NIH contract for specimen repository management awarded to EXPERIMENTAL PATHOLOGY LABORATORIES, INC. for over $41.5M

Contract Overview

Contract Amount: $41,581,952 ($41.6M)

Contractor: Experimental Pathology Laboratories, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2008-09-25

End Date: 2018-09-29

Contract Duration: 3,656 days

Daily Burn Rate: $11.4K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: MANAGEMENT AND SUPPORT OF THE NIEHS ARCHIVES, FROZEN TISSUE BANK AND SPECIMEN REPOSITORY

Place of Performance

Location: DURHAM, DURHAM County, NORTH CAROLINA, 27709

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $41.6 million to EXPERIMENTAL PATHOLOGY LABORATORIES, INC. for work described as: MANAGEMENT AND SUPPORT OF THE NIEHS ARCHIVES, FROZEN TISSUE BANK AND SPECIMEN REPOSITORY Key points: 1. Contract value of over $41.5 million over a 10-year period suggests significant investment in long-term data and sample management. 2. The contract was awarded under 'full and open competition after exclusion of sources,' indicating a competitive process with specific justifications. 3. The duration of the contract (over 10 years) may present risks related to evolving technological needs and potential vendor lock-in. 4. The 'cost plus fixed fee' pricing structure could incentivize cost overruns if not closely monitored. 5. The specialized nature of managing archives, frozen tissue banks, and specimen repositories highlights the critical role of scientific support services. 6. This contract falls within the Research and Development in Biotechnology sector, aligning with NIH's core mission.

Value Assessment

Rating: fair

Benchmarking the value of this contract is challenging without specific details on the scope of services and the volume of specimens managed. However, a 10-year duration for a contract of this magnitude suggests a substantial, ongoing need. The 'cost plus fixed fee' (CPFF) structure, while common for R&D, carries inherent risks of cost escalation if not rigorously managed and audited. Comparing it to similar long-term biobanking and archival contracts would be necessary for a more precise value assessment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: limited

The contract was awarded under 'full and open competition after exclusion of sources.' This designation implies that while the competition was intended to be open, there were specific reasons for excluding certain sources, possibly related to unique capabilities or prior performance. The number of bidders is not specified, but the 'exclusion of sources' suggests a potentially narrower field than a purely 'full and open' competition.

Taxpayer Impact: The 'exclusion of sources' aspect warrants scrutiny to ensure that taxpayer funds were still used efficiently and that the exclusion did not unduly limit competitive pricing.

Public Impact

Researchers and scientists benefit from the reliable management and accessibility of critical biological samples and data. The contract supports the National Institutes of Health (NIH) in maintaining vital archives for biomedical research. The services provided are crucial for ongoing and future studies in areas like disease research and drug development. The contract's impact is primarily national, supporting the broader U.S. biomedical research enterprise. Workforce implications include specialized roles in laboratory management, archival science, and specimen handling.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns due to the Cost Plus Fixed Fee (CPFF) contract type.
Long contract duration (over 10 years) may lead to vendor lock-in and difficulty adapting to future technological advancements.
The 'exclusion of sources' in the competition process could limit the breadth of competitive offers and potentially impact price discovery.
Dependence on a single contractor for critical archival and specimen management services poses a risk if performance falters.

Positive Signals

Long-term contract provides stability and continuity for essential research support services.
The award to a specific contractor suggests they possess specialized expertise required for managing sensitive biological archives.
The contract's focus on R&D in biotechnology aligns with NIH's strategic research objectives.
The extended duration allows for deep integration and optimization of services over time.

Sector Analysis

This contract operates within the Research and Development (R&D) sector, specifically focusing on biotechnology and life sciences support services. The market for managing large-scale biological archives, tissue banks, and specimen repositories is specialized, often involving stringent regulatory compliance and advanced logistical capabilities. Comparable spending benchmarks would likely be found within other government agencies or large research institutions that maintain extensive biobanks for long-term scientific study. The size of this contract indicates a significant investment in maintaining critical research infrastructure.

Small Business Impact

The data indicates that small business participation was not a primary consideration for this contract, as the 'small business set-aside' field is false. There is no explicit information regarding subcontracting plans for small businesses. This suggests that the primary contractor, EXPERIMENTAL PATHOLOGY LABORATORIES, INC., likely possesses the specialized capabilities required, potentially limiting opportunities for small businesses to participate in this specific contract's execution. Further investigation into subcontracting reports would be needed to fully assess the impact on the small business ecosystem.

Oversight & Accountability

Oversight for this contract would primarily fall under the National Institutes of Health (NIH), a division of the Department of Health and Human Services (HHS). Specific oversight mechanisms would likely include regular performance reviews, financial audits, and adherence to contractual milestones. Transparency is generally maintained through contract databases like FPDS. The Inspector General for HHS would have jurisdiction to investigate any potential fraud, waste, or abuse related to this contract.

Related Government Programs

NIH Research Support Contracts
Biotechnology R&D Services
Biological Specimen Management
Archival and Repository Services
Health Data Management

Risk Flags

Long contract duration
Cost Plus Fixed Fee pricing
Exclusion of sources in competition

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $41.6 million to EXPERIMENTAL PATHOLOGY LABORATORIES, INC.. MANAGEMENT AND SUPPORT OF THE NIEHS ARCHIVES, FROZEN TISSUE BANK AND SPECIMEN REPOSITORY

Who is the contractor on this award?

The obligated recipient is EXPERIMENTAL PATHOLOGY LABORATORIES, INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $41.6 million.

What is the period of performance?

Start: 2008-09-25. End: 2018-09-29.

What is the specific justification for excluding other sources in this 'full and open competition after exclusion of sources' award?

The designation 'full and open competition after exclusion of sources' implies that while the competition was intended to be open, specific justifications were made to exclude certain potential bidders. Common reasons for such exclusions include unique capabilities, proprietary technology, or the need for continuity of service from a contractor with established expertise and infrastructure critical to the ongoing operation of the service. For this NIH contract managing archives, frozen tissue banks, and specimen repositories, the exclusion might be based on the contractor's demonstrated specialized knowledge, existing infrastructure, and proven track record in handling sensitive biological materials under strict protocols. Without access to the specific justification documentation filed with the contract award, the precise reasons remain speculative but are typically rooted in ensuring mission success and minimizing disruption to critical research support functions.

How does the 'cost plus fixed fee' (CPFF) pricing structure compare to other contract types for similar R&D support services?

The 'Cost Plus Fixed Fee' (CPFF) structure is common for research and development contracts where the scope of work can be uncertain or evolve significantly. In a CPFF contract, the contractor is reimbursed for all allowable costs incurred, plus a predetermined fixed fee representing their profit. This contrasts with fixed-price contracts, where the contractor agrees to a set price regardless of actual costs, bearing more risk. For R&D support services like managing biological archives, CPFF offers flexibility, allowing the project to adapt to new scientific discoveries or changing requirements without constant renegotiation of the base price. However, it places a greater burden on the government to meticulously audit costs to prevent overruns and ensure value. Other contract types like Cost Plus Incentive Fee (CPIF) or Cost Plus Award Fee (CPAF) might offer better cost control by linking a portion of the fee to performance metrics.

What are the key performance indicators (KPIs) used to evaluate the performance of EXPERIMENTAL PATHOLOGY LABORATORIES, INC. under this contract?

While specific Key Performance Indicators (KPIs) are not detailed in the provided data, contracts of this nature typically include metrics focused on the integrity, accessibility, and security of the managed specimens and data. Potential KPIs could include: specimen retrieval time and accuracy rates, maintenance of optimal storage conditions (e.g., temperature consistency), compliance with all relevant regulatory and ethical guidelines (e.g., HIPAA, IRB protocols), data accuracy and completeness, and timely reporting. Performance would also likely be assessed based on the contractor's responsiveness to NIH requests, adherence to budget, and overall contribution to the continuity and advancement of NIH-funded research. Regular performance reviews and audits would be conducted by NIH contracting officers and technical monitors to ensure these KPIs are met.

What is the historical spending pattern for NIH's management of archives, frozen tissue banks, and specimen repositories?

Historical spending data for NIH's management of archives, frozen tissue banks, and specimen repositories prior to this $41.5M contract is not provided. However, the duration of this contract (2008-2018) suggests a significant and sustained investment in these critical research support functions. The substantial value indicates that NIH relies heavily on external contractors for these specialized services. To understand the broader historical spending pattern, one would need to analyze contract awards for similar services over a longer period, potentially looking at multiple NIH institutes and centers, as well as comparing spending trends across different contract types and awardees. This would reveal whether spending has been consistent, increasing, or decreasing, and how it aligns with broader trends in biomedical research funding and the growth of biobanking initiatives.

What are the potential risks associated with the long duration (over 10 years) of this contract?

The extended duration of this contract, spanning over a decade, presents several potential risks. Firstly, technological advancements in specimen storage, data management, and archival techniques could render the contractor's current systems obsolete or less efficient over time. This could lead to a mismatch between contracted services and state-of-the-art capabilities, potentially impacting research quality. Secondly, a long-term contract can create vendor lock-in, making it difficult and costly for the government to switch providers even if performance issues arise or better alternatives become available. Thirdly, the prolonged relationship might reduce the incentive for the contractor to innovate or maintain peak performance, assuming continued renewal. Finally, changes in scientific priorities or funding landscapes within NIH over such a long period might necessitate shifts in service requirements that are difficult to accommodate within the original contract's framework.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENT › OTHER RESEARCH/DEVELOPMENT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: NIHES 2007014

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 45600 TERMINAL DR, STERLING, VA, 20166

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Small Business

Financial Breakdown

Contract Ceiling: $41,581,952

Exercised Options: $41,581,952

Current Obligation: $41,581,952

Actual Outlays: $140,098

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Timeline