Clinical Research, Professional, Ancillary Support Services and Facilities for NIDCD

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION . The Office of Logistics and Acquisition Operations (OLAO), Office of Acquisitions (OA) on behalf of the National Institute on Deafness and Other Communication Disorders (NIDCD) intends to negotiate and award a 5-year contract to the Johns Hopkins University's Otolaryngology Department at Suburban Hospital in Bethesda, Maryland, without providing for full and open competition for clinical otolaryngology services and research expertise. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 All Other Professional, Scientific, and Technical Services. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-95. This acquisition is conducted under the procedures as prescribed in FAR subpart 12-Acquisition of Commercial Items and FAR subpart 15-Contractingy by Negotiation at an amount exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c)(1) under provisions of the statutory authority of FAR Subpart 6.302-Only one responsible source and no other supplies or services will satisfy agency requirements. DESCRIPTION OF REQUIREMENT Background - The NIDCD DIR has undertaken an expansion of an integrated laboratory and clinical research program requiring otolaryngologist-head and neck surgeon-scientists, fellowship trained otolaryngology sub-specialists, and support staff. The newly expanded NIDCD DIR clinical research program will develop a translational clinical research program with emphasis on genetic and acquired disorders of human communication affecting hearing, balance, smell, taste, voice, speech and language. Recent scientific advances in genomics, cell biology, and immunology, have created new opportunities to more rapidly translate these findings to interventions to impact the health of persons with disorders affecting human communication. Translational clinical studies represent the practical implementation of basic discoveries and critical experiments that refine and define new questions to be addressed by non-clinical investigation. As such, a synergistic relationship exists between NIDCD's basic science and clinical studies. Successful translation of basic research requires coordination of the efforts by laboratory investigators, statisticians, physician-scientists, clinicians, and other patient-care providers. Strong linkages between the bench and the Clinical Research Program enhance the likelihood of success. Currently, the services are being provided under the Intergovernmental Personnel Act (IPA) Mobility Program; there were no previous contracts in place. The IPA Mobility Program provides for the temporary assignment of personnel between the Federal Government, state and local governments, colleges and universities etc. NIDCD partnered with Johns Hopkins University via the NIDCD Otolaryngology Surgeon-Scientist Program (OSSP) and have jointly recruited and invested approximately four (4) or more years of support for otolaryngology surgeon scientists with the different specialties and specific research qualifications required for clinical patient care and specific NIDCD research projects. To support the needs of this expansion, it is in the best interest of the Government to continue the partnership between the NIDCD at the NIH and JHU, by issuing a new contract for a 5-year period, to JHU's otolaryngology department. JHU is the only an academic medical center that meets the requirements and have the only qualified surgeon-scientists and fellowship trained subspecialists that possess protocol specific experiences with NIDCD surgical patients. The contractor will support development and conduct of NIDCD DIRs translational and clinical research program, and provide all otolaryngology-head and neck surgical patient care at the NIH Clinical Research Center (CRC), located in Bethesda, Maryland. General Requirements Clinical care of increasingly complex patients from NIDCD and other institutes at the NIH CRC requires providers with training and experience in the above subspecialties for expert management of patients with sudden hearing loss (neurotology), airway emergencies (laryngology), cancers, and life threatening bleeding or infections (head and neck and rhinologic/skull base surgery). Because such life-threatening emergencies and urgent problems require response and intervention within minutes, it is essential that the providers be located at the CRC and an adjacent hospital and clinics. Immediate proximity of contractors who provide clinical research and care at NIH CRC, and at an adjacent hospital and clinics providing a full range of clinical care not available at NIH CRC, is required to provide 24/7 routine and emergency care to meet the needs of NIDCD and NIH patients and research subjects. Meeting these requirements will maximize efficiency in terms of staff cost and cross training, and provide for a common support infrastructure including but not limited to clinical laboratory and trial support for the spectrum of normative human communication and interventional trials under development. In order to initiate the expanded research agenda including normative longitudinal and interventional studies, and to provide clinical care, the NIDCD initially requires 3 otolaryngologist-surgeon scientists and 3 part-time otolaryngology clinicians. Support and coordination of the NIDCD Clinical Research Program will be under the Office of the Clinical Director (OCD), DIR, NIDCD. The NIDCD Clinical Director plans, manages, and supports the conduct of intramural clinical research on the cause, diagnosis, prevention, and treatment of human communication disorders and fosters the translation of advances in basic science into clinical applications. The NIDCD Clinical Director holds the responsibility for ensuring the quality and safety of clinical trials within the Institute. The OCD: (1) provides the infrastructure needed to promote high quality clinical research and to ensure patient safety including: protocol review, clinic infrastructure, nursing and physician support, clinical informatics, data and safety management; (2) monitors and maintains quality assurance of the intramural clinical research program; (3) develops and implements clinical program priorities, allocates clinical resources; (4) integrates the established research themes and projects with clinical relevance from various DIR laboratories and branches; (5) evaluates program effectiveness and represents the DIR in management and scientific decision-making meetings within the Institute; (6) coordinates the credentialing of health care providers within the Institute; (7) coordinates and provides clinical research training for NIDCD staff and fellows; and (8) develops novel approaches for carrying out translational research in an efficient and cost-effective manner. The OCD oversees NIDCD Clinical Laboratories housed in the CRC, Protocol and Patient Coordinators, and Clinicians supporting critical sub-components of the clinical research program, nursing, and other testing support staff in addition to resources needed to expand the clinical informatics and data management infrastructure. The OCD Office Manager coordinates the credentialing of Physicians and Nurse Practitioners (NPs) within the Institute, including maintenance of the original documentation and a Continuing Medical Education (CME) report of credentialed Physicians and NPs within the Institute. Specific Requirements and Tasks The Contractor shall provide all necessary personnel and ancillary services (except for those to be furnished by the Government as may be specified elsewhere in the contract) to perform the work required by the contract as set forth below. The Contractor shall perform work in support of direct patient care activities on a 24-hour per day, 365 day per year basis, except as otherwise directed by the NIDCD Project Officer. Clinical Research Support Services The Contractor shall initially provide highly qualified part time otolaryngology surgeon scientists and fellowship trained otolaryngology sub-specialists in Neurotology (0.4), Laryngology (0.8), Head and Neck/Oncologic/Reconstructive (0.7, 0.5, 0.5), and Rhinology/SkullBase Surgery (0.5), to support translational and clinical research in the aforementioned areas of scientific opportunities and provide clinical care for the NIDCD Clinical Research Program and NIH CRC, as directed by the NIDCD Project Officer under the overall direction of the NIDCD Clinical Director. These initially include 3 otolaryngology surgeon-scientists to perform high priority translational laboratory, clinical research and care; and 3 otolaryngology subspecialists to provide general and specialty care. Together, the 6 part-time otolaryngologists will provide otolaryngology coverage of 5 half-day clinics for NIDCD and NIH outpatient research studies, patient care, and procedures; surgery during NIDCD's Thursday block OR time; and 24/7 call coverage for inpatient and outpatient care of NIDCD and NIH patients. (Note that NIH night and weekend call is historically light duty home call requiring only 4-8 in-house consults per month due to the absence of an ER and lower acuity of most protocol patients.) The Contractor otolaryngologists shall provide various clinical duties as directed by the NIDCD Project Officer, including, but not limited to: comprehensive otolaryngology histories and physical exams, otoscopy and endoscopies for outpatient/inpatient consults and admissions, and other diagnostic evaluations and outpatient procedures as appropriate. The Contractor otolaryngologists will be provided an office/exam room in the 5th floor outpatient clinic for their work. Surgical procedures will be performed by individuals or team with appropriate specialty training in the CRC ORs. NIDCD has shared block time with the National Institute of Dental and Craniofacial Research (NIDCR) on Thursdays and to follow cases may also need to be scheduled using unutilized block time M-F. The Contractor shall provide all required services in accordance with professional standards of care and as prescribed in each specific NIDCD or NIH protocol. Where NP/Physician Assistant support may be appropriate, these individuals shall function under the medical supervision/ collaborative agreements of Maryland Licensed NIDCD physicians as required by the appropriate Board in the State of Maryland. Medical trainees including clinical fellows, residents, and students shall function under the medical supervision of NIDCD Clinical Director and physicians. All Contractor staff shall have completed the appropriate continuing education specifications required for licensure and specialty certification. The Contractor shall adhere to the Department of Health and Human Services (HHS), NIH and CRC policies, OHRP guidelines, FDA standards of Good Clinical Practice, JCAHO requirements and the Contractor's institutional guidelines and requirements. Duties of Contractor staff in the hospital and laboratories shall be determined by the Contractor's Program Manager with the advice of the NIDCD Clinical Director and the concurrence of the NIDCD Project Officer. Clinical Laboratory Research Otolaryngology surgeon scientists will be considered, evaluated, appointed under the NIDCD Otolaryngology Surgeon Scientist Program, and reviewed annually by the NIDCD Scientific and Clinical Director, mentorship committee, and every 3-4 years by the NIDCD Board of Scientific Counselors (BSC). Clinical research laboratory and offices established and maintained by NIDCD will be provided for Contractor otolaryngology surgeon scientists who will support NIDCD preclinical translational and clinical research. Laboratory staff and support will be determined by the NIDCD SD and CD with advice of the mentorship committee and BSC. The Contractor employees shall manage and operate the Clinical Laboratory, enforce and to maintain to NIH, Occupational Safety and Health Administration (OSHA), FDA, and CLIA policies and procedures, as appropriate. The NIDCD Clinical Director may provide guidance and technical expertise to the Contractor's Program Manager with regard to quality assurance/quality control, technical assistance, workload assignments, and allocation of resources. These Contractor employees shall perform research according to the NIDCD clinical research program mission, priorities, and needs. Laboratory Contractor employees shall also participate in continuing education (CE) or training within their area of research to meet all mandatory requirements. Other Clinical Support Services The Contractor physicians shall provide access to medical consultation services outside the areas of expertise represented by NIDCD DIR physician staff or facilities as needed and as directed by the NIDCD Clinical Director and Project Officer to meet patient care needs. This shall consist of providing the hospital or clinic facilities, equipment, supplies, and ancillary services necessary to conduct examinations by specialists in the needed medical specialty areas or facilities not available in the NIH CRC. The Contractor shall provide access for direct admission to the Contractor's general and emergency inpatient and outpatient medical care facilities, supplies, and ancillary services as necessary and as directed by the NIDCD Project Officer. The patient and their insurer(s) shall be responsible to the contractor for any medical consultation services and patient care provided outside the contract. Program Manager The Contractor shall designate a physician as Program Manager to direct and manage the efficient and effective delivery of all services supporting the NIDCD Clinical Research Program required in this contract. To achieve this the Contractor's Physician Program Manager shall manage the Contractor's policies, procedures, processes and resources to satisfy the contract requirements while effecting quality of service and providing for employee and patient safety. The Contractor's Physician Program Manager shall work in coordination with the NIDCD Project Officer and Clinical Director on these goals. In addition, the Contractor shall designate individual(s) at the Department Chair level, or equivalent, for purposes of overall direction and quality of physician services and patient care and for resolution of contract problems. The Physician Program Manager shall oversee the activities of the Contractor's staff, including the Contractor's Physicians, and any support staff added to the contract (e.g. Patient Care Manager, research nurses, scientists, technicians, and laboratory managers). The Physician Program Manager shall attend and serve as the Contractor's representative at all contract status meetings. The Physician Program Manager shall ensure that the Contractor staff's competencies are sufficient to meet NIDCD and NIH protocol needs. Period of Performance The Government anticipates awarding a single award, hybrid indefinite delivery/indefininte quantity (IDIQ) contract. Task order will be issued with either a firm-fixed price for recurring services in which labor hours can be determined, and time-and-materials for emergency services that cannot be predetermined; or a combination CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The nature of the acquisition is to procure the services of certified Otolaryngology surgeon-scientists and other professional personnel from JHU's Department of Otolaryngology-Head and Neck Surgery that possess historical knowledge of the protocols and patients, and expertise with the specific services already being provided by the NIDCD. To accomplish the goals of the NIDCD Otolaryngology Surgeon-Scientist Program (OSSP), the JHU's surgeon-scientists are proposed as the only source based on an essential requirement for their surgeon-scientists four-year history ; historical knowledge of protocols and patient surgery; their skills, expertise, close adjacency to the NIH; , and because only the Department of Otolaryngology Head and Neck Surgery at Johns Hopkins University-Suburban Hospital and Clinics, Bethesda, MD meet the clinical care of research participants requiring surgery. Through JHU's partnership with NIDCD via the OSSP, the only JHU otolaryngology surgeon scientists possesses the historical clinical and scientific knowledge, clinical-surgical skills, and expertise in conducting current NIDCD research protocols. They are currently Associate Protocol Investigators, and know and understand the rationale, objectives, design, and methodologies of current research protocols; including customized surgical procedures, statistical considerations, and organization of ongoing NIDCD and NIH research projects. Awarding to another hospital would jeopardize the continuity and integrity of ongoing research by generating inaccurate outcomes, and potentially endanger the health and lives of active protocol participants. The accuracy and consistency of research activities is necessary, including clinical evaluation and testing, through the lifecycle of research protocols, in order for the e measurement to provide accurate clinical outcomes and the reason why NIH is a world leader in research. Furthermore, research participants may experience clinical disorders and post-surgical complications from surgeries performed at the Clinical Center that affect the head and neck. These include life threatening airway obstruction and bleeding, for which necessary response time of a needed specialist or ambulance transport to the specialist and hospital facility is 5-8 minutes. Research shows that hypoxia, the lack of oxygen to the brain and heart exceeding 5 minutes, can rapidly cause severe brain damage or death. The Johns Hopkins University-Suburban Hospital is the only University affiliated hospital with otolaryngology department and staff trained, as part of the OSSP, with subspecialty qualifications required to meet this essential time requirement. They will manage adverse events and medical emergencies requiring otolaryngology services for the entire NIH. It's estimated that otolaryngologists see 20-40 patients per week, perform 1-2 surgeries, and are on call 24/7. The JHU-SH can also provide rapid access for patients to other sub-specialty care not available at the NIH Clinical Center, including stroke, heart attack, vascular surgery and interventional radiology, which may be life-threatening complications of head and neck disorders and surgery. Patient survival and outcomes from these emergencies are improved when they can be transferred to an adjacent hospital and receive these services within less than 30 minutes. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: technical expertise; personnel qualifications; facilities and equipment; costs; the F.O.B. Point (Destination or Origin); Dun & Bradstreet Number (DUNS); Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A final determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses shall be received no later than 9 a.m. Eastern Standard Time on Tuesday, March 21, 2017. Responses shall be submitted electronically to the contracting officer identified on the FedBizOpps notice. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."