of evaluating five zones in the superior field and compares these zones to their mirrored zones in inferior field.

3. Must be capable of evaluating the severity of disturbed points in each zone pair, relative to its normal database.

g. Kinetic Testing capability

1. Requires ability to kinetic test through light stimulus of fixed characteristics being moved into the visual field from a non-seeing area until detected by the patient.

2. Must provide a kinetic graphical interface with full 180 degrees of testing range.

Specifications for Zeiss OS|Cirrus HD-OCT Model 5000 with AngioPlex OCT or Equal:

h. Overall Technical Specifications

1. Must have capability to capture and provide OCT Angiography through a single OCT scan.

2. OCT scan must allow for visualization of both micro vascular and structural information in a noninvasive dye free scan

3. Requires ability to import and integrate Cirrus Model HD OCT 4000 raw data and be interchangeable between new Cirrus 5000 model.

4. Requires exact Macular Scan Pattern of 512x128 for retina scan with exact scanning speed at 27,000 A – scans a second within a 6mmx6mm.

5. Unit requires and exact scan pattern of 200x200 in a 6mmx6mm cube for Glaucoma Scan with exact scanning speed at 27,000 A – scans a second.

6. Scan pattern must be able to capture and provide RNFL, ONH, Neuro Retinal Rim Tissue, and 3-D Cube capabilities all in one scan. Scanning speeds required for these patterns must be available: Scan exactly 27,000 A-scans/sec, as well as the ability to scan at 68,000 A-scans/sec.

7. Unit must be capable of providing a report for Ganglion Cell Analysis that is derived from a scan comprised of 6mmx6mm cube scan with a minimum by 200x200 line scan pattern with no more than 30 microns between each slice.

8. Minimum pupil requirements must be 2.0mm or less.

9. Unit must utilize an LSO Fundus Camera.

10. Unit must automatically track to prior scan. This means the unit is required to perform this without a technician needing to align to prior scan.

11. Must provide an anterior segment scan that is at minimal 15.5mm in length x 5.8 mm in depth.

12. Must provide a global pachymetry report that is comprised of minimum of 24 radial scans and must be at a minimum 9mm length.

13. The unit must be a 90 degree configuration, so that the tech must sit to the side.

i. OCT Imaging requirements

1. Optical source must be a superluminescent diode (SLD), 840 nm

spacing between lines

j. Fundus Imaging requirements

1. Methodology must utilize line scanning ophthalmoscope (LSO)

2. Must provide live fundus image during alignment and during OCT scan

3. Optical source must be a superluminescent diode (SLD), 750 nm

4. Field of view must meet 36 degrees wide x 30 degrees height

5. Frame rate must meet >20 Hz

6. Transverse resolution must meet 25 um in tissue

k. Iris Imaging requirements

1. Methodology must utilize CCD Camera

2. Resolution must range 1280 x 1024

3. Live iris image must be available during alignment

4. Cannot weight more than 80 lbs.

5. Provides table at least 39”L x 22”W

Specifications for Networking & Warranty on both requested units:

l. Connectivity

1. Both must connect to existing GCHVCS Zeiss Forum Server located at the Biloxi VA Medical Center

amount of consideration will be made for a company who has a nationally-approved memorandum of understanding and/or interconnection security agreement (MOU/ISA).

m. DIACOM Conformance

1. Must be compliant with VA DAICOM Conformance standards.

n. Warranty

1. Must include a 1 year manufacturer warranty

2. Must provide (2) operator manuals for Eye Clinic staff

3. Must provide (2) service manuals for Biomed

4. Delivery Location Attn: Tess Finnegan (Project Manager)/Biomed Representative Mobile VA Outpatient Clinic (new) 4444 Demetropolis Road Mobile, AL 36619

5. Warranty and Support

VA Biomedical Engineering will have full access to the hardware that constitutes this equipment. The VA Biomedical Engineering point of contact must be briefed, by the vendor, on all upgrades and changes and agrees to each prior to shipment. The vendor will provide two (2) sets of user manuals and technical manuals to VA Biomedical Engineering. Additionally, Contractor shall provide the standard OEM (Original Equipment Manufacturer) warranty period for all equipment provided starting upon receipt of delivery to VA.

6. Material Safety Data Sheet (MSDS)

Contractor shall provide three (3) copies of each Material Safety Data Sheet for every product, chemical, etc. used on this project. MSDS sheets shall be provided for any material on the same day those materials arrive on VA property. At no time shall the contractor have, or permit subcontractors to have, materials on station without MSDS sheets. All instructions for use shall be followed. Products will not be used until MSDS's are submitted to the COR.

7. Delivery Coordination

Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR or Biomed Representative shall be the only VA entity signing for freight received on this requirement. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight. In event rescheduling occurs due to vendor’s failure to coordinate appropriately, all additional expenses associated will be assumed by the awarded vendor.

8. Additional Charges

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts or installation.

9. Packaging Waste management

Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contract shall fold metal and plastic banding, flatten and place in designated areas for trash as provided at CBOC.

10. Mandated GCVHCS Security Language

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.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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.

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.

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.

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.

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.

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 on site 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre- approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

SECURITY INCIDENT INVESTIGATION

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH

Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $ _______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day’s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING

All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber SecurityAwareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

HFA3 MODEL 860 W/ LIQUID TRIAL LENS, RELEYE, KINETIC, GPA, HEAD TRK, GAZE TRK, PRINTER & TABLE \F\ 1/EA\F\

LOCAL STOCK NUMBER: 266002-1154-536-PRO

266002-1161-980-PRO ZEISS OS \F\ CIRRUS HD-OCT (Model 5000) with AngioPlex OCT\F\ Angiography Version 9.5. Includes GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic

LOCAL STOCK NUMBER: 266002-1161-980-PRO

ZEISS OS \F\ FORUM BI-DIRECTIONAL DICOM INTERFACE LICENSE TO\F\ CZM INSTRUMENT (V3) \F\ EA\F\

LOCAL STOCK NUMBER: 306601-8530-101-PRO

B.3 DELIVERY SCHEDULE

4444 Demetropolis Road Mobile, AL 36619

USA

228-523-5365 tess.finnegan@va.gov

1.00

2.00

Page 1 of Page 1 of Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.2 VAAR 852.211-73 BRAND NAME OR EQUAL (JAN 2008)

(Note: as used in this clause, the term "brand name" includes identification of products by make and model.)

(a) If items called for by this invitation for bids have been identified in the schedule by a "brand name or equal" description, such identification is intended to be descriptive, but not restrictive, and is to indicate the quality and characteristics of products that will be satisfactory. Bids offering "equal" products (including products of the brand name manufacturer other than the one described by brand name) will be considered for award if such products are clearly identified in the bids and are determined by the Government to meet fully the salient characteristics requirements listed in the invitation.

(b) Unless the bidder clearly indicates in the bid that the bidder is offering an "equal" product, the bid shall be considered as offering a brand name product referenced in the invitation for bids.

(c)(1) If the bidder proposes to furnish an "equal" product, the brand name, if any, of the product to be furnished shall be inserted in the space provided in the invitation for bids, or such product shall be otherwise clearly identified in the bid. The evaluation of bids and the determination as to equality of the product offered shall be the responsibility of the Government and will be based on information furnished by the bidder or identified in his/her bid as well as other information reasonably available to the purchasing activity. CAUTION TO BIDDERS. The purchasing activity is not responsible for locating or securing any information that is not identified in the bid and reasonably available to the purchasing activity. Accordingly, to insure that sufficient information is available, the bidder must furnish as a part of his/her bid all descriptive material (such as cuts, illustrations, drawings or other information) necessary for the purchasing activity to:

(i) Determine whether the product offered meets the salient characteristics requirement of the Invitation for Bids, and

(ii) Establish exactly what the bidder proposes to furnish and what the Government would be binding itself to purchase by making an award. The information furnished may include specific references to information previously furnished or to information otherwise available to the purchasing activity.

(2) If the bidder proposes to modify a product so as to make it conform to the requirements of the Invitation for Bids, he/she shall:

(i) Include in his/her bid a clear description of such proposed modifications, and

(ii) Clearly mark any descriptive material to show the proposed modifications.

(3) Modifications proposed after bid opening to make a product conform to a brand name product referenced in the Invitation for Bids will not be considered.

(End of Clause) C.3 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)

(a) Definition. For the Department of Veterans Affairs, “Service-disabled veteran-owned small business concern or SDVSOB”:

(1) Means a small business concern:

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans or eligible surviving spouses (see VAAR 802.201 Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans (or eligible surviving spouses) or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been verified for ownership and control pursuant to 38 CFR 74 and is so listed in the Vendor Information Pages database, (https://www.vip.vetbiz.gov); and

(v) The business will comply with subcontracting limitations in 13 CFR 125.6, as applicable

(2) “Service-disabled veteran” means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(b) General.

(1) Offers are solicited only from verified service-disabled veteran-owned small business concerns. Offers received from concerns that are not verified service-disabled veteran-owned small business concerns shall not be considered.

(2) Any award resulting from this solicitation shall be made to a verified service-disabled veteran-owned small business concern.

(c) Agreement. A service-disabled veteran-owned small business concern agrees that in the performance of the contract, the concern will comply with the limitation on subcontracting requirements in 13 CFR §125.6.

(d) A joint venture may be considered a service-disabled veteran owned small business concern if the joint venture complies with the requirements in 13 CFR 125.15, provided that any reference therein to SDVO SBC is to be construed to apply to a VA verified SDVOSB as appropriate.

(e) Any service-disabled veteran-owned small business concern (non-manufacturer) must meet the requirements in FAR 19.102(f) of the Federal Acquisition Regulation to receive a benefit under this program.

(End of Clause) 852.219-74 Limitations on Subcontracting�Monitoring and Compliance.(JUL 2018)

LIMITATIONS ON SUBCONTRACTING�MONITORING AND COMPLIANCE

(a) This solicitation includes __________________________________________________ [Fill-in clause/provision] [Note: Contracting Officers must fill-in the applicable clause required to be included in sole- source and/or set-aside acquisitions (e.g., VA Acquisition Regulation (VAAR) 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside; 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) 852.219-75 Subcontracting Commitments Monitoring and Compliance.(JUL 2018)

SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. 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 contract 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 commitments.

(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 solicitation 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…