Statement of Work 07-14-2025_DRAFT COPY.pdf

STATEMENT OF WORK FOR CORE LABORATORY QUALITY CONTROL MATERIALS

GENERAL REQUIREMENTS:

1. SCOPE OF WORK:

1.1 The contractor shall provide Unity Real Time Software and quality control (QC) materials listed in Table

1 in support of Madigan Army Medical Center (MAMC), Joint Base Lewis McChord, WA.

1.1.1 The intent of this contract is to provide MAMC with all software and QC materials required to properly support the Laboratory Department within MAMC to continue patient care as required. The amount of QC materials used are driven by doctor’s order patient testing.

1.1.2 The quantities provided on the CLIN’s reflect estimated usages by the government over the ordering period of the contract. Actual usage rates will vary depending upon testing ordered by the health care provider and number of patients seen by MAMC. The government reserves the right to increase the quantity of the tests within 15% of the initial CLIN quantity at the prices established in the contract.

1.2 The contractor shall provide the customer with a comprehensive QC program that complies with the requirements in section 4. The contractor shall provide the customer will have local administrative rights to the software. The Unity Real Time Software, provided by contractor, meets regulations from Clinical Laboratory Improvement Amendments (CLIA) ’88 and College of American Pathologist (CAP) requirements.

1.3 The contractor shall provide Unity Real Time annual subscription, data management software installation for automated QC data sharing part of Unity Interlaboratory Program, that is compatible with Data Innovations Instrument Manager.

1.4 The contractor shall provide Software listed on the DHA Approved Products List.

1.5 The contractor shall provide lot reserves for 12 months or longer for high volume controls.

1.6 The estimated ordering period of this contract shall be five years from date of award. Individual Periods of Performance (POP) shall be identified at the delivery order level. Each delivery order shall detail the max quantities to be delivered during each POP and shall not be longer than a 12-month period.

1.7 The Contractor shall perform to the standards of this Product Work Statement (PWS).

2. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES

2.1. GENERAL. None.

3. SPECIFIC TASKS:

3.1. DESCRIPTION: The Contractor shall provide quality control (QC) materials in Table 1 (including all QC materials, Unity Real Time Software, support, licenses).

3.1.1 The software (incl. Unity Quality Control Software Solutions: Unity Real Time annual subscription) must be capable of interfacing with the Data Innovations Instrument Manager (DIIM). The Contractor must have an established driver compatible for interfacing the analyzer with DIIM.

3.1.2 The Contractor shall provide the QC materials and shall coordinate exact quantities and shipment schedule with the Contracting Officer’s Representative (COR) prior to shipment IAW Paragraph 3.2.3, Deliveries.

3.1.3 The Contractor shall provide peer data review software and include any cost to maintain access to the software through the lifecycle of the contract.

3.1.4 The Contractor shall provide access for the government to the Bio-Rad Quality Controls Support Center and all tools and/or support standardly provided for Software support. This shall at a minimum include Unity Software & Connectivity Support, Unity Reports and Statistics Support, EQAS Support, Technical Services and additional contractor support as required to solve any issue with software as experienced.

3.2 QUALITY CONTROL MATERIALS: All assays confirmed by the listed QC material must be FDA approved.

3.2.1 The manufacturer will sequester the required QC materials to ensure that no more than one lot change occurs per contract year.

3.2.2 All QC material provided will be identical to those used in the FDA 510K approval application. All QC materials will be provided as follows:

3.2.2.1 All QC materials/solutions are manufactured by Bio-Rad 2000 Alfred Nobel Drive, Hercules, CA 94547.

TABLE 1 Required Quality control materials

QUALITY CONTROL MATERIAL Manufacturer Part Number Liquid Assayed Multiqual Controls Level 1 694 Liquid Assayed Multiqual Controls Level 3 696 InteliQ Ethanol/ Ammonia Controls Level 2 12008300 InteliQ Ethanol/ Ammonia Controls Level 3 12008301 InteliQ Immunoassay Plus Controls Level 1 12009948 InteliQ Immunoassay Plus Controls Level 3 12009950 InteliQ Tumor Marker Controls Level 1 12008289 InteliQ Tumor Marker Controls Level 3 12008291 InteliQ Urine Chemistry Controls Level 1 12009995 InteliQ Urine Chemistry Controls Level 2 12009996 InteliQ Cardiac Advance Controls Level 2 12016485 InteliQ Cardiac Advance Controls Level 3 12016486 InteliQ Cardiac Advance Controls Level 4 12016487 InteliQ Immunology Controls Level 1 12009941 InteliQ Immunology Controls Level 3 12009943 Liquicheck Spinal Fluid Controls Level 1 751 Liquicheck Spinal Fluid Controls Level 2 752 Liquicheck Pediatric Controls Level 1 354 Liquicheck Pediatric Controls Level 2 355 InteliQ Diabetes Controls Level 1 12008309 InteliQ Diabetes Controls Level 3 12008311 InteliQ Specialty Immunoassay Plus Controls Level 1 12015706 InteliQ Specialty Immunoassay Plus Controls Level 2 12015707 InteliQ Specialty Immunoassay Plus Controls Level 3 12015708

VIROCLEAR 00112

VIROTROL I 00101E

VIROTROL II 00115B

VIROTROL III 00110A

qUANTIFY Plus Control, Bilevel 962

3.2.2.2 Any potential supplier of items required within this contract must be an authorized distributor of Bio-Rad, 2000 Alfred Nobel Drive, Hercules, CA 94547.

3.2.2.3 All delivered products must be clearly marked with the required storage temperature.

3.2.2.4 Be maintained at the proper storage temperature during transportation from the

Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

3.2.2.5 QC material will be ready to use and not require reconstitution unless prior approval is given by the customer.

3.2.2.6 Must be liquid ready and not require reconstitution. If liquid ready QC is not available, lyophilized quality control must be approved by the COR.

3.2.3 Deliveries of QC materials ordered under Delivery Orders will be intermittent, as the quantities required for delivery will be based upon existing stock levels within MAMC and will be Coordinated with the COR. Requested deliveries under the Delivery Order will be communicated by the COR to the Contractor and will be delivered as needed throughout the POP of the Delivery Order. The COR will identify the quantities to be delivered under the existing Delivery Order and notify the Contractor of the requested delivery. The contractor shall deliver the requested supplies by the COR within one week of requested date of delivery.

The COR and Contractor SHALL ensure any requested delivery of supplies does not exceed the quantities stated on the applicable active Delivery Order. If the Contractor identifies a delivery will exceed the allowable quantities on any CLIN of the applicable Delivery Order, the Contractor SHALL immediately notify the Contracting Officer and Contract Specialist in writing via email and SHALL NOT deliver the supplies unless directed by the Contracting Officer in writing.

4. INFORMATION MANAGEMENT:

4.1 The Unity Real Time Software shall (must) be capable of interfacing with the Data Innovations Instrument Manager (DIIM). The Contractor shall (must) have an established driver compatible for interfacing the analyzer with DIIM.

4.2 The Unity Real Time Software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

4.3 The Unity Real Time Software shall provide the capability to write user defined Westgard QC Rules. In addition, it shall integrate with the result manager for autoverification of results, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall (must) include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

4.4 The software shall (must) be the most up to date version of software (i.e. Windows 10) that has the most current security upgrades and security patches.

4.5 The software shall (must) be on the Defense health Agency (DHA) Approved Products List (APL).

4.6 The software shall meet regulations from Clinical Laboratory Improvement Amendments (CLIA) ’88 and College of American Pathologist (CAP) requirements.

4.7 The Contractor shall provide local administrative rights to the government in order to manage the software.

4.8 The software shall be compatible with all Core Laboratory Instrumentation to include, but not limited to

Cobas 8000, Osmo1 Osmometer, Medtox ScanReader, Quidel Sofia, Diagnostica Stago, Alifax Roller 20.

4.9 The software shall be able to allow the government user to add 3rd party quality control files to software.

4.10 The Contractor will support software source in consultation and guidance to troubleshoot QC test systems 5 business days per week.

5 COMPLIANCES:

5.1 OPSEC Training. Per DHA-AI 5200.03, Operations Security, the contractor employees must complete

Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

5.2 Contracting Officer Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions:

-Coordinates delivery for required supplies and/or is focal point for technical support;

-Assure that the Contractor performs the technical requirements of the contract;

-Perform inspections necessary in connection with contract performance;

-Maintain written and oral communications with the Contractor concerning technical aspects of the contract;

-Issue written interpretations of technical requirements, including Government drawings, designs, specifications;

-Monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies;

-Coordinate credentialing and site entry of Contractor personnel;

-Tracks quantities to ensure compliance with delivery orders and contract maximums.

The COR is NOT authorized to change any of the terms and conditions of this contract. Only the warranted Contracting Officer is authorized to make modifications/changes to the terms and conditions of this contract. If the Contractor believes any Government personnel has effectively issued a change resulting in a change in effort and price/cost of the contract, the Contractor shall immediately notify the Contracting Officer in writing.