Acquisition Planning Exercise
Read the SH 0-2 BSVD Program and answer the 4 questions.
1. Market Research & Commercial Item Use –
a. FAR Part 10 requires agencies to use market research results to identify whether a commercial item exists to meet agency needs. According to FAR Part 10, if no such commercial item exists, what steps must the agency next take to meet its requirements? (3 points)
b. According to the Commerciality Determination Report written for the BSVD program, the required biosensor is not readily available in the commercial marketplace. Analyze the report and identify four areas where either the market research does not adequately address the requirements of FAR Part 10 or the thoroughness of documentation is lacking to support its conclusions. (1 point for each identified area with supporting rationale
2. Competition – 4 points total
FAR Part 6
If your agency decides to limit competition for the BSVD contract, which FAR Subpart 6.3 exception is best justified in relation to the facts presented? Provide rationale for your response to include addressing any unique requirements contained in the FAR Subpart 6.3 exceptions.
3. Undefinitized Contract Actions (UCAs) –
DFARS Subpart 217.74
In analyzing your alternatives to get this requirement on contract rapidly and responsibly, you are now considering using a letter contract – a type of undefinitized contract action (UCA). Under a UCA, the contractor starts work before all contract terms, specifications, or prices are agreed upon.
Identify and explain four risks that are introduced into a program by use of a UCA. For each identified risk, what limitation in DFARS 217.7404 could be used to mitigate that risk? (2 points for each identified risk with supporting rationale –
Risk:
Mitigation:
Risk:
Mitigation:
Risk:
Mitigation:
Risk:
Mitigation:
4. Contract Type –
FAR Part 16
a. Cost, schedule (delivery), and technical (performance) risks are typically the major risks to successful execution of a Government contract. Describe how each of these three risks could impact execution of a BSVD program development contract. Provide specific BSVD program details in your response.
Cost risk:
Schedule/delivery risk :
Technical/performance risk:
b. Which one FAR Part 16 contract type (e.g., firm fixed price, cost plus fixed fee, etc.) and, if applicable, contract incentive(s) – (i.e., delivery incentive, performance incentive, multiple incentive) best mitigates the risks to the BSVD program you identified above? Provide rationale and relevant FAR/DFARs cites for your response.
BSVD Program Documents
This file includes the following documents:
• BSVD Program Overview
• Purchase Request (including SOO and Suggested Sources)
• Commerciality Determination Report
o Attachment 1 – NanoTech Press Release
o Attachments 2A, 2B, and 2C – Responses to BSVD Program Request for Information (RFI)
o Attachments 3A and 3B – Amendment to Purchase Request: Terrorist Ring Memo and Associated Newsflash
You have been assigned as a contract specialist to the Research and Development (R&D) Support Directorate (R&DSD) of the Ridge Federal Security Acquisition Center’s (RFSAC’s) new Bio-Sensor Virus Detector Program (BSVD Program). The Program seeks to procure or develop a virus detector capable of detecting the H5N1 virus, also known as bird flu or avian flu.
Throughout this course, your mission will be to conduct the acquisition steps necessary to award and administer program-related contracts necessary to produce virus detectors in accordance with program requirements. This will require you to apply your skills in all phases of the acquisition process – planning, pre-award and post-award. You will also have the opportunity to resolve disputes, changes, potential fraud, claims, and other acquisition hurdles along the way.
The Program is currently in the planning phase. When you have read the enclosed documentation, complete the SA 1-2 “Acquisition Planning Assignment” located in the Assignments section of BlackBoard. It poses acquisition planning questions you must answer for the planning phase. This assignment must be completed and posted no later than the last work day prior to your first class day, so be sure to allow sufficient time for this important activity.
Welcome to RFSAC and the BSVD Program!
Bio-Sensor Virus Detector (BSVD) Program Overview________________________________________
Introduction
Welcome to the Research and Development (R&D) Support Directorate (R&DSD) of the Ridge Federal Security Acquisition Center (RFSAC). Because of your excellent work on the service contract for the Technical Support Directorate, you have been selected to work in this Directorate in support of the Bio-Sensor Virus Detection (BSVD) Program. As a part of RFSAC, our goal is to make this country secure from potential viral pandemics and biological warfare threats. To meet mission requirements of all DOD and Federal agencies, the Departments of Health and Human Services (DoHHS) Center for Disease Control (CDC), Defense (DoD), and Homeland Security (DHS) are partnering to develop a portable, easy-to-use, early warning system that can be used to identify a multitude of viral and biological warfare (BW) agents.
Our Mission Statement
The R&D Directorate of RFSAC maintains the technological superiority of the U.S. military, health, and homeland security communities. Our purpose is to provide full-scale comprehensive collective protection systems against the threat of chemical, viral, and biological warfare (BW) agents. To that end, we are responsible for awarding contracts focused on addressing present and emerging national challenges and threats.
Background
The R&D Directorate of RFSAC has received direction from the White House and $4.5 million to award a contract for a system study , design and prototype that will result in a sensor that quickly surveys an area for viral or biological agents and screens potential victims to distinguish between influenza and infection or exposure to a Biologic Warfare (BW) agent.
Every year influenza epidemics result in illness and death. From time to time a new strain of influenza virus develops to which the human population does not have a natural immunity. When this occurs the virus spreads easily from person to person creating a worldwide pandemic. Pandemics have led to high levels of illness, death, social disruption, and economic loss.
Health organizations across the globe are preparing for the next potential pandemic, an avian based influenza virus, H5N1, commonly called the “Bird Flu”. The last pandemic based on an avian virus is thought to be the Spanish Flu of 1918 which resulted in up to 50 million deaths worldwide.
The need for a quick and reliable virus detector is an urgent and continuing requirement that is essential in minimizing the spread of this virus and the pandemic threat.
While identifying the H5N1 virus is the immediate need, there is an on-going need to quickly and accurately identify a range of viral and BW agents for both health and defense purposes. Current techniques for identifying viral and biological agents are time consuming, and, to be successful, require specialized knowledge, techniques and resources.
DoD is particularly concerned with potential viral and biological attacks on military personnel that could have a profound impact on their ability to complete their missions. The military’s effectiveness in protecting targets directly correlates to its ability to detect an imminent attack. This requires novel sensors with very high levels of performance to provide viral or biological threat warnings in seconds or, at a maximum, minutes. These sensors enable active protection systems or evacuations.
The Departments of Health and Human Services (DoHHS), Defense (DoD), Homeland Security (DHS), and other public communities are working together to develop a portable, easy-to-use, early warning system that can be used to identify a multitude of viral and BW agents in areas with high population density, and those related to travel, i.e.: airports, train stations, bus stations, etc.
Concentrating on areas with high population density can aid in the prevention of person-to-person transmission as much as possible. If a virus or BW agent is detected quickly, the area can be rapidly quarantined, and exposed individuals can be quickly isolated and the appropriate treatment administered.
Concentrating on areas related to travel is important for the same reasons. In the event of a biological attack at an airport, train or bus station, early detection and identification of the pathogen is essential. Early detection leads to prevention of the potential spread of a BW agent outside of the release site. In the case of viruses that can be passed from person-to-person, identifying those individuals exposed at the sight of release is also critical to containment.
Attachment 1 to Purchase Request
Statement of Objectives (SOO) For
Bio-Sensor Virus Detector (BSVD) Program
________________________________________
1.0 Background
Every year influenza epidemics result in illness and death. From time to time a new strain of influenza virus develops to which the human population does not have a natural immunity. When this occurs the virus spreads easily from person to person creating a worldwide pandemic. Pandemics have led to high levels of illness, death, social disruption, and economic loss.
Health organizations across the globe are preparing for the next potential pandemic, an avian based influenza virus, H5N1, commonly called the “Bird Flu”. The last pandemic based on an avian virus is believed to be the Spanish Flu of 1918 which resulted in up to 50 million deaths worldwide.
The need for a quick and reliable virus detector is an urgent and continuing requirement essential to minimizing the spread of the H5N1 virus and its resulting pandemic threat.
While identifying the H5N1 virus is the immediate need, there is an on-going need for a capability to quickly and accurately identify viral and biologic agents. Current techniques for identifying viral and biologic agents are time consuming, and require special knowledge, specialized chemicals, and techniques to be successful.
The Departments of Health and Human Services (DoHHS), Defense (DoD), Homeland Security (DHS), and other public communities are working together to develop a portable, easy-to-use, early warning system capable of identifying a multitude of viral and biologic agents.
1.1 Overall Objective:
To field a sensor that quickly surveys an area for viral or biological agents and screens potential victims to distinguish between influenza and infection or exposure to a Biologic Warfare (BW) agent.
2.0 Contract Objectives:
Procure a bio¬sensorvirus detection system as detailed in the solicitation.
3.0 Program Management Objectives:
a. Establish a program management system that provides accurate and timely schedule and performance information throughout the life cycle of the program.
b. Establish a sound risk management system, which mitigates program risks and integrates metrics to monitor program status.
c. Establish a government/contractor IPT partnership that is beneficial to achieving program goals and reduces the overall level of government oversight required.
d. Establish a comprehensive configuration management system.
e. Obtain sufficient rights in technical data, both software and hardware, such that the Government can maintain and modify the delivered biosensor design and can manufacture the biosensors in accordance with that design, using Government personnel and third party contractors.
f. Establish comprehensive and cost effective Contract Data Requirements List (CDRL) tailored to the proposed design solution. If a preliminary or minimum CDRL is specified by the government, that CDRL should be used as a baseline for offerors to propose a tailored CDRL for their design.
g. Use existing electronic technologies to reduce paper copies of program information generated throughout the life of this contract.
h. Use existing electronic technologies to communicate between government and contractor organizations.
3.0 Technical Objectives:
Field a system that:
a. detects and identifies the H5N1 Influenza A virus plus 9 other viral or biological warfare (BW) agents;
b. identifies whether an individual is infected with the H5N1 Influenza A virus plus 9 other viral or BW agents;
c. detects viruses selectively without becoming clogged with other particles;
d. concentrates enough particles near the sensor to detect and measure the capture of particles in real time as air flows over a detector;
e. detects in real-time and reliably quantifies BW agents in the 1000 CFU or particle per milliliter, or the 10,000 PFU per milliliter range generates a false positive rate of less than 0.1% for the initial detection in the presence of viruses and non-BW microbes, dust, smoke, pollen and dirt;
f. optimizes automated data processing under continuous, remote operations;
g. is adaptable to meet the changing virus and BW threats;
h. is of a weight and size that will allow transportation and mobility by a field soldier in a combat environment;
i. operates in a handheld or mounted configuration.
Attachment 2 to Purchase Request
SUGGESTED SOURCE(S)
________________________________________
Recommended Source: NanoTech, Inc.
NanoTech, Inc. researches, develops, demonstrates, and transitions technologies focused on addressing present and emerging national challenges. NanoTech, Inc. investments range from the development of enabling technologies to the demonstration of large prototype systems. The company has invested in technologies to provide full-scale comprehensive collective protective systems against the threat of chemical, viral, and biological warfare attacks.
For the past five years, NanoTech, Inc. has dedicated much of its resources to processes that detect both disease cells and germs that serve as biological warfare agents. It is currently developing rapid, specific, and robust tests for ribonucleic acid (RNA), deoxyribonucleic acid (DNA), protein, and detecting or analyzing single nucleotide polymorphisms (SNPs). Applications include RNA virus and protein toxin biosensors, polymerase chain reaction (PCR)-free viral load testing, and disease cell profiling. They use reporter-tagged ribonucleotide analogs for the isothermal production of thousands of detectable signals per minute. They can also be formatted for high throughput screening in clinical laboratories or for on-site detection in a portable device.
The company’s technology is amenable to the simultaneous detection of multiple pathogen biomarkers that can be harnessed for either increased specificity in detection of a single pathogen or the detection of multiple pathogens simultaneously. This technology can be used for both clinical and biodefense applications and is directly portable to the development of clinical diagnostic kits. NanoTech’s technology offers a novel approach to identifying both airborne and blood-transmitted pathogens and early disease biomarkers, and has proved its superiority in R&D with its revolutionary technologies for biological detection.
Highly recognized in the R&D community, NanoTech has a history of taking technological breakthroughs and speeding their development into commercial applications. In recent years, NanoTech, Inc. earned the reputation for successfully expediting emerging research and technology into usable products within three to six months.
Although research has shown that there are other companies working on this technology, current estimates are that it will take 2 to 3 years for these companies to incorporate their capabilities into commercial products. With the impending bird flu pandemic and escalating biological warfare terrorists’ threats, the Government cannot wait for this new technology to be incorporated into a viable end product.
Therefore, NanoTech is the recommended source that has the ability to provide us with a prototype within 90 days of contract award.
This company is a small business.
RFSAC BSVD
Commerciality Determination Report
________________________________________
1. Purchase Request (PR) #: xxxxx-5310-0250
2. Title: Biosensor Virus Detector Program
3. Product or Service Code: A – Research and Development
4. Description of requirement:
A bio-sensor virus detector that is compact, simple to use, and capable of detecting and identifying single airborne virus particles in real-time as well as detecting whether a person is infected with a viral or has been exposed to a biologic agent. This particular requirement is in response to a potential worldwide pandemic of the bird flu, but could have further application to detect other viruses, some of which have the potential to be used by terrorists. Due to fears of a possible pandemic and intelligence reports showing the potential for biological warfare attacks by terrorists, the BSVD program is designated a high priority. A working prototype must be in place ASAP. (Goal is 90 days after contract award.)
5. Estimated Contract Value (including options): $4.5 million
6. In accordance with Federal Acquisition Regulation (FAR) Part 10, market research has been conducted for this acquisition. The following techniques were used (check all that apply):
? Historical acquisition information (review of recent market research results for similar or identical supplies/services).
__ Personal knowledge in procuring supplies/services of this type.
? Contact with the requester and/or other knowledgeable people in Government and industry regarding the commercial nature of this requirement and standard industry practices in this area of supply/service.
__ Publication of a formal request for information on the internet.
? Publication of a formal request for information through the Government-wide point of entry.
? Publication in appropriate technical journals.
__ Review of Government and/or commercial databases for relevant information.
__ Review of Internet resources, such as the Commercial Advocates Forum Web.
__ Use of source lists for identical or similar items obtained from Government, professional, and/or industry sources.
? Review of catalogs and other generally available product literature (online and/or in hard copy).
? Interchange meetings or pre-solicitation conferences with potential offerors.
__ Other: N/A
7. On the basis of the results of the research documented herein, it is determined that this requirement:
____Can be met by commercial items, commercial items with customary or minor modifications, or non-developmental items.
OR
? Cannot be met by commercial items, commercial items with modifications, or non-developmental items. Further, a reevaluation has been made in accordance with FAR 10.002(c), and the Government requirement cannot be modified in a way that will allow a commercial item to meet the need.
Note: Any pre-solicitation synopsis of this requirement must include Numbered Note 26 which states the following:
: “Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government’s requirement with a commercial item within 15 days of this notice.”
The purpose of the Numbered Notes is to eliminate the unnecessary duplication of information that appears in various announcements. If a Numbered Note is included in the description of a notice, the note referred to must be read as part of the item.
OR
____Other: (Example: Market research may reveal that a combination of commercial/noncommercial items can meet the Government’s needs.)
8. Synopsize the reasons for the determination in 7:
Extensive strategic market research was conducted by DoD, DHS, NIH and other Federal Government agencies prior to the creation of RFSAC in order to monitor the progress in developing a device capable of detecting, in real time, the avian influenza virus (H5N1). RFSAC subsequently conducted its own research efforts to determine if any commercial or educational entities were capable of meeting the program requirements. This market research has determined that there is no device in the current commercial marketplace with the capability to detect and identify the H5N1 Influenza A virus, plus the nine other agents, in real time. The initial prototype will be required to concentrate enough particles near the sensor to detect and measure the capture of particles in real time as air flows over a detector.
Although an interdisciplinary team of researchers led by Yanbin Li, professor of biological engineering in the University of Arkansas, Division of Agriculture, has developed a portable biosensor for in-field, rapid screening of avian influenza virus (H5N1), there are severe limitations to their device. Dr. Li has confirmed that their device cannot meet RFSAC’s requirements. Similar products are currently being developed in the market (University of Maryland and Georgia Institute of Technology). There is no conclusive evidence presented in the market research to show that this product is available commercially. This item is believed by the team to be a non-commercial item.
Despite, major technological advancements in the area of biosensor virus detection, scientists estimate that the commercial availability of real-time bio-sensor devices will not occur for 2 to 5 years.
There are several other research facilities at educational institutions such as Purdue University, Harvard, Cal-Berkley, California Polytechnic University, and Washington University that are working on prototypes with similar capabilities, but fall short of the Government’s requirements. Additionally, there are commercial suppliers that manufacture similar type products, but they also do not meet all of the requirements. It would appear that some companies and/or University Research Groups could produce an acceptable prototype to meet our requirements within 2-3 years after contract award.
A BSVD detector that meets the performance parameters in the Statement of Objectives is not yet developed. Additionally, the commercial contractors that initially expressed interest (in response to the Government’s Request for Information), all stated that the long-term chemical warfare detection requirement was of a nature that would not necessarily have commercial application.
The commercial entities with the most promising research in biosensor virus detection are Akubio Ltd., Panasonic Technologies, Inc., Ambri Ltd., and Nanotech Inc. However, only Nanotech’s technology is mature enough to potentially meet the 90 day criteria for delivery of working prototypes. See Nanotech’s company profile at Attachment 1. Akubio, Panasonic and Ambri submitted letters confirming that they cannot meet the BSVD delivery criteria or the performance requirements. (See Attachment 2)
Signed: ___________________________ (Contracting Officer)
Date: __________________
Signed: ___________________________ (Program Manager or User)
Date: __________________
APPROVAL
Based on the above market research report, this requirement does not meet the FAR Part 2 definition of a commercial item/service. Waiver of commercial acquisition is therefore approved.
__________________________________ ______________________________
Date Competition Advocate
What are the duties and responsibilities of a Competition Advocate?
According to FAR 6.502(a), Agency and procuring activity competition advocates are responsible for promoting the acquisition of commercial items, promoting full and open competition, challenging requirements that are not stated in terms of functions to be performed, performance required or essential physical characteristics, and challenging barriers to the acquisition of commercial items and full and open competition such as unnecessarily restrictive statements of work, unnecessarily detailed specifications, and unnecessarily burdensome contract clauses.
Attachment 1
________________________________________
FOR RELEASE 9:00 am, EST, Jan 26, 20xx
Nanotech files 100th patent application
World-class invention team is inventing new technologies for the future
Pickerington, OH – January 26, 20xx — Nanotech, Inc announces its team of staff and senior inventors has recently filed its 100th patent application. By bringing together some of the world’s top scientists and technologists and providing them resources and a collaborative environment, Nanotech’s invention team is innovating in areas such as information processing, wireless communications, digital imaging, biomedical devices and advanced particle physics. “We started Nanotech with the belief that focusing time and resources solely on invention as a full-time activity – not a side line to other projects – would produce results,” said CEO and co-founder, Nathan P. Myhrvold. “Little did we know our invention efforts would be so prolific in such a short time. With recent encouragement from companies interested in licensing some of our future biomedical and software inventions, I believe the investments we and others have made in our experiment will ultimately prove to be invaluable.” To date, the privately-held invention investment company has already received 4 U.S. patents in digital imaging from its first invention session in August 20xx. In just 6 years, the team has held nearly 70 of these day-long brainstorms, in topics spanning more than 32 areas, and currently has more than 1300 invention ideas under consideration. In addition to the internal invention staff and intellectual property experts, Nanotech’s inventor network includes many of the world’s top scientists and inventors. Some of the current senior inventors include:
• Dr. Marcus Welby – search engine pioneer, software engineer, and professor of Physics at UC Berkeley
• Dr. Ken Duffey — author, bio-medical industry expert and professor emeritus, Princeton University
• Mr. Brian French – former president, R&D Walt Disney Imagineering and co-chairman and chief creative officer, Applied Mindsets
• Dr. Wayne Daniel – supercomputer pioneer and co-chairman and CTO, Applied Mindsets
• Dr. Leroy McHood – genetics pioneer and co-founder and director, Institute for Systems Biology
• Dr. Drake Remoray – former senior physicist, Lawrence Livermore National Laboratory
• Dr. Ische Khawa – physicist, chemist and Lawrence Livermore National researcher, and former NASA-Ames Research Center scientist
• Dr. Leuthardt Erickson – highly-regarded and award-winning neurosurgeon, recently honored with MIT’s Top Young Innovator award
• Sir John Pendergraff – “cloaking device” researcher and renowned professor of theoretical solid state physics, Imperial College of London
• Mr. John Rinaldo, Jr. – software engineer and user interface expert
• Dr. Mark Green – pioneering and award-winning physicist and former Lawrence Livermore National Laboratory researcher
• Dr. Chuck Whitmer – award-winning physicist, computer scientist
“When we first started holding our invention sessions, we were cautiously optimistic that bringing people from such diverse backgrounds together would produce results,” said Casey Greentea, Vice President and Chief Patent Counsel. “In retrospect, however, how could a room full of the world’s brightest computer scientists, physicists, biotechnologists, biologists, mathematicians, geologists and brain surgeons NOT come up with some interesting new ideas? While we have themes for each invention session, the collaborative nature of these meetings has taken us in surprising directions.”
ABOUT NANOTECH
Nanotech is a privately-held, “think-tank” and invention investment company based in Pickerington, OH. Founded in 2000, Nanotech’s business model centers on creating, acquiring, prototyping and licensing pure invention in a variety of technology areas. Nanotech plans to commercialize inventions through licensing, spin-offs, joint ventures and industry partnerships. Nanotech also projects entry into the potentially lucrative Government-sales arena. Nanotech does not currently possess facilities which would allow for full-scale production type contracts. As such, the company will actively seek partners to team with for such efforts.
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