Services to Continue the Scientific Registry of Transplant Recipients (SRTR).

Description This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUB Zone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide services to Continue the Scientific Registry of Transplant Recipients (SRTR). The Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA) is seeking a contractor to operate the Scientific Registry of Transplant Recipients (SRTR). The Contractor will be responsible for providing statistical and other analytic support to the Organ Procurement and Transplantation Network (OPTN) in the formulation and evaluation of organ allocation and other OPTN policies. Additionally, the Contractor will provide analytic support to the Department of Health and Human Services in a variety of areas including: policy formulation and evaluation, system performance metrics, economic analysis, and preparation of recurring and special reports to Congress, including the Biennial Report to Congress of the Clinical and Scientific Status of Organ Donation and Transplantation in the U.S. The Contractor will be responsible for working closely with the OPTN and the Contractor for the OPTN on data collection, analysis and quality improvement activities. The OPTN Contractor is responsible for primary data collection and providing these data to the SRTR on a regular basis. The OPTN collects data for each major event in the transplant process including: patient registration on the transplant waitlist, transplant procedure or removal from the transplant waitlist, and periodic follow-up of both transplant recipient and living donor following transplantation. The OPTN also collects information about the organ donor and the disposition of organs retrieved from each donor. The SRTR is responsible for the effective organization, maintenance, storage and protection of this data and supplementing these data, as necessary, with data from other available data sets, to establish and utilize an ongoing analytic data set for the purpose of conducting analyses in support of the OPTN and HRSA and for making a subset of these data available for bona fide research. BACKGROUND Section 373 of the Public Health Service (PHS) Act requires the operation of SRTR tosupport an ongoing evaluation of the scientific and clinical status of solid organ transplantation including: kidney, heart, liver, lung, pancreas, and intestine transplants. The Secretary of the Department of Health and Human Services (HHS) may include other organs within the definition of organ for purposes of the National Organ Transplant Act (NOTA) and the OPTN final rule (42 CFR 121). The OPTN Contractor is responsible for primary data collection and providing these data to the SRTR on a monthly basis. From 1987 to 2000, HRSA contracted with the United Network for Organ Sharing (UNOS) to develop and operate the SRTR. Since September 28, 2000, the University Renal Research and Education Association (URREA) has operated the SRTR. In July of 2006, URREA formally changed its name to Arbor Research Collaborative for Health. Currently, the database contains information on approximately 850,000 waitlist registrants, 475,000 transplant recipients, and 235,000 deceased and living donors. The size of most current monthly OPTN database transfer is over 60 gigabytes, including over 650 million records, and 13,870 columns in over 1,000 tables. The size of this database will continue to expand given the tremendous demand for organ transplants. Approximately 28,000 organ transplants performed in the U.S. in 2009. As of the end of March 2010, there were approximately 106,000 individuals with end-stage organ failure awaiting organ transplants in the U.S. The demand for organs for transplants far surpasses and will continue to surpass the number of organs donated each year. There is a clear need for the monitoring and evaluation of advances in transplant surgery techniques, clinical donor management and organ preservation, improvements in matching donor organs with recipients, and developments in immunosuppressive therapies in order to improve transplant outcomes. The OPTN final rule provides a framework for the structure and responsibilities of the OPTN. One of the major responsibilities of the OPTN is the development of policies that determine how deceased donor organs are allocated to transplant candidates. The OPTN final rule requires that these policies be based on sound medical judgment and reviewed periodically and revised as appropriate. It is the primary responsibility of the SRTR Contractor to provide the analytic support and evidence necessary to support the OPTN in the development and evaluation of OPTN policy. Although, the SRTR Contractor is substantively involved in the policy development process, it is the responsibility of the OPTN and not the SRTR Contractor to develop OPTN policy. REQUIRED TASKS The Contractor for the SRTR shall serve as the primary analytic resource to the OPTN and HHS. The SRTR contractor shall provide analytic expertise to support analysis of a broad range of issues relating to: waitlist and post-transplant outcomes evaluation; the evaluation of existing OPTN policies; the likely impact of proposed OPTN policies; and the operation and performance of the OPTN as a whole and of its various members. The performance of this contract requires the Contractor to establish and maintain a close working relationship with: the OPTN Contractor; the various committees and members of the OPTN; the Division of Transplantation (DOT and other entities within HHS such as Center for Medicare and Medicaid Services (CMS), National Institutes of Health (NIH), Food and Drug Administration (FDA), Agency For Healthcare Research and Quality (AHRQ), Centers for Disease Control (CDC), National Committee on Vital and Health Statistics (NCVHS); the Secretary's Advisory Committee on Organ Transplantation (ACOT); and other members of the transplant community. In the performance of this contract, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities needed to perform the tasks described in this Statement of Work (SOW). Most of the data required to perform these tasks shall be those collected by the OPTN Contractor and provided to the SRTR Contractor on a periodic basis, but will also include other datasets to be provided by the SRTR Contractor to help validate and supplement the OPTN data. A Cost type contract is anticipated, for one base year and one option year. The previous source for this requirement was the University Renal Research and Education Association, Arbor Research Collaborative, Ann Arbor, Michigan. The NAICS Code is 541690 with a small business size standard of $7.0m. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541690 (size standard $7.0m or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUB Zone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received by the Contract Specialist named below not later than 2:00 PM Eastern Standard time on May 14, 2010 for consideration. Acceptable transmittal of responses includes E-Mail, U.S. Mail, express delivery. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and HRSA may contact one or more respondents for clarifications and to enhance the Government's understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. POINTS OF CONTACT Contract Specialist: Daniel Matusiewicz, 5600 Fishers Lane, Room 13A-19, Rockville, MD 20857 Phone +1 (555) 000-0000; Email: contact@example.gov