Draft PWS 2021.docx

Performance Work Statement Operating Room Integrations System Southeast Louisiana Veterans Health Care System New Orleans, LA 04/08/2021

1. BACKGROUND

The Operating Room (OR) Integrations System was purchased in 2016 to improve access to information within multiple assigned areas at Southeast Louisiana Veterans Healthcare System (SLVHCS). Implementing the system required purchasing and installing hardware and training personnel to use the system. The proposed contract for this requirement will serve as a continuation of the software, application usage maintenance, updates, system enhancement, database management, backup and recovery, and 24-hour support necessary for the integration of surgical room technologies.

2. PURPOSE

The purpose of this requirement is to initiate a new service agreement/contract for the OR Integration System that is currently being used in the facility. The proposed service agreement/contract would cover all necessary software, application usage maintenance, updates, system enhancement, database management, backup and recovery, and 24-hour support for the following time periods: One base year of twelve (12) months and four (4) option years that are each 12 (twelve) months.

License and Service Contract Period of Performance

3. SCOPE

The vendor shall provide all labor, materials, hardware, maintenance, database management, backup and recovery, and support necessary to ensure the OR Integration System functions at full capacity while in use at the facility (to include operating as intended by the manufacturer). Required Services for the system include the following tasks/items (listed below). Required services on the equipment shall also include the Deliverables as annotated in Section 4 of this Performance Work Statement.

The proposed contract shall include a service plan for the OR Integration System which includes usage access/rights for authorized users of the system (as part of the cost of the service plan). This service plan includes the following:

· Usage Fees (inclusive) which enables users the appropriate access/rights so they can operate the system in the facility

· Application usage maintenance

· Updates and enhancements

· All system maintenance and enhancements

· All database management, back-up and recovery services

· Training on enhancements

· 24-hour Customer support and documentation

Place of performance: Southeast Louisiana Veterans Health Care System (SLVHCS), 2400 Canal Street, New Orleans, LA, 70119. Operating Room Integration System Locations

8 Operating Rooms 1 Hybrid Operating Room 2 Cath Labs 2 Interventional Radiology (IR) Suites 1 Electrophysiology 1 Endoscopic Retrograde Cholangiopancreatography Suite 1 Bronchoscopy Suite 6 Gastroenterology Suites 7 Office/Conference rooms 1 data center

Hours of operation: Surgery – 6:00 AM to 7:00 PM CST.

Requests for services shall be made via telephone or email by authorized VA Surgery personnel, VA Clinical Engineering personnel, the Contracting Officer, or other authorized VA designee only.

All work shall be approved prior to commencement.

Work shall not be considered complete until accepted by an authorized VA designee. Contractor shall only be paid for work that has been completed during the period of performance stated on the contract. Contractor cannot be paid (and should not invoice) for work/services that have not been scheduled or completed.

All work shall be coordinated through an authorized VA designee. Access to VA space must be coordinated and approved by VA Surgery personnel and/or VA Clinical Engineering personnel (or designee) prior to the beginning any work that is to be performed.

4. DELIVERABLES

Contractor shall furnish all parts, maintenance kits, consumable and expendable items, and supplies necessary to perform scheduled and unscheduled maintenance on the equipment. All materials and services provided shall be according to the Original Equipment Manufacturer (OEM) specifications and guidelines. During scheduled service intervals, all parts including new batteries and accessories shall be replaced at no additional cost.

DELIVERABLE #1 - SOFTWARE UPDATES:

Software updates and patches as necessary to maintain full functionality of the installed system. All software updates shall be installed by the contractor to current OEM specifications during the performance period of the contract at no additional cost to the government. Before installation/configuration, applicable software must be validated by the Clinical Engineering Department (or other appropriate departments/individuals) to ensure that such software conforms to the agency’s architecture and accessibility standards. Installation processes must comply with security, privacy, and safety requirements per VA standards, policies, and directives set forth. OEM software updates must meet all requirements of VA Handbook 6500 and Directive 6550. Before initiating OEM updates the contractor shall coordinate with one or more of the following parties if necessary: Clinical Engineering Department, COR, Information Security Officer (ISO).

DELIVERABLE #2: - PARTS:

Only new, standard parts shall be furnished by the contractor. All parts shall meet current manufacturer standards and have versatility with presently installed equipment. All replacement parts become the property of the Government once installed by the contractor. Replaced parts are to be disposed by the Contractor after obtaining approval from the Contracting Officer's Representative (COR).

DELIVERABLE #3 - SCHEDULED SERVICES:

Contractor shall perform the OEM's Scheduled Periodic Manufacturer's Certification, electrical safety checks, and software updates on the equipment. Scheduled travel is included as part of the service contract. The contractor shall account for all travel expenses associated with the completion of the requested tasks. Anticipated travel costs associated with the execution of the service plan(s) on the equipment shall be included in the total cost of the service plan(s). The Contractor’s technical service representative shall contact Clinical Engineering and the COR at least three (3) weeks prior to the recommended scheduled maintenance date to plan/coordinate the required work that is to be performed. All services shall be performed during normal business hours unless an alternate work schedule has been approved by Clinical Engineering and/or the COR. Normal business hours for Surgery are from 6:00 AM to 7:00 PM CST. Required services contained within the service plan on the equipment shall be delivered on a continual basis during the performance period of the contract. Required maintenance services and 24-7 support services (24 hours a day, 7 days a week) shall be provided as needed or as requested by the government.

DELIVERABLE #4 - UNSCHEDULED SERVICES:

Contractor shall perform all unscheduled services, including emergencies, when needed. This includes on-site visits during normal (Surgery) business hours to include repair, labor and travel costs relating to the services to be performed. The contractor shall account for all travel expenses associated with the completion of the requested tasks. Anticipated travel costs associated with the execution of the service plan(s) on the equipment shall be included in the total cost of the service plan(s). In cases when technical support is required over the phone, the contractor shall provide 24/7 technical support to the government at no additional cost. All site visits must be scheduled, coordinated, and approved by Clinical Engineering and/or the COR (or other authorized representative/designee) before such site visits take place.

DELIVERABLE #5 - MANDATORY SAFETY CORRECTIONS:

Safety corrections on the equipment, as required by OEM or Food & Drug Administration (FDA) regulations, is covered within the scope of this requirement (contract).

DELIVERABLE #6 MOBILE MEDIA SCANNING:

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform the tasks/deliverables during the performance period of the contract. The COR (or other authorized representative/designee) will ensure that the removable media (to be used) is scanned with anti-virus software (to include running current virus definitions) prior to connection to any medical device system located in the facility. The computer system for scanning removable media will be designated by the COR.

DELIVERABLE #7 REPORTS/DOCUMENTATION:

For any services performed on site, upon arrival at the Medical Center, the technical service representative shall check in with the Clinical Engineering Department before performing any warranty related services, repairs and/or other maintenance services. This check-in is mandatory. A legible, signed service report shall be provided directly to Clinical Engineering Department following completion of each service call/visit and shall include equipment identification (i.e. serial number), date and time of service call, list of parts replaced, results of inspections and/or calibrations, and a description of the work accomplished. This report shall be signed or initialed by the Clinical Engineering Department. Service reports shall be provided within five days after completion of the work performed. All service reports shall be emailed within five days of completion of the maintenance work to VHANOLClinicalEngineering@va.gov and the Biomedical Equipment Support Specialist coordinating the work. During the service, the contractor shall report any changes in delivery requirements/problems to the COR (Contracting Officer Representative).

DELIVERABLE #8 - PERSONNEL:

Contractor shall provide all necessary personnel to maintain the system. Labor required for both scheduled and unscheduled (emergencies) services are included as part of the cost of the service plan/contract for this requirement. Contractor employees (who will be performing work and executing tasks/deliverables) on the equipment shall be factory trained, qualified, certified, and licensed on the specific maintenance services that are required/needed. Work/tasks shall not be performed by individuals lacking the credentials/qualifications/certifications listed herein. The Contractor shall provide written assurance of the competency for their personnel and a list of credentials of approved Field Service Engineers for each system before these individuals begin work or perform services on the equipment/system. All technical service representatives provided by the contractor shall comply with VA security management program directives and shall obtain the appropriate clearances from the VA police, possess the appropriate identification (job title, position/employer), and only be allowed in areas where access has been granted/authorized. All key personnel shall be certified by the manufacturer to be able to perform maintenance, upgrades, or any other service covered under this contract.

In accordance with VA HB 6500.6 Contract Security (March 12, 2010), this applicable VA contract security language is incorporated into this Performance Work Statement (PWS):

5. 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.

6. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth.

Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

7. 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 COTR.

8. 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.

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.

9. 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 Personally Identifiable Information (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 $2,500.00 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.

10. 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.

11. 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 rolebased 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.

12. REFERENCE (S):

a. VA Affairs Handbook 6500, Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program, 10 Mar 2015.

b. Veterans Health Administration Procurement Manual (VHA PM) – 11/3/2014.

c. VA Handbook 1901.01, Health Information Management and Health Records – 19 Mar 15.

d. VHA Handbook 1605.5, Business Associate Agreements – 22 July 2014

e. Privacy Act of 1974 (5 U.S.C. 552a).