Attachment 1 - PWS - Postdoctoral Researcher.pdf

PERFORMANCE WORK STATEMENT (PWS)

Title: Postdoctoral Research Support Services

Requiring Activity Name: Madigan Army Medical Center (MAMC), Department of Clinical Investigations, Joint Base Lewis McChord, WA

1. INTRODUCTION: This is a New Award for NON-PERSONAL services to provide postdoctoral research support to the investigator in the development of stem cell biologic therapies to promote tissue regeneration and function in neuromusculoskelatal trauma which is a three year program.

2. PURPOSE AND BACKGROUND: The development of a therapeutic strategy of combining the following:

mesenchymal stem cells (MSC) , IL10-MSCs, Granulocyte-colony stimulating factor (G-CSF), Dihexa, Platelet Rich Plasma (PRP), and or Low Energy Shock Wave Therapy (LESWT), and delivering locally to graft and/or systemically to promote tissue regeneration, immunomodulation and functional recovery in Vascularized Composite Allograft (VCA) model, and have the potential to mitigate general neuromusculoskeletal injuries and improve quality of life and military readiness of injured military personnel/soldiers. The potential findings from this study could have a significant impact on medical readiness throughout the Armed Forces. Presentation and Publication will diminish significantly and funding to continue ground breaking clinical and battlefield medicine will be detrimentally affected.

3. SCOPE: Contractor shall perform research support to Principle Investigators, Co Investigators, and Research staff in the coordination of the study including surgical experiments, data collection, and reporting.

4. PERIOD OF PEFORMANCE:

Base Period: 09/15/2021 - 09/14/ 2022 Option Period 1: 9/15/2022 – 9/14/2023

5. WORK LOCATION AND SCHEDULE: Research Support Services shall be on site in the Department of Clinical Investigation, Madigan Army Medical Center (MAMC).

5.1. Telecommuting: Not applicable, due to the nature of the work.

5.2. Hours of Performance.

0730 to 1600, Monday through Friday

5.3 Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR and Contract Manager will immediately make contact to share the status of any Contractor personnel who were affected by the emergency. Prior to commencing work at the contractor location, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

5.4 Federal Holidays

The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed.

The following are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

56.5 Post Closure

All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the mission essential contractor personnel shall report for work.

6. SPECIFIC TASKS:

6.1. The Contractor shall perform the following research support services.

6.1.1. Provide compliance with regulatory affairs, data collection, and records management between Madigan Principal Investigators, Sub-investigators and Scientists performing pre-clinical research.

6.1.2. Perform animal surgical experiments such as vascularized composite allotransplants (limb transplants) and other surgical procedures in rats, sensory (foot withdrawal reflex test) and motor function (walking track) analysis on rats, Laser Doppler analysis for vascularization, X-ray imaging for bone fusion, shock wave therapy, and blood/tissue biopsy sampling for analysis.

6.1.3. Prepare and administer stem cells, drugs and growth factors to animals intravenously, subcutaneously, intraperitoneally or locally.

6.1.4. Euthanize/sacrifice animals and harvest tissues for cellular/molecular analysis.

6.1.5. Assist and perform laboratory experiments with flexibility to learn new techniques/procedures/tasks as needed for the project including but not limited to the following:

Cellular/molecular analysis (MSC isolation Mixed lymphocyte reactions Flow cytometry

Chimerism Polymerase chain reaction PCR testing Western Blots Multiplex assays RNA isolation/gene arrays Immunohistochemistry/immunofluorescence Tissue sectioning Histology Imaging Platelet rich plasma isolation

6.1.6. Store tissue samples and ship tissue samples to collaborators, communicate/interact/visit as needed and collect data from collaborators.

6.1.7. Collect, record, and analyze research data; keep a detailed notebook summarizing experiments and recording research data; maintain computer database of research data; perform statistical analysis, tabulate and display data for presentation in research conferences, and for manuscript preparation; use graphics and statistical software to analyze and present data.

6.1.8. Assist with searching pertinent scientific literature as needed, preparation of manuscripts, animal use protocols and progress reports and/or participate in scientific/professional meetings

6.1.9. Interact/communicate with project collaborators as needed to achieve the goals of the research project(s).

6.1.10. Assist Principal Investigator with surgical/research training of medical residents/students/staff /technicians as needed at the MTF attending and participating in scientific/professional/lab meetings as needed.

6.2. The Contractor shall report scientific/project/other matters to the Principal Investigator on a daily basis.

6.3. The Contractor shall report an incident of chemical safety and bio-hazard conditions to the TPOC and COR within 24 hours.

6.4. The contractor shall provide a monthly report detailing all work, including the subcontractor’s work (if applicable), and where there is critical or significant data related to the provided support. The report shall include a detailed list of all hours worked, workload accomplished, to include but not limited to, report of scheduled, completed, and outstanding tasks monthly. (Deliverable 1)

7. QUALIFICATION AND REPLACEMENT:

7.1. Education.

Ph.D. in a basic or health science USA or foreign equivalent OR MD degree USA or foreign equivalent

7.2. Experience.

Shall have a minimum of at least 1 year experience as a Postdoctoral Researcher and 1-3 years of experience working in a research environment performing tasks outlined in section 7.0.

Shall have expanded technical writing and math skills; knowledge of medical terminology; record keeping practices specific to pre-clinical animal research.

Shall possess/maintain expertise in automated processes and procedures of automated information systems, to include an understanding of Microsoft Outlook, Word, Power Point, Excel and Internet Explorer.

7.3. Contractor Personnel Performance/Replacement

Substitutions of proposed personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement shall have qualifications equal to or greater than the individuals proposed. Substitution or replacement personnel shall be replaced within 30 days.

8. PERFORMANCE REQUIEMENTS: Quality Assurance Surveillance Plans (QASP). The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor.

The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

PWS

Ref.

Performance Objective

Performance Standard

Acceptable Quality Level

Performance Measurement

Incentive

1 6.1.2. Perform limb transplant surgery on rats

Contract requirement met with few minor and no significant problems encountered

Contractor’s technical performance meets all contract requirements.

Periodic Inspection

Past Performance

2 6.1.3. Administer stem cells and growth factors to animals

Contract requirement met with few minor and no significant problems encountered

Contractor’s technical performance meets all contract requirements

Periodic Inspection

Past Performance

3 6.1.4. Sacrifice animals and harvest tissue for cellular /biological analysis

Contract requirement met with few minor and no significant problems encountered

Contractor’s technical performance meets all contract requirements

Periodic Inspection

Past Performance

6.1.5. Assist in laboratory

experiments

Contract requirement met with few minor and no significant problems encountered

Contractor’s technical performance meets all contract requirements

Periodic Inspection

Past Performance

6.1.6. Store and ship tissue

samples to collaborators

Contract requirement met with no significant problems encountered

Contractor’s technical performance meets all contract requirements

Periodic Inspection

Past Performance

6.1.7. Perform Statistical

analysis

Contract requirement met with no significant problems encountered

Contractor’s technical performance meets all contract requirements

6.1.8. Assist the PI as

needed in lab animal work including literature search, manuscript prep, Contractor requirement met with no significant problems encountered

Contractor’s technical performance meets all contract requirements

9. ADMINISTRATION

9.1. Safety. The Contractor shall ensure to comply with all installation safety regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal. Copies of these regulations are on file in the medical activity safety office or may be obtained through the TPOC.

9.2. Contractor Representation.

9.2.1. The Contractor shall designate a representative for this contract. This representative may be employed under another contract/task order with the Contractor at the same MTF. At least ten working days prior to performance start date, the Contractor shall provide in writing to the TPOC, Contractor representative contact information. Changes in the contract representative, at any time after contract commencement, shall be in writing to the TPOC at least five working days prior to the change. If at any time there is only one individual working in the facility for the Contractor, someone other than that individual must be designated as the company representative and this representative may be off-site.

9.2.2. The Contractor's representative shall, at no additional cost, meet with the TPOC when requested by the TPOC to discuss any problems that the Contractor's personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor's performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

9.2.3. The Contractor shall provide points of contact (POC) information for administration of the contract during normal business hours and after normal business hours. The POC for other than normal business hours will be contacted only in the event of emergencies. Accordingly, the named individual(s) shall possess sufficient corporate authority to effectively deal with emergency situations and the telephone number provided shall be functioning at all times other than normal business hours. If there are different POCs for different conditions, such as weekdays, weekends, holidays, clearly provide such information.

9.2.4. Quality Assessment and Improvement. Those actions taken by the Government to check services to determine if they meet the requirements of the Joint Commission, U.S. Army Medical Command, quality assurance and risk management program, and ensure that the Contractor and its HCPs comply with the terms and conditions of the contract.

9.2.5. Quality Assurance Surveillance Plans (QASP). The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

10. GOVERNMENT PROPERTY.

10.1. The Government will provide use of all available MTFs and support services, materials, publications and forms, equipment, and specialty clothing required for contract performance (except as designated in the contract). The Contractor shall ensure that its Contractor Representative keep Government-furnished supplies, equipment, and work areas in a safe, orderly and clean condition. The Contractor shall notify the Government whenever maintenance of equipment is required. Personal long distance calls are not authorized and the cost of all personal long distance calls made will be deducted from the Contractor’s invoice.

10.1.1. Government Furnished Property includes: (MAMC) network laptops and docking stations, and mobile devices for support personnel onsite and laptops and mobile devices for support personnel offsite. Government provided laptops will be profiled for (MAMC) network access, will be CAC enabled, and will have VPN access. All GFP will be tracked and in put in Procurement Integrated Enterprise Environment (PIEE) Web link: https://wawf.eb.mil/piee-landing.

10.1.2. Return of Government Furnished Equipment

The contractor shall return CACs, (MAMC) Picture ID Card, keys, and key fobs for employees no longer supporting the contract and/or on contract expiration. Specifically, the contractor shall, within two business days of employee no longer supporting the contract and/or on contract expiration, return:

a) CACs to (MAMC) Security office;

b) (MAMC) Picture ID Card to (MAMC) Security office;

c) Keys to the (MAMC) key custodian; and

d) Key Fobs to the (MAMC) key custodian.

If the contractor does not returned items a-d within 2 business days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

10.2. The Government will provide an MTF identification card and vehicle access stickers/passes. The Contractor shall ensure its Contractor Representative comply with MTF policy regarding the identification cards and stickers/passes. The Contractor Representative shall coordinate with the TPOC in obtaining an identification badge and vehicle decal. The Contractor Representative shall wear the identification badge in accordance with MTF policy. The Contractor Representative shall surrender both identification badge and vehicle decal to the TPOC on his/her last contracted day of duty at the MTF.

10.3. Any space or equipment used by the Contractor Representative in performance of this contract may be used by the Government for other purposes during his/her absence. Items of clothing, personal effects, or equipment may not be able to be secured at all locations. The Government will not incur any liability for theft, damage to, or loss of such personal items.

10.4. Emergency healthcare for Contractor Representative. The MTF will provide emergency healthcare for injuries or life threatening medical emergencies occurring while on duty. The Contractor shall reimburse the Government for such services as billed by the MTF, unless the Contractor Representative is otherwise authorized to receive such services at no cost (e.g., is retired military or is a military dependent).

11. DELIVERABLES. The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

6.4. Deliverable 1 Monthly Report Last day of each

month

12. ADDITIONAL REQUIREMENTS.

12.1. The Contractor shall ensure that all Contractor Representatives comply with the local installation requirements for vehicle registration and operation on the military facility. Any vehicle operated by the Contractor or its employees in performance of this contract must have the minimum liability coverage required by the state in which the performance is located.

12.2. The Contractor shall ensure that its Contractor Representative comply with installation and MTF personnel identification and access requirements. The Contractor is responsible for absences of Contractor Representative due to expired identification and access documents.

12.3. The Contractor shall be responsible for any keys issued by the Government to Contractor Representative for use in the MTF. The keys shall not be duplicated. The Contractor shall be financially responsible for the replacement of any lost or duplicated keys and any associated locks. Lost or duplicated keys and/or locks shall be reported to the issuing party, Department Chief, or TPOC immediately upon recognition of the loss or duplication. No unauthorized personnel shall be allowed entry into the locked area. The Contractor shall ensure that its Contractor Representative lock all areas for which they possess a key when they are not using the area and at the close of the work period.

12.4. Safeguarding Material. The Contractor shall be responsible for safeguarding all Government property provided for Contractor use. The Contractor shall safeguard information of a confidential or sensitive nature.

Neither the Contractor nor any Contractor Representative shall disclose or cause to be disseminated any information concerning the operation of the MTF that could result in or increase the likelihood of the possibility of breach of security or interrupt the continuity of operations or which breach the requirements of the Federal Privacy Act of 1974. However, the Contractor may be required to provide testimony or deposition in lawsuits or other administrative, civil, or criminal proceedings.

12.5. Antiterrorism/Operations Security (AT/OPSEC) Requirements.

12.5.1. Antiterrorism (AT) Level I Training. This text is for Contractor Representatives with an area of performance within an Army controlled installation, facility or area. All Contractor Representatives, to include subcontractor employees, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after starting performance under this contract or effective date of incorporation of this requirement into the contract, whichever is applicable. The Contractor shall submit certificates of completion for each affected Contractor Representative and subcontractor employee, to the TPOC or to the KO within 30 calendar days after completion of training by all Contractor and subcontractor personnel. AT level I awareness training is available at the following website: https://atlevel1.dtic.mil/at.

12.5.2. Access and General Protection/Security Policy and Procedures. This standard language text is for Contractor Representatives with an area of performance within an Army controlled installation, facility or area. Contractor and all associated subcontractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The Contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements as directed by DOD, Headquarter Department of the Army (HQDA) and/or local policy. In addition to the changes otherwise authorized by clause 52.212-4, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

12.5.2.1. For Contractor Representatives requiring Common Access Card (CAC). Before CAC issuance, the Contractor Representative requires, at a minimum, a favorably adjudicated National

Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The Contractor Representative will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

12.5.2.2. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

12.5.3. iWATCH Training. This standard language is for Contractor Representatives with an area of performance within an Army controlled installation, facility or area. The Contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity Antiterrorism Officer (ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the TPOC. This training shall be completed within 30 calendar days of Contractor Representative starting performance and within 30 calendar days of new employees commencing performance with the results reported to the TPOC NLT 30 calendar days after contract award.

12.5.4. Contractor Representatives Who Require Access to Government Information Systems (IS). All Contractor Representatives with access to a government info system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services, and must successfully complete the DoD Information Assurance Awareness prior to access to the IS and then annually thereafter.

12.5.5. For Contracts that Require an OPSEC Standing Operating Procedure/Plan. The Contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer, per AR 530-1, Operations Security. This SOP/Plan will include the government's critical information, why it needs to be protected, where it is located, who is responsible for it, and how to protect it. In addition, the Contractor shall identify an individual who will be an OPSEC Coordinator. The Contractor will ensure this individual becomes OPSEC Level II certified per AR 530-1.

12.5.6. For Contracts that Require OPSEC Training. Per AR 530-1, Operations Security, new Contractor Representatives must complete Level I OPSEC training within 30 calendar days of their reporting for duty. All Contractor Representatives must complete annual OPSEC awareness training.

12.5.7. For Information assurance (IA)/information technology (IT) training. All Contractor Representatives and associated subcontractor Representatives must complete the DoD IA awareness training before issuance of network access and annually thereafter. All Contractor Representatives working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M and AR 25-2 within six months of employment.

12.5.8. AT Awareness Training for Contractor Representative Traveling Overseas. This standard language text required US based Contractor Representatives and associated sub-Contractor Representatives to make available and to receive government provided area of responsibility (AOR) specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander with the unit ATO being the local point of contact.

12.5.9. For Army Training Certification Tracking System (ATCTS) registration for Contractor Representatives who require access to government information systems. All Contractor Representatives with access to a government info system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services, and must successfully complete the DOD Information Assurance Awareness prior to access to the IS and then annually thereafter.

12.5.10. Threat Awareness Reporting Program. For all contractors with a security clearance. Per AR 381-12 Threat Awareness and Reporting Program (TARP), Contractor Representatives must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

ACRONYMS LIST

Acronym Definition

AFARS Army Federal Acquisition Regulation Supplement

AKO Army Knowledge Online

AOR Area Of Responsibility

AT OPSEC Antiterrorism and Operational Security

ATCTS Army Training Certification Tracking System

CAC Common Access Card

CFR Code of Federal Regulations

CONUS Continental United States

COR Contracting Officer Representative

DFARS Defense Federal Acquisition Regulation Supplement

DoD Department of Defense

EIT Electronic and Information Technology

FAR Federal Acquisition Regulation

FPCON Force Protection Condition

FSC Federal Supply Code

FSS Federal Supply Schedule

GFE Government Furnished Equipment

GFI Government Furnished Information

GSA General Services Administration

IA Information Assurance

ID Identification

IPT Integrated Product/Process Team

IT Information Technology

NAC National Agency Check

NACI National Agency Check with Inquiries

NCIC-III National Crime Information Center Interstate Identification Index

NLT No Later Than

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States

OPSEC Operational Security

PRS Performance Requirements Summary

PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan

QCP Quality Control Plan

SOP Standing Operating Procedure

TARP Threat Awareness and Reporting Program

U.S.C. United States Code

UIC Unit Identification Code

US United States

USAMRAA United States Army Medical Research Acquisitions Activity

WAWF Wide Area Work Flow