A01_Attachment_S1_PWS_DLDM.DETA_FINAL_Post_SRB_revision_(2).docx

PERFORMANCE WORK STATEMENT

Non-personal Support Services for Walter Reed Army Institute of Research (WRAIR) Department of Laboratory Diagnostics and Monitoring (DLDM) Department of Epidemiology and Threat Assessment (DETA) US Military HIV Research Program (MHRP)

1.0 BACKGROUND:

The first mission focus of DLDM was development, optimization, and deployment of Human Immunodeficiency Virus (HIV) screening, confirmation, clinical (viral load), and therapeutic (resistance genotyping) monitoring technologies for Soldiers and their Beneficiaries. DLDM has since evolved into a world class leader in the development of diagnostic countermeasures for HIV, Sexually Transmitted Infections (STIs), Bloodborne Infections (BBIs), Transmission Transmitted Infections (TTIs), Leishmania, and prevalent and emerging pathogens of US Military, US National, and Global Health interest, as well as the critical monitoring parameters utilized by the US Military, National, and Global Health Care Providers for clinical and therapeutic management of a wide variety of infectious diseases. This mission is currently executed through five laboratory sections: (1) HIV Diagnostics and Reference Laboratory (HDRL), (2) Leishmania Diagnostic Laboratory (LDL), (3) the Technology Assessment Laboratory (TAL), (4) Clinical Evaluation Unit (CEU), and, (5) the Processing Laboratory and Bio-Repository (SPL/Bio; not included in this solicitation). See attached: Attachment PWS-P1: Acronym List and Attachment PWS-P2 – DLDM Organization Charts.

The HDRL, a College of American Pathologist (CAP) and Department of Defense (DoD) Clinical Laboratory Information Program (CLIP) accredited diagnostic reference laboratory since 1987, is the designated US Army Medical Command (MEDCOM) reference laboratory for HIV clinical laboratory services. HDRL conducts state-of-art clinical HIV, STI, BBI, TTI screening and supplemental, confirmatory testing, clinical (viral load) and therapeutic (resistance genotype) monitoring services for US Service members and their Beneficiaries; and, provides diagnostic/consultative services to DoD Providers/Physicians for HIV and STI infection classification. Specifically, HDRL provides technical oversight and final laboratory authority for HIV infection status for Army’s Active, Reserve, and National Guard units and for individuals applying for US Military service through U.S. Military Entrance Processing Command (USMEPCOM) Stations (MEPS). HDRL directly performs HIV testing services for the U.S. Military European and Central Commands (65-100K tests per annum), USMEPCOM (300-350K tests per annum; 8 hour mandated turn-around-time (TAT) from receipt of specimen at HDRL), and conducts supplemental confirmatory testing/HIV infection classification of U.S Navy, and contract-vendor HIV repeat reactive screening tests. HDRL supports the U.S Air Force by request. In addition, the Laboratory performs HIV and STI quantitative viral load testing (~6K per annum) for all Army Medical Treatment Facilities (MTFs), the US Navy and the US Air Force (by request), and performs specialized testing to include HIV-1 genotypic resistance testing (600 -1,200 per annum)—for all Tri-Service (Army, Navy, and Air Force) HIV-infected Service members and their Beneficiaries; and, conducts HIV , STI and BBI infection screens for at risk US military populations. Currently, this laboratory operates six (6) days per week with staggered shifts; weekend and evening work may also be required.

HIV, STI, BBI, and TTI testing services and consultation/interpretation of laboratory findings are provided to the Armed Forces Medical Examiner System (AFMES), USMEPCOM, US Army Human Resources Command (USAHRC), the Infectious Disease Consultant to the US Army Surgeon General, Army Blood Program (ABP), US Army Public Health Center (APHC), Armed Services Blood Program (ASBP) and sister Services, US Navy/Marine Corps; and, US Air Force. Examples include follow-up testing for exposure cases (AFMES, MTFs), cadaveric testing (AFMES), direct testing for U.S. Military accession, testing for waivers for accession into US Military service (USMEPCOM), and look-back testing for suspected cases of TTIs post transfusion of unlicensed fresh whole blood product (Hot Blood) in combat Areas of Operation (AORs).

DLDM/CEU evaluates novel HIV, STI, BBI, TTI, and Point of Care, screening, supplemental confirmatory testing, pathogen detection, and clinical and therapeutic monitoring technologies for the Defense Health Agency (DHA). CEU conducts U.S. Government (USG) interagency collaborations for evaluation and deployment of high complexity assays/platforms as well as rapid device test (RDTs) for Point of Care STI, TTI screening/confirmation, and/or infection quantification; and, collaborates with non-government organizations, commercial and academic partners for the development, evaluation, validation, and conduct of US Food and Drug Administration (FDA) Premarket Approval (PMA) clinical trials for new technologies for screening, supplemental confirmatory testing/diagnosis, and monitoring of HIV, STIs, BBIs, TTIs, and prevalent and emerging pathogens of DoD and US National Security interests. Fifty percent (50%) of the US FDA PMA clinical trials conducted for the currently available US FDA approved assays/platforms for HIV screening, diagnosis, supplemental confirmatory testing, clinical and therapeutic monitoring marketed in the US were conducted by CEU/HDRL.

As an additional example, CEU evaluated and down selected Point of Care HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) RDTs for donor screening and risk mitigation of administration of non-licensed, fresh whole (hot) blood during US Military mass casualty scenarios within Iraq and Afghanistan AORs when licensed whole blood product has been exhausted. Data was recently (August 2015) shared with NATO Military partners to facilitate safe transfusion practices under mass casualty conditions. Results have also been leveraged by the Global Health Community for RDT–based transfusion screening in severely resource limited settings.

Additionally, the HDRL research team serves as the reference laboratory for state-of-art screening/diagnosis and infection detection/monitoring for MHRP, WRAIR, MRMC, DoD, and extramural investigators for ongoing translational, i.e, vaccine, therapeutic, cure, and co-infection clinical trial initiatives for prevalent and emerging pathogens of US Military and National Security interests. HDRL leverages CEU and TAL expertise within DLDM to (1) design, develop, evaluate, validate, and implement new serological, protein, and molecular based assays in support of DoD clinical screening, diagnostic, clinical (viral load) and therapeutic (resistance genotyping) monitoring; (2) support translational, vaccine, therapeutic, cure, and Public/Global Health studies of prevalent and emerging pathogens of US Military and National Security interest; and, (3) U.S. Military Taskers which are frequently of short suspense with high visibility and enterprise-wide impact. As an example, HDRL and TAL supported a recent US FDA directed safety end point analysis of Vesicular Stomatitis Virus (VSV) viremia in plasma and VSV viral shedding in urine and saliva from volunteers from an Institutional Review Board (IRB) approved, Phase I, first in man, safety study for a recombinant Ebola vaccine, rVSV∆G-ZEBOV-GP, conducted at WRAIR and the Vaccine Research Center, National Institutes of Health. This trial encompassed multiple DoD, US Agency, and commercial partners with White House visibility. TAL modified the intended use of an FDA Emergency Use Assay for Ebola diagnosis, validated the modified assay for three specimen matrices (plasma, urine, and saliva) under CAP/ Clinical Laboratory Information Amendment (CLIA)/CLIP regulatory requirements to inform participant care/treatment, if required, within an unprecedented 21 days of acceptance of the mission. Additionally, the team designed, developed, validated, and deployed, in concert, a quantitative VSV Nuclear capsid (N) protein real time RT-PCR assay to quantify VSV viral levels. TAL assays detected VSV virema which was of limited duration. This pivotal clinical trial leveraged against TAL efforts led to successful down selection of the vaccine dosage for subsequent large Phase II international, rVSV∆G-ZEBOV-GP studies, PRAVIL in Guinea and STRIVE in Sierra Leone.

As the US Army’s low prevalence HIV rates reflect those of the general US population and its personnel are the largest repeatedly tested, low-prevalence population in the world, DLDM/HDRL clinical service delivery, clinical evaluations, and translational research, i.e, public/global health, diagnostic, clinical, prevention, intervention, and health systems studies, efforts directly impact DoD, US, and Global Health Communities. For example, DLDM was an important contributor to the formation of the 2014 updated US Centers for Disease Control HIV case surveillance definitions, including for the first time, a case definition for HIV-2 infection, recommendations for HIV diagnosis, and HIV result reporting. Current DLDM efforts in HIV encompass development of screening confirmation, and monitoring algorithms for HIV infection status in the era of HIV Treatment as Prevention (TasP), HIV Pre-exposure Prophylaxis (PreP), and HIV Post-exposure Prophylaxis (PEP). Each HIV Prevention strategy, TasP, PreP, and/or PEP, poses unique challenges to generation of laboratory evidence for determination of HIV infection status classification.

The LDL within DLDM is DoD’s best-in-class clinical screening, supplemental confirmatory, diagnostic parasitology laboratory and is the only U.S. CAP accredited clinical diagnostic laboratory providing a full spectrum of Leishmania test menu diagnostics inclusive of histology (smear, biopsy), serology, nucleic acid testing, parasite culture, parasite speciation, and xenodiagnoses. LDL staff also execute testing in support of therapeutic clinical trials for licensure of commercial and DoD sponsored products for medical management of Leishmania infected US Military Service members and their Beneficiaries. LDL will transition in 2017/2018 as a Parasitology Diagnostic Laboratory (PDL) under HDRL. This new initiative will transition LDL from a Leishmania focused diagnostic and clinical, public health, translational unit to a broader based CAP accredited parasitology section within HDRL supporting clinical screening, supplemental confirmatory testing, vaccine, therapeutic, and cure initiatives of parasitic infections of critical importance to the WRAIR, MRMC, DoD and Global Health Communities. For example, PDL will design/develop, evaluate, validate, and deploy Laboratory Developed Assays (LDAs) for malaria screening, confirmation/diagnosis, specification, and/or clinical trial safety or diagnostic end points in support of WRAIR IRB approved malaria vaccine and therapeutic challenge studies.

The TAL within DLDM is tasked with the design, development, evaluation, validation, verification, execution and deployment of molecular-based tests for detection, screening, confirmation/diagnosis and monitoring of HIV, STIs, TTI, BBIs, and prevalent and emerging infectious pathogens of US Military and National Security interest. HDRL and TAL continue a 30-year program partnership with US Agencies, industry/commercial entities, and academic sectors to conduct clinical trials for Pre Market Applications (PMA) for FDA clearance/approval of HIV, STI, BBI and other prevalent and emerging infectious pathogen. When US FDA approved, commercial tests are not available, TAL adapts or modifies the intended use of an existing FDA cleared or approved assay or platform, or if appropriate, designs, develops de novo in-house LDAs for prevalent and emerging pathogens of US Military or National Security interest, while ensuring USG Intellectual Property rights are protected for the specific requirement.

The TAL facilitates technological transfer of the validated, modified intended use assay, or LDA to HDRL and/or LDL for inclusion on CAP/CLIP clinical screening/confirmation test menus to advance clinical screening, confirmation, diagnosis, clinical/therapeutic monitoring, clinical evaluation, and/or translational, vaccine, therapeutic, and cure programmatic efforts. Assays validated and deployed by HDRL/CEU/LDL/TAL routinely enhance DoD Public Health surveillance; thus, impact DoD Public Health Intelligence though detection of changes/trends in prevalence and incidence rates and transmission of prevalent and emerging pathogens with significant implications for US Military operational and force health protection and readiness in alignment with Army Medicine Campaign Plan 2020. Army Medicine Campaign Plan 2020 seeks creation of capacity to improve individual, unit, and organizational health – critical for readiness and Army’s role in preventing, shaping, and winning the Nation’s wars. HDRL, LDL, CEU/TAL, and SPL/Bio’s efforts incentivize industry, drive diagnostic acquisitions, and lower overall cost to DoD/US Army. Additionally, these laboratories facilitate advancement, deployment, and application of the most impactful technologies responsive to DoD’s enduring requirement to field diagnostic countermeasures for force health protection and readiness and Battlefield Blood Safety, support for US populations, and the Global Health Community.

Examples of TAL efforts include leverage of real time PCR and digital droplet PCR (ddPCR) technology for exquisitely sensitive, low-level detection of HIV-2 Ribonucleic Acid (RNA)/Deoxyribonucleic Acid (DNA) and HIV-1 DNA; only three laboratories within the US, inclusive of HDRL/TAL, conduct RT-PCR HIV-2 RNA assays for clinical (viral load) monitoring; only two US CAP laboratories, inclusive of HDRL/TAL, currently conduct ddPCR RNA-2 assays for HIV-2 detection and quantification. Additional examples include: LDA Long Terminal Repeat (LTR) assays for detection of compartmentalized HIV nucleic acid in human, and primate cell populations, detection of residual DNA in whole blood of HIV patients with undetectable viral load, as well as clinical trial safety end points and/or diagnostic end points for prevalent and emerging pathogens of U.S. Military or National Security interest, e.g., assays for detection of attenuated Vesicular Stomatitis Virus (VSV) Ebola vaccine vectors as noted above; and, detection of Chikungunya, Dengue, and West Nile viruses in dried blood specimens by modification/adaptation of non FDA approved commercial products. TAL has recently modified intended use of FDA cleared assays to detect HIV infection in humanized mice; and, updated assays for detection and quantification of Simian Immunodeficiency Virus (SIV) infection in SHIV (Simian Human Immunodeficiency Virus) animal model trials. TAL partners with the US FDA, the British National Institute for Biological Standards and Controls, and the World Health Organization to establish and validate International Reference Standards for detection of HIV and emerging pathogens of US Military, National, and Global Health Security interest.

The BioRepository (BioR) Specimen Processing Laboratory (SPL) component of DLDM (not part of this solicitation) provides specimen processing, storage, tracking, and distribution services in support of MHRP, WRAIR, external Agency (USG) clinical trials/ studies as well as studies conducted by the US Military Infectious Disease Clinical Research Program (IDCRP). During FY16 SPL processed over 90,000 specimens to include serum, plasma, and peripheral blood mononuclear cells (PBMC); SPL maintains an inventory of over 2.3 million specimens acquired through IRB approved clinical research trials /studies of HIV and prevalent and emerging infectious pathogens s of U.S. Military and US National interest, e.g., the SPL is currently supporting specimen processing and archival Bio-repository support for Phase I, first in human, Ebola, MERs CoV, and Zika clinical trials in addition to its support for MHRP and IDCRP clinical research initiatives.

The DLDM laboratory section test menus with workload ranges is attached as Attachment PWS-P3. Current total mean workload is ~400,000-450,000 assays per year; upper workload estimates are subject to change relative to mission requirements.

DETA has an enduring mission to meet Department of Defense Directive (DoDI) 6485.01, “Human Immunodeficiency Virus,” in support of DoD efforts to control HIV transmission and Army policy to plan, program, and manage epidemiology and research initiatives. See attached organization chart, attachment PWS-P4. These epidemiologic and research initiatives related to HIV/HIV-related infections and prevalent and emerging pathogens are conducted among U.S. Service members, their beneficiaries, their contacts, and among populations of special interest to DoD. These activities are conducted in collaboration with the military public health, clinical, and research partners as well as civilian and academic partners to generate Knowledge Products to meet the needs of Combatant Commands (CoCOMs), the Military Healthcare System (MHS), Services, and international military and civilian partners. Knowledge products are intended to inform current knowledge of the epidemiology of HIV and transmission dynamics in the U.S. military; HIV/STI/BBP, TTI, and emerging infectious pathogen threat assessment; evaluation of existing prevention programming; identification of targets for preventive intervention; and, for policy development (e.g. screening, immunization, service delivery/clinical practice guideline development, and prevention services development and evaluation.

2.0 SCOPE: This Performance Work Statement (PWS) defines the procurement of the operational, scientific, medical, technical, and administrative services necessary to support the DLDM and the DETA, MHRP, WRAIR in execution of a fully integrated DLDM/DETA PWS conducting clinical service delivery and translational research for generation of Knowledge Products that inform response to and management of infectious pathogens of US Military and National Security interests (See DLDM/DETA Mission Overview, attachment PWS-P5; DLDM/DETA Integrated Activities, attachment PWS-P6). Performance under this contract shall involve work within Biosafety level two (BSL 2) laboratories. Individuals may be exposed to bio-hazardous materials, and infectious human and animal specimens to include, but not limited, HIV, hepatitis B, hepatitis C, herpes, HTLV, syphilis, Neisseria gonorrhea, chlamydia, trichomonas, Leishmania, etc. infected material. The individual shall be expected to practice safe handling of infectious materials and hazardous chemicals.

2.1 Execute all phases of clinical screening (serological[antigen/antibody), supplemental confirmatory testing, clinical monitoring (viral load), therapeutic monitoring (resistance genotype testing), qualitative detection of HIV, STIs, BBIs, TTIs, histologic examination of human and animal tissues, touch preparations, bone marrow for parasite detection, parasite culture, parasite speciation, vector diagnoses, xenodiagnoses in animal models for prevalent and emerging infectious pathogens of Military or U.S. National interests, i.e. , HIV, STIs, BBIs, TTIs, parasites (Leishmania, malaria) for clinical service delivery and clinical research.

2.2 Execute all phases of clinical trials for evaluation of new/novel products for submission as Pre-Market Application clinical trials for U.S. FD approval/clearance for execution in clinical diagnostic and/or research settings;

2.3 Design, develop, evaluate, validate LDAs for detection, screening, supplemental confirmatory testing/diagnosis, and/or monitoring (viral load/resistance genotyping) of prevalent and emerging infectious pathogens of U.S. Military and/or National interest;

2.4 Generate laboratory data for development of evidence based Knowledge Products to inform US Military, US Civilian, Partner Nation (Military and Civilian), Regional, and Global Health responses.

2.5 Execute all phases of clinical screening, supplemental confirmatory testing for translational research, i.e., public/global health, diagnostic, clinical, applied research/study support for MHRP, WRAIR, United States Army Medical Research and Material Command (USAMRMC), US Agency, and external (academic/commercial) collaborations for Investigative Drug/Device (IND) vaccine, therapeutic, cure clinical trials/studies of infectious pathogens of U.S. Military, US National, and Global Health interest;

2.6 Conduct comprehensive characterization of the epidemiology of infectious pathogens of US Military interest;

2.7 Conduct translational research , i.e., public/global health, diagnostic, applied, clinical, prevention, intervention, and health systems studies for generation of evidence based Knowledge Products that inform optimal screening, prevention, and service delivery policy and practice for Service and DoD stakeholders for prevalent and emerging infectious pathogens of Military or U.S. National interests)

2.8 Conduct threat assessment studies of HIV/HIV-related and emerging BBIs and TTIs associated with the battlefield blood supply among U.S. and foreign Military personnel;

2.9 Conduct threat assessment studies of prevalent and emerging infectious pathogens of Military or U.S. National interests among populations of interest to the CoCOMs and in geographic regions of U.S. military operational significance; and

2.10 Comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data, Personally Identifiable Information (PII), and Private Health Information (PHI) involved in these tasks.

3.0 OBJECTIVES: This requirement identifies services that are severable in nature. To meet the objectives the contractor shall provide administrative, technical, scientific, operational, and medical assistance to the Government for all specimen acquisition, processing/handling; implementation and maintenance of all pre-test, test, and post-test quality indicators for report of clinical screening, confirmatory testing, infection classification, diagnosis, clinical monitoring (viral load), or therapeutic monitoring (resistance genotype) results for US Service members and their Beneficiaries with highest integrity; execute serological, protein, and/or molecular testing in support of clinical service delivery and translational research, vaccine, therapeutic, and cure initiatives/studies, input/process data files, analyze data, assist in the preparation of reports, manuscripts, military briefings, and scientific presentations. The contractor shall provide assistance with adaptation, development, validation, and execution of assays/algorithms for diagnosis and/or detection of pathogens of US Military or US National interest. The contractor shall provide assistance for identification of targets for project development, protocol development, coordination of collaborative project teams, and project execution. In addition, the Contractor shall:

3.1 Provide technical, scientific, medical, operational, and administrative assistance for execution of best in class prevalent and emerging infectious pathogen screening, confirmation/infection detection, clinical and therapeutic monitoring, i.e., viral load, resistance genotyping and associated data management for US Service members , their Beneficiaries, translational, vaccine, therapeutic, and cure study participants, and global health communities.

3.2 Provide technical, scientific, medical, operational, and administrative assistance in maintenance and advancement as international leader in (1) development and deployment of prevalent and emerging infectious pathogen diagnostic countermeasures, and, (2) laboratory and epidemiological data generation and acquisition for development of Knowledge Products to inform DoD/Service Specific, US National, and/or Global Health policy.

3.3 Provide technical, scientific, medical, operational, and administrative assistance in accelerating diagnostic countermeasure acquisitions, deployment/application of most impactful screening/confirmation /monitoring methodologies/technologies for Service members and their beneficiaries, the US population, and Global Health Community.

3.4 Provide technical, scientific, medical, operational, and administrative assistance for execution of best in class screening, supplemental confirmation, diagnostic, monitoring (viral load/resistance genotyping) and data management Reference Laboratory support for vaccine, therapeutic, cure clinical trials, and threat epidemiology of pathogens of US Military , US National, and/or Global Health Security interest.

3.5 Provide technical, operational, scientific, medical, and administrative assistance in advancing DoD operational/Force Health Protection, Medical Readiness countermeasures to prevalent and emerging infectious pathogens.

3.6 Provide technical, operational, scientific, medical, and administrative assistance in conduct/execution of clinical and public health practice evaluations facilitating force health protection and readiness through detection of changes in trends/incidence rates of pathogens of U.S. Military and/or National interest or assistance as required in support of US Military Taskings.

3.7 Provide technical, operational, scientific, medical, and administrative assistance for conduct/execution of comprehensive, standardized descriptive epidemiology of prevalent and emerging infectious pathogens of Service members and their beneficiaries.

3.8 Provide technical, operational, scientific, medical, and administrative assistance in conduct/execution of natural history/observational studies of the impact of changes in DoD, service policies related to HIV/STI/BBI, TTIs and/or changes in the availability or delivery of screening/prevention services in military/military beneficiary populations.

3.9 Provide technical, operational, scientific, medical, and administrative assistance for current descriptive epidemiology of HIV/HIV-related infections among populations of special interest to US Military/government, populations in contact with US military/partner nation Forces, and U.S. Military recruit/accession populations.

3.10 Provide technical, operational, scientific, medical, and administrative assistance for Knowledge Product development that informs preventive interventions, informs DoD/Service/CoCOM policy, identifies targets for prevention, and/or that result in cost savings or maximum return on investment of MHS and DoD resources (human resources, training, etc.).

3.11 Provide technical, operational, scientific, medical, and administrative assistance for development/adaptation and evaluation of existing preventive interventions for health systems delivery, e.g, remote consultations/tele-health in military/military beneficiary populations.

3.12 Provide technical, operational, scientific, medical, and administrative assistance in identification of barriers for accession screening, care and treatment in the MHS settings; optimization of delivery and uptake of screening and prevention service delivery to individuals most at risk for HIV/STIs/BBIs, TTIs in US Military/military beneficiary populations.

3.13 Provide technical, operational, scientific, medical, and administrative assistance in design and conduct of threat assessment studies of pathogens of US. Military/National interest among U.S. Service members, individuals in contact/potential contact with U.S. Service members, and in geographic regions of military operational significance.

3.14 Provide technical, operational, scientific, medical, and administrative assistance in service delivery optimization through analysis of gaps/knowledge of providers and health systems delivery that expand access, and decrease barriers to accessing screening, prevention, and care.

3.15 Provide technical and operational assistance in maintaining laboratory operations and best in class quality systems essentials as assessed by internal (WRAIR, MRMC) and external auditing entities to include, but not limited to, US governmental Agencies, accrediting bodies, and sponsors.

4.0 REQUIRED TASKS: The contractor shall support the following tasks which integrate the totality of each requirement across the HIV clinical and research services, including epidemiology and development of knowledge products that provide the framework of the total requirement.

4.1 Clinical Laboratory Services:

4.1.1 The Contractor shall, with oversight from the CAP Laboratory Director of the HDRL and LDL and other senior Government staff, assist the Government in direct technical performance/execution of simple, rapid device, moderate, and high complexity (non-waived) serological, immunological, protein, and/or molecular assays for clinical screening, supplemental confirmation testing, speciation, xenodiagnoses, and clinical and therapeutic monitoring of HIV, STIs, BBIs, TTIs, old and new world Leishmanias, malaria, and other potential infectious pathogens of US Military and National interest. The contractor shall work in the CAP/CLIP accredited laboratories, HDRL and LDL, providing technical, quality, and administrative assistance. The contractor shall serve as Laboratory Technical Authority (as defined by CAP guidelines [Technical Supervisor]) in conjunction with the Laboratory Director and senior USG scientific and professional staff. Instrumentation and software utilized in performance of duties is included, but not limited to, that listed in Attachment PWS-P7. Principal duties will entail execution of (1) HIV, HBV, HCV serological (antigen/antibody) screening and confirmatory testing of US Service Members to include Active Army, Army Reserve, Army National Guard, Medical Entrance Process Command Accession Candidates, US Navy, US Marine Corp, and US Air Force personnel and their Beneficiaries in support of the US Army Medical Command HIV Surveillance, HIV Confirmatory Test Programs, and US Navy Bloodborne Pathogen Programs; (2) performance of molecular quantitative and qualitative assays for U.S Service Members, to include, but not limited to, quantitative HIV-1, HIV-2, HCV, HBV viral load assays, HIV-1/HCV qualitative RNA assays, Neisseria Gonorrhea (GC), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (M gen) qualitative RNA molecular screening, HIV-1 resistance genotyping for therapeutic monitoring; and (3) histological examination of human and animal tissues, bone marrow for detection of Leishmania species, qualitative DNA PCR, vector assays, antigen detection, speciation by isoenzyme profile, and xenodiagnoses incorporating animal models for new and old world Leishmania. Current annual workload is ~400,000-450,000 tests per annum; mission expansion over the period of performance may increase workload to greater than 1,000,000 tests per annum. The contractor will be responsible for the preparation and analysis of specimens yielding clinical reportable test results with highest fidelity/accuracy under stringent, short suspense, specified per test TAT (8 hours from receipt of specimens for USMEPCOM), as well as operation and maintenance of all state-of-art clinical instrumentation, and application of all pre-analytical, analytical, and post-analytical controls and quality processes. All activities shall be conducted in accordance with US regulatory agency requirements; specifically, HIPAA, CAP/DoD CLIP/ Good Clinical Laboratory Practice (GCLP), and HDRL/LDL approved Policies, Procedures, Standard Operating Procedures (SOPs) and the DLDM Quality Management Plan (QMP).

4.1.2 The Contractor shall assist in all aspects of proper handling of all clinical specimens in accordance with assigned SOPs and biohazard protocols, DoD and US regulations including, but not limited to, documented receipt, data entry in the Laboratory Information System (LIS) and or databases/data warehouses, specimen handling, decapping, testing, aliquot, archival storage, retrieval, and/or disposal of human and/or animal clinical/biological specimens.

4.1.3 The Contractor shall be responsible for the proper use of assigned instrumentation for specimen testing and analysis, to include but not limited to, computers for result data entry, automated, semi-automated, manual platforms, and all associated equipment.

4.1.4 The Contractor shall perform moderate, high complexity, non-waived tests, or waived tests to include, but not limited to, HIV, HCV, HBV, HVS, Syphilis, GC/CT, TV, M. gent, Leishmania, malaria as well as other infectious pathogens of US Military and National interest, supplemental confirmatory assays by automated, semi-automated, and/or manual methods supplied by the government in accordance with regulatory agency requirements; specifically, CAP/DoD CLIP/GCLP, and Government (HDRL/LDL) Policies, Procedures, SOPs, and HDRL established test specific TATs.

4.1.5 The contractor shall execute high complexity, non-waived HIV Resistance Genotype Testing for therapeutic monitoring of HIV infected Service members and their Beneficiaries submitted by US Army/DoD MTFs, or for biological specimens submitted by a US, international, foreign military, and/or civilian partner in accordance with all manufacturer guidelines, package inserts, Government (HDRL) SOPs and CAP/CLIP/FDA/GCLP regulations, and/or sponsor guidance documents.

4.1.6 The Contractor shall execute high complexity, non-waived HIV Polymerase Chain Reaction/Real Time Polymerase Chain Reaction (RT-PCR), and/or Transcription Mediated Amplification (TMA) technologies for molecular detection/confirmation/infection classification, clinical monitoring (viral load), and/or support of clinical evaluations using assigned automated and/or semi-automated, or manual platforms and in accordance with manufacturer guidelines, package inserts, HDRL/LDL SOPs, and DoD/FDA/GCLP regulatory requirements and CAP standards

4.1.7 The Contractor shall maintain competency on all platforms/instrumentation and assays to include automated, semi-automated, and manual platforms for which they are assigned to utilize in the performance of their duties.

4.1.8 The Contractor shall ensure proper documentation/data entry of specimen demographics, test results, Quality Control (QC) data into the appropriate validated/approved LIS, databases, work files, spreadsheets, etc.

4.1.9 The Contractor shall assist in maintaining LIS, project data, data analyses, and preparation of reports, abstracts, manuscripts, and posters for national and international conferences; and, present findings at national and international conferences as required.

4.1.10 The Contractor shall maintain up-to-date knowledge and training on all Laboratory Safety requirements and adhere strictly to all US regulatory agency guidelines.

4.1.11 The Contractor shall complete all required Safety, HIPAA, IA, Collaborative Institute Training Initiative(CITI), IT, and other related training, i.e., travel related training within specified time frames.

4.1.12 The Contractor shall perform and document all daily, weekly, monthly, semi-annual, and annual equipment maintenance in accordance with manufacturer’s specifications and in conjunction with Government (HDRL/LDL/TAL) Quality Management Plan (QMP), and relevant SOPs.

4.1.13 The Contractor shall assist in training of new employees, visiting Scientist, and assist with technology transfer and technical assistance visits at MHRP and/or National, international partner sites within prescribed scope as determined by the Government (HDRL/LDL Laboratory Manager/Laboratory Director/Associate Laboratory Director/Department Chief/Assistant Department Chief).

4.1.14 The Contractor shall assist in maintenance of all documentation as prescribed by the Government; shall maintain strict adherence to all DLDM/HDRL/LDL Quality Control/Quality Assurance procedures.

4.1.15 The Contractor will assist in monitoring and reporting workload, QC data, trends, key indicators as required by Government, e.g., creating and maintaining data summary spreadsheets, inventories, and SOPs.

4.1.16 The Contractor shall assist the Government in management and maintaining inventory, e.g., supplies, reagents, kits, consumables sufficient to meet anticipated test requirements; notify Government with sufficient lead time to acquire supplies, reagents, kits, and consumables, for performance of requirements set forth in this PWS.

4.1.17 The Contractor shall assist the Government in troubleshooting instruments, test methods, FDA approved assays, modification of intended use of FDA approved assays, or LDAs.

4.1.18 The Contractor shall assist the Government in maintenance of a safe and uncluttered work area; follow Government guidance in disposal of infectious and chemical waste.

4.1.19 The Contractor shall collaborate in support of other tasks and projects outlined in this PWS as appropriate.

4.1.20 The Contractor shall provide LIS and Associated Software Analyst support for full lifecycle LIS and ancillary applications in support of DLDM laboratory operations.

4.1.21 Evaluates LIS requirements and recommends priorities for LIS system design

4.1.22 The Contractor shall provide IT consulting and software engineering support on an as-needed basis in support of existing software used by DLDM/DETA to include, but not limited to MasterControl (document control software), SmartGene (Integrated Database Network System [HIV]), and LabWare Laboratory Information Management System. The contractor shall:

· Perform appropriate analyses of data, effectively communicate findings and make appropriate recommendations based on the findings and desired outcomes

· Perform or revises, repairs, or expansion of existing database, and/or programs to increase operating efficiency or adapt to new requirements

· Write, update, and maintain computer database, programs, or software packages to handle specific jobs such as tracking inventory, storing or retrieving data, or controlling other equipment

· Consult with managerial, engineering, and technical personnel to clarify program intent, identify problems, and suggest changes

· Assist DLDM software developers by analyzing user needs and designing software solutions

· Conduct trial runs of programs and software applications to be sure they will produce the desired information and that the instructions are correct

4.2 Diagnostic, Clinical, Translational Research Support:

4.2.1 The Contractor shall, with oversight from the Department Chief, DLDM, CAP Laboratory Director, HDRL and LDL, and other senior Government staff, assist in the conduct of all aspects of development, execution, and reporting of results from laboratory research projects supporting (1) clinical diagnostic research; (2) vaccine, therapeutic, and cure research; (3) ongoing DLDM and DETA translational research, i.e., public health practice, applied, clinical, prevention, intervention, and U.S. Military health systems studies; (4) U.S. Military Taskers and Epidemiological Consultations (EPICONs); and, (5) Global Health missions. Instrumentation and software utilized in performance of duties is included, but not limited to, that listed in Attachment PWS-P7. Specifically, the Contractor shall assist the Government in (1) development, evaluation, and validation of diagnostic algorithms for pathogens of US Military and National interest; (2) conduct of non-human subjects research, i.e., Pre-Market Application sponsored clinical trials for US FDA approval/clearance of new/novel pathogen screening, confirmatory testing, clinical monitoring, and/or therapeutic monitoring assays/platforms; (3) execution of serological, immunological, and/or molecular test support for vaccine, therapeutic, and cure non-clinical and clinical trials; (4) execution of serological, immunological, and molecular test support for translational research, U.S. Military Taskers, EPICONs, and Global Health and Public Health Practice evaluations; (5) evaluation and/or modification of the intended use of FDA cleared/approved platforms and associated tests, CE Marked platforms and associated tests in support of research initiatives; and, (6) de novo development, evaluation, optimization, validation, verification and/or execution of highly sophisticated, LDAs for detection, screening, confirmation, quantification, and/or monitoring of prevalent and/or emerging infectious pathogens of US Military or National interest. Work may involve Intellectual Property and may be conducted under PHI, PII, CAP/DoD CLIP/GCLP, and/or US regulatory agency (FDA, IRB) requirements. Assays developed and/or validated in support of clinical laboratory services and research efforts are transferred to HDRL or LDL for performance under CAP/CLIP and other US regulatory agency requirements. Research efforts ensure deployment of the most advanced HIV or other prevalent and/or emerging infectious pathogen diagnostic countermeasures for Service members, and their Beneficiaries. DLDM laboratory data is leverage by DLDM and DETA to inform (1) knowledge product development, (2) evidenced based revision or development of Service specific and/or DoD policies, and (3) support evidence based best practices.

4.2.2 The contractor shall assist in the preparation and analysis of specimens from, but not limited to, vaccine, therapeutic, cure clinical trial participants, US Military Taskers, and translation research for HIV, STI, BBI, TTI, and prevalent and emerging pathogens of US Military and National interest. All activities shall be conducted in accordance with US regulatory agency requirements; specifically, FDA, IRB, CAP/DoD/ CLIP/GCLP, and Government (HDRL/LDL) Policies, Procedures, SOPs, and DLDM Quality Management Plan (QMP).

4.2.3 The Contract shall assist the Government in testing of specimens from, but not limited to, studies determined to be not research, i.e., PMA studies for US FDA approval of new/novel assays/platforms and evaluations of new methods, assays, technologies.

4.2.4 The Contractor shall assist the Government in ensuring proper documentation/data entry of specimen demographics, test results, QC data, and laboratory findings into the appropriate approved databases, work files, spreadsheets, etc.

4.2.5 The Contractor shall assist with preparation and QC of solutions, reagents, and assays, and assist the Government in tracking laboratory reagents and consumables.

4.2.6 The Contractor shall maintain competency on all platforms/assays to include automated, semi-automated, and manual for which they are assigned to utilize in the performance of their duties.

4.2.7 The Contractor will assist the Government in assessment, validation, and/or execution of real time qPCR, nano, digital droplet PCR (dd-PCR), multiplex, or other next generation assays to detect and/or quantify infectious pathogens, e.g., HIV, HBV, HCV, VSV, Leishmania, malaria, or other prevalent and emerging infectious pathogens of US Military or National interest.

4.2.8 The Contractor shall assist in the conduct of state-of-art Laboratory Developed Tests, i.e., HIV-1 DNA PCR, HIV-2 DNA PCR, HIV-2 RNA PCR, HIV 2 LTR and other assays as required using, but not limited to, real time, nano, digital droplet technology, and next generation sequencing in accordance with CAP/CLIP/FDA regulatory agency requirements and DLDM/TAL SOPs.

4.2.9 The Contractor shall assist the Government in troubleshooting instruments, test methods (FDA approved or modified), or LDAs.

4.2.10 The Contractor shall assist the Government in performance of all daily, weekly, monthly, semi-annual, and annual equipment maintenance and Quality Control procedures in accordance with manufacturer’s specifications and in conjunction with Government QMPs and SOPs.

4.2.11 The Contractor shall assist the Government in inventory management of supplies, reagents, kits, consumables sufficient to meet anticipated test requirements.

4.2.12 The Contractor shall assist the Government in maintenance of a safe and uncluttered work area; follow Government guidance in disposal of infectious and chemical waste.

4.2.13 The Contractor shall complete all Safety, HIPAA, IA, CITI, IT and other related training within specified time frames.

4.2.14 The Contractor shall assist in training of new employees, visiting Scientist, or assist with technology transfer and/or assistance visits at MHPR and/or National, international partner sites within prescribed scope as determined by the Government.

4.2.15 The Contractor shall comply with occupational health and safety standards and other applicable regulations and guidelines, which may include medical surveillance.

4.2.16 The Contractor shall assist in identification of gaps in knowledge regarding contemporary diagnostic countermeasures.

4.2.17 The Contractor shall assist in acquisition, archival storage, comprehensive analyses, and routine and ad hoc reporting of findings from relevant existing archived laboratory and surveillance data, and prospectively collected laboratory data.

4.2.18 The Contractor shall assist in conduct of all aspects of development, execution, and reporting of results from projects, i.e., maintaining project data, data analyses, and preparation of reports, abstracts, posters/oral presentations for national and international conferences; and, present findings at national and international conferences.

4.2.19 The Contractor shall assist in meeting all relevant DoD and FDA/WRAIR IRB regulatory requirements for development, modification, and continuation of, but not limited to, clinical, translational, and Global Health studies and/or projects.

4.2.20 The Contractor shall assist in communicate of findings verbally, in writing, and through publication in the peer reviewed scientific literature and will comply with all institutional and agency requirements for publication and dissemination of results (e.g. Operations Security (OPSEC), Public Affairs Office (PAO)).

4.2.21 The Contractor shall collaborate in support of other tasks and projects outlined in this PWS as appropriate.

4.3 Specimen Processing for Prevalent and Emerging Infectious Pathogens of US Military or National Interest in Human and/or Animal Specimens.

4.3.1 The Contractor shall, with oversight from the Chief, DLDM, the CAP Laboratory Director, HDRL and LDL, and senior Government staff, support conduct of all pre-test, test, and post-test regulated requirements for processing biological specimens for detection of HIV, STIs, BBI, TTIs, or other prevalent and emerging infectious pathogens of US Military and National interest. The Contractor will assist in receipt, processing, data entry into electronic databases, e.g., LIS, LabWare, FreezerWorks (if applicable), FileMaker Pro, labeling, decapping, and route to appropriate laboratory section for prescribed testing (clinical laboratory service delivery or clinical research), and support conduct of post-test residual sample aliquot, crating, archival storage, and trans-shipment to the DoD Serum Repository or other approved external entity. The Contractor shall support shipment of specimens/samples to outside referral clinical laboratories, clients, collaborators as required under International Air Transportation Association (IATA) guidelines and Department of Transportation, Federal Transit Administration (FTA) regulatory requirements. All activities shall be conducted in accordance with US regulatory agency requirements; specifically, IATA, FTA, CAP/DoD CLIP/GCLP, IRB, and HDRL/LDL/CEU/TAL policies, procedures, and SOPs.

4.3.2 The Contractor shall assist in proper receipt of shipments/specimens, annotate condition, time, date, specimen integrity, shipping discrepancies employing HDRL/LDL/TAL/CEU LIS, other databases, in accordance with CAP/DoD CLIP/GCLP, IRB, HDRL/LDL Policies, Procedures, SOPs, and the DLDM QMP.

4.3.3 The Contractor shall verify all specimen types against pre-analytical test requirements for each assay using both automated and manual processes; follow specimen rejection criteria; notify Government in real time of specimen issues so that submitting entities may be notified promptly of specimen rejections/errors.

4.3.4 The Contractor shall maintain competency on all platforms/assays to include automated, semi-automated, and manual for which they are assigned by Government to utilize in the performance of their duties.

4.3.5 The Contractor shall prepare aliquots/specimens for testing; deliver specimens to appropriate testing laboratory in a timely manner.

4.3.6 The Contractor shall prepare sample aliquots for referral to outside laboratories in accordance with IATA standards and with FTA, CAP/DoD CLIP/GCLP, HDRL/LDL policies and SOPs.

4.3.7 The Contractor shall preform specimen/sample archival storage, retrieval, inventory, and disposal activities in accordance with Government HDRL/LDL policies, procedures and all applicable Federal regulations.

4.3.8 The Contractor in conjunction with the Government shall track and submit request for reorder by Government common lab supplies as required, prepare empty shipping containers for return transship to logistical supplier.

4.3.9 The Contractor shall perform all daily, weekly, monthly, semi-annual, and annual equipment maintenance in accordance with manufacturer’s specifications and in accordance with Government (HDRL/LDL) QMPs and SOPs.

4.3.10 The Contractor shall complete all required Safety, HIPAA, IA, CITI, IT, and other related training within specified time frames.

4.3.11 The Contractor shall be responsible for performing assigned tasks in accordance with all applicable Safety regulations and instructions.

4.4 Services to Support Comprehensive characterization of the current epidemiology of HIV among Army, Navy, Air Force, and Marine Corps personnel.

4.4.1 The Contractor shall provide support to the Chief, Department of Epidemiology, DETA and other senior Government and Military staff and Service-representatives, support conduct of all aspects of development, execution, and reporting of results from…