Attachement 1 - Statement of Work.doc

MAGNETIC RESONANCE IMAGING (MRI) VITALS MONITOR SYSTEM

For

CHEYENNE VA MEDICAL CENTER - STATION 442

STATEMENT OF WORK (SOW)

MRI Vitals Monitor System - Cheyenne VA Medical Center (Cheyenne VAMC) Background Physiologic monitoring in the Magnetic Resonance Imaging (MRI) suite for those patients receiving workups regarding cardiac, Stroke, cerebral edema ect. is a standard of care. The MRI suite at Cheyenne historically has not had this capability thus the facility has relied on transferring these patients out to care in the community. This has affected both inpatient and emergency services. There is greater risk for the patient associated with delay in testing. This delay is often the result in finding an accepting facility, setting up transfer to the accepting facility and finally the actual transfer. To reduce this risk, the facility has identified that acquiring the correct monitoring equipment is essential to the operational mission for level 3 facilities.

Scope The MRI monitoring contract is to include one central unit that can monitor, blood pressure, pulse, oxygen, and cardiac rhythm. The central monitoring equipment is to include a removable monitor so that Registered Nurses (RN’s) can continuously monitor patient outside the testing room. The monitoring unit is to be MRI safe and have the capabilities to be operate within a few feet of the MRI scanner with minimal artifact interference from the magnetic field. The unit is to be stand alone and upgradeable for future physiologic monitoring. The contract also is to include an Infusion pump with the capabilities of micro and macro infusions. The Infusion pump is to be MRI safe and have the capabilities to operate within a few feet of the MRI scanner. Lastly, both equipment pieces are to have 510k certification.

Must: MRI physiologic Monitoring

1. MRI compliant Physiologic Monitoring system.

2. Closed system.

3. MRI compliant.

4. Have remote operation and monitoring capability.

5. Printing capabilities.

6. Perform continuous EKG, Blood Pressure, Pulse, C02, O2 monitoring.

7. 510k certification.

8. User manual, instructions for use.

9. Educational Inservice to staff for usage minimum 2 day.

10. Base 1 year warranty.

11. Reusable ekg leads and oxygen monitoring probes earlobe/finger.

12. Equipment roll stand.

13. Flexible mounting adapter.

Must: MRI Infusion pump

1. MRI compliant Infusion Pump.

2. Closed system.

3. Ability to perform micro/macro infusions.

4. MRI compliant.

5. Non-magnetic IV Pole.

6. Wireless control.

7. Modular pump channel.

8. Operate independently.

9. 510k certification.

10. User manual, instructions for use.

11. Educational Inservice to staff for usage minimum 2 day.

12. Base 1year warranty.

Specific Tasks

The contractor shall provide equipment, supplies and other items as defined below:

Task 1 - Enterprise Management Controls Subtask 1 - Integration Management Control Planning. Provide the technical and functional activities at the required level for integration of all tasks specified within this SOW. Include productivity and management methods such as quality assurance, progress/status reporting and program reviews. Provide the centralized administrative, clerical, documentation, and related functions.

Subtask 2 - Contract Management. Prepare a Contract Management Plan describing the technical approach, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout Contract execution. Provide a monthly status report monitoring the quality assurance, progress/status reporting and program reviews applied to this contract.

Deliverables:

Contract Management Plan Monthly Status Report Task 2

a. Subtask 1

a. All deliverables rendered under contract are subject to the inspection of the Chief, Healthcare Technologies Management. Should any deliverables not be to the satisfaction of the Chief, Biomedical Engineering, as submitted, the POC has the right to reject it or require replacement before payment will be authorized.

b. Subtask 2 Deliverables will be sent to:

Chief, Biomedical Engineering Biomedical Engineering Department

Cheyenne VA Medical Center 2360 E. Pershing Dr. Cheyenne Wy. 82001

Deliverables:

Performance Monitoring The government shall evaluate the Contractor’s performance under this contract in accordance with the Government’s Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government will do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Security Requirements

a. If the Contractor has access to printed and/or electronic files containing sensitive information in the performance of official duties, or inadvertently comes in contact with any such information, all information or data must be protected under the provision of the Privacy Act of 1974 and other applicable laws and regulations. The Contractor shall be responsible for: 1) protecting the information from unauthorized release, from loss, alteration, or unauthorized deletion; and 2) following applicable regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in VA Policy Memorandums.

b. The Successful Offeror shall be required to sign a Business Associate Agreement (BAA) similar to the one attached to the Solicitation prior to contract award.

Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) The Contractor will provide stand-alone wireless equipment that does not require network connections. This equipment is will not be considered Government-Furnished Equipment(GFE)/Government-Furnished Information (GFI).

Other Pertinent Information or Special Considerations Recorders Management

Records Management Language for Contracts

When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records.

Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. National Archives and Records Administration (NARA) has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. The majority of contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations.

This language should not replace specific records management requirements included within Federal information system contracts.

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.

2. does not include personal materials.

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

4. 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 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. Cheyenne VAMC 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 Cheyenne VAMC 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.

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 [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).

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 [Agency] 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 [Agency] policy.

8. 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.

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 [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.

11. 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.

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

There are 11 Federal Holidays set by Law:

BY DATE:

-New Year’s Day

January 1st

-President’s Day

February 20th -Juneteenth

June 19th -Independence Day

July 4th -Veterans Day

November 11th -Christmas Day

December 25th

BY MONTH/DAY:

-Martin Luther King Jr.’s Birthday Third Monday in January

-Memorial Day

Last Monday in May

-Labor Day

First Monday in September

-Columbus Day

Second Monday in October

-Thanksgiving Day

Fourth Thursday in November Identification of Possible Follow-on Work The vendor will provide scheduled preventative maintenance on a yearly basis per manufactures guidelines.

Identification of Potential Conflicts of Interest (COI) The vendor has not previously or currently been awarded a contract with Cheyenne VAMC Diagnostic Imaging or Magnetic Imaging Resonance service lines for medical equipment or any other contracted service agreements.

Identification of Non-Disclosure Requirements There are no non-disclosure requirements identified for this SOW based upon the determination that there is no sensitive or proprietary information to which the contractor will have access to during the performance contract.

Packaging, Packing and Shipping Instructions The equipment will be delivered to the Cheyenne VAMC Biomedical Engineering Department for inspection and installation prior to final acceptance.

Inspection and Acceptance Criteria The equipment will be delivered to the Cheyenne VA Medical Center Biomedical Engineering Department and the Contracting Officer Representative for inspection and installation prior to final acceptance.

Risk Control The Contractor shall address any infectious control cleaning and maintenance requirements to ensure optimal functionality of all medical grade MRI safe equipment. This shall include types of cleaning agents recommended by the manufacture and methods to be used for routine and preventative maintenance.

Place of Performance The equipment to be used under this contract shall be performed at the:

Cheyenne VAMC 2360 E. Pershing Blvd.

Cheyenne, WY 82001.

Period of Performance:

30 Sep 2024 thru 29 Sep 2025

PRS # 1

The Contractor shall provide the highest quality MRI compliant physiologic monitoring equipment equal to or better than other similar vendors.

PRS # 2

The Contractor shall comply with the pickup and delivery criteria contained within paragraph 13. of the Performance Work Statement.

Delivery Schedule The Contractor is responsible for conducting business, between the hours of 7:00 a.m. to 4:30 p.m., Mountain Time, Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government-directed facility closings. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this SOW, when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.