SOURCES SOUGHT
R -- Services in Support of the Perinatology Reseacrh Branch/Program in Perinatal Research and Obstetrics, Division of Intramural Research, NICHD, NIH
- Notice Date
- 3/20/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-PRB-2012-08
- Archive Date
- 3/30/2012
- Point of Contact
- Dana Harris, Phone: 301-443-7798, Marlene T. Mireles, Phone: 301-443-7795
- E-Mail Address
-
dh307s@nih.gov, mirelesm@mail.nih.gov
(dh307s@nih.gov, mirelesm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Small Business Sources Sought Notice 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 there are small businesses; HUBZone small businesses; service-disabled sources; veteran-owned small businesses; 8(a) small businesses; veteran owned small businesses; woman-owned small businesses; or small disadvantaged business; and (3) their size classification relative to 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. A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government. Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and through the Division of Intramural Research (DIR) created the Perinatology Research Branch (PRB) in response to Sec. 452B of the Public Health Service Act that was passed by Congress and signed into law by the President as part of the NIH Revitalization Act of 1993. As a result and extensive consultation, the most effective approach to develop this branch was to establish a research facility in an institution with a large obstetrical patient population in a single campus. A Request for Proposal was issued, calling for full and open competition within the continental United States. After several attempts to establish this program, NICHD issued an RFP for full and open competition on January 12, 2001. On September 30, 2002, a service contract was awarded to Wayne State University/the Detroit Medical Center in Detroit, Michigan. These institutions offered access to more than 5,000 deliveries per year, had a prominent obstetrical service, Division of Maternal-Fetal Medicine, Division of Neonatology in the Department of Pediatrics, research building (C.S. Mott Center, devoted to research in reproduction and human growth and development), and were prepared to give priority to NIH for access to patients, biological materials and clinical data. Sources Sought Notice Purpose and Objectives: The purpose of this Small Business Sources Sought Notice is to identify qualified small business concerns including HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small 2 businesses; women-owned small businesses; or small disadvantaged businesses that are interested in and capable of performing the work described herein. The NICHD does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. As a result of this SBSS notice, the NICHD may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claim against the NICHD shall arise as a result of a response to this Small Business Sources Sought Notice or the NICHD's use of such information as either part of our evaluation process or in developing specification for any subsequent requirement. If a RFP is issued, the NIICHD anticipates a single award may result from the issuance of the RFP. Project Objective: The objective of this procurement is to seek a medical center to house and support NICHD's Perinatology Research Branch (PRB)/Program for Perinatal Research and Obstetrics (PPRO). This contract shall provide the PRB access to a large, stable patient population of pregnant women with a high rate of adverse pregnancy outcomes, who seek prenatal, intrapartum, and post-partum care at a single site within the continental United States. This service contract will also provide for the staffing of non-professional and certain professional support positions, communications and computer support, and support for the operation of several laboratories. The Contractor must have a strong academic environment, including established residency programs in Obstetrics and Gynecology, Pediatrics, and Pathology, and accredited fellowship programs in Maternal-Fetal Medicine, Neonatology, Reproductive Endocrinology, Pediatric Cardiology and Human Genetics. The Contractor will implement and maintain a policy that encourages patients and their providers (resident staff, nursing staff, faculty and private attendings) to actively participate in research studies conducted by the PRB/PPRO. Additionally, the Contractor will implement an assessment program to identify and remove barriers to the conduct of clinical research by the PRB/PPRO. In conjunction with the PRB/PPRO, the Contractor will implement uniform standard procedures for the management of medical records of patients with complication of pregnancy (e.g., preeclampsia, intrauterine growth restriction, preterm labor, preterm PROM, gestational and insulin dependent diabetes, congenital anomalies, fetal death), as well as uniform methods for collection of clinical specimens for clinical care and research studies (maternal blood, umbilical cord blood, placentas, surgical pathology specimens, placental bed biopsies, saliva, urine, etc.) in order to facilitate the conduct of research by the PRB/PPRO. The Government has, and will retain, complete authority and jurisdiction for the development, direction, and execution of the PRB/PPRO scientific agenda, research priorities, and training mission. The objectives of this contract are: • to gain access to an obstetrical population providing at least 4,500 deliveries per year and to efficiently recruit patients during pregnancy to participate in research protocols designed and executed by the PRB/PPRO; and • to obtain the dedicated services and intermittent services required to support all facets of the operation of the PRB/PPRO. Project Scope of Work: This project will provide the infrastructure necessary to accomplish the mission of the PRB/PPRO, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development. This contract will provide a wide range of dedicated and intermittent services required to support all facets of the operation of the PRB/PPRO. The scope of these services is broad and encompasses the following: i. The Contractor will provide access to a large, stable, obstetrical population and will efficiently recruit patients to participate in research protocols designed and executed by the PRB/PPRO. Professional and support services will be provided exclusively for the PRB/PPRO (Dedicated Services), to assist Government personnel in the execution of the research agenda of the Branch. ii. Specialty and routine services normally required to support the operation of a hospital Department will be made available by the Contractor (Intermittent Services) to assist Government personnel in the execution of the research agenda of the PRB/PPRO. iii. The Contractor will implement standard procedures for the management of medical records, treatment of high-risk pregnancies, and for the collection of clinical specimens. iv. Existing fellowships in Maternal-Fetal Medicine and Neonatologyand specialty training programs which could be expanded to integrate additional trainees (Fellows) eligible for Board certification. Project Services: The support services required are listed below : 1. Administration & Management 2. Maternal-Fetal Medicine and Obstetrics 3. Prenatal Clinic/Prenatal Diagnostic Center Neonatology and Developmental Follow-Up, Fetal and Neonatal Magnetic Resonance Imaging (MRI) to study fetal and neonatal anatomy and function 4. Informatics (including Data Collection, Database Management, Perinatal Epidemiology, Biostatistics and Computational Biology) 5. Placental and Perinatal Pathology 6. Laboratory Support (parturition, biomarker discovery and validation, microbiology, reproductive immunology, perinatal neurobiology, management of a repository of biological samples) 7. Molecular Evolution of Reproduction (focused on placentation and parturition) Project Mandatory Qualifications: Offerors must meet all the Mandatory Qualification Criteria set forth below at the time of initial proposal submission in order for their proposal(s) to be considered for contract award. Therefore, in a separate clearly identifiable section of the Technical Proposal and Business Proposal, offerors shall provide evidence demonstrating they meet the following Mandatory Qualification Criteria: 1. Availability to required patient population. The goal of the PRB/PPRO is to study pregnancy complications leading to the excessive rate of infant morbidity and mortality. The frequency of individual pregnancy complications is low, ranging from 1 to 6% of births (i.e., preterm delivery <32 weeks, severe preeclampsia, congenital anomalies, severe small for gestational age). Consequently, access to a large obstetric population is required to efficiently recruit patients during pregnancy, obtain adequate neonatal outcome and infant follow-up information on a scientifically valid number of patients within a defined period of time. Therefore, offerors must provide evidence that they have an obstetrical population delivering a minimum of 4,500 deliveries at a "single site". A "single site" is defined as one hospital with one labor and delivery suite, and not a "system", "consortium" or "group" of affiliated hospitals. This requirement is paramount to maintain efficacy of this federally funded program. Since a patient can deliver any time during a 24 hour period, it is more cost-efficient to house the program at a single site. This will avoid the need to replicate and maintain a research infrastructure (space, equipment, faculty, nursing staff and laboratory personnel) in more than one hospital. This approach will also simplify the management of the research operation. Institutions with two labor and delivery suites located in different hospitals under the same name do not meet the requirement of a "single site" if neither of the units has a minimum of 4,500 deliveries per year. The conditions of stability of the patient population and access to patients defined elsewhere must be met at the time of the submission of the offer, negotiations and contract administration. NICHD wishes to avoid housing this Branch in an institution with a rapidly shifting patient population away from the site that will house the Branch. Buildings that house Branch personnel or Contract personnel in support of the Branch or to which Branch and Contract personnel will need to go to accomplish their goals, shall be located within a mile of the building which houses the labor delivery unit and the Administrative Offices of the Branch. 2. Medical Center with a strong academic environment. The mission of the PRB/PPRO is to conduct original clinical and translational research and training of health care professionals in disciplines related to perinatal medicine. An important goal of the Branch is to translate advances in basic sciences into clinical perinatal medicine. In order to accomplish this goal, close collaboration among clinicians and basic scientists is essential. The likelihood of this collaboration would be optimized if scientists and clinicians work in close proximity at the same institution. Therefore, a Medical Center with a strong academic environment is essential to attract, recruit and retain qualified personnel to staff the PRB/PPRO and the Contractor. A Medical Center with a strong academic environment is also required to optimize collaborations among clinicians and basic scientists and to enable training of health care professional in disciplines related to perinatal medicine. 3. Availability of the administrative, clinical and laboratory space as specified in the RFP as well as the legal authority to renovate the proposed space and to enter into a lease agreement with the Federal Government for the space. NICHD seeks to contract with an institution capable of providing the space to house an Intramural NIH Clinical Branch in close proximity to the Labor and Delivery Suite, Antepartum Ward, Post-Partum Ward, Newborn Special Care Unit, Prenatal Clinic, Obstetrical Ultrasound, Antepartum Testing and Laboratories of the Department of Pathology. The space must be adequate in both quantity and quality (i.e. infrastructure, environmental safety, and location in relationship to clinical services and other operations of the Branch). If the offeror does not operate and control the hospital, it shall demonstrate that it has a relationship with the medical center which guarantees to the Government that the offeror has the authority to renovate the space to meet Government specifications in a timely manner and in compliance with the specification of the Government during Contract administration. The relationship between the offeror and the medical center must be such that environmental services, security, parking, and housekeeping are responsive to the needs of the Branch as outlined in this RFP and lease agreement. The NICHD requires approximately 33,000 net usable square feet of laboratory and support space for the full operation of this project. Space will be broken down approximately as follows: • Office & Support Space 13,000 sq. ft • Laboratory & Clinical Space 20,000 sq. ft 4. Approved residency programs in Obstetrics and Gynecology, Pediatrics and Pathology. The execution of clinical research in obstetrics and perinatology is a 24 hours per day, 7 days per week effort as labor and delivery of complicated pregnancies can rarely be scheduled. Residency programs in Obstetrics and Gynecology, Pediatrics and Pathology assure around the clock staffing of basic services required to conduct clinical research. The existence of approved programs in these disciplines is also an indicator of the commitment of the institutions to a training mission, which is also an important goal of the Branch. 5. Board approved fellowships in Maternal-Fetal Medicine, Neonatology, Reproductive Endocrinology, Human Genetics, and Pediatric Cardiology. An important goal of the PRB/PPRO is to train sub-specialists in disciplines related to perinatal medicine. This training must qualify Fellows for sub-specialty certification by the appropriate Division of the American Boards. The existence of already approved fellowship programs in these areas will obviate the need for a new application and will expedite accomplishment of the Branch's training goal. It is expected that existing programs will be expanded or modified to accommodate the needs of the Branch. If expansion is not possible, then it is required that priority will be given to clinical Fellows appointed by the PRB/PPRO. In order to justify expansion of the program and obtain Board approval, institutions must have an adequate case load and training opportunities. The presence of approved fellowship programs in Maternal Fetal Medicine, Human Genetics, Neonatalogy, Reproductive Endocrinology and Pediatric Cardiology is generally considered evidence that an academic culture fostering training and research exists at the hosting institution. Training and research programs in Reproductive Endocrinology and Human Genetics are important because the PRB/PPRO is interested in studying complications of the first trimester of pregnancy, genetic diagnosis, fetal dysmorphology, prenatal diagnosis and treatment of genetic diseases including anatomic anomalies and inborn errors of metabolism. The Branch will also focus on improving the prenatal diagnosis of congenital heart disease and fetal cardiovascular dysfunction, which may underlie the increased risk of growth-restricted fetuses for coronary artery disease, stroke and hypertension in adult life. 6. Pediatric sub-specialties including cardiology, hematology, surgery, neurology, and neurosurgery must be located in the same campus. It is expected that many unborn children affected by congenital disorders will be delivered at the institution housing the Branch. Adequate support from pediatric sub-specialties is required to provide optimal care as well as professional services, training and education to members of the Branch. It is recognized that many cities in the United States have Children's Hospitals providing such services. NICHD seeks an institution in which pediatric sub-specialties are available on site or in close proximity to the obstetrical hospital. This is designed to avoid the risk of transporting critically ill newborns in ambulances immediately after birth. Anticipated Period of Performance: The period of performance for this requirement is ten (10) years and the anticipated state date is on or about November 1, 2012. NAICS Code and Size Standard: In the event an RFP is issued, the NAICS code is 541712 and a size standard of 500 employees. Capability Statement/Information Sought: Sources are expected to have the personnel, facilities, equipment, and experience to outline a strategy and propose the specifications for the purchase or synthesis of compounds not readily available in the quality or quantity required. Tailored capability statements shall demonstrate a clear understanding and past performance of all activities and space as specified above. Information Submission Instructions: 1. Page Limitations: Interested, qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty-four (24) single-sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the firm's ability to perform the aspects of the notice described above and in the draft SOW. Tailored capability statements should also include an indication of current certified small business status. This indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible small business concern's name, point of contact, address and DUNS number. 2. Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Dana L. Harris, Contracting Officer, at harrisd@mail.nih.gov with a cc to Marlene T. Mireles, Contracting Officer at mirelesm@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NIH-NICHD-PRB-2012-08. Facsimile responses will not be accepted. 3. Common Cut-Off Date: Electronically submitted tailor capability statements are due no later than 12:00 PM (Eastern Standard Time) Thursday, March 29, 2012. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for information provided in the 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 organizations 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 notice 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).
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