HHPC SOW_Sec C.pdf

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SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

SECTION C – STATEMENT OF WORK

TABLE OF CONTENTS

1.0 CONTRACT MANAGEMENT AND ADMINISTRATION

1.1 Contract Management

1.2 Safety and Health

1.3 Quality Management System (QMS)

1.4 Environmental Management System (EMS)

1.5 Configuration Management

1.6 Cost Estimating for TDOs

1.7 Financial Reporting

1.8 Facilities and Equipment Management

1.9 Property Management

1.10 Communicating, Reporting, and Metrics

2.0 HEALTH, RESEARCH, AND LABORATORY SERVICES

2.1 Health Services

2.1.1 Flight Medicine, Occupational Medicine, and Dive Medicine Clinics

2.1.2 Clinical Laboratory

2.1.3 JSC Institutional Occupational Health

2.1.4 WSTF Industrial Hygiene

2.2 Animal Care Facility (ACF)

2.3 Biomedical Research Laboratories

2.3.1 Biomedical Engineering for Exploration Space Technology (BE2ST) Laboratory

2.3.2 Biostatistics

2.3.3 Bone & Mineral Laboratory

2.3.4 Cardiovascular Research Laboratory

2.3.5 Extra-Vehicular Activity Physiology (EVA) Laboratory

2.3.6 Exercise Physiology and Countermeasures (ExPC) Laboratory

2.3.7 Immunology Laboratory

2.3.8 Neuroscience Laboratory

2.3.9 Nutritional Biochemistry Laboratory

2.3.10 Pharmacotherapeutics Laboratory

2.4 Environmental Sciences Laboratories

2.4.1 Acoustics and Noise Control Laboratory (ANCL)

2.4.2 Core Analytical Laboratory

2.4.3 Environmental Health Laboratory (EHL)

2.4.4 Microbiology

2.4.5 Radiation Laboratories

2.4.6 Toxicology and Environmental Chemistry Laboratory (TEC)

2.5 Human Factors Laboratories

2.5.1 Anthropometry and Biomechanics Facility (ABF)

2.5.2 Graphics Research and Analysis Facility (GRAF)

2.5.3 Habitability Design Center (HDC)

2.5.4 Lighting Evaluation and Test Facility (LETF)

2.5.5 Space Food Systems Laboratory (SFSL)

2.5.6 Usability Testing and Analysis Facility (UTAF)

2.5.7 Behavior and Performance Laboratory (BHP)

3.0 ENGINEERING, RESEARCH AND PROJECT MANAGEMENT

3.1 System Management

3.1.1 Primary Interface

3.1.2 Strategic Planning

3.1.3 Tactical Planning

3.1.4 System Acceptance

3.1.5 System Problem Resolution

3.2 Project Management

3.2.1 Engineering, Research and Technology Development

3.2.2 Hardware and Software Development

3.2.3 Human Factors Engineering

3.2.4 Product Safety and Mission Assurance

3.2.5 Sustaining Engineering

3.3 Mission Integration

3.3.1 Program Safety & Mission Assurance

3.3.2 Flight Certification

3.3.3 Mission Support

3.3.4 Mission Planning

3.3.5 Training

3.3.6 Flight Support

3.3.7 In-Flight Data Management

4.0 INTEGRATION

4.1 Health and Medical Technical Authority (HMTA)

4.2 Human System Integration (HSI)

4.3 Human Research Program (HRP)

4.3.1 Program Support

4.3.2 HRP Elements

4.3.3 International Science Collaboration

4.3.4 ISS Medical Projects (ISSMP)

4.4 Risk Management

4.5 Knowledge Capture and Dissemination

4.6 Information Systems Architecture (ISA)

4.6.1 ISA Management and Planning

4.6.2 Information Systems Application Acquisition & Development

4.6.3 Information Systems Operations

4.7 Collaborative Innovation

4.8 Education and Development

The Human Health and Performance Contract (HHPC) will be the next major support services contract for the Human Health and Performance Directorate (HHPD). The major responsibilities of the HHPD are to ensure crew health, safety, and performance; to provide occupational health services for Johnson Space Center (JSC) and the White Sands Test Facility (WSTF); and to conduct research and develop technologies to help mitigate risks to the health, safety, and performance of future space flight crews.

The HHPC Statement of Work (SOW) includes four sections, namely, 1) Contract Management and Administration that describes the role of the contractor in the administration and management of HHPC

2) Health, Research, and Laboratory Services that provides for the maintenance and operation of all HHPD laboratories and the JSC and WSTF flight and ground occupational health programs; 3) Engineering, Research and Project Management that includes system management, project management including flight hardware, software, sustaining engineering, and mission integration, and 4) Integration that includes activities integrated across the Directorate including: Health and Medical Tech Authority (HMTA), Human Research Program (HRP), Risk Management, Knowledge Capture and Dissemination, Information Architecture, Collaborative Innovation, and Education and Development.

The structure of the SOW and associated work breakdown structure should not be construed as defining a required organizational configuration. The types of work and services described herein may more aptly be distributed over multiple organizations whose purpose is to provide the products and services required by the HHPD Directorate and its customers.

1.0 CONTRACT MANAGEMENT AND ADMINISTRATION

1.1 Contract Management

The contractor shall be responsible for the management of the contract to assure accomplishment of contract work and compliance with contract clauses. The contractor shall prepare and maintain a comprehensive Contract Management Plan (DRD HHPC-MGMT-01) that describes the overall management approach, identifies key personnel, associates all subcontracts with the work they support, and includes an accurate organization diagram.

The contractor shall provide and maintain a Contract Work Breakdown Structure (WBS) in accordance with DRD HHPC-MGMT-02, Work Breakdown Structure and Dictionary. The contractor shall use the Contract WBS as the framework for contract planning, budgeting, cost reporting, and schedule status reporting to the Government.

The contractor shall provide reports in accordance with DRD HHPC-MGMT-03. The contractor shall conduct monthly Contract Management Reviews (CMRs) with NASA management to status the contractor’s financial and technical activities under the contract per DRD HHPC-MGMT-03.

The contractor shall be responsible for the timely procurement and receipt of supplies, materials, hardware, and services necessary to fulfill contract requirements. The contractor shall provide logistics support necessary to support all contract work in accordance with DRD HHPC-BP-07.

The contractor shall develop and implement an External Customer Plan in accordance with DRD HHPC- MGMT-08. The intent of the plan is to allow the contractor to market and use the HHPD facilities, contractor personnel, limited NASA personnel, and equipment for the purposes of retaining skills and improving technical capabilities without compromising safety, process integrity or infrastructure resources.

The contractor shall develop and implement an Organizational Conflict of Interest (OCI) Mitigation Plan in accordance with DRD HHPC-MGMT-10.

1.2 Safety and Health

The contractor shall develop and implement a Safety and Health Plan in accordance with DRD HHPC- SMA-03 (Safety and Mission Assurance (SMA)). This plan shall ensure compliance with JSC Procedural Requirement (JPR) 1700.1, “JSC Safety and Health Handbook” for on-site work and shall ensure the safety of work conducted off-site. The contractor shall conduct Safety and Health Program Self Evaluations, and provide a Lessons Learned Program Plan and Lessons Learned in accordance with DRD

HHPC-SMA-03.

The contractor shall support compliance with the JSC Safety and Health Program.

1.3 Quality Management System (QMS)

JSC is SAE AS9100 registered and intends to maintain this certification. The contractor shall perform all work on-site in accordance with the JSC Quality Management System and shall ensure work involving this contract performed off-site is in accordance with the requirements of SAE AS9100. The contractor shall develop and implement a Quality Plan in accordance with DRD HHPC-SMA-01 for work conducted off-site. On-site quality assurance functions, responsibilities, and tasks will be specified, if required, per Task/Delivery Order (TDO).

The contractor shall register with and be a participative member of the Government-Industry Data Exchange Program (GIDEP). The contractor shall respond to all GIDEP notifications and NASA Advisories issued from the JSC NASA-Advisory/GIDEP Documents Status Tracking System in accordance with DRD HHPC-SMA-05.

The contractor shall comply with the requirements in Attachment J-26, Quality Requirements.

1.4 Environmental Management System (EMS)

The contractor shall conduct all on-site work in compliance with JSC's Environmental Management System (EMS) in accordance with JPR 8550.1, Johnson Space Center Environmental Compliance Procedural Requirements in accordance with HHPC-MGMT-13.

1.5 Configuration Management

The contractor shall develop and implement a Configuration Management (CM) Plan in accordance with DRD HHPC-BP-03. The plan shall define processes for CM of hardware, software and firmware, engineering drawings, hardware parts lists, configuration accounting, and maintenance. The contractor shall prepare and coordinate appropriate configuration control board directives, waivers, deviations, exceptions, and maintain accurate, complete, and current CM data.

1.6 Cost Estimating for TDOs

Contract business shall be conducted in the most efficient and cost effective manner consistent with a high level of management insight and control. Cost estimates shall be accurate and permit the efficient and effective utilization of resources to accomplish the HHPC work in a very constrained budgetary environment. The contractor shall implement a system for rapid and accurate cost estimating for TDOs.

1.7 Financial Reporting

Accurate reporting of costs is a necessity for properly managing both the work and the available resources. The contractor shall provide accurate, complete, and timely financial reports that provide reliable and timely data in accordance with the contractor Financial Management Report DRD HHPC- BP-01. The data shall accurately reflect the cost incurred on the contract at the level of detail needed to manage the tasks and subtasks on the contract.

The contractor shall provide supplemental reports to the government that accurately reflect the financial status of work below the subtask level.

1.8 Facilities and Equipment Management

The activities of the HHPD are conducted in government-furnished laboratories and facilities and in contractor-provided laboratories and facilities. The contractor shall maintain a set of HHPC facilities and laboratories that are fully functional, and capable of accomplishing the work in SOW sections 2.0, 3.0, and 4.0. The contractor shall maintain the labs’ operational status to support both nominal and contingency operations. The contractor shall achieve and maintain accreditation of laboratories as directed by NASA. The government will maintain a listing of the facilities, laboratories, and equipment that are available for HHPC activities (Attachments J3, J4, J23, J24, and J28).

The contractor is fully authorized to use all government furnished property that is assigned to the contract.

The contractor shall maintain the functionality of the government property that it uses including all required calibrations and certifications. The contractor shall keep equipment in good repair or replace it as noted in TDOs.

1.9 Property Management

The contractor shall support HHPD asset management through implementation of its property management plan and by providing property and logistics management plans. The contractor shall provide and implement, a Government Property Management Plan in accordance with DRD HHPC-BP-

09. The contractor shall provide reports of NASA property in the custody of the contractor in accordance with DRD HHPC-BP-08. The contractor shall provide Logistics Reporting in compliance with DRD HHPC-BP-07. Initial Property to be a transfer of accountability to the contractor is listed in Attachment J-4, Government Furnished Property. Initial Property to be made available to the contractor for use on site is listed in Attachments J-3, J-23, and J-24 (Installation Property includes IT hardware and software).

1.10 Communicating, Reporting, and Metrics

The contractor shall provide clear, concise, and accurate communication of HHPC management information, that reports progress and problems as well as technical information that is essential for the HHPD to accomplish its mission.

The contractor shall create a set of technical and management metrics for the HHPC and for HHPD. The government will review and approve the metrics.

2.0 HEALTH, RESEARCH, AND LABORATORY SERVICES

HHPD Health, Research and Laboratory Services are grouped into five categories: 1) Clinical and Occupational Health Services 2) Animal Care Facility 3) Biomedical Research Laboratories; 4) Environmental Science Laboratories; and 5) Human Factors Laboratories. The contractor shall enable and maintain all HHPD clinical, occupational health, and research laboratory facilities and functions as required in support of spaceflight research, engineering and development, and operations to maintain and optimize health and performance of the astronauts, and personnel at JSC and White Sands Test Facility

(WSTF).

The contractor shall provide laboratory, technical, scientific, and logistical support for flight and ground-based research and operations in support of the safe and productive human habitation of space. This includes research in human health, engineering and development, and support of spaceflight operations on the International Space Station (ISS) and beyond, as well as ground-based facilities and analogs.

Activities include characterization of human adaptation to multiple gravity environments and development and deployment of countermeasures for the deleterious effects of spaceflight. The results of the activities will support continued safe operations of ISS, enable human exploration beyond Low Earth Orbit (LEO), support commercial space operations and research, and improve the health, safety and quality of life for people on Earth. The contractor shall support and conduct peer-reviewed research associated with HHPD objectives, and submit research manuscripts for publication in peer-reviewed journals.

The contractor shall maintain a temperature monitoring system for all HHPD laboratory freezers, refrigerators, refrigerator/freezers, incubators and ambient areas. Additionally, the contractor shall be responsible for implementing an alarm and notification system, and responding to alarms during and after normal business hours to assure the integrity of the samples in the enclosed systems. The contactor shall procure dry ice for all day to day laboratory operations as well as maintain a contract for immediate access to sufficient amount of dry ice to support contingencies during the peak hurricane months.

The contractor shall maintain certifications for all pressure systems used in HHPD Laboratories. The contractor shall procure extended warranties for critical lab equipment as determined by NASA.

Additionally, any software licensing agreements for unique lab software shall be procured by the contractor as noted in the TDO.

2.1 Health Services

The contractor shall provide clinical and occupational health services to support NASA’s occupation health program for Astronauts, and JSC and WSTF employees. The contractor shall support the prevention, recognition, evaluation, and control, of injury, illness and disease associated with the space flight and institutional work environment and to ensure the health, productivity and wellness of the workforce.

The Contractor shall provide all necessary resources to conduct a comprehensive program that fulfills the HHPD requirements for clinical and occupational health programs. These programs are carried out at

JSC, Sonny Carter Training Facility (SCTF), Ellington Field, and WSTF. The contractor shall provide primary care services to NASA personnel supporting remote space training operations, and launch and landing operations at remote sites. These include training operations in Moscow/Star City, Russia, and four times a year at Baikonur Cosmodrome when US astronauts launch and land in Kazakhstan. The contractor shall support direct return of the crew members to JSC after landing. The contractor shall support planning operations for support of remote operations for Multi-Purpose Crew Vehicle (MPCV) and Commercial Crew vehicles.

The contractor shall provide clinical support services including laboratory, pharmacy, medical imaging, health information management, and management of the human test subject screening services.

Clinic operations shall be performed in accordance with applicable Federal, state, and local regulations as well as NASA standards including JPR 1700.1 and applicable NASA Procedural Documents (NPD), NASA Procedural Requirements (NPR), procedures and guidelines. The contractor shall provide support for HHPD clinical operations as described in the following sections.

2.1.1 Flight Medicine, Occupational Medicine, and Dive Medicine Clinics The contractor shall support operation of the Flight Medicine Clinic, and provide full Occupational Medicine Clinic and Dive Medicine Clinic services. The contractor shall ensure that all clinic operations are implemented in accordance with NASA Office of the Chief Health and Medical Officer Directives including quality assurance, credentialing, and source verification. The contractor’s medical services shall be compliant with appropriate NASA regulations and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Ambulatory Care Standards. For all NASA clinics, the contractor shall provide standard health information management services. The contractor shall meet the standards set forth in the Privacy Act of 1974 as Amended (5 United States Code (USC), Part 552a), Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”; Legislative Clarification of the Health Insurance Portability and Accountability Act (HIPAA; Public Law 104-191)), NASA Privacy Act Regulations (14 CFR Part 1212), and NASA specific 10 HIMS(Health Information Management System) system of record notice (SORN) regulations in its management of patient medical records.

2.1.1.1 Flight Medicine Clinic (FMC)

NASA will provide civil servant physicians to support primary care and aerospace medicine requirements of astronauts and NASA aviators in the FMC. In addition, there are two astronaut support programs:

behavior and performance operations for psychological support for astronauts and their families during a mission, and the astronaut conditioning program to aide astronauts in their physical preparation for and recovery from a spaceflight mission. The contractor shall support these clinical and astronaut support services with properly licensed and certified support staff to address the nursing, athletic training, psychological, epidemiological, and administrative support required. FMC services are provided at JSC only.

2.1.1.2 Occupational Medicine Clinic (OMC)

The contractor shall provide full occupational medicine services within the OMC. This includes regular civil servant health screening physical exam, occupation specific exams (per NASA and Occupational Safety and Health Administration (OSHA) regulations) as well as diagnosis and medical treatment of occupational injury or illness to JSC civil service personnel, other Federal Government employees assigned to JSC, Armed Forces personnel detailed to JSC and onsite contractors. Additionally, the OMC addresses minor illnesses/injuries for on-site personnel. OMC services are provided at JSC and White Sands Test Facility in New Mexico. Additional services requiring licensed and certified contractor support in the OMC include: ambulance; pharmacy; digital x-ray imaging; injury/illness case management to respond to civil servant and contractor occupational injuries and illnesses; and a Medical Review Officer (MRO) as well as trained administrative staff person to support NASA’s Drug Free Workplace policy.

2.1.1.2.1 Test Subject Selection (TSS)

The contractor shall recruit and maintain a pool of qualified test subjects that have passed a physical and meet approved experiment criterion for participation in approved intra- and extramural investigations.

OMC personnel shall perform flight-type physicals and required medical screenings to qualify potential test subjects for participation in NASA-approved ground based and fractional gravity experiments. The contractor shall coordinate and provide medical monitoring for assigned fractional gravity studies and ground studies excluding hypobaric/hyperbaric chamber studies, Neutral Buoyancy Laboratory (NBL) activities and the Crew and Thermal System chamber flights which are addressed by the Dive Medicine Clinic. The contractor shall maintain, update, and keep secure subject and/or subject candidate medical records for tests conducted at JSC.

2.1.1.2.2 Employee Assistance Program (EAP)

The EAP provides individual or group outreach services, including crisis intervention, critical incident debriefing, and trauma processing as well as workshops and presentations on a wide variety of topics relating to emotional health and well-being. The contractor shall provide EAP professional and administrative services at JSC including: limited employee and family counseling, participation in JSC emergency and incident management teams, and EAP education and seminars. EAP provides services for employees, contractors, and dependents experiencing difficulty with emotional health disorders, family/relationship problems, substance abuse, grief/loss, and stress management. The contractor shall provide consultation to the EAP providers for WSTF monthly to address active cases.

2.1.1.3 Dive Medicine Clinic

The contractor shall provide full dive medicine services at the Neutral Buoyancy Lab located at the Sonny Carter Training Facility. This includes a Texas licensed and dive medicine trained physician, who is able to provide for acute care needs for the divers and astronauts working in the pool at the NBL. The contractor shall maintain and be able to operate a hyperbaric chamber for treatment of dive related disorders such as air gas embolism and decompression sickness. The contractor shall coordinate and provide medical monitoring for hypobaric/hyperbaric chamber studies, NBL activities, and the Crew and Thermal System chamber flights. Additionally, the contractor shall have a staff qualified to train personnel in flight physiology. This contractor shall operate the hyperbaric and hypobaric chambers for instruction training and treatment.

2.1.2 Clinical Laboratory

The contractor shall provide all Clinical Laboratory Operations services including phlebotomy, laboratory analysis, and reporting services for all clinical laboratory clients; laboratory testing for astronaut selection as well as pre- and post-flight support. The contractor shall maintain accreditation by the College of American Pathologists (CAP). The contractor shall ensure laboratory procedures are in compliance with the CAP.

2.1.3 JSC Institutional Occupational Health

The contractor shall support the JSC Occupational Health Program which provides identification, management, assessment, prevention and control of hazards and exposures to biological, chemical, and physical (radiation, heat, noise, ergonomic, etc.) hazards. Contractor support shall consist of workplace health inspections; industrial hygiene exposure assessments (including chemical hygiene and asbestos control); hazard communication (HAZCOM); drinking water assessment; a radiation safety program; a hearing conservation program; an ergonomics program, Ellington Field safety and health program; and a comprehensive occupational health training program. The occupational health training program shall include: hearing conservation; respiratory protection; ergonomics; laboratory safety; asbestos awareness, and class III and IV asbestos worker; Cardiopulmonary Resuscitation (CPR); first-aid; Automated External Defibrillators (AED); blood-borne pathogens; and confined space entry.

2.1.4 WSTF Industrial Hygiene

The contractor shall implement a comprehensive WSTF industrial hygiene program. Functions include:

evaluating and characterizing workplace health hazards; characterizing and assessing workplace exposures; maintaining workplace survey plan and assessment data; conducting annual workplace health inspections as required by 29 CFR 1960; developing an exposure assessment and annual Industrial Hygiene (IH) sampling strategy and plan; assisting the Asbestos Program Manager and Chemical Hygiene Committee with program implementation and assessment; and providing recommendations to WSTF resident contractor personnel on industrial hygiene requirements, guidelines and practices.

2.2 Animal Care Facility (ACF)

The JSC Institutional Animal Care and Use Committee (JSC IACUC) is the body responsible for developing, recommending and monitoring the JSC policies and standards related to animal acquisition, care and use. This committee manages the overall animal care program, providing direction to the ACF and courtesy oversight to the Longhorn Heritage Project, Prairie Chicken Breeding Facility, as well as the Deer Protection and Control Program. The Animal Care Facility (ACF) is maintained and operated in accordance with the American Association for the Accreditation of Laboratory Animal Care (AAALAC) certification requirements. The contractor shall support the maintenance and operations of the ACF in accordance with all defined requirements for animal acquisition, care and use, as well as support the routine certification of the laboratory by the AAALAC. The contractor shall support the Animal Conservation Projects at JSC, the operation of the JSC Animal Care Facility, and crew involvement with animals associated with spaceflight experiments.

2.3 Biomedical Research Laboratories

The Biomedical Research laboratories include a variety of life science physiology laboratories that conduct peer-reviewed applied research as well as provide specific clinical/operational expertise in support of flight surgeons responsible for the health and safety of astronauts. This includes support of ISS operations and human research conducted under the HRP to investigate, mitigate and develop countermeasures in addressing the highest risks to human health and performance. These laboratories are responsible for the performance of operations and biomedical research focused on: 1) understanding the normal human response to space flight, and 2) developing, testing, and delivering countermeasures for responses that adversely affect crew health, safety, or performance during or after space flight missions.

In accomplishing its mission, the laboratories implement clinical and operational research involving the execution of discipline specific research projects, both ground and flight based. The contractor shall support the maintenance and operation and any required certification of the Biomedical Research Laboratories.

2.3.1 Biomedical Engineering for Exploration Space Technology (BE2ST) Laboratory The Biomedical Engineering for Exploration Space Technology Laboratory is a unique collaboration between the HHPD and the Engineering Directorate dedicated to the development of innovative technologies and countermeasures to close existing gaps for future human space exploration as well as improved quality of life on Earth. Examples of this collaborative work includes biomedical technology for the study and prevention of muscle atrophy, bone loss, tissue welding for wound closure, biofilm eradication, the design and fabrication of new radiofrequency and electromagnetic instrumentation, and the generation of a wide variety of novel, customized, cell/tissue based models to facilitate the proof of concept, prototype development, and final validation of the technology. The contractor shall support the BE2ST laboratory’s collaborative development of technologies and countermeasures, and customized test beds for new smart medical systems.

2.3.2 Biostatistics

The Biostatistics office provides consulting expertise with the application of statistical theory and practice to ongoing biomedical research, aiding in the preparation of research proposals that describe experimental design, statistical modeling and subsequent analysis of anticipated research data. The biostatistics office also assists in data analysis, visualization, and interpretation of results with the goal of maintaining statistical integrity. The contractor shall provide Biostatistics consulting expertise for experiment design, data modeling and analysis, proposal preparation, and documentation of research results. Specific tasks include estimating subject sample size(s), and the number of repeated observations necessary to achieve a given accuracy for estimating the effectiveness of countermeasures, helping investigators answer research questions by making the most accurate inference possible from their experimental data, implementation or development of special analysis techniques when standard statistical procedures are not applicable, and contributing to manuscripts submitted for publication by describing statistical modeling, analysis methodology, and estimation results.

2.3.3 Bone & Mineral Laboratory

The Bone & Mineral Laboratory supports ground based and flight research to characterize the effects of real or simulated spaceflight on the musculoskeletal system as well as evaluate the efficacy of countermeasures. The contractor shall support laboratory activities to measure changes in bone that occur as a result of space flight or bed rest or other research and test countermeasures for those changes, support medical operations by providing Duel-Energy X-ray Absorbtiometry (DXA) scans of bone density for all astronauts every 3 years, and before and after every long-duration mission, provide guidance in the development of astronaut medical standards and in the physiological interpretation of data on bone and muscle loss, support musculoskeletal evaluations for both on-site research studies and collaborative studies with extramural institutions, and assist in evaluation of proposed exercise hardware.

2.3.4 Cardiovascular Research Laboratory

The Cardiovascular Research Laboratory performs ground-based and spaceflight research to establish a normative database of cardiovascular changes due to space flight and associated mechanisms, develop effective countermeasures, and assess new clinical and research technologies. The contractor shall support the laboratory’s medical evaluation tests before and after flight on all crew members to assist in determining return to duty status, the monitoring of crew health and the predicting of individual susceptibility to spaceflight-induced cardiovascular deconditioning. Tests performed include operational tilt tests, in-flight Holter monitoring, baroreflex measurements, re-entry monitoring on all long-duration crewmembers, ultrasound examination of the heart, blood vessels, skeletal muscle, tissue thickness and other organs as needed, and changes in blood volume after flight. The contractor shall support ultrasound/echocardiography for astronaut selection, diagnostic ultrasonography for referrals from the JSC Clinic and the testing of countermeasures against post-flight orthostatic intolerance. The contractor shall support hardware development by providing science support and testing for next generation medical devices such as ultrasound devices, Holter monitors, and just-in-time medical imaging training tools, and in-flight “lab-on-a-chip” technologies. The contractor shall support research activities in both animal and human models of spaceflight as well as spaceflight biomedical research. These include hypovolemia studies, bed rest studies, parabolic flight studies and studies conducted aboard the ISS.

2.3.5 Extra-Vehicular Activity Physiology (EVA) Laboratory

The EVA Physiology Laboratory engages in the design and execution of experiments, activities and analyses related to potential protocols to assist in the mitigation of the risk of decompression sickness, environmental physiology, and suited human performance (e.g. metabolic demand and mitigation of injury). The laboratory supports operational EVA onboard the ISS, the development of individual exercise prescriptions for the exercise pre-breathe reduction protocol, and suited metabolic rate characterization during EVA training at the Neutral Buoyancy Laboratory. The contractor shall support the overall operation and maintenance of the EVA Physiology Laboratory, the tasks associated with suit and life support system hardware development and testing, and the tasks associated with the investigation of methods of assessing mechanisms of decompression sickness (DCS).

2.3.6 Exercise Physiology and Countermeasures (ExPC) Laboratory

The Exercise Physiology and Countermeasure Laboratory team develops exercise protocols and hardware to maintain astronaut health and fitness to preserve crewmembers’ ability to perform tasks while in zero gravity or on a planetary surface. The contractor shall support the ExPC in the execution of space medicine operations; support astronaut medical assessment testing; evaluate and validate exercise countermeasures hardware, protocols, and conditioning programs; and perform research that will inform the development of future exercise protocols and countermeasures to maintain crew health and performance.

2.3.7 Immunology Laboratory

The Immunology Laboratory is responsible for investigating the adverse effects of spaceflight on the human immune system and the increased risk of kidney stone formation during flight due to bone demineralization. The laboratory investigates the mechanisms responsible for these physiologic changes so appropriate countermeasures can be developed. The Immunology Laboratory conducts ground-based and flight research, and is involved in conceptual design, prototype development, and clinical validation for specific flight hardware. Studies have included investigations on the effects of space flight on the human immune system, with a particular emphasis on viral shedding (in collaboration with Microbiology laboratory) and renal stone formation. The contractor shall perform the laboratory’s operational assessments (e.g., renal stone), ground-based and space flight research investigations, and participate in countermeasures development/validation activities. The contractor shall support the laboratory’s basic cellular/molecular research which can include the use of a) Flow cytometry, b) Scanning electron microscopy, c) Digital image analysis, d) Molecular biology/biochemistry and e) Fluorescence/transmitted light microscopy.

2.3.8 Neuroscience Laboratory

The Neuroscience Laboratory has the capability to perform human subject data collection and analyses for ground-based and flight studies. The laboratory conducts functional neurological assessments that provide an objective test of neurosensory re-adaptation to Earth’s gravity following prolonged weightlessness, and develop countermeasure to mitigate sensorimotor disturbances, investigate new technology, procedures and tests. The laboratory is comprised of various smaller laboratory capabilities that allow for research and analyses in motion, neuro-autonomic evaluations, constant velocity rotation, dynamic postural control, tilt-translation, combined centripetal and translational linear acceleration, manual control, sensorimotor, and visual-vestibular gaze investigations. The contractor shall support the Neuroscience Laboratory in its performance of both ground-based and space flight investigations that focus on the effects of space flight on the human nervous system, with a particular emphasis on sensorimotor, vestibular-autonomic and perceptual functions, and on development of countermeasures.

The contractor shall support the Neuroscience Laboratory’s activities for medical operations by conducting pre- and post-flight testing of astronauts. The contractor shall provide support for the sensorimotor standards measures for the NASA Flight Analogs Project.

2.3.9 Nutritional Biochemistry Laboratory

The Nutritional Biochemistry Laboratory’s primary goal is to determine the nutritional requirements for extended-duration spaceflight, maintain astronaut health, and develop, evaluate, and validate nutritional countermeasures to prevent or minimize the negative effects of long-duration spaceflight. The laboratory supports both spaceflight operations and the conduct of nutritional research. The contractor shall support the Nutritional Biochemistry Laboratory’s identification and definition of nutritional requirements, support spaceflight medical operations, and support research projects where nutrition plays an integral role across the disciplines such as bone, muscle, cardiovascular, vision and other systems. The contractor shall support the Clinical Nutritional Assessment Profile Medical Requirement for extended-duration crewmembers.

2.3.10 Pharmacotherapeutics Laboratory

The Pharmacotherapeutics Laboratory works to mitigate pharmacotherapeutics risk by identifying and providing safe and effective diagnostics tools, pharmaceutical preparations, therapeutic procedures and intervention strategies to enable successful space medical operations. The Pharmacotherapeutics Laboratory functions also include research in pharmacokinetics, pharmaco-dynamics, applied physiology, drug stability and packaging, and therapeutic drug monitoring.

The contractor shall support Pharmacotherapeutics research and regulatory activities involving the usage of medications and surveillance of new drug development. The contractor shall support the pharmacotherapeutics laboratory to identify and provide treatment and monitoring methods in support of medical operations that will enhance health and well-being of astronauts.

2.4 Environmental Sciences Laboratories

This suite of laboratories is a multi-disciplinary group charged with addressing the scientific challenges and uncertainties associated with the spaceflight environment. The contractor shall ensure that environmental standards and crew health and safety are achieved onboard space vehicles, provide critical analytical data, develop NASA spacecraft environmental standards and flight program requirements for air and water quality, toxicology and microbiology. The contractor shall provide environmental chemistry expertise and analytical support for environmental and occupational health responsibilities of the JSC.

2.4.1 Acoustics and Noise Control Laboratory (ANCL)

The ANCL performs noise emissions testing to verify compliance with acoustics requirements for the spacecraft environment. The noise of flight hardware must be minimized and is accomplished through a comprehensive set of requirements where acoustic noise levels are limited and compliance verified before the hardware is approved for flight. To help ensure acceptable spacecraft acoustic environments, the contractor shall support the acoustic monitoring of ISS modules, spacecraft habitable volumes, payloads and Government Furnished Equipment (GFE) designs and hardware. The contractor shall support on-orbit acoustic measurements and analyses and reports, provide acoustic modeling and characterization of spacecraft acoustical environments, develop and recommend noise controls and methods to mitigate acoustical risks, investigate and recommend acoustic materials for use in specific applications and spacecraft operating environments, and investigate and develop new and innovative acoustic flight materials, acoustic monitoring devices, and reduced acoustic emission sources, and noise control means.

2.4.2 Core Analytical Laboratory

The Core Analytical Laboratory provides enhanced cellular and biological analytical capabilities at JSC.

The instruments are available for any investigator who acquires the appropriate training and abides by the policy and safety standards of the lab. A scheduling program allows investigators to sign up for specific time blocks on the requested instrument. A senior scientist is available for training, instrument trouble shooting and collaboration. The contractor shall support the laboratory operations by providing safety training, equipment maintenance, and technical assistance to the Core Lab investigators. The contractor shall perform research and analysis using specialized instrumentation, which may include bioreactors, bioanalyzers, microscopy, and other imaging devices.

2.4.3 Environmental Health Laboratory (EHL)

The Environmental Health Laboratory is accredited by the American Industrial Hygiene Association and the National Environmental Laboratory Accreditation Program. The EHL provides analyses of personal and area samples for possible workplace exposure to solvents and other organic chemicals, metals (in coated surfaces and air), asbestos (in air and building materials), and any other potential workplace health hazard including mold and fungi. The EHL provides analytical services to the JSC Environmental Office and the JSC Environmental Contractor company offices. These include groundwater profiling, hazardous waste characterization, waste water, potable water, storm water and spill response testing. The EHL performs high-volume gas analysis for such entities as Crew and Thermal Systems, Ellington Field, the Lunar Specimen Curation Laboratory and the Energy Systems Test Area. The contractor shall operate the EHL for the purposes of performing chemical and physical analyses of industrial hygiene, environmental and breathing gas samples. This includes personal breathing zones, ambient air, stack emissions, breathing gases, industrial atmospheres, potable water, waste water, industrial chemicals, soil, ground water, vegetation, biological specimens, food and drugs, and other substances as directed by NASA.

The contractor shall conduct all field sampling, preservation, processing, analysis, and quality control of all environmental samples in accordance with Environmental Protection Agency (EPA), Texas Department of Health (TDH), Texas Commission on Environmental Quality (TCEQ), or other agency regulatory requirements and recommended guidance materials. All environmental samples from collection to final report stage shall be conducted under either project specific or media specific Sampling and Analysis Plan and Procedures (SAPP), and Quality Assurance Plans and Procedures (QAPP).

The contractor shall achieve American Industrial Hygiene Association (AIHA) and National Environmental Laboratory Accreditation Commission (NELAC) accreditation within one year of contract start. The contractor shall achieve and keep current the EPA, TCEQ, TDH or equivalent drinking water laboratory certifications.

2.4.4 Microbiology

The Microbiology Laboratory is a biosafety level two facility responsible for addressing crew health and environmental performance issues related to microbial infection and contamination. This responsibility is achieved by operational monitoring and investigative research using classical microbiological, advanced molecular and immuno-histochemical techniques. The Microbiology Laboratory supports the Biosafety Review Board whose mission is to identify, evaluate, control and prevent biological hazards in conformance with NASA, Federal and International health and safety regulations. The contractor shall provide operational support to spaceflight programs to mitigate microbiological risk to crew health and performance during spaceflight missions. The contractor shall be responsible for collecting, culturing, and analyzing specimens from the crew, spaceflight food and food facilities, JSC buildings and facilities (JSC Flight Medicine Clinic, the Occupational Medicine Clinic), and the spacecraft environment, define and execute pre-flight, on-orbit, and post-flight microbiology operations and activities, review and update programmatic microbiology requirements and identify, track and resolve issues, develop and implement spacecraft environmental monitoring strategies and schedules. The contractor shall support any related hardware development, provide technical and administrative support to the JSC Biosafety Review Board and the JSC IACUC, and conduct and support peer-reviewed microbiology research.

2.4.5 Radiation Laboratories

The Radiation Laboratories are comprised of a diverse set of capabilities designed to address the acute and long term risks as well as the uncertainty associated with space radiation exposure. Ground-based research in the Radiation Laboratory aims to answer questions on the biological effects of energetic ions and specifically to address critical questions ranked as top priorities in NASA’s Human Research Roadmap. These research findings contribute to the development and support of radiation risk assessment tools. The Space Radiation Dosimetry Laboratory (SRDL) focuses assessment of the radiation exposure to the astronauts during all phases of spaceflight. The SRDL personnel prepare physical dosimeters and active radiation hardware for each mission and assess results post mission to calculate career exposure to provide reports to the Directorate, the Astronaut Office, and NASA Headquarters.

The contractor shall perform radiation risk assessments, provide real-time mission support and training, prepare and analyze physical dosimeters, perform the analyses required to advise astronauts of their risk from all occupational radiation exposures. A secret security clearance is required for certain mission control support tasks. The contractor shall support radiation research to enable the safe human exploration of space within acceptable risks from space radiation exposures, and assist in conducting space radiation research and advocating Human Research Program goals and collaboration with other U.S. institutions (academia, National Space Biomedical Research Institute (NSBRI), National Labs), Federal Agencies (Department of Energy, National Cancer Institute, Department of Defense), and international partners.

2.4.6 Toxicology and Environmental Chemistry Laboratory (TEC) The TEC provides assessments of health hazards associated with all compounds that could enter spacecraft air or water, off gas testing to control airborne contaminants in the spacecraft atmosphere, onboard monitoring, provides assessments of toxicological risks to the crew, and conducts toxicological and environmental chemistry research. The TEC provides comprehensive analyses of spacecraft foods so that the spaceflight menus can be judiciously designed to fulfill the nutritional needs of the astronauts.

The TEC is responsible for developing technologies for real-time on-orbit water and air quality monitoring as well the analyzing air and water samples returned from the ISS. The contractor shall perform hazard assessments of payload and spacecraft system chemicals and off-gas testing of hardware and whole modules, conduct analyses of samples to assess crew health risks. The contractor shall support the preparation and delivery of on-orbit instrumentation for monitoring of environmental quality, investigate advanced air monitoring technologies and recommend instrumentation upgrades, provide mission support and analyses and report trends in data from air quality monitors, propose and document exposure standards (e.g. Space Maximum Allowable Concentrations for Airborne Contaminants (SMACs) and Space Water Exposure Guidelines for Selected Waterborne Contaminants (SWEGs)) for health assessment of air and water quality. The contractor shall provide comprehensive chemical analyses of food, water, and air samples in support of NASA flight program operations; provide expertise to assess life-support systems for continued crew health; and coordination of environmental sampling and analyses.

The contractor shall investigate advanced environmental monitoring technologies and recommend instrumentation upgrades, provide complete post-mission reporting of all environmental monitoring efforts. The contractor shall support the laboratory’s research that focuses upon toxicological and environmental chemistry.

2.5 Human Factors Laboratories

The Human Factors Laboratories support a broad range of design and visualization, data collection and analysis, and research activities to support safe and productive human operations in space. The laboratories provide infrastructure to ensure that space human factors, including physical parameters and performance capabilities and limitations are defined, documented, and applied to the design and operation of vehicles, habitats, and flight crew systems equipment. While each of the following facilities may operate as a stand-alone facility, NASA’s goal is to operate the Human Factors Laboratories integrated strongly with each other and with external facilities/laboratories/institutions. The contractor shall promote integration and effective, efficient, collaborative work. The contractor shall provide the unique personnel and laboratory support to provide the capabilities listed below in support of HHPD research, development, and space flight operations.

2.5.1 Anthropometry and Biomechanics Facility (ABF)

The ABF provides unique hardware, software, and personnel to accurately measure human physical parameters including changes to those parameters as affected by the space environment or unique equipment or hardware such as EVA suits. Examples of the functions performed by the ABF are the development and compliance of anthropometric, strength, range of motion and mobility requirements, ergonomic and biomechanic evaluations, suit sizing and volumetric analysis, testing and evaluation of crew work procedures and equipment, and evaluation of spacesuit designs. The contractor shall conduct a variety of space anthropometric and biomechanic evaluations and research studies to address issues humans will encounter while living, working, and exploring in space.