HHS awards $19.18M contract for stem cell therapeutic outcomes database maintenance

Contract Overview

Contract Amount: $19,175,112 ($19.2M)

Contractor: THE Medical College of Wisconsin, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2012-09-27

End Date: 2017-07-14

Contract Duration: 1,751 days

Daily Burn Rate: $11.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST NO FEE

Sector: Healthcare

Official Description: IGF::CT::IGF CRITICAL FUNCTION MAINTAIN THE STEM CELL THERAPEUTIC OUTCOMES DATABASE WHICH COLLECTS AND MAINTAINS INFORMATION RELATED TO PATIENTS WHO HAVE RECEIVED STEM CELL THERAPEUTIC PRODUCTS IN A STANDARDIZED ELECTRONIC FORMAT

Place of Performance

Location: MILWAUKEE, MILWAUKEE County, WISCONSIN, 53226

State: Wisconsin Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $19.2 million to THE MEDICAL COLLEGE OF WISCONSIN, INC. for work described as: IGF::CT::IGF CRITICAL FUNCTION MAINTAIN THE STEM CELL THERAPEUTIC OUTCOMES DATABASE WHICH COLLECTS AND MAINTAINS INFORMATION RELATED TO PATIENTS WHO HAVE RECEIVED STEM CELL THERAPEUTIC PRODUCTS IN A STANDARDIZED ELECTRONIC FORMAT Key points: 1. Contract focuses on maintaining a critical database for stem cell therapeutics, ensuring standardized data collection. 2. The Medical College of Wisconsin, Inc. is the contractor, indicating a specialized entity for this task. 3. Awarded under full and open competition, suggesting a market-driven pricing approach. 4. The contract type is a definitive contract, implying a fixed scope and duration. 5. The duration of over 1700 days highlights the long-term nature of maintaining such a database. 6. The absence of small business set-asides suggests the primary contractor is not a small business.

Value Assessment

Rating: fair

The contract value of $19.18 million over approximately 4.8 years for maintaining a specialized database appears reasonable given the critical nature of the data. Benchmarking against similar IT maintenance contracts for health databases is challenging without more specific cost breakdowns. However, the cost-no-fee pricing structure suggests that the contractor is expected to cover its costs and potentially earn a profit within the awarded amount, which can sometimes lead to less aggressive pricing compared to fixed-price contracts.

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. This process is designed to foster price discovery and ensure the government receives competitive pricing. The number of bidders is not specified, but the open competition suggests a healthy market for these services.

Taxpayer Impact: Full and open competition generally benefits taxpayers by driving down costs through market forces and encouraging a wider pool of qualified contractors to participate.

Public Impact

Patients receiving stem cell therapeutic products benefit from the standardized collection of their treatment outcomes. Researchers and healthcare providers gain access to a valuable dataset for understanding stem cell therapy efficacy and safety. The Health Resources and Services Administration (HRSA) is the primary agency benefiting from this service. The database supports advancements in medical research and public health initiatives related to regenerative medicine. The geographic impact is national, as the database collects information on patients across the United States.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for data integrity issues if maintenance is not rigorously performed.
Reliance on a single contractor for a critical data repository could pose a risk if performance falters.

Positive Signals

Contract awarded through full and open competition, suggesting competitive pricing.
The long duration indicates a stable and ongoing need for the service.
The contractor is a specialized medical institution, implying relevant expertise.

Sector Analysis

This contract falls within the professional, scientific, and technical services sector, specifically related to health data management. The market for maintaining specialized health databases is driven by regulatory requirements and the increasing volume of health data. Comparable spending benchmarks are difficult to establish without more granular data on database size, complexity, and specific maintenance requirements. However, the annual cost per year is approximately $4 million, which is within a reasonable range for complex IT system maintenance.

Small Business Impact

The contract was not set aside for small businesses, and the contractor, The Medical College of Wisconsin, Inc., is a large institution. There is no explicit information regarding subcontracting plans for small businesses. This suggests that the primary focus of this contract is on the core capabilities of the awarded institution rather than leveraging the small business ecosystem for this specific service.

Oversight & Accountability

Oversight for this contract would typically be managed by the Health Resources and Services Administration (HRSA) contracting officers and program managers. Transparency is facilitated through contract databases like FPDS. Accountability measures would be tied to performance metrics outlined in the contract. Inspector General jurisdiction would apply to any potential fraud, waste, or abuse related to the contract.

Related Government Programs

National Institutes of Health (NIH) research databases
Food and Drug Administration (FDA) drug and device databases
Centers for Disease Control and Prevention (CDC) disease surveillance systems

Risk Flags

Data Security Risk
Technological Obsolescence
Contractor Performance Risk
Data Integrity Risk

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $19.2 million to THE MEDICAL COLLEGE OF WISCONSIN, INC.. IGF::CT::IGF CRITICAL FUNCTION MAINTAIN THE STEM CELL THERAPEUTIC OUTCOMES DATABASE WHICH COLLECTS AND MAINTAINS INFORMATION RELATED TO PATIENTS WHO HAVE RECEIVED STEM CELL THERAPEUTIC PRODUCTS IN A STANDARDIZED ELECTRONIC FORMAT

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 $19.2 million.

What is the period of performance?

Start: 2012-09-27. End: 2017-07-14.

What is the specific nature of the 'stem cell therapeutic outcomes database' and its criticality?

The Stem Cell Therapeutic Outcomes Database is a critical system managed by the Health Resources and Services Administration (HRSA) that collects and maintains information on patients who have received stem cell therapeutic products. Its purpose is to standardize electronic data collection, enabling researchers, clinicians, and policymakers to track the efficacy, safety, and outcomes of these advanced therapies. The criticality stems from the rapidly evolving field of stem cell therapeutics, where robust data is essential for understanding treatment effectiveness, identifying potential risks, informing clinical practice, and guiding regulatory decisions. Maintaining this database ensures the integrity and accessibility of vital information for advancing regenerative medicine and patient care.

How does the 'cost no fee' (Cost-No-Fee) pricing structure impact value for money compared to other contract types?

The Cost-No-Fee (CNF) pricing structure means the government reimburses the contractor for allowable costs incurred in performing the contract, but the contractor receives no fee or profit. This structure is typically used when the scope of work is uncertain or when the contractor is a non-profit organization performing a public service where profit is not the primary motive. For value for money, CNF can be beneficial if it leads to lower overall costs by eliminating profit margins. However, it can also reduce the contractor's incentive to control costs rigorously, as they are guaranteed reimbursement for expenses. In contrast, fixed-price contracts incentivize cost efficiency to maximize profit, while cost-plus-fee contracts allow for profit, potentially driving higher performance but also higher overall cost. For this specific contract, the CNF structure with The Medical College of Wisconsin, Inc. suggests a focus on service provision over profit generation, but requires diligent oversight to ensure cost control.

What are the potential risks associated with maintaining a critical database for an extended period?

Maintaining a critical database over an extended period presents several risks. Firstly, technological obsolescence is a significant concern; the systems and software used to manage the database may become outdated, requiring costly upgrades or replacements. Secondly, data security risks increase over time, as cyber threats evolve, necessitating continuous investment in robust security measures to prevent breaches. Thirdly, there's a risk of data degradation or loss if maintenance protocols are not consistently applied or if backup and recovery systems fail. Fourthly, institutional knowledge loss can occur if key personnel involved in database management leave the organization. Finally, changes in regulatory requirements or research priorities could necessitate significant database modifications, posing a risk if the contract or contractor is not agile enough to adapt.

How does the contractor's status as The Medical College of Wisconsin, Inc. influence the contract's execution and outcomes?

The Medical College of Wisconsin, Inc. is a prominent academic medical institution. Its involvement suggests a strong foundation in medical research, clinical practice, and data management within the healthcare domain. This expertise is likely to enhance the quality and relevance of the data collected and maintained in the Stem Cell Therapeutic Outcomes Database. As an academic institution, its primary mission may align well with the public service goals of maintaining such a database, potentially leading to a strong commitment to data integrity and scientific rigor. However, as a large organization, it may also have higher overhead costs compared to a purely commercial IT service provider, which could be a factor in cost management, although the Cost-No-Fee structure mitigates direct profit-driven cost inflation.

What are the implications of this contract for the broader field of stem cell therapeutics research?

This contract has significant positive implications for the broader field of stem cell therapeutics research. By ensuring the maintenance of a standardized, comprehensive database of patient outcomes, it provides a crucial resource for evidence-based decision-making. Researchers can utilize this data to identify trends in treatment effectiveness, compare different therapeutic approaches, and pinpoint potential adverse events or long-term side effects. This facilitates the validation of new therapies, supports the development of clinical guidelines, and ultimately accelerates the translation of promising stem cell research from the laboratory to clinical application. The availability of reliable outcome data is fundamental for building confidence in the field and attracting further investment and research.

Industry Classification

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

Product/Service Code: SUPPORT SVCS (PROF, ADMIN, MGMT) › MANAGEMENT SUPPORT SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: COST NO FEE (S)

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)

Financial Breakdown

Contract Ceiling: $19,175,112

Exercised Options: $19,175,112

Current Obligation: $19,175,112

Subaward Activity

Number of Subawards: 5

Total Subaward Amount: $10,053,718

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline