DataRay Statement of Need 08.2026 KNW Update.docx

Statement of Need (SON)

Organization: HHS, IHS, Billings Area, Fort Peck Service Unit, Verne E Gibbls Health Center (Poplar) & Chief Redstone Health Clinic (Wolf Point)

Project Title: FPSU Laboratory & Nursing Label Printers/Maintenance/Software Support

1. Type of Statement of Need

|X| Statement of Need - Equipment |X| Statement of Need – License Agreement

|X| Statement of Need – Supply/Product |_| Statement of Need – Subscription Services

|X| Statement of Need – Maintenance Service |_| Statement of Need – Warranty Agreement

|X| Statement of Need – Other

To update software & add additional label printers for more departments and annual service agreement to maintain functionality of printers. Fort Peck Service Unit, Laboratory Department & Nursing Department requires a specimen labeling system that meets the requirement for laboratory accreditation set by our accrediting body (TJC) federal regulation set by CMS.

2. Technical Background and Contractual History

|_| This is a new requirement (Describe Technical Background below)

|X| This is a follow-on requirement

|X| Technical Background:

Fort Peck Service currently uses DataRay software/Drivers/Printers within the laboratory. Additional DataRay printers would be compatible with equipment already in use within the Service Unit.

The manufacturer provides software and updates to software to communicate with RPMS, Data Innovations Middleware and laboratory instruments to generate labels for the performing of tests and reporting of results, standard technical support, maintenance service, license renewal. Maintenance and Support Services do not include training of Customer’s personnel, consulting, or other available training, implementation, installation, and/or other professional services.

Convert information from the lab package to a format that can be understood by label printer to print: order, collection, accession and chart labels as necessary.

DataRay thermal label printers print readable barcodes from RPMS for all laboratory specimens. Nursing department requires a labeling system for labeling patient specimens at the patient's side. Currently all labeling is handwritten, smearing of ink, labels do not stay on specimen. Handwriting specimen labels creates specimen identification and labeling errors. Price includes annual maintenance/software support from DataRay.

The agreement is between Fort Belknap Service Unit (“Customer”) and the manufacturer, to provide standard technical support and maintenance service to diagnose and address a Software Error when the Software has been properly installed, if applicable, and is being Used to perform in accordance with the specifications set forth in the applicable Documentation. Maintenance and Support Services do not include training of Customer’s personnel, consulting, or other available training, implementation, installation, and/or other professional

3. Applicable Conditions

|_| Not Applicable

|_| Brand Name Requirement (A brand name justification is attached)

|X| Limited Source Requirement (A limited source justification is attached)

Data Ray has proprietary software specifically for IHS’s lab package, label printers and Data Innovations (the middleware that every IHS lab utilizes). Data Ray is the system in use at FPSU. Software is not available from any other vendor. They are also the label system company that the new IHS electronic system is going to be using so we will not have to change our label system when the new electronic health system goes live.

4. Compatibility or Performance Characteristics for Supply of Service

|X| Required Features & Benefits of the acquisition:

Data Ray is the system in use at FPSU. Data Ray has proprietary software specifically for IHS’s lab package, label printers and Data Innovations (the middleware that every IHS lab utilizes). Software is not available from any other vendor. They are also the label system company that the new IHS electronic system is going to be using so we will not have to change our label system when the new electronic health system goes live. Adding additional printers for nursing department will replace handwriting labels to reduce/prevent specimen identification and labeling errors.

a. Maintenance Services Example:

Requirements:

The Contractor shall provide all labor, material and equipment necessary to maintain and provide maintenance services for the Government-owned “equipment name” with the following specifications:

Equipment Description(s):

1. Product Code/Parts Number of the equipment requiring maintenance

2. Catalog Number of the Maintenance Plan

3. Name of Maintenance Plan (Gold, Silver…)

4. Serial Number of the equipment

5. Property Identification Number of the equipment

Other Considerations & Specifications:

1. Service Level Agreement (SLA) requirements (Response time, availability, responsibilities, etc…)

2. Types of Required Visits (Preventative, Emergency, or other)

3. Replacement Parts, Labor, Travel, and/or Equipment Software Updates included?

4. Number and types of visits per year? Per month?

5. Personnel Qualifications – X or more years of factory training and experience.

6. Provide information regarding the Contractor’s access to Government facilities if applicable.

7. Inspection/Acceptance: List additional requirements/conditions to be met for the services to be accepted? (Approval from Project Officer if applicable)

b. Equipment, Supply, Product Example:

Equipment Description(s):

1. Product Code/Parts Number of the Equipment, Supply, Product be procured

2. Catalog Number of the Equipment, Supply, Product be procured

3. Serial Number of the Equipment, Supply, Product be procured

4. NIH property identification number if there is a trade-in.

Other Considerations & Specifications:

1. Provide information regarding the contractor’s access to Government facilities for delivery/testing of the equipment, if applicable.

2. Inspection/Acceptance: list additional requirements/conditions to be met for the items to be accepted? if applicable.

|X| Compatibility/Performance Requirements

Data Ray is the system in use at FPSU. Data Ray has proprietary software specifically for IHS’s lab package, label printers and Data Innovations (the middleware that every IHS lab utilizes). Software is not available from any other vendor. They are also the label system company that the new IHS electronic system is going to be using so we will not have to change our label system when the new electronic health system goes live. Adding additional printers for nursing department will replace handwriting labels to reduce/prevent specimen identification and labeling errors.

5. Delivery or Performance-Period Requirements

|X| Period of Performance:

Base + 4 years Annual Software Maintenance Product for D4-MMP.

BASE PERIOD: Nov 30, 2026, to Nov 29, 2027 Option Year ONE: Nov 30, 2027, to Nov 29, 2028 Option Year TWO: Nov 30, 2028, to Nov 29, 2029 Option Year THREE: Nov 30, 2029, to Nov 29, 2030 Option Year FOUR: Nov 30, 2030, to Nov 29, 2031

|_| Delivery Requirements:

Services/Delivery Location to be provided at:

Fort Peck Service Unit:

Katherine Wanna – Laboratory Manager or Dana Matajovsky Facilities Manager