HemoHub.Justification - Copy.docx

Attachment C

HHS Template and Instructions for a Justification for Other than Full and Open Competition

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity

a. Federal agency and contracting activity. HHS. National Institutes of Health (NIH)

b. Sponsoring organization. Clinical Center, Critical Care Medicine Department

c. Project Officer information.

· Project Officer name. Khanh Nghiem

· Mailing address. 10 Center Dr. Bldg 10, Rm 2C306, Bethesda, MD 20892

· E-mail address. knghiem@nih.gov

· Telephone number. 240-506-6038

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The DLM Hematology-Coagulation Laboratory currently operates two ACL TOP 750 analyzers that perform a large volume of specialized coagulation testing for a complex patient population. The laboratory's current quality control (QC), quality assurance (QA), instrument monitoring, and workflow management processes rely significantly on manual review and tracking, which can be time-consuming, labor-intensive, and prone to human error.

The purchase of HemoHub will provide a centralized data management and middleware solution specifically designed for hemostasis laboratories. HemoHub will receive, process, display, store, and manage data generated by the ACL TOP analyzers while providing enhanced oversight of instrument performance, QC activities, and patient testing workflows.

It is therefore deemed to be in the Government’s best interest that this agreement is approved.

b. Project background.

The Department of Laboratory Medicine serves as the clinical laboratory of the NIH Clinical Center. It provides laboratory support for patient care and research protocols and performs research and training in disciplines of Clinical Pathology. In doing so it provides state-of-the-art laboratory testing in support of Clinical Center patient care and serves as a center of excellence in research and training in laboratory medicine, particularly in areas which utilize the unique strengths of the National Institutes of Health.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Werfen ACL HemoHub Software

b. Project description. See attached Statement of Work

· Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

· Type of action.

New requirement Follow-on Other (specify): Non-reoccurring services

· Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

· Acquisition identification number. N/A

c. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Werfen USA, LLC. (IL) 180 Hartwell Road Bedford, MA 01730-2443 USA Phone: 1-800-955-9525 customerservice.na@werfen.com

Contact:

Matthew Lewis Werfen USA LLC Bedford, MA 01730 Cell phone: 302-943-2427 Email: mlewis@werfen.com

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

HemoHub is a specialized middleware and data management system developed specifically for hemostasis laboratories and the ACL TOP coagulation platform. Unlike a traditional Laboratory Information System (LIS), which primarily manages orders and reports results, HemoHub is designed to provide advanced quality management, analyzer oversight, workflow optimization, and clinical decision-support capabilities tailored to coagulation testing. The unique qualifications of HemoHub include:

1. Hemostasis-Specific Middleware

· Designed exclusively for coagulation and hemostasis testing workflows.

· Integrates directly with ACL TOP analyzers and captures detailed analytical information not typically available through the LIS.

· Provides specialized review tools for coagulation assays and clotting curve analysis.

2. Advanced Quality Control Management

· Real-time monitoring of QC performance across all connected analyzers.

· Automated QC trending and statistical analysis.

· Peer-group comparison capabilities that allow laboratories to compare QC performance with other users nationwide.

· Early detection of shifts, trends, calibration drift, reagent deterioration, or analyzer performance issues.

3. Configurable Patient Result Management

· Ability to establish customized rules for holding, reviewing, rerunning, or releasing patient results.

· Additional safeguards to reduce the risk of reporting results when QC or instrument performance concerns exist.

· Enhanced oversight beyond what is available through standard analyzer and LIS functionality.

4. Clinical Decision Support Tools

· Automatic flagging of critical, unusual, or potentially problematic results.

· Side-by-side comparison of clot reaction curves and assay signatures.

· Supports investigation of abnormal results and troubleshooting of patient sample issues.

5. Comprehensive Analyzer Performance Monitoring

· Centralized monitoring of multiple ACL TOP analyzers from a single platform.

· Tracks instrument utilization, maintenance activities, calibration status, QC performance, and error events.

· Provides early warning indicators of analyzer or reagent-related problems before patient testing is affected.

6. Enhanced Regulatory and Accreditation Support

· Comprehensive audit trails for QC, calibration, maintenance, and result review activities.

· Supports compliance with CAP, CLIA, and institutional quality management requirements.

· Facilitates inspection preparation and documentation retrieval.

7. Workflow Automation and Efficiency

· Reduces reliance on manual QC tracking and review processes.

· Streamlines documentation and quality management activities.

· Improves laboratory efficiency by consolidating information from multiple analyzers into a single management platform.

8. Protection of Patient Samples and Resources

· Earlier identification of analyzer, reagent, and sample-related issues helps prevent specimen loss and unnecessary repeat collections.

· Reduces the likelihood of delayed testing, emergency reagent replacement, and unplanned instrument downtime.

9. Scalability for Future Growth

· Supports expansion of coagulation testing menus and future laboratory initiatives.

· Provides a flexible infrastructure for incorporating additional assays, workflows, and quality management tools.

Overall, HemoHub offers capabilities that extend well beyond standard analyzer software and traditional LIS functions. Its specialized focus on hemostasis testing, advanced QC management, peer-comparison analytics, customizable result management, and comprehensive performance monitoring make it a uniquely valuable tool for improving laboratory quality, efficiency, regulatory compliance, and patient safety.

It is therefore deemed to be in the Government’s best interest that this procurement is approved.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

9. Any other facts supporting the use of other than full and open competition.

In accordance with FAR 6.302-1(a)(2)(ii) there will be unacceptable delays in fulfilling the agency’s requirements. This requirement can only be satisfied by one responsible source for a follow-on acquisition, as full and open competition would create unacceptable delays in fulfilling the agency’s requirements. The proposed period of performance is the minimum acceptable period necessary to meet mission requirements.

10. Listing of sources, if any that expressed, in writing, an interest in the acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Market research will be performed in accordance with FAR PART 10. While other vendor may provide similar products the variation in the reagent is not ideal or sufficient for patient testing. Furthermore, a change would require extensive validation/verification studies according to regulatory and accreditation agencies.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

13. Contracting Officer certification. The CO shall complete the information required below and sign the certification in the block provided. [NOTE: The CO’s signed certification may serve as approval of a JOFOC over $100,000 but not exceeding $650,000[footnoteRef:1], depending on OPDIV procedures.) [1: ]

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer