Drafted SOW.docx

Locations:

Central California HCS 2615 E. Clinton Avenue Fresno, CA 93703 Attention Carol Barquis

Sierra Nevada HCS 1000 Locust Street Reno, NV 89502 Attention Kylynn Nelson

San Francisco VAMC 4150 Clement Street San Francisco, CA 94121 Attention Gabby Orteza

Northern California HCS 10535 Hospital Way Mather, CA 95655 Attention Maia Gomez

Palo Alto HCS 3801 Miranda Avenue Palo Alto, CA 94304-1290 Attention Greg Chun

VA Pacific Islands HCS 459 Patterson Rd, Honolulu, HI 96819 Attention Kylie Matsumoto

Las Vegas VAMC 6900 North Pecos Road, N. Las Vegas, NV 89086 Attention Nick Summary

SOLICITATION FORMAT OF STATEMENT OF WORK

SECTION – ISCV SYSTEMS

DESCRIPTION/SPECIFICATIONS

FOR EMERGENCY AND ROUTINE SERVICE

1. EQUIPMENT IDENTIFICATION:

A. NAME/DESCRIPTION OF SYSTEM:

· MANUFACTURER – Philips Medical

· MODEL – ISCV IntelliSpace

· LOCATIONS – VISN 21 HOSPITALS

B. ISCV SOFTWARE COMPONENTS/PACKAGES

· TOMTECH (4D and 2D)

· Sites: Las Vegas, San Francisco, Palo Alto, and NorCal

· XPER interface

· Sites: Las Vegas, Fresno, and Mather

· CASS Workstation

· Sites: Hawaii, San Francisco, Palo Alto, Fresno, NorCal

· MUSE Interface

· All sites listed in locations

C. LICENSE COUNTS

· 10 concurrent users: Palo Alto, Las Vegas, NorCal, and San Francisco

· 5 concurrent users: Hawaii, Reno, and Fresno

2. DEFINITIONS/ACRONYMS:

A. Biomedical Engineer(ing) - Supervisor or designee.

B. CO - Contracting Officer

C. COR - Contracting Officer's Technical Representative

D. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAH premises.

E. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

F. Authorization Signature - COR signature or designee; indicates COR accepts work status as stated in ESR.

G. OEM - Original equipment manufacture of the hardware and software with full access to source code.

H. VHA - Department of Veterans Affairs Hospital

3. CONFORMANCE STANDARDS: - Contract service shall ensure that the ISCV software functions in conformance with original manufacture’s specifications.

4. COMPONENTS COVERED: - All ISCV, IBE (interface broker), and associated software components. This include HL7 inbound and outbound orders and includes reporting back into VISTA EMR. All interface, DICOM Modality Worklist, results and reporting must apply to both echo and XA systems used in VISN 21.

5. HOURS OF COVERAGE:

A. Clinical Application Support and Education: Monday through Friday from 8AM to 5PM (local time)

B. Hardware Support: Monday through Friday from 8AM to 5PM (local time)

Only included in base year of contract

C. Telephone Support: 24 hour 7 days a week.

All service/updates will be performed during normal hours of coverage unless requested or approved by Facility POC designee.

6. UNSCHEDULED MAINTENANCE (Emergency Repair Service):

A. Contractor shall maintain the equipment in accordance with the manufacturer’s specifications. The Contractor will provide repair service that may consist of software updates, critical software patches, product enhancements, and technical support.

B. The CO, COR or facility designee has the authority to approve/request a service call from the Contractor.

C. Response Time: - Contractor's FSE must respond to a phone call within 2 hours. For onsite service, contractor and repair parts must be on site by next business day if issue cannot be resolved via remote support or telephone.

7. SCHEDULED MAINTENANCE:

A. Not Applicable

8. SOFTWARE: - The Contractor will have access to the latest version of the ISCV software and provide the latest updates, patches, and or revisions as they are released. All software must come from and be validated by the OEM. Contractor must ensure that ISCV software licenses never expire during the duration of the contract. Contractor will support software, patches. and upgrades on all servers and reading station used for ISCV.

9. EDUCATION/CLINICAL APPLICATION SUPPORT: - The contractor shall provide OEM approved and validated training to the clinical staff on the ISCV software. All educators shall have current certification from the OEM. Education shall be provided for any major or minor software release and be scheduled at the request of the clinical staff

The contractor shall provide clinical application support of the ISCV software. Support hours are covered in Section 5. Application support shall be provided by OEM certified staff (certification must be current). Application support can be provided via phone and or remote computer support.

10. SERVICE MANUALS/TOOLS/EQUIPMENT: - The VAH shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request.

11. DOCUMENTATION/REPORTS: - The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, required to maintain the equipment in accordance with the OM specifications. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C. Contractor service ESR number/log number.

D. Date, time (starting and ending), downtime and hours for service call.

E. Total Cost to be billed (if applicable - i.e., item(s) not covered).

F. Description of problem reported by facility designee (if applicable).

G. Identification of equipment to be serviced:

1) Manufacturer's name,

2) Device name,

3) Model number,

4) Location,

5) Any other manufacturer's identification numbers.

H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

NOTE: - Any additional charges claimed must be approved by facility designee before service is completed!

12. REPORTING REQUIREMENTS: - The Contractor shall be required to report to Biomedical Engineering to check in for onsite service. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s) (preferably electronic). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to facility designee.

13. PAYMENT: - Invoices will be paid in arrears on a monthly basis. Invoices MUST INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered and covered period of service.

14. ADDITIONAL CHARGES: - Not Applicable

15. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: - The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or the development of any defects in, or repairs required, to the equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

16. CONDITION OF EQUIPMENT: - The Contractor accepts responsibility for the software, in "as is" condition. Failure to inspect the software prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

17. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Each respondent must have an established business, with an office and full time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup at minimum.

B. "Fully Qualified" is based upon authorized OEM training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program with the OEM, be currently approved by OEM to work on the system, and have full rights to software and hardware code.

C. The FSEs shall be authorized by the Contractor to perform the services. All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs. The CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel.

D. If subcontractor(s) are used, they must be approved by the COR and CO; the Contractor shall submit any proposed change in subcontractor(s) to the COR and CO for approval/disapproval.

18. COMPETENCY OF PERSONNEL PROVIDING CLINICAL SUPPORT AND EDUCATION:

A. Each respondent must have an established business, with an office and full time staff. The staff includes a "fully qualified" clinical support and education staff and a "fully qualified" backups.

B. "Fully Qualified" is based upon authorized OEM training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program with the OEM, be currently approved by OEM to support and educate clinicians on the system, and have full rights to software.

C. The clinical support and education staff shall be authorized by the Contractor to perform the services. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs. The CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel.

D. If subcontractor(s) are used, they must be approved by the COR and CO; the Contractor shall submit any proposed change in subcontractor(s) to the COR and CO for approval/disapproval.

19. ADDITIONAL SUPPORT SERVICES: -

· Contractor will assist with 3rd party systems that interface with ISCV systems and provide support to resolve issues.

· Contractor will perform health checks on hardware and provide recommendations on health to include risks, availability, and usage.

· Contractor can send authorized FSE and clinical support and education staff to assist with software updates.

20. REMOTE SUPPORT: The contractor shall have proper access and control to remotely monitor all equipment as required in Section 4. The contractor must demonstrate active security clearance before award or ability to remotely monitor devices. The contractor must furnish all remote support software and any associated costs. All support personnel must reside within United States of America and be US citizens unless approved via a MOU/ISA.

21. MOBILE MEDIA SCANNING: - The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Facility 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 located in the biomedical engineering shop at VISN 21 sites.

22. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: - The Contractor's FSE’s shall wear visible identification at all times while on the premises of the VAH. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VAH Police Section. The VAH will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAH. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

Security Language:

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/subcontrator 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 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.

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 COR.

6. 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 COR 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.

c. 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.

d. 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.

7. 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.

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.

9. 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 COR 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.

Invoicing: All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-invoice email: vafsccshd@va.gov

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

C. Requirements

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flow down of requirements to subcontractors