SPECIFICATIONS 36C26326Q0493.docx

FUNCTIONAL/PERFORMANCE/SPECIFCATION

Description & Salient Characteristics: The Fargo VA Medical Center requires the purchase of a portable reverse osmosis (RO) water purification system in the Dialysis unit. The Fargo VA currently has a preventative maintenance contract with Evoqua for the units in Dialysis and SPS.

This request is a firm-fixed price.

STATEMENT OF WORK (SOW)

SCOPE:

-The contractor shall deliver and install the system with all specified salient characteristics. --Only new equipment will be accepted.

-The contractor shall provide shipping, transport, installation, and all equipment necessary to meet the requirements and capabilities listed within the scope.

-The contractor shall deliver the system to the Fargo VA Medical center.

-The assembly and validation of the system must be performed by a vendor service trained representative.

-The contractor is responsible for identifying any missing parts or components not included in the order for the RO Systems to be successfully installed and validated to their full potential.

-The contractor shall include accessories and consumables that have been detailed

Salient Characteristics Brand Name or Equal: Evoqua W3T591409 Kit, RO Eon Rover ALX SCB Fully integrated endotoxin removal filter Ultrafilter assists in preparing water or bicarbonate concentrate to meet the requirements for the production of ultrapure dialysate according to the ANSI/AAMI 11663 standard. The filter’s unique proprietary single-stage design removes bacteria, viruses, endotoxins and other contaminants greater than 0.005 micron (5 nanometers) Multi-Stage Filtration System, including carbon filtration, reverse osmosis (RO), and ultra-filtration in one unit Features easy-to-use controls and instant access to key parameters Prevents RO shutdown when the inlet water has low PSI Uses heat to disinfect rather than chemicals Continuous flow of hot water with no time constraints Provides single heat, storage heat Multiple Leak Detector options, internal or remote sensor with user alert or shutdown Color touch screen LCD control panel, clear display of operational functions Recirculation product line Filter and membrane access – removable back panel, machine disassembly not required Certified to UL 61010-1, IEC 61010-1, CAN/CSA C22.2 No: 61010-1, IEC 61326-1 FDA approved 510(K) Medical Device Must be designed to meet AAMI-Grade water standards according to ANSI/AAMI 13959 standards Leak Detection System

CART:

Rust-proof and corrosion resistant. Aluminum frame, including built-in rubber bumper guard Large 6” dual swivel casters with locking features Rear directional locking casters with integrated braking mechanism Centrally located monitoring area that features pressure and temperature gauges, and sample ports with drip tray Includes booster pump for low-pressure inlet situations Open design to allow for easy access to filter and other areas of maintenance Complies with ETL Tip and Threshold Testing Standards, and meets and adheres to the latest ANSI, AAMI, ISO Standards provides hose and cord management options All-in-one water treatment delivery system

Brand Name or Equal: Evoqua W3T578738 Kit, Booster, MHX/WRO, Rover Family

Includes booster pump for low-pressure inlet situations System Design Small footprint for ease of use in vicinity of patients without interrupting patient care due to limited space in patient area Includes installation and start up System orientation provided

INSPECTION AND ACCEPTANCE

-The contractor shall conduct a joint inspection with the COR upon delivery equipment.

-The contractor shall provide the VA COR a list of missing and /or damaged items found upon inspection and have those items replaced at no cost to the Government.

-The COR shall ensure all work is completed satisfactorily prior to acceptance.

Disputes shall be resolved by the VA Contracting Officer

This service does not involve storage, generating, transmitting, or exchanging VA sensitive information.

“Privacy training is required if the contractor(s) will be working in areas with sensitive Veteran information with an increased risk of inadvertent disclosures. These are areas where only authorized personnel are allowed (nurse stations, PACT team areas, Laboratory, Pharmacy, etc.) and where visitors are typically be escorted and are not allowed to roam around freely (4B, ER, 3M, ICU, CLC, etc.). The contractor(s) must read and sign TMS 20939, VA Privacy Training for Personnel without Access to VA Computer Systems or Direct to or the Use of VA Sensitive Information, prior to beginning work in these areas.

Delivery Location

Delivery and Installation

1. The vendor will be responsible for delivering the materials 60 days ARO.

Contacts:

2. All items to be shipped F.O.B. destination. Shipping shall be included in the product price and shall not be billed separately.

NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language

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 VA records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their VA 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. Fargo VA 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 Fargo VA 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 Fargo VA Medical Center. 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 Fargo VA 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).

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 Fargo VA Medical Center 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 Fargo VA Medical Center policy.

1. The Contractor shall not create or maintain any records containing any non-public Fargo VA Medical Center 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 Fargo VA 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 Fargo VA 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.

1. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Fargo VA Medical Center 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.