S02 - ATTACHMENT 3 - STATEMENT OF WORK - BIPAP V60 REPLACEMENT - BRAND NAME OR EQUAL TO NIHON KOHDEN IAW SOW - 03-18-2025.pdf

B.2 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

BIPAP V60 REPLACEMENT

A. GENERAL:

Scope of Services:

The purpose of this requirement is to replace the current V60 non-invasive positive pressure ventilators for the Respiratory Department at the Louis A. Johnson VAMC. The brand name NKV-330 Ventilator System or equal requirement includes the ventilators, accessories/carts, and software for the eight (8) systems. The procurement shall include all parts, materials, labor, software/licenses, and travel to complete the full installation of the ventilators.

Location: Louis A. Johnson VA Medical Center, 1 Medical Center Drive, Clarksburg, WV 26301

Performance Period: Delivery within 90 days from contract award

B. WORK HOURS:

a. Hours of Operation: Normal business hours are Monday through Friday, 7:00 a.m. to 4:00 p.m., excluding holidays. Should the Contractor require work afterhours, the Contractor shall arrange in advance with the Contracting Officer’s Representative (COR).

b. Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday, 7:00 a.m. to 4:00 p.m., excluding holidays.

c. National Holidays: The holidays observed by the Federal Government are:

New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.

Contractor may work on holidays with prior communication and coordination.

C. SPECIFICATIONS:

a. Minimum Technical Requirements: Brand name NKV-330 Ventilator System or equal:

i. The procurement is for a quantity of eight (8) non-invasive positive pressure ventilators.

ii. Six ventilators shall include a wheeled trolley, bedrail hook, ETCO2 cable, dual oxygen cylinder holder, circuit arm, waterbag pole, and 8ft DISS oxygen hose.

iii. Two ventilators shall include a wheeled trolley, bedrail hook, dual oxygen cylinder holder, circuit arm, waterbag pole, and 8ft DISS oxygen hose.

iv. The ventilators shall have bilevel positive airway pressure (BIPAP) capability.

v. The devices should have heated high flow nasal cannula capability.

vi. The ventilator shall be able to be used in the following modes:

1. SPONT – PS (spontaneous ventilation with pressure support)

2. S/T (spontaneous with timed backup)

3. PCV (pressure control ventilation)

4. PRVC (pressure regulated volume control)

5. PPS (proportion pressure support ventilation)

6. O2 therapy (high flow oxygen therapy)

vii. The systems shall be functional with or without built-in leak circuits.

viii. The systems shall have dual HEPA filtration.

ix. The system shall have visible alarms for critical ventilator events.

x. The ventilators shall include full data disclosure with at least 72 hours of continuous analog signals stored.

xi. The procurement shall include roll stands and the required brackets/mounts for use with the roll stands.

xii. The system shall include all necessary software and licenses.

xiii. The ventilators shall have a color touch screen at least 12 inches diagonally.

xiv.The ventilators shall have a battery life of at least 5 hours and/or continuous battery life with hot-swappable batteries.

xv. The devices should feature integrated capnography (ETCO2) monitoring capability.

xvi.The devices should be compatible with NPPV masks.

xvii. The unit must have or accept the bracket necessary for the Fisher & Paykel

MR850 heated humidifiers that will be used in-circuit.

xviii. The systems should include an anti-asphyxiation valve.

xix.Contractor shall provide two copies of the operating and service manuals.

b. Delivery Requirements

i. Delivery is required 90 days from award of the contract.

ii. Large deliveries are to be coordinated in advance with the COR to ensure necessary planning takes place.

iii. Contractor is to provide the COR with shipment tracking information.

c. Installation Requirements

i. Full installation of the system shall be included as a part of this contract.

ii. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract.

iii. Contractor is required to complete all configuration for the system to be usable.

iv. Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation.

v. Patient Health Information

1. The Contractor shall safeguard patient health information.

2. The Contractor shall report to the Biomedical Engineering

Department any issues with disclosed or unsecure patient health information.

d. De-Installation Requirements

i. Contractor shall not remove any hard-drives or storage systems containing sensitive or patient health information.

e. Training Requirements

i. Contract shall include training for the end-users in the operation of the system.

1. Training shall be on the function and use of the device, in addition to any software/applications during the one week of installation.

2. Training shall be on-site.

ii. Contract shall include training for the technical professionals (Biomedical

Equipment Support Specialists)

1. Training shall include two days of on-site instruction covering operation, basic servicing, preventative maintenance, disassembly and reassembly, and system servicing.

f. Contractor Requirements

i. All Contractor personnel performing installation services of the equipment shall have factory training and experience in the implementation of the equipment.

ii. Contractor shall provide copies of training certificates for the Contractor personnel performing work on-site upon the request of the Government.

g. Warranty Information

i. The equipment shall have a warranty of 1 year from the full installation/acceptance of the equipment.

ii. Warranty support shall include repair of the system.

iii. Warranty support shall include all parts, materials, labor, and travel to complete the repair or maintenance.

iv. Requests for warranty support shall be made to the telephone support number provided by the Contractor.

v. Warranty support requests shall be responded to within 1 day.

vi. Contractor shall provide a copy of the service report, complete with test data, to the contract COR within five working days after completion of any services.

vii. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer names of the personnel performing work, and the date service was provided.

viii. On-Site Procedures

1. Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department.

2. Contractor personnel shall sign in using the department’s vendor sign in sheet, filling out all required information.

3. Contractor personnel’s tool bags are subject to inspection by the

Biomedical Engineering department upon arrival and upon departure.

4. Contractor personnel shall sign out upon completion of visit.

5. Prior to departure, Contractor personnel are required to, at a minimum, verbally report any issues with the equipment to the Biomedical Engineering department, especially noting if the system is still down or not fully repaired.

6. The VA campus is non-smoking. Contractor personnel are required to comply with this policy.

7. Parking. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

h. Safety and Security

i. Contractor shall follow all Occupational Safety and Health Administration

(OSHA) laws and regulations. The Contractor is responsible for reporting any hazards they come across to their point of contact.

ii. Contractor shall follow all local procedures concerning infection control.

Should the Contractor be unsure of the requirements, the COR can provide the specific information and procedures.

iii. Contractor personnel shall wear visible identification at all times while on VA property. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials.

iv. Property Damage

1. The contractor shall take all necessary precautions to prevent damage to any Government property.

2. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor unless corrective action is taken.

3. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the Government, upon approval of the Contracting Officer.

D. QUALITY ASSURANCE

a. End-users, Biomedical Engineering, and/or the contract COR shall perform system verification tests to ensure the system is fully functional following service/repairs.

b. Issues with the quality of the Contractor’s work will be communicated through the Contracting Officer to the Contractor point of contact for resolution.

c. Documentation with be completed in the Government systems.

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 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. [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.

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.

E. EVALUATION FACTORS

• Brand Name or Equal to Nihon Kohden IAW SOW (Specifications in C).

• Must provide an OEM (Original Equipment Manufacturer) authorized distributor/authorization from the manufacturer is required for all quotes if no OEM letter and not fully completed Buy American Certificate (0001 – 0006) received at the time RFQ will close quoter will be considered non-responsive and vendor will be disqualified.

• Price.

• IAW SOW, OEM letter, fully completed Buy American Certificate (0001 – 0006)

Items and Price when combined, Brand Name or Equal to Nihon Kohden IAW

SOW, OEM letter and fully completed Buy American Certificate are more important than price.