36C26119Q0793-003.pdf

Northern California VA Medical Center

Mather, CA 95655

SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR AUTOMATED TABLET PACKAGER

1. Background:

Purchasing one (1) OPTOS California P200DTXICG with color, AF, FA, and ICGA for Mather

EYE.

2. Project Scope:

To purchase one (1) OPTOS California P200DTXICG with color, AF, FA, and ICGA for Mather

EYE. The vendor will provide implementation and installation of the system.

Equipment Specifications:

• Single image must be able to capture 82% of the retina

• Single capture must be able to cover 200 degrees of the internal surface of the retina

• Single capture image must be able to reach beyond the equator showing vortex vessels and ampullae

• Ultra-widefield (200 degree) image must be able to be captured in less than ½ second

• Montage image must be able to show up to 97% of the retina (1166 mm^2)

• Ellipsoidal mirror with virtual point technology must enable maximum imaging field of view

• Must have clinically validated color imaging – must be proven to be equivalent to color fundus photography for pathology detection

• Must provide multiple wavelength color imaging: color, red-free, choroidal, and true-color views with a single capture

• Must present the images in a consistent geometry that accurately represents anatomical features across the retina and that allows for accurate measurements across the retina

• Must have color imaging with red/green lasers to minimize exposure to blue light

• Must have auto capture capabilities

• Must be non-mydriatic, cSLO technology images through 2 mm pupil

• Must include the following light source wavelengths: red 635 nm, green 532 nm, blue

488 nm, IR 802 nm

• Must include DICOM and be DICOM compliant

• Must be on the VistA imaging approved DICOM list

• Must be able to perform fundus autofluorescence (AF) with green laser to minimize exposure to blue light

• Must be able to perform fluorescein angiography (FA)

• Must be able to perform indocyanine green angiography (ICGA)

• Must include the following functions in one system: color photo, red-free photo, choroidal imaging, AF imaging, FA, and ICGA

• Must include alignment software to ensure that pictures are taken in the same place each time and that images in the same place taken w/different modalities and/or on different dates can be accurately overlaid for clinical comparison

• Must include image overlay software for accurate comparison of images from different days and in different modes

• Must be HIPAA compliant

• Must include image measurement tools

• Must be capable of combined FA and ICGA capture

• Must be able to connect to 3rd party image management software

• Must include an automatic, wheelchair accessible table

• Must be powered via connection to a standard AC outlet (100 to 240V)

• Maximum weight 75 lbs

• At least two-year warranty

• Must include installation and training

2. Delivery Location:

Sacramento VA Medical Center

10535 Hospital Way

Mather, CA 95655

3. Installation:

Vendor will deliver the equipment and provide all necessary labor, management, skills, materials, etc. required to install, train and maintain the fundus camera as described above. Installation activities to include the need for network access working in conjunction with IT department and

Biomed as needed. Any necessary files created during maintenance will not be saved via vendor.

Retention of data will be on internal VA server only. All backup data will be completed, performed and maintained by Ophthalmology Service.

All work and installation will be coordinated with the COR and individual sites Ophthalmology, OI&T, and Biomedical Engineering groups. The installation will occur at the discretion of the

COR and be coordinated with the site. All requested products will be completely manufactured as specified and delivered to Sacramento VAMC maximum of 30 days after contract award. The vendor will be responsible for installing a working system that meets Sacramento VAMC needs.

In addition to the COR, an additional representative at each of the facilities will act as a liaison to ensure that the vendor meets government expectations and follows the guidelines as set by the

Contracting Officer.

The vendor will confine operations (including storage of materials) on Government premises to areas authorized and approved by the Contracting Officer. The Contractor shall hold and save the Government, its officers and agents, free and harmless from liability of any nature occasioned by the Contractor’s performance. Working space and space available shall be as determined by the COR.

4. Warranty and Support:

Warranty of the equipment will be provided for two years upon receipt and acceptance of the equipment. The Chief Biomedical Engineer must sign off on acceptance before the warranty cycle begins. The warranty must be provided in the quote to cover all components of the OPTOS

California P200DTXICG with color, AF, FA, and ICGA system and hardware equipment.

Key Terms for warranty support:

• Two years of warranty upon initial receipt and acceptance signature

• 30 min call back response during normal business hours of 7AM to 5PM PST

• 24 hours, 7 days a week on-site coverage availability

• 24 hours’ on-site response time

• 6 hours’ on-site response for disabled systems

• Service reports sent to all appropriate points of contact with quarterly aggregate reports

• Uptime commitment of 96%

• Includes remote software and interface diagnostics, repair and replacement parts, software updates and upgrades

VA Engineering will have full access to the hardware and software that constitute the system, including any diagnostic software features and general administration rights. The VA Engineering point of contact must be briefed, by the vendor, on all software upgrades and changes and agrees to each prior to installation. The vendor shall provide and install manufacturer recommended software upgrades and changes at no additional charge during warranty/contract period. The vendor will provide one (1) set of user manuals and technical manuals to VA Engineering.

For any repairs or services that will be performed during normal working hours, the vendor’s service representative will report upon arrival to the VA Engineering Point of Contact or his designee. Upon completion of the work, the vendor’s service representative must report in person to the Point of Contact and must present a copy of his/her field service report signed by the service using the equipment. This report must reflect date and time of service, name of company, and the name of the vendor’s service representative. At a minimum, this report must contain a detailed description of any services or repairs performed and identification of the units serviced.

It must include a listing of replacement parts, when applicable. The report will also include the vendor’s recommendations necessary to maintain the equipment in best operating condition.

Preventive maintenance procedures followed should be thoroughly documented (step-by-step) on the service report.

A copy of the service report shall be provided to both the using Service and Biomedical

Engineering.

5. Testing:

The contractor shall verify to Engineering and Ophthalmology that the system meets all requirements stated on this contract through demonstration and validation. Warranty period will start upon sign off and acceptance signature from COR and using services.

6. Operations and Storage Areas:

The Contractor shall confine all operations (including storage of materials) on Government premises to areas authorized and approved by the Contracting Officer. The Contractor shall hold and save the Government, its officers and agents, free and harmless from liability of any nature occasioned by the Contractor's performance.

Working space and space available shall be as determined by the COR.

Debris will be removed daily by the contractor unless otherwise directed.

Workmen are subject to rules of the Medical Center applicable to their conduct. All personal automobiles and contractor trucks shall be parked at the contractor's staging area or offsite of the VA premises.

Execute work to interfere as little as possible with normal functioning of the Medical Center including operations of utility services, fire protection systems and any existing equipment, with work being done by others. Do not store materials and equipment in other than the designated contractor storage areas.

Daily, Contractor shall keep work, storage, and staging areas clean and neat. Contractor shall provide sufficient trash containers so that there is no debris lying around. The containers shall be emptied at least weekly and more frequently, if needed.

7. Protection of Existing Structures, Equipment, Utilities, and Improvements:

The Contractor shall preserve and protect all structures and equipment on or adjacent to the work site. The contractor shall replace at his own expense damage to such items to the satisfaction of the Contracting Officer.

Contractor shall take all measures and provide all materials necessary for protecting and preserving existing equipment and property in affected areas of installation against dust, debris and physical damage, so that equipment and affected areas to be used in Medical Center operations will not be hindered. Contractor shall permit access to VA personnel through installation areas as required for maintenance and normal Medical Center operations.

When the installation area is turned over to Contractor, Contractor shall accept entire responsibility therefore. Contractor shall maintain in operating condition, existing fire protection, alarm equipment and other operating equipment in the installation area. IT IS VERY IMPORTANT

THAT ESSENTIAL AND LIFE SAFETY SYSTEMS BE CONTINUOUSLY MAINTAINED AND NOT

INTERRUPTED WITHOUT TWO WEEKS PRIOR WRITTEN NOTICE AND APPROVAL FROM THE VA

MEDICAL CENTER.

8. Sign-in Procedures:

All Contractor workers are required to sign in and out at the VA Police Dispatch at the corresponding locations as directed by the COR or designee at each facility. A valid state driver’s license or state identification card is mandatory for all employees to have access to these facilities.

All contractor employees are required to wear the assigned VA badge always.

If after-hour key service is needed, contact VA Police Dispatch at the corresponding facilities.

9. Mobile Media Scanning:

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties.

Chief, Biomedical Engineering or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is in the biomedical engineering shop.

Safety Data Sheet (SDS):

Contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. used on this project. SDS 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 SDS sheets. All instructions for use shall be followed.

Products will not be used until SDS's are submitted to the COR.

The contractor shall maintain a current, green in color, loose-leaf notebook on the job site always, which is readily available for viewing by the COR or VA Safety Officer.

10. Work Hours:

Normal business hours are 7:30AM to 4:30PM Monday thru Friday excluding Federal Holidays.

Work completed outside this time must be requested through the COR.

Requests for after hours work must be submitted in writing to the COR two (2) weeks prior to work. The VA requires that information submitted must contain: extent of work, workers involved, the affected areas, and the estimated times of operation.

11. ID Badges:

All workers are required to obtain a time-limited I. D. badge from the VA Police Service located on the ground floor of Building 203. This badge must be worn at all times when workers are on site.

12. Estimates:

Vendors will submit one quotation for the purchase of the equipment and match the requirements outlined in this RFP. In the quotes, vendors will indicate whether their solution has MET, NOT MET or MET WITH QUALIFICATIONS for each line item in this document (MET WITH QUALIFICATIONS will require a detailed listing of non-compliance). In addition, vendors will complete the

Instructions to Offertory’s (ITO) and respond in detail to each question. Vendors are required to respond to each item individually in both documents. Include the specification/question number and text in your response document to facilitate review.

13. Records Management Language for Contracts Required

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR

Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. 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 by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the

Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the

Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. 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, this contract. The Contractor (and any sub-contractor) is required to abide by

Government and Agency guidance for protecting sensitive and proprietary information.

Security Language for inclusion in SOW/PWS

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. 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. 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.

c. 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.

d. 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.

e. 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.

f. 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.

4. Security Incident Investigation

a. 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.

b. 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.

5. Liquidated Damages for Data Breach

a. 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. However, it is the policy of the VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in the amount determined to be adequate by the agency.

b. 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.

c. 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.

d. 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 $37.50 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.

6. Training

a. 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 Security Awareness 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.]

b. 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.