36C24222Q0120_1.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

POINT OF CONTACT*

Contract Specialist Fuqua, Stacey Stacey.Fuqua@va.gov Stacey.Fuqua

PLACE OF PERFORMANCE

79 Middleville Road

Northport, NY

ADDITIONAL INFORMATION

DESCRIPTION

Synopsis:

Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. Network Contracting Office (NCO) 2 of the Department of Veterans Affairs is currently conducting a market survey for qualified firms capable of providing “Maintenance Services Software Maintenance Contract for the Bernoulli Virtual ICU Suite License at located at 79 Middleville Road, Northport NY 11768, at the Northport VA Health Care System. The contractor shall provide necessary labor, equipment, tools, materials, software updates, parts, etc., for complete Licenses Subscription, On-Site SW Maintenance, phone and e-mail SW updates Services. The North American Industry Classification Systems (NAICS) is 811219. Responses to this notice must be submitting in writing (email) and must be received not later than November 12, 2021 at 10:00AM. Email: Stacey.Fuqua@va.gov. No telephone inquiries will be accepted. Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic.

The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business), relative to NAICS 811219. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.

STATEMENT OF WORK

VETERANS AFFAIRS NORTHPORT MEDICAL CENTER

BERNOULLI VIRTUAL ICU SUITE LICENSE SOFTWARE MAINTENANCE SERVICE CONTRACT

STATEMENT OF WORK

The Department of Veterans Affairs Medical Center is currently seeking Software Maintenance Services Contract for the Bernoulli Virtual ICU Suite License. Bernoulli Virtual ICU Suite License surveillance and medical device Ventilator alarms integration and Reporting software for Pulmonary and Nursing services. The Contractor shall furnish all necessary labor, equipment, tools, materials, software updates, parts, etc., for complete Licenses Subscription, On-Site SW Maintenance, phone and e-mail SW updates Services.

SCOPE OF WORK:

Software support and updates Services will be provided, at the request of the VA, to diagnose and correct equipment malfunctions on a routine basis. All software updates shall be performed solely by manufacturer trained staff, with current applicable certifications from the Original Equipment Manufacturer (OEM). Contractor will follow manufacturer’s recommendation for software maintenance (SW-M), updates, calibrations and modifications. Full-service contract shall include all necessary labor, tools, equipment, transportation and parts required to perform software support and updates on listed equipment. All equipment shall be maintained in proper operating condition as specified by the manufacturer. Vendor shall have access to OEM’s latest software version release to perform the service.

No work shall be performed outside the scope of this contract. Any justification must be pre-approved by the Contracting Officer, and a modification to the contract as well as a purchase order must be issued before any work can commence. Failure to obtain prior authorization shall result in NON-PAYMENT of charges incurred.

1. SOFTWARE PREVENTATIVE MAINTENANCE:

a. The contractor shall perform software updates maintenance services to ensure that equipment listed under Section 12 performs in accordance with Conformance Standards (Section 11). The contractor shall make thorough technical inspections of the equipment listed in Section 12 within ten (10) days after the award of the contract. The contractor shall submit a schedule of services describing in detail the scheduled maintenance procedures for each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM.

b. Service shall be mutually scheduled within 10 days after submission and approval of the scheduled services as outlined above.

c. Software updates performed shall be in accordance with manufacturer’s specifications, documented, and submitted in writing to biomedical engineering at inception of contract. Upon completion of software updates, the unit shall be clearly labeled with a sticker stating the date last software and software version, as well as name of technician that performed said software updates.

d. Contractor shall perform all unscheduled services, including software patching and software vulnerabilities mediations when needed. This includes on-site visits during normal business hours and repair, labor and travel costs relating to the services to be performed. 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 before such site visits take place.

e. The contractor assumes the risk of, and shall be responsible for, any loss, damage, destruction, or theft of Government furnished property as well as the equipment being serviced by the Contractor.

f. Prior to commencement of work on this contract, contractor shall provide the VAMC with a copy of the current calibration certification on all test equipment which is to be used by the contractor on VAMC equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

g. Software services shall include, but are not limited to the following (where applicable):

i. Reviewing operating system software diagnostics to ensure that the system is operating to the manufacturer's specifications.

ii. Performing remedial maintenance of non-emergent nature.

iii. Measuring and adjusting and calibrating as necessary for optimal performance, output or image quality.

iv. Image quality assessment.

v. Returning the equipment to the operating condition defined in Section III, Conformance Standards.

vi. Providing documentation of services performed.

2. RESPONSE TIME:

Contractor shall provide a phone call back by a qualified technician within 2 hours of a service request and an onsite response by a qualified technician within 6 hours. The Contractor shall proceed progressively without undue delay to correct the misfunction or mechanical breakdown. Equipment shall be returned to fully functionality, to manufacturer specifications within 16 business hours of initial service call.

Place of performance

· VETERANS AFFAIRS NORTHPORT MEDICAL CENTER

79 Middleville Road, Northport NY 11768

3. ESTIMATE PERIOD OF PERFORMANCE:

· Base Option Year: November 22, 2021- November 21,2022

· Option Year (1) One: November 22, 2022- November 21,2023

· Option Year (2) Two: November 22, 2023- November 21,2024

· Option Year (3) Three: November 22, 2024- November 21,2025

· Option Year (4) Four: November 22, 2025- November 21,2026

4. HOURS OF COVERAGE:

· 8:00am to 4:30pm, Monday-Friday (excluding Federal Holidays). Overtime shall only be paid for emergencies and pre-approved situations as determined and approved by the Contracting Officer.

· Federal Holidays observed by the VAMC are: And any other day specifically declared by the President of the United States to be a national holiday.

New Year’s Day Labor Day Martin Luther King Day Columbus Day President's Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day

5. DOCUMENTATION REQUIREMENTS:

At the completion of each service call/PM, the contractor shall provide a written service report to Biomedical Engineering. This report shall clearly show the date of service, type of service performed, model and serial numbers, name of field technician(s), a description of the work performed (including time spent for labor and travel) and a list of any parts replaced. The contractor shall leave the service report with Biomedical Engineering Administrative Office, building 11, room 1 after servicing equipment. Certification of invoices is clearly dependent upon receipt of service reports as proof of services rendered. Payment shall be declined if proper documentation is not provided.

a. If work is not completed prior to leaving the premises, a service report shall be left, as per the above procedures, indicating the equipment status.

b. No payments shall be made if the above procedures are not complied with.

6. QUALIFICATION OF VENDOR:

To be eligible for consideration, offerors shall have acquired certification in servicing the equipment listed for a period of no less than two (2) years prior to award. The contractor’s representative shall have received service training from the equipment manufacturer specifically on the model(s) listed and shall be capable of presenting certification of such training. No allowance will be made for the contractor not having qualified personnel available to respond as specified in this contract at all times within the contract period.

7. SECURITY AND REPORTING:

a. All vendors/contractors will sign-in at the Biomedical Engineering Administrative Office building 11 room 1, before reporting to their respective work site. Each vendor/contractor will be issued a temporary identification badge that must be worn at all times above the waist, in front, with the face of the card visible.

b. Upon completion of the scheduled work, the vendor/contractor will return to the Biomedical Engineering Administrative Office building 11 room 1, to sign-out, return the temporary identification badge, and leave any Service Reports.

c. Outside of Normal Business Hours, the Service Report(s) may be left in the Biomedical lock-box located at the entrance to Biomedical Engineering (Building 11, Basement Level, Room 1). Detailed Service Report(s) must be received within five (5) business days after completion of work, electronically e-mailed to the COR.

d. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and COR in writing, of the existence or the development of any defects or repairs required to the scheduled 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.

8. STANDARD BIOMEDICAL PROCEDURE:

For the sake of this contract, equipment capabilities and diagnostic analysis of equipment as they relate to storage of and access to patient sensitive information will be determined by the separate completion of the Information Security 6500.6 Checklist. Contractors shall be expected to comply with Department protocol regarding removable media (i.e. USB or DVD/CD Device), hard drives, optical disks, remote system diagnosis, and compliance with applicable Federal and VA information confidentiality and security laws, regulations and policies.

9. CONFORMANCE STANDARDS:

The contractor shall ensure that the equipment (hardware and software) functions in conformance with the latest FDA (medical device regulations (including but not limited to Class I, Class II, Class III and MDDS), validation, quality assurance and compliance), latest published edition of NFPA-99, TJC, OSHA, CDRH, and any other performance standards and specifications used when the equipment was procured by VA and any upgrades/updates.

10. SERVICE MANUALS

The VAMC shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its Service Technicians all operational and technical documentation, (such as; operational and service manuals, schematics, and parts list), 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. NATIONAL ARCHIVES and RECORDS ADMINISTRATION (NARA) RECORDS MANAGEMENT

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

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

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

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

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

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

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

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with The Department of Veterans Affairs Northport Medical Center policy.

8. The Contractor shall not create or maintain any records containing any non-public The Department of Veterans Affairs Northport Medical Center information that are not specifically tied to or authorized by the contract.

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

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

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

12. Information Security and Privacy The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

· Data, for the sake of this contract, equipment capabilities and diagnostic analysis of equipment as they relate to transmission, storage of and access to patient sensitive information will be determined by the Business Associate Agreement (BAA).

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.

VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data

- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

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 $______ 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.

Sources Sought Notice