HHS Awards $23.3M Contract to Medical College of Wisconsin for Stem Cell Therapeutic Outcomes Database

Contract Overview

Contract Amount: $23,291,867 ($23.3M)

Contractor: THE Medical College of Wisconsin, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-27

End Date: 2026-09-26

Contract Duration: 1,460 days

Daily Burn Rate: $16.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD) - ESTABLISH AND MAINTAIN A SCIENTIFIC DATABASE OF INFORMATION RELATING TO PATIENTS WHO HAVE BEEN RECIPIENTS OF A STEM CELL THERAPEUTICS PRODUCT (INCLUDING BONE MARROW OR CORD BLOOD) FROM A DONOR.

Place of Performance

Location: MILWAUKEE, MILWAUKEE County, WISCONSIN, 53226

State: Wisconsin Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $23.3 million to THE MEDICAL COLLEGE OF WISCONSIN, INC. for work described as: STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD) - ESTABLISH AND MAINTAIN A SCIENTIFIC DATABASE OF INFORMATION RELATING TO PATIENTS WHO HAVE BEEN RECIPIENTS OF A STEM CELL THERAPEUTICS PRODUCT (INCLUDING BONE MARROW OR CORD BLOOD) FROM A DONOR. Key points: 1. Contract aims to build a comprehensive database of stem cell therapy recipients. 2. The database will track outcomes for patients receiving bone marrow or cord blood stem cell products. 3. This initiative supports advancements in understanding the efficacy and safety of stem cell treatments. 4. The contract is structured as a firm-fixed-price definitive contract. 5. The Medical College of Wisconsin, located in Wisconsin, is the sole awardee. 6. The contract duration is set for approximately four years.

Value Assessment

Rating: good

The contract value of $23.3 million over four years represents a significant investment in health data infrastructure. Benchmarking this against similar large-scale data management and research contracts is challenging without more specific details on the scope of data collection and analysis. However, the fixed-price nature suggests a defined scope, which can be advantageous for cost control. The Medical College of Wisconsin's established role in medical research provides a foundation for effective execution.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. The specific number of bidders is not provided, but the open competition process generally fosters a more competitive pricing environment and allows the government to select the most capable offeror. This approach is designed to ensure fair market value.

Taxpayer Impact: Taxpayers benefit from a competitive process that aims to secure the best value for public funds, ensuring that the contract price reflects market conditions and the quality of services offered.

Public Impact

Patients who have received stem cell therapies (bone marrow or cord blood) will benefit from improved understanding and potential future advancements in their treatment. The contract will establish and maintain a critical scientific database, contributing to medical knowledge. The primary geographic impact is within the United States, focusing on data collection and analysis relevant to national health outcomes. The project may have implications for the healthcare workforce involved in stem cell therapy and data management.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for data scope creep if not managed tightly within the defined contract.
Ensuring long-term data integrity and accessibility for future research.
Reliance on a single entity for a critical national health database requires robust oversight.

Positive Signals

Award to a reputable medical institution with research expertise.
Firm-fixed-price contract provides cost certainty.
Full and open competition suggests a well-vetted selection process.
Clear objective to improve understanding of stem cell therapy outcomes.

Sector Analysis

This contract falls within the Professional, Scientific, and Technical Services sector, specifically under 'All Other Professional, Scientific, and Technical Services.' This broad category encompasses a wide range of specialized services. The market for health data management and research databases is substantial, driven by increasing healthcare expenditures and the growing emphasis on evidence-based medicine and personalized treatments. Comparable spending benchmarks would likely be found in contracts related to large-scale clinical data repositories, health registries, and biomedical research support.

Small Business Impact

The contract was not set aside for small businesses, and there is no indication of specific subcontracting requirements for small businesses in the provided data. The primary awardee is a large institution, suggesting that the focus of this contract is on specialized expertise rather than broad small business participation. Further analysis would be needed to determine if any subcontracting opportunities exist within the execution of this database project.

Oversight & Accountability

Oversight for this contract will likely be managed by the Health Resources and Services Administration (HRSA) within the Department of Health and Human Services. As a definitive contract with a fixed price, the primary accountability measure is the delivery of the established database and associated services according to the contract terms. Transparency will be facilitated through reporting requirements and the eventual accessibility of the data for research purposes, subject to privacy regulations. Inspector General jurisdiction would apply in cases of fraud, waste, or abuse.

Related Government Programs

National Institutes of Health (NIH) research grants
Centers for Disease Control and Prevention (CDC) data initiatives
Food and Drug Administration (FDA) drug and therapy approvals
Agency for Healthcare Research and Quality (AHRQ) research

Risk Flags

Data standardization challenges
Patient privacy and security risks
Long-term data integrity and accessibility
Reliance on a single contractor for critical data infrastructure

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $23.3 million to THE MEDICAL COLLEGE OF WISCONSIN, INC.. STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD) - ESTABLISH AND MAINTAIN A SCIENTIFIC DATABASE OF INFORMATION RELATING TO PATIENTS WHO HAVE BEEN RECIPIENTS OF A STEM CELL THERAPEUTICS PRODUCT (INCLUDING BONE MARROW OR CORD BLOOD) FROM A DONOR.

Who is the contractor on this award?

The obligated recipient is THE MEDICAL COLLEGE OF WISCONSIN, INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Health Resources and Services Administration).

What is the total obligated amount?

The obligated amount is $23.3 million.

What is the period of performance?

Start: 2022-09-27. End: 2026-09-26.

What is the specific scope of data to be collected for the STEM CELL THERAPEUTIC OUTCOMES DATABASE?

The provided data indicates the database will collect information relating to patients who have received a stem cell therapeutic product, including bone marrow or cord blood, from a donor. The specific data points, such as patient demographics, treatment protocols, adverse events, treatment efficacy metrics, and long-term follow-up data, are not detailed in the summary. A comprehensive understanding of the data scope would require reviewing the contract's Statement of Work (SOW). This scope is critical for assessing the database's utility and the resources required for its establishment and maintenance.

How does the $23.3 million contract value compare to similar health data initiatives?

Direct comparison of the $23.3 million contract value for the STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD) to similar health data initiatives is challenging without a detailed breakdown of the SCTOD's specific data collection, management, and analytical requirements. However, large-scale health data repositories and research databases can range from millions to hundreds of millions of dollars, depending on their complexity, duration, and the breadth of data captured. For instance, contracts for national disease registries or large clinical trial data management systems often represent significant investments. The Medical College of Wisconsin's role as a research institution suggests a focus on scientific rigor, which can influence cost. The firm-fixed-price structure provides a degree of cost certainty for this $23.3 million award over its four-year term.

What are the key performance indicators (KPIs) for this contract?

Key performance indicators (KPIs) for the STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD) contract are not explicitly detailed in the provided summary. However, typical KPIs for such a contract would likely include metrics related to data completeness, data accuracy, timeliness of data entry and updates, system uptime and accessibility, adherence to data security and privacy protocols (e.g., HIPAA compliance), and the successful generation of reports or analytical outputs as specified in the Statement of Work. The Medical College of Wisconsin would be expected to meet defined targets for these indicators to ensure the successful establishment and maintenance of the database.

What is the track record of The Medical College of Wisconsin, Inc. in managing large federal data contracts?

The Medical College of Wisconsin, Inc. (MCW) has a strong track record in medical research and education, often involving the management of sensitive patient data and participation in federally funded research projects. While specific details on their history managing large, sole-source federal data contracts are not provided here, their status as a prominent academic medical center suggests experience with grant management, data handling, and compliance with federal regulations. Their involvement in research funded by agencies like NIH and HRSA would indicate a capacity for managing complex projects and data, though the scale and nature of this specific $23.3 million database contract may represent a significant undertaking.

What are the potential risks associated with establishing and maintaining this outcomes database?

Potential risks associated with establishing and maintaining the STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD) include challenges in data acquisition and standardization from diverse sources, ensuring patient privacy and data security compliance (e.g., HIPAA), maintaining data accuracy and completeness over time, potential for technological obsolescence of the database system, and ensuring continued funding and institutional commitment for long-term data stewardship. Furthermore, the effectiveness of the database is contingent on the quality and representativeness of the data collected, which can be influenced by reporting practices of healthcare providers and patient participation. The reliance on a single awardee for this critical function also presents a risk if performance falters.

How will the data collected be used to improve stem cell therapies?

The data collected for the STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD) is intended to provide a scientific foundation for understanding the efficacy, safety, and long-term effects of various stem cell therapies, including those derived from bone marrow or cord blood. By analyzing outcomes across a broad patient population, researchers and clinicians can identify best practices, potential adverse event patterns, and factors that contribute to successful treatment. This evidence can inform clinical decision-making, guide the development of new therapeutic protocols, support regulatory reviews, and ultimately lead to improved patient care and outcomes in the field of regenerative medicine.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Other Professional, Scientific, and Technical Services › All Other Professional, Scientific, and Technical Services

Product/Service Code: SPECIAL STUDIES/ANALYSIS, NOT R&D › SPECIAL STUDIES - NOT R and D

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: 75R60222R00018

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 8701 WATERTOWN PLANK RD, MILWAUKEE, WI, 53226

Business Categories: Category Business, Corporate Entity Tax Exempt, Educational Institution, Higher Education, Nonprofit Organization, Not Designated a Small Business, Higher Education (Private), Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $29,563,729

Exercised Options: $23,291,867

Current Obligation: $23,291,867

Actual Outlays: $18,257,149

Subaward Activity

Number of Subawards: 2

Total Subaward Amount: $6,385,972

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline