AAM-600 Aerospace Medical Research PWS_Rev D Jan 06 2021 (LS)(AT)(2).pdf

PERFORMANCE WORK STATEMENT

Civil Aerospace Medical Institute (CAMI) Aerospace Medical Research Division (AAM-600)

In support of

Aerospace Medical Research and

Technical Support Services

DRAFT

January 06, 2021

Contents

1.0 Introduction and Overview

1.2 Objectives

1.3 Scope of Work

2.0 References

3.0 Task Requirements and Performance Objectives

4.0 Deliverables

5.0 Period of Performance

6.0 Place of Performance

6.1 Security

6.2 Badges

6.3 Government Supplied Facilities

6.4 Government Supplied Equipment and Supplies

6.5 Obtaining Replacement of Government Supplied Equipment

6.6 Contractor Supplied Facilities

6.7 Safeguarding Sensitive but Unclassified (SBU) Information

7.0 Over and Above

8.0 Transition In/Transition Out Plan

9.0 Other Direct Costs (ODCs)

10.0 Government Property

11.0 Conflict of Interest

12.0 Working Hours

13.0 Definitions/Acronyms

13.1 General Definitions

13.2 Acronyms

1.0 Introduction and Overview

The Civil Aerospace Medical Institute (CAMI) is the medical certification, education, research, and occupational medicine arm of the Office of Aerospace Medicine (AAM) under the auspices of the Federal Aviation Administration (FAA’s) Office of Aviation Safety (AVS). The Aerospace Medical Research Division of CAMI (AAM-600) is located at the Mike Monroney Aeronautical Center (MMAC), in Oklahoma City, OK. The Aerospace Medical Research Division accomplishes the following core functions in support of the FAA’s aviation safety mission:

Assembles medical data from internal and external sources for pilots involved in aviation mishaps and performs medical case reviews

Performs state-of-the-art toxicological analyses on postmortem samples derived from transportation mishaps

Maintains and upgrades the CARI-7 model used to calculate individual inflight radiation exposures resulting from space weather

Conducts research into the epidemiology of aircraft accidents and studies performance decrements resulting from disease processes to determine their effects on aviation

Conducts research into environmental factors influencing human physiology and performance in aviation environments, with a primary focus for on the study of protective breathing equipment for use in emergency situations aboard aircraft

Conducts research to determine how human factors stressors change gene expression and correlate changes in gene expression to human performance in the aviation domain

Conducts research into novel ways for quantifying and visualizing risk within the aviation medicine environment

Evaluates the impact protection potential of new materials and structures for aircraft, and provides equipment and crash expertise for protection and survival research programs

Conducts research studies and tests pertaining to the emergency evacuation of aircraft, onboard aircraft emergency equipment and its effectiveness, the effectiveness of cabin air crew training, passenger education, water evacuations and survival, and post-crash survival

In the past, the division has needed onsite contractor staffing support to assist Government personnel responsible for accomplishing the aforementioned core mission functions. The need for contractor staffing support continues, although a mix of onsite and offsite/remote staffing support will now be considered based on lessons learned from the COVID-19 pandemic. Additionally, forecast changes to the scope of the division’s research-related functions drives the need for the following services:

Provide access to on demand technical expertise through in house contractor staff, partnerships, sub-contracts, etc., as required to accomplish specific research project tasks and in direct support of Government researchers

Provide or procure access to facilities, equipment, data, and/or key partners in academia or industry as required to accomplish specific research projects and in direct support of Government researchers

Develop project plans to achieve Government defined aeromedical research objectives and independently manage and execute those plans with oversight of Government researchers

1.2 Objectives

The objective of this acquisition is to provide the Aerospace Medical Research Division staff agile access to a range of technical support services, as required, so they can successfully execute core mission functions as previously described.

1.3 Scope of Work

The scope of work will include providing both staffing and non-staffing support services. Staffing support is scoped to the provision of continuous (i.e., throughout the period of performance) onsite and offsite technicians and professionals in defined labor categories. Non-staffing support is scoped to the provision of temporary/on-demand technical expertise/consultation, logistical support for research project execution, and independent execution of research projects.

1.4 Inherently Governmental Functions

In its performance of this Contract, the Contractor will not perform any inherently governmental functions, as identified in the Office of Federal Procurement Policy Letter 11-01. These functions are so intimately related to the public interest as to require performance by Federal Government employees. The term includes functions that require either the exercise of discretion in applying Federal Government authority or the making of value judgments in making decisions for the Government. This would include, among other things, binding the Government to take or not to take some action by contract, policy, regulation, authorization, order, or otherwise, and exerting ultimate control over the acquisition, use, or disposition of the property of the United States, including the collection, control, or disbursement of appropriations and other Federal funds.

2.0 References

The Contractor will support all Tasks in accordance PWS Section 3 and Schedule B

Monthly Status Reports IAW Sub-task 3.4.2 Quality Control Plan IAW Sub-task 3.4.3 Program Management Review IAW Sub-task 3.4.4

3.0 Task Requirements and Performance Objectives

Performance Objectives Description

Task 1: Provide contract/program management

The Contractor will provide contract and program management, to include supervision of all support staff, to ensure tasks are accomplished efficiently, accurately, on time, and in compliance with requirements. The Contractor will participate as a member of a government-led team as requested by the Contracting Officer’s Representative (COR).

The Contractor will provide a kickoff meeting between the FAA, COR, and Contractor to review PWS requirements and understand work scope and deliverables. The Contractor will be available within one business day to receive notices, reports, or requests from either the Contracting Officer or the

COR.

The Contractor will deliver Monthly Status Reports in Contractor format and including at least the following elements:

Overview of work completed it the past month, work in progress, and work planned during the next month for each task

Hours expended by task, labor category, and personnel Status of individual deliverables Identification of risk areas with recommended remedial actions Status of all outstanding risks identified in previous MSRs Any additional information pertinent to the Government in administering the performance of this effort or as requested by the COR

The Contractor will deliver a Quality Control Plan (QCP) in Contractor format and accomplish the following:

Identify the standards applicable to this effort Include procedures for complying with those standards Identify metrics and techniques for measuring quality and performance Include an approach for eliminating the causes of unsatisfactory performance Address Contract and PWS task level performance for applicable tasks The QCP will be approved by the COR and will support any FAA Quality Assurance Surveillance Plans (QASPs) put in place to monitor Contractor performance. Within 15 calendar days of receipt of request, the Contractor will update and present the revised QCP for COR approval.

The Contractor will lead a quarterly Program Management Review (PMR) using a Government-directed modality (i.e., onsite at MMAC or virtual) addressing the following:

Vendor Contract/Contract Information Financial Summary Contract Staffing Summary Subcontractor Status Performance Summary Accomplishments Delivery Order Information Action Item Summary Backup Information Meeting minutes and presentation slides will be submitted to the COR as a quarterly deliverable.

Task 2: Provide continuous onsite staffing support of key positions

Provide onsite staffing for the following positions, as defined in Schedule B, starting on day 1 of the period of performance:

Epidemiologist, Computer Information and Research Scientist, Biological Science Laboratory Technician (x2), Data Analyst, and Machinist.

Task 3: Provide continuous onsite staffing support

Provide onsite staffing for positions as identified in subsequent task award(s). Positions within scope to potentially be included in subsequent task awards are as defined in Schedule B.

Positions will be filled within 45 calendar days of task award.

Task 4: Provide continuous offsite staffing support

Provide offsite staffing for positions as identified in subsequent task award(s). Potential positions are as defined in Schedule B. Positions will be filled within 45 calendar days of task award.

Task 5: Provide temporary/on-demand technical expertise/consultation

Provide access to on demand technical expertise through in house contractor staff, partnerships, sub-contracts, etc., as required to accomplish specific research project tasks and in direct support of Government researchers as identified in subsequent task award(s).

Task 6: Provide support for research project execution

Provide or procure access to facilities, equipment, data, and/or key partners in academia or industry as required to accomplish specific research projects and in direct support of Government researchers. This task may involve collaboration with large corporations in the aerospace domain.

Task 7: Execute research projects Develop project plans to achieve Government defined aeromedical research objectives and independently manage and execute those plans with oversight of Government researchers

The following requirements apply for tasks related to staffing support:

The Contractor will verify candidates have the requisite knowledge, experience, and technical skills as specified in Schedule B.

The Contractor will ensure employees continue to meet qualifications as specified in Schedule B throughout the contract period of performance.

Contract employees will be proficient using email and Microsoft Office products (Word, PowerPoint, and Excel).

Contractor personnel will be capable of working independently and in coordination with federal government employees in accomplishing assigned work.

Contractor personnel will perform to Federal Aviation Regulation (FAR) Part 67, ISO-9001 certified FAA AVS QMS procedures and written policies as appropriate for the position.

The Contractor will provide Hepatitis B vaccination/testing/exposure monitoring as appropriate for the position.

Contractor personnel will participate in Government provided training and attend professional conferences as appropriate to the position.

Additionally, all Contractor personnel supporting this PWS will fluently read, write, and speak the English language.

The specific work requirements and qualifications will be identified and ordered through Fixed Price Program Management, Fixed Price Labor Rates, and Time & Materials as outlined in Task Order work statements issued prior to performance by the FAA Contracting Officer or delegated Contracting Officer’s Representative (COR).

4.0 Deliverables

The Contractor will provide the following reports in Contractor format:

• Monthly Invoices within 7 days from the end of the previous month for hours incurred by contract employees itemized by position/employee.

• Document monthly reports by employee and task within 7 days from the end of previous month itemized by team.

All days are business days unless otherwise specified.

Task End

Result/Deliverable Due Date Acceptance Criteria

1 Monthly Status Reports

10th day of the following month

The MSRs are accurate, complete, submitted on time in the COR approved format and is prepared in accordance with PWS Section 3.0

1 Quality Control Plan 30 days after Contract award;

updates within 15 days of COR request or change to the Contract

The QCP is accurate, complete, submitted on time in the COR approved format and is prepared in accordance with PWS Section 3.0

1 Program Management Review Meeting Minutes and Presentations

Quarterly The Meeting Minutes are accurate, complete, submitted on time in the COR approved format and is prepared in accordance with PWS Section 3.0

1 Project Schedules As required by the

COR

The Project Schedules are accurate, complete, submitted on time in the COR approved format

2 Recommendations As required by the

COR

Recommendation with hours

5.0 Period of Performance

The contract is expected to provide for one 12-month base year (and two one-year renewable options. The periods of performance for this contract are outlined as follows:

Basic Year: August 1, 2021 through July 31. 2022 Option Year 1: August 1, 2022 through July 31. 2023 Option Year 2: August 1, 2023 through July 31. 2024

6.0 Place of Performance

Place of performance will be determined by the government on a task by task basis. The Contractor will have the ability to provide the staffing for onsite and offsite support. Ongoing staffing support (unless otherwise specified) will be provided within the CAMI Building location on the MMAC, building 13, Oklahoma City, OK.

6.1 Security

The Contractor will ensure employees observe and comply with all FAA/CAMI policies, regulations and procedures concerning; fire, safety, environmental protection, sanitation, identification, security, traffic, parking, limited access areas, gratuities, and conduct. The Contractor and all employees will comply with additional policies and procedures enacted during times of public health concerns.

Contract employees working in government facilities will be responsible for compliance with applicable building and physical security requirements. These requirements include, but are not limited to, the use of authorized entrance and exit points, responsibility for securing doors, protecting government property from loss theft abuse or damage, and the use of telephones and computers for only mission related activities. The Contractor will be responsible for safeguarding all Government property issued for Contractor use. Specific security requirements for tasked projects will be identified in the Contract.

6.2 Badges

The Contractor will be responsible for transitioning employees if required and obtaining an FAA issued identification badge and car decal for each employee upon initial entry to the work site.

While on FAA premises, each Contractor employee will wear his/her FAA identification badge at all times in accordance with FAA/MMAC current policies and directives.

6.3 Government Supplied Facilities

The Government will provide, without cost, adequate and necessary working space. All operating expenses, maintenance, and repairs of Government-provided property will be furnished by the Government when the work is performed on a Government site such as MMAC. Government property has been inspected for compliance with the Occupational Safety and Health Act (OSHA).

No hazards have been identified for which work-around procedures have been established.

Should a hazard be subsequently identified, the Government will correct OSHA hazards according to government-developed and approved plans of abatement taking into account safety and health priorities. A higher priority for correction will not be assigned to the property provided hereunder merely because of this contracting initiation. The fact that no such conditions have been identified does not warrant or guarantee that no possible hazard exists, or that work-around procedures will not be necessary, or that the property as furnished will be adequate to meet the responsibilities of the Contractor.

Compliance with OSHA and other applicable rules and regulations for the protection of employees is exclusively the obligation of the Contractor. Further, the government will assume no liability or responsibility for the Contractor. The Contractor or its employees will not alter the property in any way and will provide in written detail the need to address modifications to Government-provided facilities or equipment. The Contractor will return the property to the Government in the same condition as received, fair wear and tear. The Contractor will reimburse the Government for repairs resulting from negligence of the contract employees. The property will only be used in the performance of this contract.

6.4 Government Supplied Equipment and Supplies

The Government will provide to the Contractor, without cost, all office furniture, equipment, supplies, and materials required to successfully accomplish the requirements outlined in the PWS when the work is performed on a Government site such as MMAC. Computers issued to Contractor provided staff may be used at the AWL.

6.5 Obtaining Replacement of Government Supplied Equipment

The Contractor will submit requests for replacement of Government Supplied Equipment to the COR for processing. Such requests will specify the reason for the replacement request. It is important to note the Contractor and its employees will take reasonable care of the Government supplied equipment. The Government manages and provides Facilities, equipment and supplied.

6.6 Contractor Supplied Facilities

The Contractor will provide, without cost to the government, adequate and necessary working space in the event that an AWL is needed and is requested for either a permanent time and/or a temporary term. The Government will furnish all operating expenses, maintenance, and repairs of Government-provided property when the work is performed on a Government site such as MMAC.

All operating expenses, maintenance, and repairs for the Contractor AWL are the responsibility of the Contractor.

Compliance with OSHA and other applicable AWL laws and regulations for the protection of employees is exclusively the obligation of the Contractor. Further, the government will assume no liability or responsibility for the Contractor. The Contractor or its employees will not alter the property in any way and will provide in written detail the need to address modifications to Government-provided facilities or equipment. The Contractor will return the property to the Government in the same condition as received, fair wear and tear. The Contractor will reimburse the Government for repairs resulting from negligence of the contract employees. The property will only be used in the performance of this contract.

6.7 Safeguarding Sensitive but Unclassified (SBU) Information

The Contractor will have established procedures for securing materials and data (re: NIST Special Publication 800-171, Protecting Controlled Unclassified information in non-federal information systems and organization) upon contract award that will include:

1. Procedures for safeguarding "Confidential" and "Sensitive" materials

2. Procedures for assurance that all documents are secured at all times and are never left unattended including safeguard measures for Protected Health Information (PHI)/Health Insurance Portability and Accountability (HIPAA) data.

3. Procedures to prevent discussion outside of information contained on any medical or other document containing personally identifiable information (PII)

4. Procedures to prevent addresses or information from being disseminated to anyone regarding a specific individual, e.g., celebrities or dignitaries

7.0 Over and Above

The acquisition may necessitate additional support services deemed necessary to the Aerospace Medical Research Division’s mission as outlined in its Research Project Plans. The Contracting Officer will request a proposal from the Contractor as the necessity for additional support is required (i.e., research subjects, subject matter experts). These changes will be incorporated into the Contract through bilateral modification.

8.0 Transition In/Transition Out Plan

The FAA requires a transition in plan 6 weeks prior to the period of performance start date – in Contractor format.

Within 6 months of the end of this contract, the FAA will require a transition out plan. In addition, approximately four weeks prior to this Contract’s end date, the FAA will require the Contractor to provide the following:

All documentation as of the most recent version A final financial report A final status report that includes a projection of activities for the remainder of the

Contract A closeout meeting with the FAA (details and participants to be determined by the FAA)

All FAA security badges, if issued, will be turned in to the COR by closeout of the Contract.

9.0 Other Direct Costs (ODCs)

Other Direct Costs that may be required for the performance of this contract. These include travel, miscellaneous material and supply expense(s) not provided by CAMI. All ODCs, including travel, will be defined and approved in advance and in writing by the CO and as delegated to the COR.

10.0 Government Property

For the purpose of implementing this provision, AMS Clause 3.5-16, Rights in Data–Special Works, applies to this Contract. All FAA property will be delivered to the FAA in accordance with this PWS or as requested by the FAA.

11.0 Conflict of Interest

Due to the nature of the work required by this PWS, AMS Clause 3.1.7-1, Exclusion from Future Agency Contracts, is applicable to this Contract.

12.0 Working Hours

The Contractor will provide services commencing no earlier than 6:00 AM and ending no later than 6:00 PM (local time for offsite/remote work) for not more than 10 hours in one shift, Monday through Friday except Federal Holidays or any other day(s) designated by Federal Statute, Executive Order, or Presidential Proclamation, or as required by research needs such as data collection. The ten federal holidays include New Year's Day; Martin Luther King, Jr. Day;

Presidents' Day; Memorial Day; Independence Day; Labor Day; Columbus Day; Veterans Day;

Thanksgiving Day; and Christmas Day. Limit of 10-hour daily shifts with the following exception:

Operational need may necessitate working outside of the normal 6:00 AM to 6:00 PM schedule and some weekends, on a case-by case basis. Notice will be given at least 24 hrs. in advance.

Travel may be required.

13.0 Definitions/Acronyms

As used throughout this contract, the following terms will have the meaning set forth below and specified as applicable:

13.1 General Definitions

Aircraft Certification- The prescribed safety standards outlined under specific Federal Aviation Regulations, which will be met before the FAA issues a type certificate for new aircraft, engines or propeller models.

Acceptable Quality Level (AQL) - The standard at which service is considered satisfactory as agreed upon by the Contractor and the Government.

Alternative Work Location: The Contractor may request, at its own expense a permanent Alternative Work Location for SME’s. Upon issuance of a National Emergency (i.e. COVID-19) or other such emergency the Contractor may be permitted on a case-by-case basis to provide AWL for staff deemed necessary and critical to maintain ongoing research.

Aviation Safety (AVS) Quality Management System (QMS) (https://employees.faa.gov/org/linebusiness/avs/programs/qms/) AVS- is committed to continuously improving the world's safest aerospace system. AVS fulfills this commitment by responding to our stakeholders, supporting the interests of the flying public, valuing the contributions of each employee, and meeting the requirements of the AVS quality management system.

Compatible: The quality of handling data and programs devised from one type of computer system to another

Computer Security-The Safeguarding of computing resources against unauthorized use, especially the protection of data from deliberate or accidental damage, unauthorized change, or disclosure of controlled or Privacy Act material.

Contractor- The term Contractor as used herein refers to both the prime Contractor and any subcontractor. The Prime Contractor will provide a single point of contact (an employee of the prime) to coordinate all tasking, schedules, and requirements. The Contractor will ensure that his/her subcontracts (if any) comply with the provisions of this contract. The offsite supervisor will be an employee of the Prime Contractor.

Contracting Officer (CO) - One with authority to enter into, administer, and/or terminate contracts and make related determinations.

Contracting Officer’s Representative (COR) - One who is designated and authorized in writing by the CO to be responsible for surveillance/monitoring of the Contractor's performance.

Contractor-Owned Property- All property used on this contract that is owned or furnished by the Contractor.

Government Supplied Equipment- All equipment owned by, leased to the Government, or acquired by the Government under the terms of the contract. Government supplied equipment includes equipment provided by both the Government and the Contract as defined in AMS Guidance T3.10.3.

Quality Assurance (QA) - Those actions taken by the Government to assure services meet the acceptable quality level established by the contract between the Contractor and Government.

Quality Control (QC) - Those actions taken by the Contractor to ensure Contractor performance meets the requirements of the contract.

Off-Site Supervisor - refers to the person designated by the Contractor who has authority to act for the Contractor on a day-to-day basis at the work site, and who directly supervises the Contractor’s work force. Assigned by the Contractor to manage the services outlined in the

PWS.

Sensitive but Unclassified (SBU) Trash- All material that contains PII or an "Official Use Only" designation. All SBU trash collected from work areas will be designated for shredding.

13.2 Acronyms

(AAM) Office of Aviation Medicine (ATC) Air Traffic Control (AMS) Acquisition Management System (ANG) Office of NextGen (AQL) Acceptable Quality Level (AVS) Office of Aviation Safety (AWL) Alternative Work Location (CAMI) Civil Aerospace Medical Institute (CDRL) Contract Deliverable Requirement List (CO) Contracting Officer

(COR) Contracting Officer’s Representative (EMS) Environmental Management System (FAA) Federal Aviation Administration (FAR) Federal Aviation Regulation (FOIA) Freedom of Information Act (HIPAA) Health Insurance Portability and Accountability (IRB) Institutional Review Board (ISO) International Organization for Standardization (MMAC) Mike Monroney Aeronautical Center (MSR) Monthly Status Reports (NTSB) National Transportation Safety Board (OSHA) Occupational Safety and Health (PA) Privacy Act (PHI) Protected Health Information (PII) Personally Identifiable Information (PMR) Program Management Review (SBU) Sensitive But Unclassified (SME) Subject Matter Expert (QC) Quality Control (QA) Quality Assurance (QASP) Quality Assurance Surveillance Plan (QMS) Quality Management System (PWS) Performance Work Statement