A01_Attachment_PWS-P13_QASP_28_nov.docx

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1. Introduction: This Quality Assurance Surveillance Plan (QASP) has been developed to ensure the performance of critical contract elements. The QASP serves as the plan for surveillance of performance and identifies the performance indicators, standards, inspection methods and procedures to be used in monitoring performance.

1.1. Purpose. The purpose of this contract is to provide operational, scientific, medical, technical, and administrative non personal service for the Departments of Laboratory Diagnostics and Monitoring (DLDM) and Epidemiology and Threat Assessment (DETA), US Military HIV Research Program, Walter Reed Army Institute of Research.

1.2. Objective. SCOPE OF WORK of this contract is to provide expert, best in class operational, scientific, medical, technical, and administrative assistance for (1) execute all phases of clinical screening, supplemental confirmatory testing, clinical monitoring (viral load), and therapeutic monitoring (resistance genotype testing) for HIV, sexually transmitted infections (STIs), blood borne infections (BBIs), transfusion transmitted infections (TTIs) and prevalent and emerging pathogens of Military or US National interests; (2) execute all phases of clinical trials for evaluation of new/novel products for Pre-Market Application to the US Food and Drug Administration and/or execution in clinical diagnostic settings; (3) develop, design, evaluate, validate Laboratory Developed Assays (LDAs) for detection, screening, supplemental confirmatory testing/diagnosis, and/or monitoring (viral load/resistance genotyping) of prevalent and emerging pathogens of US Military and/or National interest; (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; (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 of prevalent and emerging pathogens of US Military, US, and Global Health interest; (6) conduct comprehensive characterization of the epidemiology of infectious pathogens of US Military interest; (7) conduct translational research, i.e., public/global health, diagnostic, applied, clinical, prevention, intervention, and health systems studies for evidence based Knowledge Products that inform optimal screening, prevention, and service delivery policy and best practices for Service and DoD stakeholders for prevalent and emerging infectious pathogens of US Military and National interest ; (8) conduct threat assessment studies of HIV/HIV-related and emerging BBIs and TTIs associated with the battlefield blood supply and HIV-related STIs among US military and foreign military personnel; (9) conduct threat assessment studies of prevalent and emerging infectious pathogens among populations of interest to the Combatant Commands (CoCOMs) and in geographic regions of US military operational significance; and (10) comply with the Health Insurance Portability and Accountability Act (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.

2. Responsibilities: The contractor is responsible for management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved.

2.1. The contractor is responsible for the management and quality control actions to meet the terms and conditions of the contract. The role of the government is quality assurance to ensure that contract standards are achieved.

2.2. The government COR desires to maintain a quality standard for the Performance Work Statement.

Methods of Surveillance

Surveillance: The government COR will evaluate the services required by each task to ensure compliance.

Standard: 95% of the tasks will be satisfactorily completed and/or reworked.

Procedures: The COR will inspect all work tasks required by the contract to ensure contractor compliance with the appropriate paragraphs of the PWS each time the service is performed. The COR will record results of inspection, noting the date and time of inspection. If the inspection indicates unacceptable performance, the COR will inform the contract manager of the deficiencies for correction. The contractor shall be given a reasonable amount of time after notification to correct the deficiencies.

Primary Method of Surveillance: 100% inspection and random monitoring will be used for surveillance. Contractor’s performance will be evaluated in five general areas. A rating of Exceptional, Very Good, Satisfactory, Marginal or Unsatisfactory will be assigned to each area.

Evaluation Procedure

3. Primary Function:

3.1. All Contract personnel shall work semi-independently within assigned projects that are within the Scope of Work.

3.2. The work supporting DETA shall be performed at the US Government site, at WRAIR, in leased space in the National Capital Area near WRAIR, at the San Antonio Military Medical Center, the Womack and Madigan Army Medical Centers at Fort Bragg, North Carolina and Joint Base Lewis McChord, respectively, at other locations as needed and to be determined, and in the metropolitan DC and San Antonio areas; work supporting DLDM, MHRP, shall be performed at Bldg 508 and Bldg 503 Forest Glen Annex, WRAIR, Silver Spring, MD 20910, or alternative US government or non- US government leased space within the National Capital Region;.work assisting Government in off-site audits for some contractor personnel may encompass approximately 15-20% of the time. In addition, some personnel may be required to assist the US Government in technology assistance and technology transfer of waived, non-waived, and/or moderate to high complexity testing to international settings where the US Military HIV Research Program conducts vaccine, therapeutic, and/or cure initiatives or engages in Public Health activities such (President’s Emergency Plan for AIDS Relief).

3.3. The Contractors shall conduct all activities in accordance with regulatory agency requirements; specifically, HIPAA, CAP, CLIA, DoD CLIP, GCLP, US FDA, and IATA regulatory guidelines to include Human Subjects Protection regulatory requirements as well as DLDM, HIV Diagnostic and Reference Laboratory (HDRL), Leishmania Diagnostic Laboratory (LDL), Clinical Evaluation Unit, and Technology Assessment Laboratory (TAL) Policies, Procedures, and Standard Operating Procedures (SOPs); and, DETA Policies, Procedures, and SOPs. The Contractors must strictly adhere to all WRAIR safety guidelines, policies, and SOPs.

3.4. At the completion of the project, the contractors shall provide a detailed report of work conducted.

3.5. Specific Tasks: The Contractors working under this contract shall be able to independently/semi-independently perform specified techniques, keep meticulous laboratory/work records, both written and electronic, and meet all US and DoD regulatory guidelines (IRB, HIPAA, CAP, DoD CLIP, GCLP, US FDA, IATA) as applicable for conduct of work.

4. Evaluation of Performance:

4.1. Training: Provide documentation of full training to perform all required tasks specified in the scope of the work as per DLDM, HDRL, LDL, TAL policies and procedures; DETA policies and procedures.

4.2. Quality of Product or Service – Addresses the extent to which the contractor (a) meets contract technical requirements, including the accuracy and completeness of reports/data delivered; (b) methods and approaches employed to ensure fully successful performance; (c) consistently convey intended approach clearly and completely to ensure that there are no unintended consequences; (d) is proactive and demonstrates initiative; (e) remains flexible/adaptable to internal or external changes; and, (f) is effective in developing and implementing process improvements to ensure the end product is accurate, efficient, and effective.

5. Evaluation Process.

100% Inspection - Will be accomplished by monitoring and documentation. Each month, the contractor will generate a detailed list of tasks performed. Each month, the COR (HDRL/LDL Laboratory Director) and Chief, DETA will review the generated documentation.

Random Monitoring - Random monitoring will be conducted if and when specified in individual tasks.

On a yearly basis the Contractor shall provide a report which outlines the status of tasking:

· Performance requirements for the reporting period and status of those requirements;

· Problem areas encountered and appropriate resolution(s);

· Other relevant issues: Any other detail necessary to adequately assess performance for the quarter. Review and input shall be shared with the contractor to the extent required to resolve any outstanding issues.

· The Contractor shall be required to provide a mitigation plan to resolve the issues identified.

1. Quality Control Plan: All of tasks will be performed under direction of the COR, Laboratory Director, HDRL, Chief DLDM, Assistance Chief, DLDM, and Chief, TAL as per PWS; Chief, DETA as per the PWS.

2. The contractors will work independently/semi independently within assigned projects that are within the scope of the work and per above.

3. Contractors will follow all the specific guidelines (IRB, HIPAA, CAP, CLIA, DoD CLIP, GCLP, US FDA, IATA, DLDM, HDRL, LDL, TAL and DETA Policies, Procedures, Standard Operating Procedures, and must strictly adhere to all WRAIR safety guidelines.

4. Report issues and problems to the COR immediately if the problem or issue or both jeopardize PHI or PII of any US Military Services Member, their Beneficiary, or clinical trial participant.

5. Original data, images, and documents will be collected and stored in accordance with DLDM, HDRL, LDL, TAL and DETA policies, procedures and in accordance with all IRB, HIPAA, CAP, CLIA, DoD CLIP, GCLP, USFDA regulatory requirements as applicable.

6. The results, accomplishments and issues or problems or both will be documented according to regulatory requirements (IRB, HIPAA, CAP, CLIA, DoD CLIP, GCLP, US FDA, IATA) and in accordance with DLDM, HDRL, LDL, TAL and DETA requirements.

7. All issues or problems or both, if any, will be discussed with the COR. A risk mitigation strategy will be developed to remedy and solve the issues and problems.

8. 95% of the tasks shall be satisfactorily completed or reworked until satisfaction is achieved.

9. At the completion of the project, the contractor will provide a detailed report or presentation or both of the findings and conclusions as appropriate.

Quality Plan Measurements:

CPARS

Inspection When performance falls below the standard, past performance will be reported in CPARS

specified TATs; DETA specified TATs Meet TATs as specified by HDRL/LDL Submission Guidelines 95% of the time; DLDM/DETA specified TATs for protocols, reports, manuscripts, knowledge products

US FDA regulatory guidance

inspection When performance falls below the standard, past performance will be reported in CPARS

inspection When performance falls below the standard, past

performance will be reported in CPARS

later than the 20th working day of each month.

Inspection When performance falls below the standard, past performance will be reported in CPARS

Inspection When performance falls below the standard, past performance will be reported in CPARS

Inspection When performance falls below the standard, past performance will be reported in CPARS