SOLICITATION NOTICE
R -- FULL AND OPEN COMPETITION: SERVICES IN SUPPORT OF THE PERINATOLOGY RESEARCH BRANCH/PROGRAM IN PERINATAL RESEARCH AND OBSTETRICS, NICHD, NIH
- Notice Date
- 6/12/2012
- Notice Type
- Presolicitation
- 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), 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. Section 452B states that: "The Director of the Institute (NICHD) shall establish, and maintain within the Institute, an intramural laboratory and clinical research program in obstetrics and gynecology." For a number of years, Congress has expressed concern over the unacceptably high infant mortality rate throughout the United States. In order to effectively and efficiently address the perinatal aspects of this problem, the NICHD must establish the PRB in a location that has access to the patient population and research infrastructure necessary to accomplish the goals of the Branch. The NICHD has determined that the most effective approach is to locate the PRB within an academic institution that serves a large obstetrical and neonatal patient population. The mission of the PRB/Program in Perinatal Research and Obstetrics (PPRO) is to conduct clinical and laboratory research in maternal, fetal, and neonatal diseases responsible for perinatal morbidity and mortality; and to train health care professionals in perinatal medicine and related disciplines. The PRB/PPRO emphasizes a multi-disciplinary approach and utilizes expertise from clinical disciplines (obstetrics, neonatology, perinatal pathology), basic sciences (molecular and developmental biology, biochemistry, physiology, etc.), and clinical epidemiology to improve the etiologic understanding, diagnosis, treatment, and prevention of disorders related to maternal and infant mortality. The PRB/PPRO currently has, or is developing, research protocols addressing the following areas: 1. The role of inflammation and other mechanisms of disease in preterm parturition and the ‘great obstetrical syndromes'. 2. Physical and biochemical biomarkers for the prediction of spontaneous or "indicated preterm birth" (e.g. an example of this is the use of angiogenic and anti-angiogenic factors to identify patients at risk for preeclampsia and other complications of pregnancy). 3. Systematic reviews and meta-analyses to evaluate the effectiveness of diagnostic tools and therapeutic interventions in obstetrics and perinatal medicine. 4. Pharmacoeconomic studies of interventions to prevent preterm birth (e.g. vaginal progesterone). 5. Pharmacogenomic studies to identify DNA variants that predispose to a short cervix and identify patients who respond or do not respond to vaginal progesterone administration. 6. Characterization of fetal growth in singleton and twin gestations using 2D and 3D ultrasound. 7. Use of 2D and 3D ultrasound in the labor and delivery floor to identify the patient at risk for failure to progress in labor in the first or second stage. 8. Application of magnetic resonance imaging to evaluate perinatal brain injury by assessing anatomy, hemodynamics and functional biochemistry. 9. Development of intelligent navigation to characterize normal and abnormal fetal anatomy using 3D and 4D ultrasound. 10. Characterization of pathologic lesions of the human placenta associated with the ‘great obstetrical syndromes' (preterm labor, prelabor rupture of membranes, preeclampsia, intrauterine growth restriction, large for gestational age, fetal death, gestational diabetes, etc.). 11. Transcriptomic and proteomic analysis of the chorioamniotic membranes, myometrium and cervix in term and preterm labor, including labor disorders responsible for major morbidity. 12. Proteomic analysis of the amniotic fluid, maternal and umbilical cord blood to identify biomarkers for mechanisms of disease responsible for the ‘great obstetrical syndromes'. 13. Characterization of the maternal and fetal white blood cell transcriptome in fetal systemic inflammation types I and II. 14. Identification and characterization of placental microRNAs involved in human labor, preterm labor, preeclampsia, small for gestational age, fetal death, preterm PROM and other obstetrical syndromes. 15. Longitudinal studies of the vaginal microbiome, mucosal immunity of the lower genital tract in non-pregnant women, normal pregnant women and those who have a preterm delivery with and without intra-amniotic infection. 16. Longitudinal studies of pregnant women to identify biomarkers for preeclampsia, SGA, LGA and fetal death. 17. Use of molecular microbiologic techniques to identify the endometrial flora in the non-pregnant state, and how it differs from the lower genital tract. 18. Further characterization of the role of microbial biofilms in ascending intrauterine infection. 19. The role of neuroinflammation in the genesis of cerebral palsy and other developmental disorders. 20. The use of nanotechnology and regenerative medicine to induce central nervous system repair and prevent the development of cerebral palsy and other neurodevelopmental disorders. 21. The use of molecular imaging to identify congenital neonatal neuroinflammation. 22. Characterization of maternal and fetal genetic factors that predispose to adverse pregnancy outcome. 23. A randomized clinical trial of vaginal progesterone in twin gestations in women with a short cervix. A. OBJECTIVE The objective of this procurement is to seek a medical center to house and support its Perinatology Research Branch (PRB). This contract shall provide the PRB access to a large, stable patient population of pregnant women with a high rate of adverse outcome, who seek prenatal, intrapartum, and post-partum care at a single site within the United States. This 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, 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. Additionally, the Contractor will implement an assessment program to identify and remove barriers to the conduct of clinical research by the PRB. In conjunction with the PRB, the Contractor will implement uniform standard procedures for the management of medical records (e.g., pre-eclampsia, intrauterine growth retardation, preterm labor, preterm PROM, gestational and insulin dependent diabetes, congenital anomalies), 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 biopsies, etc.) in order to facilitate the conduct of research by the Branch. The Government has, and will retain, complete authority and jurisdiction for the development, direction, and execution of the PRB 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 at risk patients during pregnancy to participate in research protocols designed and executed by the PRB; and • to obtain the dedicated services and intermittent services required to support all facets of the operation of the PRB. B. SCOPE OF WORK This project will provide the infrastructure necessary to accomplish the mission of the Perinatology Research Branch/PPRO, Division of Intramural Research, 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 fellowship and specialty training programs will be expanded to integrate Government Clinical Fellows. Dedicated Services 1) To continually recruit patients with a high rate of adverse pregnancy outcomes such as: preterm delivery less than 32 weeks; intrauterine growth retardation; pre-eclampsia; HELLP syndrome; congenital anomalies; maternal sepsis; postpartum hemorrhage, in order to provide a scientifically-valid number of study subjects to participate in PRB/PPRO research protocols. 2) To assist Government staff with professional and support services to ensure the efficient operation of the Branch and successful execution of the research agenda. 3) To provide services in Project Management, Protocol Coordination, Post-Graduate Medical Education, Maternal-Fetal Medicine, Neonatology, Placental Pathology, Perinatal Epidemiology, Intrapartum Research, Obstetrical Ultrasound, Fetal Echocardiography, maintenance of a Bank for Biological Fluids and Tissues, Parturition Laboratory (cell culture, immunoassays, mRNA assays, silencing, functional assays related to inflammation), Microbiology, Reproductive Immunology, Neurobiology, and services required for the maintenance of a database (data entry clerks, database managers, programmers, hardware and software specialists). 4) The integration of Government Staff and Maternal-Fetal Medicine Fellows into sub-specialty Board Fellowships in Maternal-Fetal Medicine, Neonatology, and Human Genetics as required by the Perinatology Research Branch/PPRO; 5) The implementation of a uniform, computerized, obstetrical and neonatal clinical medical record system which meets the needs of patient care as well as the research needs of the PRB/PPRO; 6) To obtain institutional support for PRB/PPRO research protocols encompassing randomized clinical trials of labor management, prenatal diagnosis, perinatal cardiology, fetal endoscopic diagnosis and surgery, and developmental and molecular embryology. Intermittent Services 1) To gain access to a variety of specialty and routine services, including those described below, in much the same manner as other departments of the Contractor's organization. a) Intermittent clinical support services, available 24 hours/day, 7 days/week, in the following areas: Level III newborn intensive care unit capable of providing Extra Corporeal Membrane Oxygenation (ECMO) support; obstetrical anesthesia; a microbiology laboratory which performs cultures of aerobic and anaerobic bacteria as well as mycoplasmas; an investigational pharmacy; b) Intermittent services in the following areas: genomics, bioinformatics; infectious diseases in obstetrics; and flow cytometry; c) Intermittent support from pediatric sub-specialties including pediatric neurology, pediatric cardiology, pediatric urology, pediatric radiology, pediatric surgery and neurosurgery; d) Intermittent services from epidemiologists and biostatisticians with special expertise that would be project-dependent; e) Access to an AAALAC accredited animal care facility, and associated intermittent support services, for the development of animal models of maternal and fetal diseases as required. The primary objective of this project is to obtain the requisite infrastructure necessary to support the mission of the Perinatology Research Branch/PPRO, Division of Intramural Research, National Institute of Child Health and Human Development. Definitions 1. "Single Site" A "single site" is defined as one hospital and, specifically, 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 in 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 and access outlined elsewhere must be met for contract performance. NICHD wishes to avoid rapidly shifting patient populations away from the site that will house the Branch. Buildings which house Branch personnel or contract personnel or to which Branch and contract personnel will need to go shall be located within a mile of the building which houses the labor delivery unit and the Administrative Offices of the Branch. 2. "Access to Patients" The Perinatology Research Branch/PPRO is a clinical Branch with a research and training mission as well as an obligation to maintain the clinical and research skills of government appointees who are Board eligible or certified or other health care professionals pursuing training goals with the PRB/PPRO. Access to an adequate patient population is required to achieve these goals. Although this solicitation is planned for the procurement of space, equipment, supplies, a workforce and other services, the success of the Perinatology Research Branch depends on the access to patients and the absence of obstacles that would render the operation inefficient. Consequently, NICHD seeks to establish this Branch in an institution with a culture supportive of clinical research in obstetrics and with experience in removing barriers and obstacles to the successful completion of research and training. Given the magnitude of the commitment by the federal government, NICHD seeks an institution capable of giving priority to research protocols of the Perinatology Research Branch/PPRO. The PRB/PPRO has access to patients, biological materials, and training opportunities only if all the following conditions are met: i. The patients can be invited to participate in a research protocol approved by the Perinatology Research Branch/PPRO and the hosting institution IRB without additional approval of staff physicians, private attendings, nurse midwives or other personnel. Before the implementation of a protocol, the Perinatology Research Branch will communicate with the leadership of the Departments involved, as well as representatives of the faculty and community physicians. The protocol developed by the Branch will be distributed to medical and paramedical personnel before the initiation of the study. If after information is provided and the staff is consulted, additional approval is required from individual faculty members, private physicians, nurse midwife before research staff is allowed to invite patients to participate in a study, this will be considered "qualified access". If this "case by case" approval is not required this will be considered "unqualified access". NICHD will give preference to institutions that offer "unqualified access". ii. The collection of biological materials (i.e., maternal blood, umbilical cord blood, saliva, urine, amniotic fluid, maternal and neonatal urine, tracheal bronchial fluid lavage, cerebral spinal fluid, placentas, placental bed biopsy, vaginal secretions, uterine cervical fluid, endometrial biospies, etc.) required for the execution of the research agenda of the Branch will be given priority over other research protocols which compete for the same material and/or patient. iii. Members of the PRB/PPRO and contract personnel in a support capacity are allowed to: i. observe operative procedures in the operating room ii. visit patients in the antepartum, intrapartum (Labor and Delivery) and postpartum ward iii. observe invasive procedures such as chorionic villous sampling, fetal blood sampling, fetal endoscopic surgery, etc. iv. observe autopsies of perinatal deaths as well as maternal deaths v. access to videotapes or records of files (i.e., ultrasound records) of previously diagnosed cases of conditions which may be of interest to the Branch for research or educational purposes (e.g., congenital anomalies, placenta accreta, amniotic fluid embolism, etc.) vi. access to diagnostic imaging including radiology, magnetic resonance imaging and CAT scanning vii. access to the angiography suite where patients are undergoing embolization for the treatment of postpartum hemorrhage or other conditions viii. access to the Maternal Special Care and Intensive Care Units for research and educational purposes regarding critically ill mothers ix. access to laboratories for obtaining specimens which patients may have provided to clinical hematology, clinical chemistry, coagulation laboratory, immunology laboratory, microbiology laboratory x. access to paraffin blocks, histologic slides/photographs of gross specimens of patients who may have delivered in the hospital and may have a condition of interest to the Branch xi. access to obstetric, pediatric and pathology conferences where cases are discussed and which may represent educational or research opportunities for members of the Branch or contract support staff access to videoconference facilities. C. GENERAL DESCRIPTION OF PROPOSED ACTIVITIES TO BE PERFORMED Independently and not as an agent of the Government, the Contractor shall furnish all of the necessary services, qualified personnel, material, and facilities, not otherwise provided by the Government, to support the execution of the research agenda of the Perinatology Research Branch/PPRO, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development. As a result of the Contractor's necessity to furnish all of the services, qualified personnel, material and facilities, the Contractor shall provide evidence demonstrating they meet or exceed the following Mandatory Criteria Qualifications: Mandatory Qualifications 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 pre-eclampsia, congenital anomalies, severe small for gestational age). Consequently, access to a large obstetric population is required to efficiently recruit 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 conduction of clinical research in 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 also is a 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 Board. 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 as government appointees. 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 is 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 May XX, 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 1, 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
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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
- SN02773233-W 20120614/120612235217-a29e67d8047d4b2d59dc56351bf5a5c8 (fbodaily.com)
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