PWS - BioRad Unity Software.pdf

Department of Defense Defense Health Agency

Performance Work Statement

Bio-Rad Unity and Support Software Subscriptions

60th Medical Group David Grant Medical Center

Travis AFB, California

Solicitation Number:

Version: 1

Date: 22 May 2025

TABLE OF CONTENTS

Section

1. General Information

2. Definitions/Acronyms/Publications/HIPAA

3. Specific Tasks

PART 1

1.0 GENERAL INFORMATION

1.1 This is a supply contract to provide: Unity Real Time, Direct Connect and Westgard Advisor Subscriptions for Quality Control Procedures in the Laboratory at 60th Medical Treatment Facility (MTF), David Grant Medical Center (DGMC), Travis AFB, CA. This contract covers the supply of software and associated support.

1.2 Description of supply/introduction: The contractor shall supply Unity Real Time, Direct Connect and Westgard Advisor Subscriptions for Quality Control Procedures in the DGMC Laboratory. Bio-Rad’s advanced QC data management tools, including Unity software solutions, help laboratory personnel connect and compare their data with labs worldwide. Quality control data management is essential to efficient and reliable lab outcomes. Greater than 29,000 peers in more than 100 countries rely on Unity’s advanced QC data management capabilities to achieve a higher level of confidence in their patient test results.

1.3 Background: David Grant Medical Center requires Bio-Rad Unity software to properly perform its Quality Control Procedures. It is currently a requirement for the current Chemistry Analyzer Task Order, as well as the follow-on Task Order when the current one ends.

1.4 Objectives: The Contractor shall supply subscriptions for Unity Real Time, Direct Connect and Westgard Advisor for the 60th Medical Treatment Facility (MTF), David Grant Medical Center, Travis AFB, CA.

- Unity Real Time Subscription

- Direct Connect Support

- Westgard Advisor Subscription

1.5 Scope: The contractor shall supply software subscriptions as described herein, ensuring compatibility with existing laboratory systems as outlined in Part 5.

1.6 Period of Performance (PoP):

Base Year: 1 Oct 2025 – 30 Sep 2026 Option Year 1: 1 Oct 2026 – 30 Sep 2027 Option Year 2: 1 Oct 2027 – 30 Sep 2028 Option Year 3: 1 Oct 2028 – 30 Sep 2029 Option Year 4: 1 Oct 2029 – 30 Sep 2030 6 Month Ext: 1 Oct 2030 – 31 Mar 2031

1.7 Reporting & Invoice Oversight

1.7.1 Invoice Oversight/Manager: An individual will be designated to oversee invoice accuracy and ensure timely payment. This individual will monitor the delivery of the software subscriptions and associated support.

1.8 Contracting Authority:

1.8.1 The Contractor shall only accept modification instructions from the Contracting Officer (CO). The CO is the only authorized individual with the authority to modify or make changes to performance under this contract.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.2 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.2 Acronyms:

AFB Air Force Base AI Administrative Instructions CDRL Contract Data Requirements List CLIA Clinical Laboratory Improvement Amendments CO Contracting Officer COR Contracting Officer Representative COTR Contracting Officer's Technical Representative DAD Deputy Assistant Director DGMC David Grant Medical Center DHA Defense Health Agency DOD Department of Defense FAR Federal Acquisition Regulations HCA Head of the Contracting Activity

HIPAA

Health Insurance Portability and Accountability Act

ISO International Standardization Organization LIS Laboratory Information System MDG Medical Group MTF Military Treatment Facility PST Pacific Standard Time QC Quality Control QCP Quality Control Plan PWS Performance Work Statement

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

Applicable Publications (Current Editions): The Contractor shall abide by all applicable regulations, publications, and manuals. Following is a list of basic publications applicable to the PWS. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF. Current issues of publications and links to other publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the contract.

Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS

INSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDD 5500.7 Standards of Conduct DoDI 5400.7-R Freedom of Information Act DoD 6025.18-R Health Information Privacy Regulation Jan 03 DoDD 8500.1 Information Assurance DoD 8580.02-R HIPAA Security Rule DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI 33-332 Air Force Privacy and Civil Liberties Program DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework DFARS 239.7602-2 Required Storage of Data within the United States or Outlying Areas

AIR FORCE INSTRUCTIONS/MANUALS

Publications Code:

DAFI—Department of the Air Force Instruction DAFMAN- Department of the Air Force Manual AFP--Air Force Pamphlet AF Form--Air Force Form DD Form--Department of Defense Form MDGI – Medical Group Instruction

PART 3

3.0 SPECIFIC TASKS

3.1 Must be compliant under Clinical Laboratory Improvement Amendments (CLIA) and International Standardization Organization (ISO), ISO 15189. Should a newer revision of the above be made available after award, Contractor must remain compliant with the updated/revised version.

3.2 Must provide real-time bench and supervisor Quality Control (QC) review.

3.3 Must implement best QC rules when used with Westgard Advisor.

3.4 Must run validation with comprehensive audit trails.

3.5 Must provide advanced charts and reports for data analysis.

3.6 Must provide for reduce non-essential retests with Analytical Goal options.

3.7 Must be able to upload QC data points from an LIS, middleware or instrument to national peer-review database.

3.8 Must be compatible with current QC solutions and reagents employed by the Laboratory’s Chemistry Department.

3.9 Must not require the purchase of additional licenses to be compatible with instrument or middleware.