IHS1513055 SOW rev 08.24.2025.pdf

STATEMENT OF WORK AND JUSTIFICATION

Clinical Laboratory Instrument Management Solution Software, Hardware, Support, and Maintenance Great Plains Area (GPA)

BACKGROUND:

The Great Plains Area (GPA) laboratories has a continual need to have an instrument interface solution which allows for the communication of clinical laboratory instruments to the Indian Health Service (IHS) Resource and Patient Management System (RPMS). This instrument interface translates RPMS data via an HL7 interface to allow laboratory test orders placed in RPMS/EHR to transmit to the laboratory instruments and once the tests are completed, to send results back to the patient’s electronic health record that the medical staff use for direct patient care.

OBJECTIVE:

The GPA is seeking a new annual contract 1/1/2026 – 12/31/2026.

SYSTEM REQUIREMENTS:

The contractor must provide proof that they have at least five years of experience with providing middleware support/service to either an IHS or US Veterans Affairs (VA) hospital that uses the VISN/RPMS with MUMPS coding for their LIS. In addition, the contractor must be able to interface with our existing HL7 interface and to provide programming service should they be needed to interface with RPMS. The contractor must provide instrument interface solution that is capable of using HL7 protocol and capable of supporting both serial and TCP/IP protocols. In addition, the instrument interface solution must be capable of supporting industry standard protocols such as HL7, ASTM, XML, CSV and CDF protocols.

In addition, it is critical that the equipment, software and service be supplied from one vendor so as to standardize and manage the installation throughout the GPA. It is the contractor’s responsibility to ensure that the equipment, hardware, software and services communicate properly. The Contractor shall have expert knowledge of software middleware systems.

The contractor shall adhere to the IHS Standard Software Policy and IHS Security Policy. The current IHS standard Operating System (OS) is Windows Server 2022. As computer operating systems are approved and/or discontinued by the IHS, the contractor will test its current version or provide newer versions for the newer operating systems. IHS will provide anti-virus software and will ensure antivirus software is installed and updated regularly with the latest virus definitions to ensure continuous protection from computer viruses, malware and other vulnerabilities. All OS security patches must be kept current. The contractor will provide all necessary support to ensure anti- virus software and/or OS security patches do not affect the functionality of the solution.

Contractor will evaluate the IHS Active Directory Group Policies to determine the system can be joined to the IHS Domain without interfering with the functionality of the system.

• Software o New instrument interface software running Windows Server 2022 o Communication traces o Specimen event log o All applicable licenses; including applicable concurrent user licenses (min. of 3) o HL7 tracing o Specimen Management Configuration and Rules Processing o Instrument management software backup solution o Laboratory Maintenance Solution

Subject: SOW GPA Information Management Solution o Proficiency Test Reporting capabilities o Specimen Storage and Retrieval Solution capabilities o Soft security key

• Hardware o Device servers capable of converting Serial connections to TCP/IP connections.

o TCP/IP connections o Backup system.

• Current locations: All are minimum connections with the possibility of adding more.

o Belcourt – 10 o Eagle Butte – 10 o Fort Thompson – 7 o Fort Yates – 12 o Lower Brule – 7 o Pine Ridge – 20 o Rosebud – 9 o Sisseton – 7 o Wagner - 7

• Current Equipment List (subject to change) o Beckman Coulter Hematology Analyzer DXH 900, IRIS o Siemens Clinitec Status+ Analyzer, EXL, Expand, o Vitros System 350, 5600, and 7600 Chemistry Analyzer o Siemens DCA Vantage A1c Analyzer o Sysmex XN-450 and CA 2500 o RPMS HIS/LIS o Other major manufacturers

CONTRACT AWARDEE RESPONSIBILITIES & TASKS:

The Contractor shall provide support services for the Instrument Manager software installed at the GPA Service Units of IHS. The Contractor shall provide non-emergency customer service and support (8:00 AM

– 5:30 PM MST Monday - Friday) and 24/7 emergency support from a remote location.

The Contract customer support/ helpdesk staff will be available for software and equipment assistance.

PRIVACY ACT (APR 1984)

(a) The Contractor agrees to—

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the

Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies—

(i) The systems of records; and

(ii) The design, development, or operation work that the contractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a system of records on individuals that is subject to the Act; and

(3) Include this clause, including this paragraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a system of records.

(b) In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a system of records on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a system of records on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a system of records on individuals to accomplish an agency function, the Contractor is considered to be an employee of the agency.

(c)(1) “Operation of a system of records,” as used in this clause, means performance of any of the activities associated with maintaining the system of records, including the collection, use, and dissemination of records.

(2) “Record,” as used in this clause, means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and that contains the person’s name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a fingerprint or voiceprint or a photograph.

(3) “System of records on individuals,” as used in this clause, means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

Privacy or Security Safeguards (Aug 1996)

(a) The Contractor shall not publish or disclose in any manner, without the Contracting Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.

(b) To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of Government data, the Contractor shall afford the Government access to the Contractor’s facilities, installations, technical capabilities, operations, documentation, records, and databases.

(c) If new or unanticipated threats or hazards are discovered by either the Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.

Privacy Act (December 18, 2015)

This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations.

The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)).

The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement:

(a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and

(b) Specifies the disposition to be made of such records upon completion of contract performance.

Confidential Information (December 18, 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract:

Any types of PI or PII

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: The contractor doesn’t have a need to publish this type of information to the public.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Indemnification, Liability, Statute of Limitations: Any provisions in the TOS related to indemnification and filing deadlines are hereby waived, and shall not apply except to the extent expressly authorized by law.

Liability for any breach of the TOS as modified by this Amendment, or any claim arising from the TOS as modified by this Amendment, shall be determined under the Federal Tort Claims Act, or other governing federal authority. Federal Statute of Limitations provisions shall apply to any breach or claim.

Governing law: Any arbitration, mediation or similar dispute resolution provision in the TOS is hereby deleted.

The TOS and this Amendment shall be governed by and interpreted and enforced in accordance with the laws of the United States of America without reference to conflict of laws. To the extent permitted by federal law, the laws of the State of [Company to insert name of state if one is mentioned in its TOS] (excluding

[Company's state] choice of law rules) will apply in the absence of applicable federal law.

SUPPORT AND MAINTENANCE SERVICES:

The contractor shall provide the following:

• Support and maintenance.

• Support requests may be initiated via phone, email, or Customer Web Portal (CWP).

• Non-emergency support.

• Emergency support 24x7x365.

• Access to the Driver Downloads via web for updated and new drivers.

• Individual username and password access to Customer Web Portal (CWP).

• Allow creation and tracking of support requests.

• Includes a Knowledge Base.

• Opportunity to join any of the email notification services.

TRAINING:

Customer assistance is available through the customer support/ helpdesk for technical oversight processes for software support.

WEB REQUIREMENTS:

The contractor shall provide individual username and password access to Customer Web Portal (CWP). The contractor shall also be responsible for providing a web portal that will allow IHS personnel to download instrument drivers, create and monitor incidents, and access training materials.

PERIOD OF PERFORMANCE:

Contract performance shall be for the base year.

MINIMUM QUALIFICATIONS:

We require that any company submitting a bid have at least five years’ experience with providing middleware support/service to either an IHS or US Veterans Affairs (VA) hospital using the VISN(MUMPS code). The middleware must be capable of using HL7 protocol and capable of supporting both serial and TCP/IP protocols. RPMS information can be exchanged over a local area network (LAN) within a single facility, a wide area network (WAN) with other facilities, and the Internet with other providers and medical researchers.

1. Contracting Officer (CO) Authority

1.1. No person other than the Contracting Officer has authority to bind the Government with respect to this contract.

1.2. No action or omission of any government employee or representative other than the Contracting Officer shall increase or decrease the scope of this contract or shall otherwise modify the terms and conditions of this contract.

1.3. In no event shall any of the following be effective or binding on the Government or imputed to the Contracting Officer with respect to this contract:

1.3.1. An understanding or agreement between the Contractor and anyone other than the Contracting Officer;

1.3.2. A purported modification or change order issued by anyone other than the Contracting Officer;

1.3.3. A promise by anyone other than the Contracting Officer to provide additional funding or make payments; or

1.3.4. An order, direction, consent, or permission from anyone other than the Contracting Officer to:

1.3.4.1. Incur costs in excess of a specified estimated cost, allotment of funds, or other ceiling; or

1.3.4.2. Expend hours in excess of a specified level of effort.