a_chs_redacted_ja.docx

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 (NIH)

b. Sponsoring organization. National Heart, Lung, and Blood Institute (NHLBI), Division of Cardiovascular Sciences (DCVS), Prevention and Population Sciences Program (PPSP), Epidemiology Branch

c. Project Officer information.

· Project Officer name: XXXXXXX

· Mailing address: XXXXXXXXX

· E-mail address: XXXXXXXXXX

· Telephone number: XXXXXXXXXX

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

a. Acquisition purpose and objectives.

The objective of this acquisition is to obtain services and expertise in maintenance of the Cardiovascular Health Study (CHS) Biospecimen Repository and enablement of continued access to the biospecimens for research purposes by qualified investigators. The biorepository consists of approximately 350,000 blood, urine, and DNA specimens collected from research participants enrolled in the CHS. The collection is housed in approximately sixteen freezers at the University of Vermont. Together with a large data base of accompanying participant data maintained at the University of Washington with the deliverables copies at the NHLBI and its designated data repository, the biospecimens are of great value to researchers for addressing questions concerning risk factors for and progression of cardiovascular disease and related conditions in older adults.

The Epidemiology Branch, in the Prevention and Population Sciences Program within the Division of Cardiovascular Sciences, NHLBI, conducts epidemiologic studies of associations of cardiovascular disease. The information obtained is used to develop programs to control these diseases. The biospecimens (and data) collected in CHS represent a major national resource for the study of development and progression of cardiovascular and other aging-related conditions in older and oldest old adults. The study will continue to identify the contributions of traditional and novel determinants of development and progression of cardiovascular and cerebrovascular diseases; the contributions of genetic and genetic-environmental factors in the development of these diseases; and the impact of these and related conditions on overall health status and function in this age group.

This J&A is requesting approval to issue a noncompetitive solicitation to the University of Vermont to continue as the contractor for the CHS Biospecimen Repository.

b. Project background.

CHS was initiated by the NHLBI to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults. In 1989-90, the study recruited and conducted a detailed examination of 5,888 adults aged 65 and older at entry in four communities. Nine follow-up exams were conducted annually through 1999, followed by semi-annual phone calls to ascertain new CVD events through May 2005.

The data and specimens collected in CHS and its more than 360 ancillary studies represent a major national resource for the study of development and progression of cardiovascular and other chronic diseases in older adults. To promote continued use of this resource, the NHLBI provided contract support for core functions to the CHS Coordinating Center at the University of Washington from 2005 to 2015. The contractor maintained the CHS data sets and core study operations, and through a subcontract to the University of Vermont, the biorepository.

The previous CHS contract, HHSN268201200036C, ended December 31, 2015. At that time, all but the biospecimen repository was transitioned to a grant to the University of Washington. NHLBI wished to maintain ownership of the biospecimen collection, to assure its integrity and continue the effective and efficient mechanism already in place to provide access to the biospecimens by interested investigators. As such, purchase orders were issued to the University of Vermont for each of calendar years 2016 (HHSN268201600006P, $98,569) and 2017 (HHSN268201700024P, $84,248). This new acquisition will provide continuation of services, outlined in the statement of work, for 2.5 years to align with the end of the grant period plus transition time and effort for possible restructuring of the CHS in the future. Obtaining the requested multiple year services will enable stability of the biorepository and an orderly transition, if applicable, more efficiently than yearly purchase orders.

Together, the grant data repository and core functions along with the contract biospecimen repository serve as the infrastructure for investigator-initiated research in this cohort of older adults, and CHS continues to be highly productive scientifically.

Further details about the initial and subsequent awards and basis for past approved JOFOC are provided in section 5b below.

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

a. Project title. Cardiovascular Health Study (CHS) - Biospecimen Repository

b. Project description. XXXXXXXXXX

· 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): ______________________

· 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 (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

· Acquisition identification number. Solicitation No. HHSN26818HV00020R

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

The total estimated cost for this acquisition is $XXXX. The period of performance will be from January 1, 2018 to June 30, 2020.

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).

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).

University of Vermont 208 South Park Drive, Suite 2 Colchester, VT 05446-5864

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

Through a full and open competition, the University of Vermont was awarded the NHLBI contract for the CHS Central Blood Analysis contract and has served as the biorepository since CHS began in 1988. Its work scope shifted from that of both a laboratory and biorepository to primarily a biorepository in 2005, supported as a subcontractor to the University of Washington. Since 2016, purchase orders directly to the University of Vermont support maintenance and utilization of the CHS biorepository. The University of Vermont is uniquely qualified to continue providing biorepository services for the following reasons:

(i) The collection and storage of biospecimens began at a time before the technology of barcoding biospecimen vials for inventory tracking was available. A custom inventory system was created that enables biorepository staff to locate vials from specific participants containing a specific type of biospecimen, but each vial is not uniquely identified. Nowadays biorepositories - commercial repositories in particular – rely on a computerized inventory system based on barcoded vials. Expecting another source to integrate the CHS inventory system into its own would represent an operational challenge requiring time and additional expense for both the incumbent and any other offeror.

(ii) Maintaining the CHS biospecimen collection in its present location would avoid risk of biospecimen loss incurred during transfer of the biospecimen collection to another entity. Many of CHS’s sixteen 80°C freezers are very old and susceptible to damage during transport via truck to another location. This loss was indeed experienced by another NHLBI study during a biorepository relocation a few years ago. Relocation of the biospecimens and likely required replacement of irreparably damaged freezers would also add costs.

(iii) Maintaining the repository in its current location would avoid potential delays in providing needed biospecimens to researchers with limited research grant funding and time to conduct their research projects.

(iv) The CHS study design, huge data set, and availability of biorepository biospecimens are complicated. Using the data and biospecimens most effectively for research requires the expertise and input of investigators and staff familiar with these resources and the study design, and who can therefore advise and collaborate with researchers in designing research projects that are doable and make good and efficient use of the resources. This is particularly true for use of the limited resource of the biospecimen collection. The personnel at the University of Vermont, who have been an integral part of the CHS, including participating in its design, and working with the data and biorepository for more than 25 years, are uniquely qualified to provide this expertise. The biorepository director is a highly accomplished and internationally recognized scientist.

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.

A Sources Sought notice was posted to FedBizOpps on May 23, 2017 (notice closed June 7, 2017). The intent of the notice was to solicit qualified sources capable of performing the work of the biorepository related to CHS. See Section 8 for a description of this market research.

A pre-solicitation notice of NHLBI’s intent to issue an award to the University of Vermont will be posted on FedBizOpps prior to release of the solicitation. Additionally, the J&A notice will be posted to FedBizOpps once the contract is executed.

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

This acquisition will be XXX, fixed priced, options contract. An independent government cost estimate has been developed based on the history with this contractor and other biorespository contractors. Historical costs will be used as a reference point as part of the cost analysis of the contractor’s proposal to include labor, fringe, materials, other direct costs and indirect costs. Internet searches were also performed to compare salaries, travel costs, equipment and supplies.

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 included a number of efforts to ensure that offers were solicited from as many potential sources as practicable. A Sources Sought notice was posted to FedBizOpps on May 23, 2017 (notice closed June 7, 2017). The intent of the notice was to solicit qualified sources capable of performing the work of the biorepository related to CHS. One business, XXXXXXXXX, responded to the notice. The Program Officer reviewed their capability statement and determined that the company was not capable. While they have experience in maintaining a repository, including for some NIH collections, they did not demonstrate any of the required familiarity with the CHS data and biospecimen resources. While the CHS website, with publicly accessible CHS Policies and Procedures, was listed in the Sources Sought notice, there is no evidence that it was reviewed or incorporated into their response.

This service was previously procured on orders HHSN268201600006P and HHSN268201700024P. These orders were awarded to the University of Vermont as a sole source. The market research completed on HHSN268201700024P was taken into consideration for this acquisition.

As described in item 5. above, the University of Vermont collection and storage of biospecimens began at a time before the technology of barcoding biospecimen vials for inventory tracking was available. A custom inventory system was created that enables biorepository staff to locate vials from participants containing a specific type of biospecimen, but each vial is not uniquely identified. Even though other contractors can provide services to maintain the biorepository, it would be detrimental to the biospecimen collection should another contractor take over the repository.

The incumbent, the University of Vermont, was determined to be the only capable source to perform the service and maintain the biospecimens as-is without a loss to the Government of inventory data and/or biospecimens.

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

As noted above in 5.b.(a-d), the complicated nature of the CHS’ existing resources of longitudinal data and biospecimens, long term integration of the current CHS Biospecimen Repository staff into CHS study procedures including evaluation of new biospecimen requests, and potential loss incurred by a relocation, would result in significant delays or gaps in Repository services if transitioned to a new Contractor. There would also be significant costs to the incumbent and new Contractor to affect such a transition, including hiring and training of new staff to work with the CHS Biospecimen Repository, the CHS Steering Committee and scientific community. Delays in service would adversely impact the biospecimen users, who have limited time within their funding sources to receive and utilize these biospecimens. Thus, the overall CHS study productivity would be adversely impacted and reduce the Government’s ability to leverage these legacy resources while maintaining appropriate oversight and stewardship.

Therefore, 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 the CHS Biospecimen Repository, instead of allowing the current, uniquely qualified and responsible contractor to complete performance of the SOW.