J A_REDS-III_Central_Lab_Redacted.pdf

JOFOC – REDS-III Central Laboratory Contract HHSN268201100001I, Modification No. 6 Page 1 of 7

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

b. Sponsoring organization. HHS. National Heart, Lung, and Blood Institute (NHLBI), Division of Blood

Diseases and Resources (DBDR)

c. Project Officer Information.

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

a. Acquisition purpose and objectives.

The proposed action is a modification to an existing single award Indefinite Delivery, Indefinite Quantity (IDIQ) contract. The modification will increase the maximum ordering value of the IDIQ contract by $900,000, from $9,989,578 to $10,889,578. This modification does not obligate any funds; funds are obligated under task orders that are issued against the base IDIQ contract. Additionally, the modification will extend the period of performance of the contact by two years, through March 14, 2020. These modifications are necessary to award Phase 3 of the contract under Task Order 3 (planned for award in 2017).

This contract is for the Central Laboratory of the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) program. The objective of REDS-III is to assure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks.

Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the most commonly employed, and, arguably, one of the least understood medical procedures in the U.S., affecting about five million recipients annually. This research program is not only critical to public health in the U.S., but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. The REDS-III program is comprised of one Central Laboratory, one Data Coordinating Center, four Domestic Hubs, and three International collaborative sites in Brazil, China, and South Africa.

b. Project background.

The nine contractors participating in REDS-III were each awarded single award IDIQ contracts in March 2011. Task orders have been awarded under these contracts for project phases. The Central Laboratory contract information is as follows:

Contract Number: HHSN268201100001I Name of Contractor: Blood Systems, Inc. dba Blood Systems Research Institute Period of Performance: 03/15/2011 – 03/14/2018 Maximum Contract Value: $9,989,578 Total Dollar Amount Obligated to Date: $9,863,071 Competition of Initial Award: Full and open competition under RFP No. NHLBI-HB-11-01

Contract HHSN268201100001I, Modification No. 6 Page 2 of 7

The REDS-III program consists of three phases. In Phase 1, investigators participated in the Steering Committee, which first identified the key scientific priorities in blood banking and transfusion medicine that will bring the most benefit to the Government and public health in the most cost-effective manner.

These priorities were reviewed by an External Panel of experts and recommended to NHLBI for approval.

The Steering Committee then created and recommended for approval to the Executive Committee and NHLBI several specific protocols that address these priorities. The Steering Committee recommended for approval to NHLBI both Phase 1 and Phase 2 studies. Phase 1 studies were also called ‘fast track’ studies, in that they could be designed and completed within Phase 1; some of these were designed to pilot the work of Phase 2 in order to better inform protocol development of Phase 2 studies. The Phase 1 and 2 protocols represent the full REDS-III portfolio of studies and the protocol specifics are well known at this stage of the Program.

During Phase 1 performance, NHLBI received appropriated funding both from the FDA as well as funding for AIDS-related research, and a determination was made to use the REDS-III contract vehicle to perform two additional studies within the scope of work. This was unforeseen work that in effect led to expenditures toward the maximum value at a faster rate than originally planned, thereby not allowing NHLBI to complete the studies initially selected and approved.

When we negotiated the costs for Task Order 2 (Phase 2), we used the protocols approved by the Steering Committee, Executive Committee, and ultimately NHLBI. At the Central Lab, these protocols ended up requiring more lab participation and higher cost testing than NHLBI anticipated when we awarded the IDIQ contracts in 2011. We based the maximum value at award on negotiations with the contractor based on the average cost of historical studies conducted in blood banking and transfusion medicine within NHLBI. However, it was not possible to predict what scientific priorities the investigators would focus on once the Steering Committee convened. For example, it became clear that it would be very important scientifically to conduct a study to evaluate the genetic determinants of why some donors do not become iron deficient despite repeated blood donations (resistant to iron deficiency) and why red blood cells from some donors do not store as well as some others (this is very important to ensure a robust blood supply for patients in need). This led to the development of the Red Blood Cell Omics (RBC-Omics) study, which the Central Lab substantially supports. This study involves the use of high cost genome wide arrays (GWA), Instead of originally inflating the maximum value to allow for every possible scientific scenario within the REDS-III portfolio, we used the best information available to us at the time of award. Consequently, prior to the award of Task Order 2, a modification to the IDIQ contract for the Central Laboratory was required to increase the maximum value by $2,367,517. A JOFOC was approved March 5, 2013 for this purpose.

REDS-III is now halfway through performance of Phase 2. As such, we are now at a point where we can accurately estimate that the amount of the increase to the maximum value is sufficient to allow for award of a task order for performance of Phase 3 (data analysis and publication).

Regarding the delays in Phase 1 and 2, there are many protocols/studies conducted under REDS-III with the participation of many sites, so there are various delays in the program that have led to the extension of the period of performance. The delays impacting the Central Lab include OMB clearance delays for several studies that include a survey component, and the extension of the enrollment phase in the RBC- Omics study to allow sites to reach their minority enrollment goals. Additionally, funding under sequestration in FY13 caused protocol design changes and a partial change of the program portfolio overall, which required reorganization of resources at each site, leading to delays in study implementation. Finally, now that we are halfway through the actual performance of studies, we understand that the 12-month period of performance originally planned for Phase 3 should be

Contract HHSN268201100001I, Modification No. 6 Page 3 of 7 lengthened to 18 months. We can now use the study design to accurately estimate that the data analysis will take a bit longer than we originally planned.

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

a. Project title. Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory

b. Project description. Please see section 2.b. above for a brief narrative description of the Central

Laboratory component of REDS-III.

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): Modification to IDIQ Contract HHSN268201100001I to increase maximum contract value (with no money obligated at this time), and to extend the period of performance.

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: Indefinite Quantity Other (specify): ___________ Completion Form Term form

Acquisition identification number. Contract HHSN268201100001I (awarded under Solicitation No. NHLBI-HB-11-01).

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

Contract period: March 15, 2011 – March 14, 2020 (extended by two years) Current contract maximum: $9,989,578 Proposed new contract maximum: $10,889,578 Total dollars obligated: $0

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).

Contract HHSN268201100001I, Modification No. 6 Page 4 of 7

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).

Blood Systems, Inc. dba Blood Systems Research Institute (BSRI) 270 Masonic Avenue San Francisco, California 94118

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

The contractor, BSRI, was awarded a contract based on full and open competition under Solicitation No.

NHLBI-HB-11-01. Full source selection procedures were followed during pre-award activities, including conduct of a peer review and a secondary review of the proposal submitted, discussions with the offeror regarding the technical and cost proposals, and past performance evaluation. The contract was awarded in March 2011. The Contractor has successfully completed the first four years of performance under this contract.

This JOFOC is required to extend the period of performance of the existing IDIQ contract by two years to allow for the closeout phase (Phase 3) of the REDS-III program, which includes transfer of biospecimens, database closeout, data analysis, and manuscript preparation and publication to disseminate the findings of the protocols conducted under Phase 2. The current period of performance will not provide sufficient time for completion of this phase, due to various delays in Phase 1 (protocol development and fast track studies) and Phase 2 (study conduct and database compilation). There are a total of 12 large, complex, multicenter Phase 2 protocols in REDS-III that are ongoing. Following the completion of Phase 2, NHLBI will award a task order to the incumbent contractors for performance of Phase 3.

The contractor for the Central Laboratory, BSRI, is uniquely qualified to perform the closeout phase of REDS-III for the following reasons:

BSRI has not only the laboratory expertise, but more importantly the scientific expertise in blood safety and availability and transfusion medicine that allows them to lead and participate in the REDS-III protocols in an optimal way. In particular, BSRI is the lead on the largest study that has ever been conducted to evaluate the properties of red blood cells donated by 14,000 blood donors in the US (the Red Blood Cell Omics (RBC-Omics) study). Without their expertise, NHLBI would not be able to complete this study, nor interpret the findings.

BSRI staff are trained in and currently conducting all protocols involving biospecimens. They have the expertise necessary to carry out these protocols and address issues that arise.

BSRI owns and maintains the equipment necessary to house the REDS-III biospecimens that have been sent to the Central Laboratory from the Domestic Hubs to date under the contract, which will continue through the end of Phase 2 in accordance with study protocols. BSRI is highly familiar with and trained in using the biospecimen tracking system that is held and maintained by the REDS-III Data Coordinating Center.

BSRI has trained investigators at the REDS-III International Sites in transfusion laboratory methodology. BSRI is instrumental in providing transfusion laboratory expertise to International sites related to the conduct of laboratory protocols and compilation of biospecimens.

BSRI investigators have protocol-specific training and expertise that will be necessary to complete closeout phase of REDS-III and will be key to proper interpretation of laboratory data and their publication.

In order to ensure that another source would have the resources, data, and expertise to conduct the final closeout phase of REDS-III (beginning 2017), the incumbent contractor, BSRI, would essentially have to conduct a closeout (similar in scope to that planned for Phase 3) of the databases and biospecimen repositories in order to transfer the datasets and biospecimens to the Government, which would then

Contract HHSN268201100001I, Modification No. 6 Page 5 of 7 transfer data to a new contractor – and the new contractor would then only be analyzing data and publishing manuscripts in the closeout phase. It would not be in the Government’s best interest to incur substantial delays and duplicative costs in order to award to a new source for data analysis and publication, instead of allowing the current, uniquely qualified and responsible contractor to complete performance of the SOW over an additional two years. Additionally, any potential new contractor would be in the position of interpreting data and publishing manuscripts on studies that they did not develop, conduct, lead, or have any experience with. In the event that a qualified source could be found through re-procurement, substantial costs would be incurred to award the additional two year period, including: direct labor costs to train new Central Laboratory staff to perform REDS-III protocols;

equipment transfer costs; packaging and proper transfer of biospecimens collected thus far in the program; and all associated indirect costs. Finally, the REDS-III program, including the Central Laboratory, is critical to the mission of the Institute in its ability to quickly respond to emerging threats to the nation’s blood supply. It is essential that a fully operational, qualified, and properly trained Central Lab exist within this program to be able to conduct tests and studies and provide expertise in the event that a new threat emerges.

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.

Two notices – an R&D Sources Sought Notice, and a Small Business Sources sought notice – were posted on FedBizOpps (FBO) on December 30, 2014 for 15 days (notices closed January 15, 2015). The intent of the notices was to solicit qualified sources capable of performing the work in Phase 3 of the contract. See Section 8 for a description of this market research.

A pre-solicitation notice of NHLBI’s intent to increase the maximum value of the contract and extend the period of performance and ordering period will be posted on FBO prior to final JOFOC approval.

Additionally, the J&A notice will be posted to FBO once the modification is executed.

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

Contract HHSN268201100001I, Modification No. 6 Page 6 of 7

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.

The pre-award activities for the subject contract included a number of efforts to ensure that offers were solicited from as many potential sources as practicable. A Small Business Sources Sought notice was published in FedBizOpps (FBO, www.fbo.gov) on September 16, 2009 in order to determine whether the procurement could be set-aside for small businesses. No capability statements were received by the closing date; however, one capability statement which did not address the tasks listed in the Sources Sought announcement was received from after the due date. It was determined that the acquisition would be conducted through full and open competition. A pre-solicitation notice was issued in FBO on September 30, 2009. Request for Proposals (RFP) No. NHLBI-HB-11-01 was published in FBO on October 22, 2009. Only one proposal was received (from the awardee, BSRI) by the receipt date of February 18, 2010.

For the current action, two notices – an R&D Sources Sought notice, and a Small Business Sources Sought notice – were posted on FBO on December 30, 2014 for 15 days (notice closed January 15, 2015). The intent of the notices was to solicit qualified sources capable of performing the work in Phase 3 of the contract.

One capability statement was received in response to the Small Business Sources Sought notice from

. The capability statement was reviewed by three program experts from the Division of Blood Diseases and Resources (DBDR), who determined that did not demonstrate that it is capable of providing all the needed services outlined in the sources sought notice.

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

As stated above, in order to award Phase 3 of the contract under a task order (planned for award in 2017), the maximum value of the contract must be increased, and the period of performance/ordering period must be extended. The alternative – opening competition for a renewal to procure a Central Lab to perform Phase 3 – would be prohibitive both in terms of time and cost. The current contractor for the REDS-III Central Laboratory has expertise and knowledge in the program infrastructure, study protocols and manuals of procedures, and data. The transfer of data and biospecimens, procurement or transfer of equipment, time spent training a new contractor in the program particulars, and integration of a new contractor’s systems into the REDS-III infrastructure for the purpose of performing a data closeout and analysis phase would be cost prohibitive to the Government, and would delay the dissemination of critical public health information that is being investigated in the ongoing studies.

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

Please see Section 8, which describes one capability statement received in response to the sources sought notices published. Subsequent to that notice, no other sources have 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.

In the event that this program is renewed, a full search for potential sources will be conducted at that time, including the possibility of a complete re-competition of the requirement. However, at present, the program is not being renewed; only an increase in maximum contract value and extension of the period of performance to meet the needs of the program is being contemplated at this time.

Contract HHSN268201100001I, Modification No. 6

Justification for Other than Full and Open Competition

Contract Number HHSN268201100001I

Name of Contractor: Blood Systems, Inc. dba Blood Systems Research Institute

List of Attachments

1. Independent Government Cost Estimate

2. FedBizOpps Sources Sought Synopses

3. Sources Sought Responses

4. Sources Sought Evaluation Group Report

5. FedBizOpps Pre-solicitation non-competitive (notice of intent) synopsis

Notice Type:

Sources Sought

Posted Date:

December 30, 2014

Response Date:

Jan 15, 2015 4:30 pm Eastern

Archiving Policy:

Manual Archive

Archive Date:

Original Set Aside:

N/A

Set Aside:

N/A

Classification Code:

A -- Research & Development

NAICS Code:

541 -- Professional, Scientific, and Technical Services/541712 -- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Synopsis:

Added: Dec 30, 2014 1:45 pm

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: 1) the availability and capability of qualified small business sources; 2) whether they are small businesses, HUBZone small businesses, service-disabled, veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses; and 3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this acquisition is 541712.

BACKGROUND

The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Central Laboratory for an ongoing program -the Recipient Epidemiology and Donor Evaluation Study III (REDS-III). The objective of REDS-III is to assure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks.

Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the

Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory Solicitation Number: HHS-NIH-NHLBI-SBSS-HB-15-08 Agency: Department of Health and Human Services Office: National Institutes of Health Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ HHS‐NIH‐NHLBI‐SBSS‐HB‐15‐08 ‐ F...

12/13/2015 most commonly employed, and, arguably, one of the least understood medical procedures in the U.S., affecting about five million recipients annually. This research program is not only critical to public health in the U.S., but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. The REDS-III program is comprised of one Central Laboratory, one Data Coordinating Center, four Domestic Hubs, and three International collaborative sites in Brazil, China, and South Africa.

REDS-III contractors are currently completing Phase 2 of the contract, conducting several study protocols and compiling donor, recipient, and linked databases, and performing laboratory testing. The NHLBI anticipates that the Central Laboratory will be needed until March 14, 2020 to complete the development, review and approval of analyses, presentations and publications based on the research conducted in Phase 2, as well as closure of databases.

PROJECT REQUIREMENTS

During the period from September 15, 2017 - March 14, 2020, the Central Laboratory (CL) is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below:

1. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III International Advisory Committee.

As a member of the International Advisory Committee, actively participate in the review and approval of the REDS -III International study portfolio and evaluate program progress to ensure that the overall objectives of the REDS- III program are being met.

2. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III Domestic Steering Committee and each International Steering Committee.

As a member of the Domestic Steering Committee and each International Steering Committee (and their subcommittees, as appropriate), provide technical laboratory expertise and serve as an active participant in developing and prioritizing REDS-III domestic and international research activities, in overseeing and ensuring the progress of ongoing studies, and in developing, reviewing and approving analyses, presentations, and publications.

3. The Central Laboratory shall contribute in presenting study data in the form of presentations at scientific meetings and publications in peer-reviewed scientific journals.

4. The Central Laboratory shall coordinate with the Data Coordinating Center (DCC) to provide containers to the REDS-III domestic hubs and international sites for shipment of biospecimens to the CL. For the Domestic hubs, the CL shall bear the cost for shipping biospecimens from the hubs to the CL or other testing sites, and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. For international sites, the CL shall bear the cost for shipping biospecimens from the sites to the CL or other testing sites in the U.S., and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. The international sites shall be responsible for the costs associated with shipping biospecimens to in-country testing facilities and for the costs of storage of biospecimens that are not shipped to the U.S.

5. In accordance with REDS-III study protocols, the Central Laboratory shall perform infectious disease, molecular, genetic, immunological, and hematological tests such as antigen, antibody, and nucleic acid assays for infectious agents, testing for human leukocyte antigens (HLA), testing for products with immunomodulatory, pro-apoptotic and pro-inflammatory properties such as cytokines and chemokines, characterization of leukocyte

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ HHS‐NIH‐NHLBI‐SBSS‐HB‐15‐08 ‐ F...

22/13/2015 populations with immunoregulatory properties, etc. It is expected that most testing in the U.S. shall be performed by the CL. For those assays that are better conducted by other testing facilities, the CL shall be responsible for arranging and managing the necessary subcontracts with each U.S. testing facility.

6. Transmit laboratory test results electronically to the DCC in an acceptable format within the timeframe specified in the study-specific Manual of Operations. Results from any quality control assessments specified in protocols shall be transmitted to the DCC.

7. Store biospecimens from participating hubs according to study protocols. Biospecimens shall be stored at the CL until no longer needed. If the biospecimens and associated genotypic and/or phenotypic data may be of value for further study by the scientific community, the REDS-III Domestic and International Steering Committees can consider submitting applications to the NHLBI for consideration to transfer biospecimen collections to the NHLBI Biologic Specimen Repository for long-term storage and access by the scientific community. Shipping costs from the CL to the NHLBI Biologic Specimen Repository shall be borne by the NHLBI Biorepository.

8. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the Principal Investigator and laboratory staff are members.

OTHER IMPORTANT CONSIDERATIONS

The Government intends to negotiate (1) cost reimbursement task order for the period of September 15, 2017 - March 14, 2020.

CAPABILITY STATEMENT - HOW TO SUBMIT A RESPONSE

Small businesses that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees; 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 3) a description of general and specific facilities and equipment available, including the software used analyze study data; 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; and 5) any other information considered relevant to this program. The capability statement must not exceed 16 single sided or 8 double sided pages in length using a minimum 11-point font size.

Interested organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives.

Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

All capability statements sent in response to this Small Business Sources Sought Notice must be submitted electronically (via email) to Allison Cristman, Contracting Officer at allison.cristman@nih.gov in either MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered.

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ HHS‐NIH‐NHLBI‐SBSS‐HB‐15‐08 ‐ F...

32/13/2015

DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

CONFIDENTIALITY

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Contracting Office Address:

Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902 Bethesda, Maryland 20892-7902

Primary Point of Contact.:

Allison M Cristman, Contracting Officer allison.cristman@nih.gov Phone: 301-435-0359

Secondary Point of Contact:

Cheryl A Jennings, Contracting Officer cj19f@nih.gov Phone: (301) 435-0347

Opportunity History Original Synopsis■

Dec 30, 2014 1:45 pm

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ HHS‐NIH‐NHLBI‐SBSS‐HB‐15‐08 ‐ F...

42/13/2015

Sources Sought

Posted Date:

December 30, 2014

Response Date:

Jan 15, 2015 4:30 pm Eastern

Archiving Policy:

Manual Archive

Archive Date:

Original Set Aside:

N/A

Set Aside:

N/A

Classification Code:

A -- Research & Development

NAICS Code:

541 -- Professional, Scientific, and Technical Services/541712 -- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Synopsis:

Added: Dec 30, 2014 1:45 pm

This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement.

BACKGROUND

The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Central Laboratory for an ongoing program -the Recipient Epidemiology and Donor Evaluation Study III (REDS-III). The objective of REDS-III is to assure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks.

Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the most commonly employed, and, arguably, one of the least understood medical procedures in the U.S., affecting about five million recipients annually. This research program is not only critical to public health in the U.S., but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. The REDS-III program is comprised of one Central Laboratory, one Data Coordinating Center, four Domestic Hubs, and three International collaborative sites in Brazil, China, and South Africa.

Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory Solicitation Number: HHS-NIH-NHLBI-RDSS-HB-15-08 Agency: Department of Health and Human Services Office: National Institutes of Health Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ HHS‐NIH‐NHLBI‐RDSS‐HB‐15‐08 ‐ ...

12/13/2015

REDS-III contractors are currently completing Phase 2 of the contract, conducting several study protocols and compiling donor, recipient, and linked databases, and performing laboratory testing. The NHLBI anticipates that the Central Laboratory will be needed until March 14, 2020 to complete the development, review and approval of analyses, presentations and publications based on the research conducted in Phase 2, as well as closure of databases.

PROJECT REQUIREMENTS

During the period from September 15, 2017 - March 14, 2020, the Central Laboratory (CL) is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below:

1. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III International Advisory Committee.

As a member of the International Advisory Committee, actively participate in the review and approval of the REDS -III International study portfolio and evaluate program progress to ensure that the overall objectives of the REDS- III program are being met.

2. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III Domestic Steering Committee and each International Steering Committee.

As a member of the Domestic Steering Committee and each International Steering Committee (and their subcommittees, as appropriate), provide technical laboratory expertise and serve as an active participant in developing and prioritizing REDS-III domestic and international research activities, in overseeing and ensuring the progress of ongoing studies, and in developing, reviewing and approving analyses, presentations, and publications.

3. The Central Laboratory shall contribute in presenting study data in the form of presentations at scientific meetings and publications in peer-reviewed scientific journals.

4. The Central Laboratory shall coordinate with the Data Coordinating Center (DCC) to provide containers to the REDS-III domestic hubs and international sites for shipment of biospecimens to the CL. For the Domestic hubs, the CL shall bear the cost for shipping biospecimens from the hubs to the CL or other testing sites, and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. For international sites, the CL shall bear the cost for shipping biospecimens from the sites to the CL or other testing sites in the U.S., and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. The international sites shall be responsible for the costs associated with shipping biospecimens to in-country testing facilities and for the costs of storage of biospecimens that are not shipped to the U.S.

5. In accordance with REDS-III study protocols, the Central Laboratory shall perform infectious disease, molecular, genetic, immunological, and hematological tests such as antigen, antibody, and nucleic acid assays for infectious agents, testing for human leukocyte antigens (HLA), testing for products with immunomodulatory, pro-apoptotic and pro-inflammatory properties such as cytokines and chemokines, characterization of leukocyte populations with immunoregulatory properties, etc. It is expected that most testing in the U.S. shall be performed by the CL. For those assays that are better conducted by other testing facilities, the CL shall be responsible for arranging and managing the necessary subcontracts with each U.S. testing facility.

6. Transmit laboratory test results electronically to the DCC in an acceptable format within the timeframe specified in the study-specific Manual of Operations. Results from any quality control assessments specified in protocols

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ HHS‐NIH‐NHLBI‐RDSS‐HB‐15‐08 ‐ ...

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7. Store biospecimens from participating hubs according to study protocols. Biospecimens shall be stored at the CL until no longer needed. If the biospecimens and associated genotypic and/or phenotypic data may be of value for further study by the scientific community, the REDS-III Domestic and International Steering Committees can consider submitting applications to the NHLBI for consideration to transfer biospecimen collections to the NHLBI Biologic Specimen Repository for long-term storage and access by the scientific community. Shipping costs from the CL to the NHLBI Biologic Specimen Repository shall be borne by the NHLBI Biorepository.

8. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the Principal Investigator and laboratory staff are members.

OTHER IMPORTANT CONSIDERATIONS

The Government intends to negotiate (1) cost reimbursement task order for the period of September 15, 2017 - March 14, 2020.

CAPABILITY STATEMENT - HOW TO SUBMIT A RESPONSE

Organizations that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 2) a description of general and specific facilities and equipment available, including the software used analyze study data; 3) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; and 4) any other information considered relevant to this program. The capability statement must not exceed 16 single-sided or 8 double-sided pages in length using a minimum 11-point font size.

The Government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the notice number.

All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Allison Cristman, Contracting Officer at allison.cristman@nih.gov in either MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered.

DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ HHS‐NIH‐NHLBI‐RDSS‐HB‐15‐08 ‐ ...

32/13/2015 acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

CONFIDENTIALITY

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Contracting Office Address:

Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902 Bethesda, Maryland 20892-7902

Primary Point of Contact.:

Allison M Cristman, Contracting Officer allison.cristman@nih.gov Phone: 301-435-0359

Secondary Point of Contact:

Cheryl A Jennings, Contracting Officer cj19f@nih.gov Phone: (301) 435-0347

Opportunity History Original Synopsis■

Dec 30, 2014 1:45 pm

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42/13/2015

Presolicitation

Posted Date:

February 2, 2015

Response Date:

Feb 17, 2015 3:30 pm Eastern

Archiving Policy:

Manual Archive

Archive Date:

Original Set Aside:

N/A

Set Aside:

N/A

Classification Code:

A -- Research & Development

NAICS Code:

541 -- Professional, Scientific, and Technical Services/541712 -- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Synopsis:

Added: Feb 02, 2015 10:10 am

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT MODIFICATION WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING

BRAND-NAME).

The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) intends to negotiate and award a contract modification without providing for full and open competition (Including brand-name) to Blood Systems, Inc. dba Blood Systems Research Institute for the Recipient Epidemiology and Donor Evaluation Study III (REDS- III) Central Laboratory.

REGULATORY AUTHORITY

The resultant contract modification will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-80, January 29, 2015.

Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory Solicitation Number: NHLBI-ECB-HB-15-08-AC Agency: Department of Health and Human Services Office: National Institutes of Health Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ NHLBI‐ECB‐HB‐15‐08‐AC ‐ Federal...

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This acquisition is conducted under the procedures as prescribed in FAR subpart 15-Contracting by Negotiation at an amount exceeding the simplified acquisition threshold ($150,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

BACKGROUND

The incumbent Contract No. HHSN268201100001I is for the Central Laboratory of the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) program. The objective of REDS-III is to assure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the most commonly employed, and, arguably, one of the least understood medical procedures in the U.S., affecting about five million recipients annually. This research program is not only critical to public health in the U.S., but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. The REDS-III program is comprised of one Central Laboratory, one Data Coordinating Center, four Domestic Hubs, and three International collaborative sites in Brazil, China, and South Africa.

REDS-III contractors are currently completing Phase 2 of the contract, conducting several study protocols and compiling donor, recipient, and linked databases, and performing laboratory testing. The NHLBI anticipates that the Central Laboratory will be needed until March 14, 2020 to complete the development, review and approval of analyses, presentations and publications based on the research conducted in Phase 2, as well as closure of databases.

PURPOSE, CONTRACT STRUCTURE, AND PERIOD OF PERFORMANCE

The proposed action is a modification to an existing single award Indefinite Delivery, Indefinite Quantity (IDIQ) contract, with cost-reimbursement task orders. The contract modification will increase the maximum ordering value of the IDIQ contract. This modification will not obligate any funds; funds are obligated under task orders that are issued against the base IDIQ contract. Additionally, the modification will extend the period of performance of the contact by two years, through March 14, 2020.

PROJECT REQUIREMENTS

The parent contract will be extended in order to accommodate the anticipated task order for Phase 3, which will be performed during the period September 15, 2017 - March 14, 2020. In Phase 3, the CL is expected to provide the

Recipient Epidemiology and Donor Evaluation Study III (REDS‐III) – Central Laboratory ‐ NHLBI‐ECB‐HB‐15‐08‐AC ‐ Federal...

22/4/2015 necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below:

1. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III International Advisory Committee.

As a member of the International Advisory Committee, actively participate in the review and approval of the REDS -III International study portfolio and evaluate program progress to ensure that the overall objectives of the REDS- III program are being met.

2. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III Domestic Steering Committee and each International Steering Committee.

As a member of the Domestic Steering Committee and each International Steering Committee (and their subcommittees, as appropriate), provide technical laboratory expertise and serve as an active participant in developing and prioritizing REDS-III domestic and international research activities, in overseeing and ensuring the progress of ongoing studies, and in developing, reviewing and approving analyses, presentations, and publications.

3. The Central Laboratory shall contribute in presenting study data in the form of presentations at scientific meetings and publications in peer-reviewed scientific journals.

4. The Central Laboratory shall coordinate with the Data Coordinating Center (DCC) to provide containers to the REDS-III domestic hubs and international sites for shipment of biospecimens to the CL. For the Domestic hubs, the CL shall bear the cost for shipping biospecimens from the hubs to the CL or other testing sites, and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. For international sites, the CL shall bear the cost for shipping biospecimens from the sites to the CL or other testing sites in the U.S., and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. The international sites shall be responsible for the costs associated with shipping biospecimens to in-country testing facilities and for the costs of storage of biospecimens that are not shipped to the U.S.

5. In accordance with REDS-III study protocols, the Central Laboratory shall perform infectious…