A01_Attachment_PWS-P14DLDM_DETA__Key_Pers.docx

ATTACHMENT PWS-P14

DLDM AND DETA KEY PERSONNEL

5.19 Key Personnel:

5.19.1 Contractor Personnel Performance Replacement: Substitutions of proposed Key Personnel shall not be allowed for a period of six (6) months after award, except under extreme circumstances. Any substitution or replacement of Key Personnel shall have qualifications that are equal to or better than the qualifications of the person to be replaced. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two (2) weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance.

5.19.2 DLDM Key Personnel

5.19.2.1 Operations Director (Senior Laboratory Scientist ); Demonstrated Subject Matter expertise in execution of GCLP, CLIA, and CAP regulatory standards and laboratory operations in support of clinical laboratory service delivery, clinical research, sponsored clinical trials, specimen management, and biorepository operations for US and international clinical trials networks; Demonstrated experience in international and global health environments and human capacity building.

5.19.2.2 Chief Scientist: Demonstrated Subject Matter expertise in oversight of design, development, and validation of reagents, test kits, platforms, and laboratory developed tests for use in prevalent and emerging infectious pathogen screening, confirmation, monitoring, regulated epidemiological, vaccine, therapeutic, cure pre-clinical and clinical trials for prevalent and emerging pathogens; Demonstrated experience and scientific accomplishments in writing specialized peer-reviewed, scientific and technical reports, design and preparation of research protocols, peer reviewed manuscripts, regulatory documents.

5.19.2.3 Quality Assurance Manager Senior (supervisory): certification as a Medical Technologist from American Society of Clinical Pathologist (ASCP) or Canadian Society for Laboratory Medical Sciences (CSLMS); Demonstrated Subject Matter expertise in quality management inclusive of application, implementation, and administration of CLIA, CLIP, CAP, American Associate Blood Bankers(AABB), in regulated laboratory settings, specifically, implementation and maintenance of Quality System Essentials, CAP re-accreditation inspections and US FDA 483 audits; experience with Occurrence Management, all phases of pre-test (analytical), test (analytical), and post-test (post-analytical) quality processes for both accredited clinical laboratories and research regulated environments.

5.19.2.4 Quality Assurance Specialist – Senior: certification as a Medical Technologist from ASCP or CSLMS; Demonstrated experience in monitoring performance in high complexity, non-waived regulated clinical and clinical research laboratories; experience identification and analysis of key quality indicators; analyses and presentation of Quality Control data as well as monitoring quality improvement programs; implementation and maintenance of accrediting body and regulatory agency requirements through the application of laboratory information management systems.

5.19.2.5 Medical Technologist II/III (Technical Supervisors: Serology [1]; Molecular [1]), CAP, CLIP, CLIP regulated laboratory: certification - certification as a Medical Technologist from ASCP or CSLMS. Demonstrated experience in the application of CLIA, CLIP, CAP, analytical laboratory principles, theories, practices, and established methodologies sufficient to perform the full range of duties clinical diagnostics in a regulated (CLIA, CLIP, CAP) environment; Demonstrated experience leading daily activities and operations of high complexity, non-waived clinical laboratory. Fouryears professional knowledge and experience sufficient to act as the Laboratory Technical Authorities in the discipline (42 CFR 493 requirement).

5.19.2.6 Medical Technologist (Team Lead, Level II/III [Serology [1]; Molecular [1[)- certification as a Medical Technologist from ASCP or CSLMS. Demonstrated experience in application and skills sufficient to enable the individual to execute daily oversight responsibilities of the Serology (Serology Lead) laboratory operations or Molecular (Molecular Lead) Sections laboratory operations of a CAP/CLIA/CLIP accredited high complexity, non-waived laboratory conducting HIV, STI, BBI, and TTI test support.

Knowledge of laboratory information management systems; ability to recommend corrective action and policy changes in accordance with Quality Control and Quality Assurance procedures.

5.19.2.7 Medical Technologist II (Clinical Research Evaluation Unit Lead): certification as a Medical Technologist from ASCP or CSLMS ; Demonstrated experience managing, coordinating, and executing clinical testing to include but not limited to serological and nucleic acid testing for STIs, BBI, TTIs in support of clinical laboratory missions and IRB approved clinical, translational, applied, and public health research under CAP, CLIA/CLIP, US FDA regulatory requirements, specifically US FDA Pre-Market Clinical Trials, IRB approved clinical trials, non-clinical (not research) studies; experience with maintaining ethical standards; supporting IRB submissions,; supporting internal, manufacturer (sponsor), CAP, and/or US FDA 483 regulatory audits; Acts as the point of contact and coordination with manufacturers and/or sponsor study coordinators; maintaining product accountability; communicates progress with Principle Investigators and the Laboratory Director.

5.19.2.8 Technology Assessment Unit Supervisor (Research Assistant III); scientific knowledge and experience in managing daily laboratory operations, developing, managing, coordinating, and executing laboratory developed assays for detection and /or quantification of pathogens as well as FDA approved assays to include but not limited to STIs, BBI, TTIs, and emerging pathogens under CAP, CLIA/CLIP, US FDA regulatory requirements and in support of IRB approved clinical trials, applied, clinical, public health and translational research. Experience in review and release of assay run data, conduct of data analyses, preparation of reports, abstracts, posters for presentation for national and international scientific forums and assistance in preparation of manuscripts for publication in peer reviewed journals.

5.19.2.9 Laboratory Information Systems (LIS) Programmer and Software Analyst II/III; Science background and IT knowledge and experience in full LIS life cycle from implementing requirements and design through configuration and development for use in CAP accredited laboratory; experienced in integrating clinical diagnostics processes into LIS processes through software development lifecycle test, and verification and validation; experienced in development of custom visual workflows for laboratory processes; development of instrument interfaces from LIS to clinical laboratory instruments, and data interfaces with external stakeholders.

5.19.2.10 LIS Administrator; Science background and IT knowledge and experience in maintaining compliance with information technology policies, laboratory policies in CAP, CLIP, CLIA, GCLP regulated environments; experienced in integrating clinical diagnostics processes as a senior member of the diagnostics and IT team; management of laboratory data and transmittal to customers/clients; experience with LIS design methodologies, database administration; and, system validation and documentation practices for a regulated laboratory environments.

5.19.3 DETA Key Personnel

5.19.3.1 Public Health Researcher Supervisory, Senior: experience conducting all phases of public health research, experience managing multidisciplinary public health research teams, knowledge of relevant regulatory, laboratory, and ethical policies, experience executing military relevant HIV/HIV-related infections military research.

5.19.3.2 Public Health Nurse Practitioner (2): licensed in nursing with nurse practitioner certification/qualification. Demonstrated clinical experience in public health and research and/or public health experience required. Familiarity with delivering healthcare to military beneficiaries and health information systems; Experience in patient/participant tracking and education/preventive intervention/screening, service delivery and data acquisition.