SOW Pulmonary Function System.docx

Statement of Work Eastern Colorado HealthCare System Rocky Mountain Regional VA Medical Center

1. Purpose:

1.1 Rocky Mountain Regional VA Medical Center (RMRVAMC) located in Denver, Colorado would like to procure Vyntus One PFTs and Vyntus One Complete systems as well as upgrades and support for the systems.

2. Description of Work:

2.1 The Contractor shall furnish the systems and parts listed below.

2.2 Nomenclature and Part Number(s):

3. Contractor Requirements:

3.1 The Contractor shall provide all products listed in Description of Work without substitutions (unless pre-approved by the VA POC).

3.2 Contractor shall provide mandatory safety and performance-related updates to covered equipment and software.

3.3 Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete unscheduled maintenance is included within this contract unless specifically stated in writing otherwise and approved by the VA POC.

4. Delivery:

4.1 Delivery will be made within 30 days of award unless specified differently within the scope of the contract.

4.2 Contractor shall deliver all equipment and supplies to the following address:

4.3 Delivery Hours of Operation: Monday – Friday; 0700hrs – 1500hrs; excluding all Federal Holidays and any other day specifically declared a National Holiday by the President of the United States.

· New Year’s Day

· Dr. Martin Luther King Jr’s Birthday

· Presidents’ Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veteran’s Day

· Thanksgiving Day

· Christmas Day

4.4 When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by US Government Agencies.

5. Operation and Maintenance Deliverables:

5.1 Operation and Maintenance Manuals

5.2 Digital Copies; Quantity of 1 each for items listed in Paragraph 2, Section 2 if applicable.

6. Security Requirements:

6.1 Security background checks are not required.

6.2 The Contractor will not have access to VA Desktop computers they will not have access to online resources belonging to the government.

6.3 The Contractor will not have access to protected Patient Health Information (PHI), nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required; any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

6.4 The C&A Requirements do not apply.

6.5 The Security Accreditation Package is not required

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:

1. includes [Agency] records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

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.

1. 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.

1. 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.

1. [Agency] 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 [Agency] 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 [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

1. 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 [Agency] 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).

1. 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 [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

1. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

1. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

1. 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.

1. The [Agency] 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 [Agency] 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.

1. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-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.

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

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

1. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.