Solicitation A-J - ID07200010.2 July.Amendment2.pdf

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Research and Development Biomedical Solutions Provider - Request for Proposal
Solicitation number
47QFWA20K0014
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This document is a solicitation notice for a Request for Proposal to provide research and development biomedical solutions. The General Services Administration Federal Acquisition Service Assisted Acquisition Service Region 7 is seeking proposals to support the 59th Medical Wing Science and Technology office in conducting clinical and translational research to advise the Air Force Surgeon General on matters pertaining to emergency medical care, combat casualty care, force health protection, restorative medicine, and clinical and rehabilitative medicine for Air Force personnel and beneficiaries.

The solicitation includes attachments outlining the requirement details in the performance work statement, pricing worksheets, labor categories, evaluation criteria, and instructions for a pre-proposal teleconference. Offerors are asked to submit an email with contact information to register for the pre-proposal conference scheduled for June 18, 2020. Proposals are due based on the response dates outlined in Sections B-M of the solicitation. The requirement is an 8(a) set-aside to be awarded as a single-award time and materials contract.

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Attachment 17 SF-30 Amendment 2.pdf PDF
Solicitation K-M - ID07200010.2 July.Amendment2.pdf PDF
A12.2 Attachment 12 Previous Experience Worksheet - Phase 1- Amendment2.July2.docx DOCX document
RFP Question Answer Log.2 july.final.xlsx XLSX spreadsheet
Attachment 16. General Information.pdf PDF
Attachment 18.1 AASR7-Pre-Proposal TeleConference.briefed.pdf PDF
Attachment 18.2 59th requirement deep dive.pdf PDF
A13.1 Attachment 13.1 Pricing Worksheet. Additional Labor Categories.xlsx XLSX spreadsheet
A10.1 Attachment 10.1 Pricing Workheet Evaluation - AM1.xlsx XLSX spreadsheet
3.1 PWS K-M - ID07200010.24 June.Amendment1.pdf PDF
Attachment 17 SF-30 Amendment 1.pdf PDF
Attachment 18.3 Attendance Log.pdf PDF
3. Solicitation K-M - ID07200010.12 June.pdf PDF
A3.1 Attachment 3.1 (QASP).xc.pdf PDF
A15.0 Pre-proposal Conference Dial In Information.pdf PDF
1. Published Pre-Solicitation Notice beta.SAM.gov.pdf PDF
2. Solicitation A-J - ID07200010.12 June.pdf PDF
A11.0 Attachment 11 Section K Full Text REPS and CERTS.pdf PDF
A8.0 SCA WD.pdf PDF
A13.0 Attachment 13 Pricing Worksheet. Additional Labor Categories.xlsx XLSX spreadsheet
A4.0 Attachment 4 (CTP Form).pdf PDF
A14.0 Attachment 14. SF 26 Section A.pdf PDF
A12.0 Attachment 12 Previous Experience Worksheet - Phase 1.docx DOCX document
A6.0 Attachment 6 - Labor Category Position Description and Key Personnel.pdf PDF
A3.2 Attachment 3.2 (QASP Supplement).pdf PDF
A10.0 Attachment 10 Pricing Workheet Evaluation.2.xlsx XLSX spreadsheet
A1.0 PWS Attachment 1 (Project Tracking Spreadsheet).xlsx XLSX spreadsheet
A9.0 PWS Attachment 9 (DD254).pdf PDF
A7.0 Attachment 7 AFTERBURN.xc.pdf PDF
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ID07200010

Solicitation Section A - J

General Services Administration Federal Acquisition Service (FAS)

Greater Southwest Region

REQUEST FOR PROPOSAL

Solicitation Number 47QFWA20K0014

AAS FILE ID07200010

Science Technology and Research Team (START) for the

AIR FORCE MEDICAL SERVICE

ENTERPRISE-WIDE TECHNICAL

CLINICAL RESEARCH TEAM (TCRT) I

59th Medical Wing (59 MDW)

Performance Work Statement (PWS)

Open Market 8(a) Set Aside

541714 (Research and Development in Biotechnology (except Nanobiotechnology)

PART I – THE SCHEDULE

(Sections A - J)

July 2, 2020

Amendment 2

INTENTIONALLY BLANK FOR INSERT OF SF 26.

INTENTIONALLY BLANK FOR INSERT OF SF 26.

PART I – THE SCHEDULE

– SECTION B –

SUPPLIES OR SERVICES AND PRICE/COST

B. 1.0 Services

B. 1.1 Scope The scope of work for this contract will include providing support in the area of technical and professional services for the 59th Medical Wing (59 MDW) in support of the Headquarters United States Air Force Surgeon General (HQ USAF/SG for the following requirements listed in Section C.

B. 1.2 Contract Type

This is a single award Time and Material, severable, non-personal, non-commercial services contract issued in accordance with FAR Part 15.

B. 1.3 Contract Structure

The total ceiling value will include the following CLIN structure for each period of performance.

● Labor

● Travel

● Other Direct Costs (ODC’s) / Materials

● Surge Support

B. 1.4 Pricing Spreadsheet Reference Attachment 10 for the Pricing Spreadsheet to be incorporated at time of contract award.

INTENTIONALLY BLANK FOR INSERT OF PRICING SPREADSHEET

[End of Section B]

– SECTION C –

DESCRIPTION / SPECIFICATIONS/ SCOPE AND DESCRIPTION OF WORK

C.1.0 Introduction

The purpose of this Performance Work Statement (PWS) is to establish a contract that will provide support in the area of technical and professional services for the 59th Medical Wing (59 MDW) in support of the Headquarters United States Air Force Surgeon General (HQ USAF/SG).

C.1.1 Background

The 59th Medical Wing (59 MDW) Science and Technology (ST) office advises and conducts clinical and translational research under the guidance of the Air Force Surgeon General (AF/SG), the Secretary of the

Air Force (SAF), Air Force Chief of Staff, and the Office of Assistant Secretary of Defense for Health Affairs

(ASD/HA) on matters pertaining to the medical aspects of the Air Expeditionary Force and the health of Air

Force (AF) personnel and beneficiaries. In order to support the required research, ST offices conduct translational research in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine and specialty centers.

C.1.2 Program Objectives/Description of Work

The contractor shall support the 59 MDW with wing operations located within the continental United States

(CONUS). PWS Attachment 7 (Projects at Award), which identifies each preliminary and pre-determined project for this requirement, which will go live at contract award.

NOTE: Some projects/ thrust areas may start out with an inexact set of requirements that are refined and adjusted as the effort progresses. The contractor shall be able to respond to these changing needs within a time-constrained and aggressively-scheduled environment that meets delivery time frames.

C.2.0 Scope

The contractor shall provide technical and professional services in support of the Air Force Medical Service.

The contractor shall provide the services as outlined in this PWS in support of the clinical and translational research activities in all capacities ranging from providing personnel services to developing research execution plans and protocols. The contractor may be asked to provide consultation, support, and/or execution services on all aspects of the Research and Development (R&D) process from concept development through FDA approval and market/field introduction. The Contractor is expected to coordinate/partner with educations institutions, non-profit entities, not for profit entities, or for profit entities.

C.3.0 Reserved

C4.0 Tasks/Requirements

This contract includes the following requirements:

● Task 1: Expeditionary Medicine (EM) Thrust Area

● Task 2: Operational Medicine (OM) Thrust Area

● Task 3: Force Health Protection (FHP) Thrust Area

● Task 4: Human Performance (HP) Thrust Area

● Task 5: En Route Care (EC) Thrust Area

● Task 6: General Support Services

● Task 7: Program Management

Note: Refer to PWS Attachment 6 (Labor Category Position Description and Key Personnel) for related labor categories and descriptions required to satisfy this requirement.

C.5.1 Task Requirements Descriptions

C.5.2 Task 1 – Expeditionary Medicine (EM) Thrust Area

EM research and technology development encompass interests in Expeditionary Logistics and

Expeditionary Casualty Care. The aim is to enhance or improve expeditionary medical care during contingency operations including: improvement of expeditionary equipment capability enhancements by addressing needs related to platform capability sustainability (energy, supplies and materials);

miniaturization of equipment to reduce logistics footprint; technology identification; development and/or validation of next-generation critical humanitarian/disaster relief equipment/material sets; deployed casualty care optimization and improvements; and field identification, diagnosis and treatment of emerging threat

Directed Energy Weapons (DEW) injuries.

Task 1 consists of the following sub-tasks:

C.5.2.1 Expeditionary Logistics: Seeks to enhance existing or developing new expeditionary logistics procedures, materials and supplies including development and/or validation of techniques/tools.

● Contractor expected to provide:

o Reduction in size and weight;

o Optimize power requirements;

o Decrease or minimize the associated logistics footprint associated with expeditionary operations;

o Provide in-transit visibility of medical supplies and equipment.

C.5.2.2 Expeditionary Casualty Care (ECC): Optimizes existing and developing new casualty care tools

& techniques; improving methods and techniques for use of remote monitoring and triage systems; identifying and mitigating issues related to casualty care in an expeditionary setting and validation of best-fit technologies in casualty care mission(s).

● Contractor expected to provide:

o Mechanisms, techniques and tools to improve outcomes associated with care delivered in the expeditionary settings including para-rescue first response and resuscitative care, surgery in preparation for long-range transport, and treatment of directed energy injuries.

C.5.3 Task 2 – Operational Medicine (OM) Thrust Area

Operational Medicine research encompasses interest in definitive diagnosis, care and treatment in-garrison. The overall aim is to ensure the provision of the highest quality health care for active duty members and their families. OM is based on the Military Health Services priorities and gaps identified in the

AFMS 2009 Capabilities Review and Risk Assessment (CRRA) and the needs/gaps of the MAJCOMs.

Task 2 consists of the following sub-tasks:

C.5.3.1 Clinical Patient Safety: The National Committee on the Quality of Health Care, identified a comprehensive strategy to reduce preventable errors because of the tens of thousands of

Americans that die yearly as a result of medical errors. The Committee on Quality of Health Care identified six aims of quality care: care should be safe, effective, patient-centered, timely, efficient and equitable. The National Defense Authorization Act of 2001 mandated a Department of

Defense (DoD) Patient Safety Programs as a result of safety gaps identified in the areas of human factors, medical complexity and system failures. Clinical patient safety seeks solutions dealing with human factor variations in healthcare provider education, training, modeling and simulation, fatigue, experience, depression and burnout.

● Contractor expected to provide:

o Additional research/technology development relating to the medical complexity involved in the use of complicated technologies o Additional research/technology development relating to the multitude of available medications and care of critically ill patients for prolonged periods of time.

o Additional research needed to explore communication failures, unclear lines of authority between members of the health care team and reliance on automated systems that lead to patient errors when the equipment malfunctions.

C.5.3.2 Psychological Health/Resilience: In-garrison health care staff is tasked with providing quality care even in the face of staffing shortages due to deployments, budget cuts and inability to hire personnel for temporary positions. To meet staffing shortages, members of the Air Force

Reserves and Air National Guard are often activated and deployed for extended periods of time to locations in the very area in which they live and work as civilians. These prolonged deployments are sources of stress to these Airmen.

o Research to assess these specific populations for sources of stress, as well as their resiliency and resilience enablers.

o Research to assess reservists, guardsman, and active duty members that staff medical treatment facilities during periods of minimal manning that assesses stressors and resilience enablers.

C.5.3.3 Obesity: This focus area seeks research and technology development to identify and treat the scope of the obesity in AFMS beneficiaries. This research also seeks to assess the activity levels and physical functional capabilities of AFMS beneficiaries. Once the scope of the problem has been identified, the information will be utilized to drive research to explore and identify effective treatment programs specific to AFMS beneficiaries.

o Translational research from information gathered to support development and enhancement of currently successful patient educational programs that promote healthy lifestyles to treat obesity and prevent development of chronic diseases such as diabetes mellitus and cardiovascular disease.

C.5.3.4 Autism: This focus area seeks to continue development of an Autism Spectrum Disorder Registry of families from Wright-Patterson Air Force Base with the goal of collaborating with other military

Medical Treatment Facilities to provide psychological testing. These efforts will increase the number of studies affected in the registry for increased statistical power for molecular studies, and will continue research to identify autism susceptibility variants in candidate genes by direct sequencing and screening for regulatory variation by measuring Allelic mRNA Expression

Imbalance (AEI) and altered gene splicing.

o Exploration of the use of telemedicine to deliver Autism healthcare services with the potential to: improve access to care; improve patient compliance with specialty referral; and broadening the scope of patients and families who can be effectively managed.

o Design of a medical infrastructure capable of meeting unique provider and patient circumstances that will use telemedicine for Autism improving the impact of existing resources, especially in rural and underserved communities.

C.5.4 Task 3 – Force Health Protection (FHP) Thrust Area

Research and development in FHP is focused on technologies to prevent injury and illness and the early recognition or detection of emerging threats. The intent is to pursue research and development/technology advancement integration into existing risk assessment/reduction processes to reduce the manpower, time and/or logistical impact; increase the capability to characterize exposures; and provide near real-time risk information to Commanders. The FHP focus areas are Directed Energy (DE), Occupational &

Environmental Health (OEH) Hazards and Personalized Medicine Initiatives. Current projections demonstrate that the Directed Energy and Occupational & Environmental Health focus areas dominate research needs in the FHP thrust area.

Task 3 consists of the following sub-tasks:

C.5.4.1 Directed Energy: Various forms of DE are threats that the U.S. Air Force and other military forces will encounter on the modern battlefield. As DE incidents become more frequent in both domestic and foreign areas, the threat to Air Force and other military operators increase.

o Research to develop technologies that "detect to warn" and "detect to protect" to allow operators to be aware of the hazards and take appropriate actions to prevent or minimize exposure and associated adverse health effects.

o Exposure evaluation allowing correct interventions and reducing uncertainty in treatment protocols.

o Analysis of medical decisions concerning treatment needs that can be made as far forward as possible (i.e., minimizing the need for medical evacuation out of a theater of operations).

C.5.4.2 OEH Hazards: The focus of this research area is on operational and emerging OEH hazards.

o Identification of capabilities that assist AFMS Preventive Medicine personnel in identifying and characterizing potential hazards, increasing knowledge and support policy response, identifying and implementing risk reduction methodologies, and providing near real-time information to medical advisors.

C.5.4.3 Patient-Centered Precision Care – Personalized Medicine Genomic Medicine Research: The personalized medicine modernization effort focuses on advancing the field of genome-informed personalized medicine with an emphasis on targeted prevention, diagnosis and treatment for common, complex conditions typically treated in the primary care setting. The program is comprised of multiple focus areas including: addressing the ethical, legal and social policy implications and policy development for the use of genomic information; education for the healthcare team to include the empowered patient.

● Contractor expected to provide:

o Knowledge generation studies to include effectiveness of specific genomic testing and cost-benefit analysis;

o Development of a bioinformatics/computational biology system that will support continuous learning while integrating genomic information into health informatics tools o Development of an advanced genomic diagnostic system to translate genomic sequence testing into clinically actionable information for providers and patients.

C.5.4.4 Omics Research (metabolomics, proteomics, transcriptomics; microbiomics, epigenetics):

The modernization program for omics includes knowledge generation studies to advance a rapidly expanding spectrum of omics research for integration into the genomic medicine research program, and the eventual implementation into routine medical care.

● Contractor expected to provide:

o Analysis of markers guiding targeted prevention, diagnosis, and therapies for improved health throughout the patient lifecycle.

o Analysis of solutions that mitigate environmental threats to military service personnel.

C.5.4.5 Functional Medicine Research: The modernization effort is interested in the science, methodologies and comparative effectiveness research within the field of functional medicine, especially common, complex conditions typically treated in the primary care setting.

● Deliverables will be determined by product at the time of project execution.

C.5.5 Task 4 – Human Performance (HP) Thrust Area

Human Performance encompasses research and technology development interests in Cognitive

Performance and Fatigue Management, Physiological Performance and Targeted Conditioning, Operational and Environmental Challenges to Performance, Training for Optimal Performance of AF

Medical Personnel and Personnel Selection for Performance. The overall aims of AFMS Human

Performance research are to enhance, optimize and maintain personnel performance in carrying out their assigned missions. The research performed is intended to address unique AF operational needs, with the possibility of collateral benefit to other DoD entities.

Task 4 consists of the following sub-tasks:

C.5.5.1 Cognitive Performance and Fatigue Management: This focus area seeks to develop diagnostic methods to determine impaired or ineffective cognitive function as well as treatments to restore/recover cognitive function depleted as a result of intense or prolonged AF operational demands on cognitive load. This area also focuses on minimization and validated treatment of fatigue in select populations including, but not limited to, Battlefield Airmen, Para-rescue and other special operations/tactics personnel, Remotely Piloted Aircraft Operators, as well as AFMS personnel providing care in demanding operational environments such as deployed or en route care settings.

● Contractor expected to provide:

o Feedback of the proposed methods to determine success or failure of the developed diagnostic methods for cognitive performance and fatigue management.

C.5.5.2 Physiological Performance and Targeted Conditioning: This focus area seeks to identify select AF populations with unique physiological performance requirements.

● Contractor expected to provide:

o Research to optimize, enhance and maintain the physical characteristics required of these personnel with possible expected results that are validated regimens to prepare and train select AF personnel to perform their mission requirements, at least as effectively as current training approaches, while decreasing attrition rates and rates of non-mission capable personnel secondary to injury from training and operations.

C.5.5.3 Operational and Environmental Challenges to Performance: This focus area is concerned with the mitigation and prevention or treatment to enhance performance in challenging environments.

The environment may be operationally (motion, vibration, orientation, length of mission) challenging or environmentally (high-altitude, hot, cold, low-visibility, information overload) challenging.

C.5.5.4 Training for Optimal Performance of AF Personnel: AF medical personnel have a complex, demanding mission. They receive excellent preparation through a variety of training platforms and programs prior to deployment in support of AF or DoD medical operations. However, continual advances in state-of-the-art treatment, public concerns over live-tissue training and rigorous readiness skills requirements dictate the AF must ensure the best possible training is available to

AF medics caring for our injured military. This focus area is concerned with ensuring the best platforms, right approaches and most effective training tools and techniques are available to our medical personnel.

C.5.6 Task 5 – En Route Care (EC) Thrust Area

En route care seeks to enhance the Air Force Medical Service (AFMS) ability to rapidly but safely transport patients from point of injury to definitive care while reducing footprint and variability and improving efficiency. AFMS seeks to maximize technological advancements and groundbreaking clinical research to match care during transport with state of the art ground medicine throughout the continuum. EC Thrust

Area focus is on continuum of care during transport of patients from point of injury to point of definitive care.

Task 5 consists of the following sub-tasks:

C.5.6.1 Physiological Effects of Aeromedical Evacuation:

● Deliverables will be determined by product at the time of project execution.

C.5.6.2 En route Trauma and Resuscitative Care:

● Deliverables will be determined by product at the time of project execution.

C.5.6.3 En route Patient Safety:

● Contractor expected to provide:

o Research that addresses knowledge gaps during patient transport and staging.

o Research/technology development on non-invasive and specific methods for assessing trauma resuscitation and timing of interventions and transport.

o Clinical research to complement critical care and routine patient transport technology development.

C.5.7 Task 6 – General Support Services

Task 6 consists of the following sub-tasks:

C.5.7.1 Medical Clinical/Clinical Laboratory Support Services including:

● Providing medical judgement, diagnosis, or specific medical treatments.

● Hyperbaric medicine, dental, aeromedical and occupational medicine examinations.

● Clinical research studies and clinical medical support.

● Provision of psychiatric/psychological examinations, interviews, diagnoses and execution of treatment remedies.

C.5.7.2 Management Support Services including:

● Data entry and integration of information into required reports, generation and maintenance of files, forms and establishment of file plans.

● Correspondence and mail preparation and processing.

● Generating/coordinating text, graphics, tables, charts, photographs, and conceptual/geographic/electronic artwork.

● Curriculum development, coordination, and approval process.

● Financial oversight, coordination on execution, and provide status of fund updates for training, travel, supplies, technical programs and reimbursable projects.

C.5.7.3 Professional Support Services including:

● Providing support, assistance, advice or training for efficient and effective management and operation of the designated project/task.

● Programmatic planning of manpower and resources.

● Corporate business development and financial support.

● Development, execution, and analysis of course instruction.

● Scheduling of activities and meeting milestones.

● Outlining contractor activities.

● Forecasting and making recommendation of funding changes, interim status, and overall results.

● Independent review and assessment of R&D contract cost, schedule and performance.

C.5.7.4 Laboratory support services including:

● Possessing and maintaining appropriate certification credentials that qualify the individual to perform specified functions or practice specified medical skills.

● Receiving, preparing, and analyzing specimens.

● Utilizing equipment for medical and/or clinical research testing and analysis.

C.5.7.5 Technical support services including:

● Supporting indirect operational services.

● Assisting in medical readiness processes such as medical training oversight, conducting medical readiness training, and preparing medical deployment requirements.

● Assisting logistics and supply to include Defense Medical Logistics Standard Support (DMLSS) knowledge, Equipment Review Authorizations Activity (ERAA) preparation and coordination, and direct customer support/service on logistical processes.

● Providing information management/information technology (IM/IT) support to include customer support/service in areas of computer, audiovisual, graphic, video-telecommunications (VTC), and IM/IT processes within the 711 HPW.

● Assisting wing facility to include coordination and collaboration on all facility requirement and process within the 711 HPW.

● Assisting wing security.

● Equipment maintenance support.

C.5.7.6 Studies, analyses and evaluations support services including:

● Assistance organizing studies, analytical assessments, and evaluations.

● Conducting technical studies, analysis and evaluations.

● Implementation of plans and development of executive and project level roadmaps and portfolios.

● Recommending solutions to identified problems.

C.5.7.7 Engineering and technical support services including:

● Providing support to offer advice, assistance, and training required to maintain and operate infrastructure.

● Organizational consulting report.

● Participating in testing activities.

● Operations and maintenance of experimental facilities.

● Operations and maintenance of centrifuge and Research Altitude Chambers (RAC).

● Laboratory and systems analyses development and evaluations.

● Statistical analysis data interpretation.

● Scientific literature research and review.

● Preparation of briefings and reports.

● Systems analyses and troubleshooting.

● Technical writing.

● Assisting in development and preparation of planning analysis and documentation.

● Inspect and evaluate laboratory equipment, materials, and practices for adherence to all Air

Force, Federal, State and local Environmental, Safety, and Occupational Health (ESOH) standards and regulations.

C.5.8 Task 7 – Program Management:

● The contractor shall recruit/replace/substitute staff/qualified personnel to fulfill the duties, qualifications, and requirements in the PWS.

● The contractor shall provide a stable workforce in order to ensure continuity until contract completion. In the event of sickness, leave, and voluntary or involuntary termination from employment, the impact to the Government shall be minimal and position vacancies shall not exceed 10 business days. Contractor shall notify the CO and COR of any projected vacancies exceeding 10 business days.

● The contractor shall comply with the requirements of the PWS and in Wright Patterson Air

Force Base regulations and various other locations supporting the mission concerning conduct of employees as referenced herein.

● Contractor shall manage the workforce and workload and shall maintain continual qualifications without Government involvement.

● Contractor shall resolve all validated performance issues identified by the Government within the timeframes specified in the PWS.

● Contractor will provide human resource management and will record arrival or departure times, report absenteeism, sign payroll timesheets or complete corporate appraisal reports for contracted personnel. Contractor shall have an internal management process in place to confirm hours worked and conduct performance assessments for all contracted employees.

● Contractor shall monitor, track and manage all expenses, to include billable hours for labor contract line item numbers (CLINS) and Travel/ODC CLINS.

C.6.0 Risk Mitigation Plan – Comprehensive for All Tasks

Risk Mitigation Plan (RMP) - No later than 15 days after contract award, the contractor shall provide a risk mitigation plan to address the risk covered across all tasks listed within Section C.4.0. and C.5.0. The contractor shall define the risk management methodology to be used, identify the risk assumptions, and establish the roles and responsibilities, and the timeframes upon award of the contract. Also define the risk communications, and risk tracking process. The Contractor must control risks of the services and deliverables provided in support of this task; the Contractor must maintain substantiating evidence that services conform to contract RMP and furnish such information to the government if requested.

C.7.0 Quality Control Plan (QCP) – Comprehensive for All Tasks

The Contractor shall develop a comprehensive Quality Control Plan (QCP) covering all tasks, providing methods of surveillance the Contractor will use to monitor performance under this basic contract. The

QCP shall be developed using the Contractor’s internal quality control methods and shall address surveillance of all deliverables under the terms of this contract. The Contractor shall develop and implement procedures to identify, prevent and ensure non-recurrence of defective and/or, non-conforming services. The Contractor shall develop and maintain a quality process to ensure services are performed in accordance with commonly accepted commercial practices and existing quality control systems throughout the life of the order. The Contractor may modify the minimum standards of performance compliance as appropriate to improve the required compliance level; however, the compliance levels may not be adjusted down.

The QCP shall be revised, updated and submitted to the CO and COR within fifteen (15) days after contract award for approval. The Contractor must control the quality of the services and deliverables provided in support of this task; the Contractor must maintain substantiating evidence that services conform to contract quality requirements and furnish such information to the government if requested.

C.8.0 Estimated Level of Effort (LOE)

Refer to the Pricing Spreadsheet (Attachment 10) for the level of effort estimate. This is only an estimate but will be used for evaluation purposes.

Note: Refer to Attachment 6 (Labor Category Position Description and Key Personnel), which relates to the labor categories and descriptions required to satisfy this comprehensive requirement.

The labor rates proposed and awarded under the terms of this contract shall be applicable to work performed anywhere in the contiguous US for all labor categories that are determined to be professional in nature. For non-professional labor categories for which the Service Contract Labor Standards (SCLS) apply, the contractor shall identify these labor categories pay at least the wages required by the prevailing wage rates and comply with all labor standards as applicable.

C.8.1 Key Personnel

The following labor categories are considered Key Personnel:

● Bio-Scientific and Statistical Subject Matter Expertise

● Clinical Research Nurse (RN I)

● Epidemiology Data Analyst

● Nurse Practitioner

NOTE: Resumes for Key Personnel must clearly delineate how each person meets what is outlined within

PWS Attachment 6 (Labor Category Position Description and Key Personnel).

Labor shall be performed at the rate agreed to at the time of contract award for the applicable period of performance. All awarded rates shall be fully-burdened labor rates, and the rates shall not be subject to

“finalized audited rates” by the Defense Contract Management Agency (DCMA) or other third party auditor.

If personnel have to obtain a background check prior to being able to perform under the terms of the order, the vendor is not permitted to bill until the contractor’s personnel are fully able to perform the requirements of the PWS.

C.8.1.1. Total Key Personnel

Change 24. The identified key personnel include only one position for each the following labor categories for a total of four key personnel: LCAT Name: Bio-Scientific and Statistical Subject Matter Expert. Number of Personnel (1); Clinical Research Nurse (RN 1) Number of Personnel (1); LCAT Name: Epidemiology

Data Analyst. Number of Personnel (1); LCAT Name: Nurse Practitioner. Number of Personnel (1).

C.9.0 Estimated Travel

Travel shall be treated as a reimbursable item and will be administered in accordance with Federal Travel Regulation (FTR). Contractor employees will be required to travel for the purpose of program reviews, training support, etc.

C.9.1 Approval for Travel - All travel shall be scheduled, to the greatest extent possible, at least two weeks in advance, and shall be approved by the COR prior to making travel reservations. All travel shall be coordinated and approved on Consent to Purchase (CTP) form. If travel is not approved in advance of the travel taking place, the Government will not reimburse for the travel expenses. Emergency requirements shall be defined/initiated and approved/validated by the COR. All travel shall be in accordance with the FTR and all lodging shall be at or below allowable, published lodging rates for the respective locality.

● The Contractor is required to ensure good stewardship of travel funds, and shall seek rates lower than the approved FTR lodging rates whenever possible.

● The Contractor shall locate and utilize the airport that will provide the lowest total cost of travel possible.

● The Contractor is required to submit a cost benefit analysis to support any travel prior to incurring travel expenses to the COR [this documentation shall also be submitted with the Contractor’s invoice].

● Excessive travel costs shall not be allowed.

In the event lodging is not available at the published lodging rates (or below the published rates), the Contractor shall request approval by submitting a complete explanation of the circumstances in advance of the travel dates, and the backup documentation from at least three hotels in the TDY location to substantiate the unavailability claim form, directly to the CO. Travel charges over and above allowable lodging rates and/or per diem without proper approval and support documentation from three lodging facilities, shall be paid at the expense of the Contractor. The Contractor shall make every effort to save Government dollars, to stay at hotels that are below the Government rate, negotiate the lowest airfares and car rentals, and shall plan travel in as far advance as possible.

C.9.2 Travel Requirements

In support of this contract, contractor personnel may be required to travel (CONUS and OCONUS) to various locations and work in excess of 40 hours/week on occasion. Infrequent travel to hazardous duty locations may also be required

After travel is incurred, documentation/receipts shall be sent to the COR (with the invoice submittals). NO

PAYMENT WILL BE MADE WITHOUT DOCUMENTATION and RECEIPTS. The COR and GSA CO / PM shall approve travel (in writing on the CTP form – Attachment 4) based on the applicable micro-purchase threshold.

During performance, only actual travel costs are reimbursed in accordance with the FTR and other applicable regulations, subject to the Government’s approval. On the first and last day of approved contractor personnel travel, the rate is 75 percent of the appropriate Meals and Incidental Expenses (M&IE) rate regardless of the departure and return time.

*** NOTE: Profit, G&A and Overhead indirect costs shall not be applied to travel costs for any reason.

Travel shall be a direct reimbursed expense, at cost. Costs above and beyond the approved rates, and costs that are unreasonable, shall not be reimbursed by the Government. ***

NOTE: The Government reserves the right to audit, thus; the Contractor shall keep on file all backup support documentation for travel, materials, and ODC procurements (travel) made on behalf of the Government under the terms of the contract.

C.9.3 Trip Reports For all travel required under the terms of this PWS, the Contractor shall submit (as an official deliverable) Trip Reports five working days after completion of a trip for all long distance travel and for local travel.

The Trip Report shall include the following information:

● Personnel traveled,

● Dates of travel, Destination(s),

● Purpose of Trip, o Contract effort supported and contract ID number o Government Agency supported (if applicable) o Explain the benefits of the travel to the Government.

● Actual Trip Costs, Approval Authority (i.e. CTP),

● Summary of events.

NOTE: Trip reports shall be uploaded into ITSS once a month when invoices are uploaded.

C.9.4 T&M After award, the contractor shall not utilize and subsequently bill above each awarded labor category ceiling without a written modification from the Contracting Officer. Within those labor category ceiling amounts, the contractor shall not independently decide which labor categories may be utilized and subsequently billed in support of the client’s requirements without prior written approval from the client COR and GSA COR.

The contractor understands that neither the funded amount, ceiling value, or the hours on the T&M, are a guarantee to the contractor. The total contract ceiling value may not be exceeded without a written modification from the Contracting Officer. The Contractor shall notify the Contracting Officer and GSA

Project Manager (GSA COR), in writing, whenever it has reason to believe that Labor Category hour has met 75% of the proposed hours per Option Period/CLIN.

C.9.4.1 Productive Labor Hours

For purposes of this order and specific services, the Government will pay only for productive direct labor hours, which are those hours expended by contractor personnel in performing work under the scope of this contract. This does not include sick leave, vacation leave, holidays, jury duty, military leave, or any other kind of administrative leave.

C.9.4.2 Project Tracking Spreadsheet (Attachment 1) –

The contractor shall keep track of work for each individual project via the Project Tracking Spreadsheet.

The contractor shall submit the Project Tracking Spreadsheet with the monthly invoice via ITSS. The

Project Tracking Spreadsheet shall be a separate document and not embedded in the invoice. The contractor may also be asked to provide the spreadsheet directly to the government COR/GSA via email at any time prior to invoice delivery.

The document will be uploaded in ITSS, and the contractor shall notify the client COR that the information has been uploaded. The overall spreadsheet file/report shall be cumulative over the life of the contract and shall include all work under the contract as of the date of submission of the deliverable, monthly. The spreadsheet shall include the data as specified in Attachment 1. The required level of quality shall be 100% complete and accurate spreadsheet, with all work listed on the document that has been awarded, broken out by fiscal year, and individual project.

C.9.4.2. Proposed Staffing and Approval Upon Initial Contract Award

Prior to assigning any contractor employees to a labor category to perform work under the terms and conditions of this requirement/PWS, the contractor must obtain the written approval of the client COR and

GSA COR.

At the discretion of the Government (and upon Government request) –

● Prior to commencing work on this contract, the Contractor shall receive approval of the proposed personnel and staffing level for this contract. The Contractor shall ensure the proposed personnel meet all qualifications and certifications necessary to perform the required tasks. The Contractor shall ensure the proposed personnel are available to begin upon contract start date.

C.9.4.3. Proposed staffing for New Hires after Contact Award.

At the discretion of the Government (and upon Government request) –

● If, during performance of this contract, a vacancy of an existing position occurs, existing staff need to be replaced, or additional staff need to be hired in support of additional operations, the contractor shall submit a formal written request to the COR and GSA providing detailed information regarding the proposed individual that is being recommended to fill the vacancy. The information provided at a minimum should include the recommended individual’s background, education, experience, certifications, any circumstances requiring any kind of waivers, and why this individual would be a good fit to fill the vacancy. Prior to the recommended individual providing work towards this contract, the Contractor shall receive written approval from the COR.

C.9.4.4. Penalty for Vacant Positions in Excess of 30 Days The contractor shall identify, track, update, and report on any position that becomes vacant and provide that information in the monthly report submittal. After a position has been vacant for more than 30 days, the Contractor shall be subject to a penalty of 20% of the daily wage rate for that vacant position during the days that vacant position should have been providing work, during a normal work week.

Once the contractor has identified a potential candidate who meets the qualifications of the position, the Contractor shall submit a resume detailing the education, certifications, experience and any other relevant information of the proposed candidate to the COR.

Once the COR has received the resume, the COR has seven (7) calendar days to determine if the proposed candidate will be acceptable to fulfill the vacant position. During this review time, the contractor will not be subject to a penalty.

The penalty will resume and be enforced again the day after the COR accepts the position until the official start date.

If it is determined that the proposed candidate meets the qualifications, but is not acceptable, then the Contractor is granted an additional seven (7) calendar days without penalty to propose a replacement candidate who meets the qualifications of the vacant position.

The penalty will be calculated in the following manner based on the given example of a vacancy of 39 days, and five days after the acceptance by the COR until the official start date of the accepted candidate.

Example Provided:

● Position has been vacant for 39 days. The Contractor submits a proposed candidate resume on the 39th day. This results in a penalty of 20% for only the days that work should have been provided from Day 31 to Day 39. During the time the COR reviews the resume, and the penalty is paused and not applied. Once the COR accepts the resume of the proposed candidate and notifies the contractor of acceptance, the penalty becomes active again and will be applied until the proposed candidate reports for duty on the official start date. For example, once the COR accepts the resume and notifies the contractor, the penalty becomes active. If the candidate cannot start until 5 working days after the COR accepts the proposed candidate then the penalty would be applied to the five days after the acceptance by the COR until the official report date. The penalty for those five days would only be applied to each of the normal working days, not holidays, not weekends.

C.10.0 Reserved

C.11.0 Materials/Hardware/ODCs and Ancillary Supplies and/or Services

The Contractor will be required to provide materials/hardware/ODCs or ancillary supplies and/or services for the purpose of executing contract requirements. The Contractor will need to use their own work force to procure any necessary materials/hardware/ODCs required for the performance of the contract.

Before an ODC may be included in the awarded contract, the ODC must satisfy the criteria expressed in the scope of the contract and be critical to the scope of the services being provided. ODCs may be procured via subcontracting efforts, which are managed by the prime contractor.

When purchasing ODCs, the Contractor must use the CTP form to obtain prior authorization and approval before purchasing the ODCs.

A material handling fee will not be included. Direct labor hours used to purchase ODCs will be reimbursed for the labor category conducting the purchases.

Shipping and transportation cost of the material will be directly reimbursed and must be itemized and labeled on the CTP form prior to purchase of the ODC.

C.12.0 Hardware - Not Applicable

C.13.0 Warranty Service - Not Applicable

C.14.0 Post Award Orientation Conference

The contractor shall participate in a post-award conference for the purposes of making introductions, coordinating security requirements, discussing schedules, prioritizing PWS requirements, and providing details regarding the transition of work requirements from the incumbent contractor.

The contractor shall commence work on the first day of the period of performance. The Post Award

Orientation Conference shall occur within 10 business days of contract award.

C.15.0 Deliverables/Milestones

This contract is a performance based contract with measurable standards in terms of quality and timeliness of deliverables and compliances. See Table 1 RFP list of deliverables below. Deliverables shall be provided to the Government COR. Deliverables shall be delivered in electronic medium and/or via ITSS accompanied by one (1) original hard copy using Microsoft Office, Excel, Project and/or Adobe format unless otherwise agreed upon.

Table 1 RFP List of Deliverables

Required Deliverables/Reports

FORMAT

Frequency / Due Date

Submit To

Performance Threshold

Risk Mitigation Plan

(RMP)

Microsoft Word or PDF via

ITSS

Final copy Due 15 days post award. Thereafter, submit a new RMP if any changes are made.

GSA,

COR and Technical

POC

100% Compliance/On-time delivery.

Quality Control Plan

(QCP)

Microsoft Word or PDF via

ITSS

Final copy Due 15 days post award. Thereafter, submit a new QCP if any changes are made.

GSA,

COR and Technical

POC

100% Compliance/On-time delivery.

Project Tracking Spreadsheet (PWS Attachment 1)

Microsoft Excel via

ITSS

Monthly with invoice

GSA,

COR and Technical

POC

100% Compliance/On-time delivery.

Proposed Initial Personnel and Staffing Plan

Microsoft Word Doc Submitted After contract award.

GSA,

COR and Technical

POC

100% Compliance/On-time delivery.

New Employee Hire Request with Resume

Microsoft Word Doc

Upon New Employee Hire Request Submission

GSA,

COR and Technical

POC

100% Compliance/On-time delivery.

Trip Report Email/P Once a month when COR/ 95% of the time submitted

Note: The method of surveillance is disclosed/included in the attached Quality Assurance Surveillance Plan and its supplement (Attachment 3.1 and 3.2) .

[END of SECTION C]

DF

invoices are uploaded to ITSS.

GSA PM timely/accurately.

Final Invoice

Submit through

ITSS

Due 30 days from completion.

Interested parties through

ITSS

100% Timely/Accurate Delivery

Release of Claims ITSS and Email

Due within fifteen (15) calendar days of final payment.

PM, COR

and CO

100% Timely/Accurate Delivery

– SECTION D –

PACKAGING AND MARKING

D1.0 Packaging and Marking

Reserved.

[END OF SECTION D]

- SECTION E -

INSPECTON AND ACCEPTANCE

E.1.0 Inspection Term

E.2.0 Inspection and Acceptance of Services

All reports and task deliverables shall be inspected, tested (where applicable), reviewed, and accepted by the Government within a reasonable period of time in accordance with FAR 52.246-6 and the acceptance criteria set forth in the QASP (Attachment 3.1 and 3.2) and its supplement..

Inspection -- Time-and-Material and Labor-Hour (May 2001)

(a) Definitions. As used in this clause--

“Contractor’s managerial personnel” means any of the Contractor’s directors, officers, managers, superintendents, or equivalent representatives who have supervision or direction of --

(1) All or substantially all of the Contractor’s business;

(2) All or substantially all of the Contractor’s operation at any one plant or separate location where the contract is being performed; or

(3) A separate and complete major industrial operation connected with the performance of this contract.

“Materials” includes data when the contract does not include the Warranty of Data clause.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the material, fabricating methods, work, and services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all materials furnished and services performed under this contract, to the extent practicable at all places and times, including the period of performance, and in any event before acceptance. The Government may also inspect the plant or plants of the Contractor or any subcontractor engaged in contract performance. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspection or test on the premises of the Contractor or a subcontractor, the

Contractor shall furnish and shall require subcontractors to furnish all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) Unless otherwise specified in the contract, the Government shall accept or reject services and materials at the place of delivery as promptly as practicable after delivery, and they shall be presumed accepted 60 days after the date of delivery, unless accepted earlier.

(f) At any time during contract performance, but not later than 6 months (or such other time as may be specified in the contract) after acceptance of the services or materials last delivered under this contract, the

Government may require the Contractor to replace or correct services or materials that at time of delivery failed to meet contract requirements. Except as otherwise specified in paragraph (h) of this clause, the cost of replacement or correction shall be determined under the Payments Under Time-and-Materials and

Labor-Hour Contracts clause, but the “hourly rate” for labor hours incurred in the replacement or correction shall be reduced to exclude that portion of the rate attributable to profit. The Contractor shall not tender for acceptance materials and services required to be replaced or corrected without disclosing the former requirement for replacement or correction, and, when required, shall disclose the corrective action taken.

(g)

(1) If the Contractor fails to proceed with reasonable promptness to perform required replacement or correction, and if the replacement or correction can be performed within the ceiling price (or the ceiling price as increased by the Government), the Government may --

(i) By contract or otherwise, perform the replacement or correction, charge to the Contractor any increased cost, or deduct such increased cost from any amounts paid or due under this contract; or

(ii) Terminate this contract for default.

(2) Failure to agree to the amount of increased cost to be charged to the Contractor shall be a dispute.

(h) Notwithstanding paragraphs (f) and (g) above, the Government may at any time require the Contractor to remedy by correction or replacement, without cost to the Government, any failure by the Contractor to comply with the requirements of this contract, if the failure is due to --

(1) Fraud, lack of good faith, or willful misconduct on the part of the Contractor’s managerial personnel; or

(2) The conduct of one or more of the Contractor’s employees selected or retained by the Contractor after any of the Contractor’s managerial personnel has reasonable grounds to believe that the employee is habitually careless or unqualified.

(i) This clause applies in the same manner and to the same extent to corrected or replacement materials or services as to materials and services originally delivered under this contract.

(j) The Contractor has no obligation or liability under this contract to correct or replace materials and services that at time of delivery do not meet contract requirements, except as provided in this clause or as may be otherwise specified in the contract.

(k) Unless otherwise specified in the contract, the Contractor’s obligation to correct or replace Government-furnished property shall be governed by the clause pertaining to Government property.

(End of Clause)

[END OF SECTION E]

– SECTION F –

DELIVERIES AND PERFORMANCE

F.1.1 Place of Performance/Hours of Performance Work should be performed at the Contractor’s / Government’s facilities San Antonio, Texas. Any variation from this will be determined by the program/project specific needs.

F.1.2 Normal operating hours are 0630-1630, Monday-Friday, unless otherwise…

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