36C24424Q0158.docx

Department of Veterans Affairs Medical Center

(460) Wilmington, DE 19805 Statement of Work/ Statement of Need

GENERAL INFORMATION

Network Contracting Office 4 Pittsburgh VA Medical Center 1010 Delafield Road

POINT OF CONTACT*

Jacquelyn Mazurek jacquelyn.mazurek@va.gov Angelamarie.Scott@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Intent to Sole Source

NOTICE OF INTENT TO SOLE SOURCE:

IAW FAR 5.101 this notice is to advise the public that The Department of Veterans Affairs Network Contracting Office 4, intends to award a sole source, Firm-Fixed-Price Contract to Abbott Rapid Diagnostics Informatics Inc. Per FAR 8.405-6(a)(1)(B) VA requires software maintenance and software support for RALS Point of Contact Software for Wilmington VA Healthcare System for a base year with four (4) option years, exercisable at the Government’s discretion. This critical component with Software is that it meets the requirements per the Statement of Work.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS or QUOTATIONS.

Responsible sources may identify their interest by submitting capability information that clearly demonstrates the capability to perform the required work and licenses for Software. Capability information is required by 10 AM EST, Friday, December 15, 2023 to establish the ability of the source to meet this requirement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs associated with the preparation of responses to this notification. All inquiries and submittals must be sent via email to Jacquelyn Mazurek, Contracting Officer, jacquelyn.mazurek@va.gov . Telephone inquiries will not be accepted.

Special Notice Special Notice

Special Notice

STATEMENT OF WORK

Description: Abbott Informatics Point of Care RALS System

Facility 2237#: TBA

1. INTRODUCTION/BACKGROUND:

The Abbott RALS data management system works with our Point of Care Accuchek Inform II Fingerstick Glucose and Coagucheck XS Plus meters, ACT Plus Coagulation analyzer, and Nova STAT Sensor Creatinine meters. Licensure for this software is required in order for laboratory results to automatically upload from the meters into patient’s charts following testing.

2. OBJECTIVE:

a. The Pathology and Laboratory Medicine Service at the Department of Veterans Affairs Medical Center, (460) Wilmington, Delaware, hereby referred to as the VAMC Wilmington (460), is seeking the acquisition of a data management (DM) system that supports the use of point of care (POC) instrumentation. POC instrumentation is monitored by the Laboratory. This instrumentation is utilized for patient testing at the main facility and Community Based Outpatient Clinics (CBOCs).

b. The required term of this contract is one Base year from the date of award with four options for renewal.

c. To meet the needs of this acquisition, the following salient characteristics or needs must be met:

The DM system must provide the ability to remotely monitor and record the usage and quality testing of POC instrumentation at multiple locations within the main facility and remote locations.

(1) The DM must provide functionality that meets or exceeds regulations identified by the Veterans Health Administration (VHA), The Joint (JC) Commission and College of American Pathologists (CAP) regulations for the use and monitoring of POC testing.

(2) The DM must be compliant with HL7 and the hospital information system utilized by the Department of Veterans Affairs Medical Center (VISTA). Testing results meeting established criteria must automatically be entered into patient records.

(3) The DM must be compatible with current instrumentation used by the Laboratory. This includes the Roche AccuCheck Inform II glucometers, Coagucheck XS Plus, ACT Plus, and Nova STAT Sensor instruments.

(4) The DM must be able to integrate future instrumentation needs. Due to the rapidly changing nature of POC testing, a wide variety of manufacturers and instrumentation must be supported.

(5) The company must provide continuous support for the DM by remote access and direct customer service during normal business hours (08:00 to 16:30), Monday through Friday.

(6) Software upgrades are established as part of the contract and are performed at no charge.

3. MAJOR REQUIREMENTS:

a. The Contractor/ Vendor must complete the following tasks to meet the needs of this acquisition:

(1) Supply a DM hardware and/or software system meeting the salient characteristics described in Section 2.

(2) The DM must work with existing data communications architecture.

(3) DM downtime must may not exceed 24 hours during the term of the contract. Errors or issues involving DM communication of patient results to the HIS must be resolved within 24 hours of contact by the laboratory. The Contractor/ Vendor must be able to provide support to the facility information technology and biomedical departments for issues not directly DM related.

(4) Provide onsite or remote training for identified laboratory staff. Training topics must include usage and system maintenance.

(5) Communicate the need for any hardware/ software upgrades or changes to the identified point of contact for the laboratory. Notifications must be made as early as possible to enable the point of contact to coordinate with other departments within the facility.

b. The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor’s employees.

4. GOVERNMENT FURNISHED INFORMATION OR MATERIAL:

a. This acquisition does not include Government-furnished property (GFP), identify in the Statement of Work all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more.

b. This acquisition does not include Contractor-acquired property (CAP).

5. MEETINGS AND REVIEWS:

Not Applicable for this acquisition

6. TRAVEL REQUIREMENTS:

Not Applicable for this acquisition

7. CONTRACTING OFFICER'S REPRESENTATIVE (COR):

a. The identified COR and technical representative for this acquisition is:

(1) Name: JoAnna M. Bakanas, Manager, Pathology and Laboratory Medicine

b. "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification."

8. REPORTS/DELIVERABLES:

a. Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Wilmington (460). This will include documentation of receipt and assignment of a facility based “EE” number for identification and tracking purposes.

b. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service.

9. PERIOD OF SERVICE:

12/31/2023-12/30/2028; Delivery must occur within the timeframes designated by the Federal Government

10. CONTRACTOR QUALIFICATIONS:

Not Applicable

11. SECURITY/NATIONAL AGENCY CHECK REQUIREMENTS:

Not Applicable

12. RECORDS MANAGEMENT OBLIGATIONS

“Records Management Language for Contracts” will be necessary. Please see Attachment A.

VA IT SECURITY LANGUAGE : ATTACHMENT A

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. 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 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.