MODIFICATION
R -- FULL AND OPEN COMPETITION: SERVICES IN SUPPORT OF THE PERINATOLOGY RESEARCH BRANCH/PROGRAM IN PERINATAL RESEARCH AND OBSTETRICS, NICHD, NIH
- Notice Date
- 6/18/2012
- Notice Type
- Modification/Amendment
- 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
- 7/12/2012
- 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
- The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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. Wayne State University in Detroit, MI is the current contractor and has provided the support services of the PRB/PPRO since 2002. 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. 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. 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. 3. 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. It is anticipated that one-cost reimbursement-term, incrementally funded, type of contract will be awarded, for a period of performance of 10 years, beginning on or about November 1, 2012. The RFP will be posted on or about June 27, 2012 on the Federal Business Opportunities website: http://www.fbo.gov. The due date for submission of proposals in response to the RFP is anticipated to be on or about August 12, 2012. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541712. Any questions concerning this announcement must be submitted in writing to Mr. Dana L. Harris, Contracting Officer at dh307s@nih.gov, or Ms. Marlene T. Mireles, Contracting Officer at ms70j@nih.gov or addressed to NICHD Acquisition Services Branch, Office of Acquisitions, NICHD, NIH, 6100 Executive Blvd., Room 5Z00, Rockville, Maryland 20852. No collect calls will be accepted. This is not an RFP and this announcement does not commit the Government to award a contract. The reference number to be used for this announcement is: RFP: NIH-NICHD-PRB-2012-08. All correspondence must cite the reference number as provided.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-PRB-2012-08/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN02778679-W 20120620/120618235001-969b10825134b71c85b8829f841f5097 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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