PWS Behavioral Health Consultatant Contract 03-02-23.docx

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Limited Sources Justification: Behavioral Health Consultation Services for Pilot and Air Traffic Control Specialist (ATCS) case reviews.
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03222023
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Draft Version: 02/10/2023 V 8

Offices of the Federal Air Surgeon Aviation Safety Behavioral Health Consultation Professional Services Contract

Performance Work Statement

Contents

1.0 INTRODUCTION/BACKGROUND3
2.0 SCOPE OF WORK4
2.1 Services:4
2.2 Behavioral Health SME Tasks4
2.2.1Case Reviews:4
2.3 Period of Performance:5
2.4 Working Hours:5
The5
2.5 General Requirements6
3.0 CONTRACT EQUIPMENT6
3.1 Government Furnished Equipment (GFE)6
3.2 Contractor Furnished Equipment (CFE)6
4.0 SECURITY6
4.1 Safe Guarding Pilots Sensitive But Unclassified (SBU) Information7
5.0 QUALIFICATION(S)7
6.0 DELIVERABLES8
7.0 Travel9
8.0 Over and Above (O&A)10
9.0 Quality Assurance10
9.1 Quality Assurance Surveillance Plan10
10.0DEFINITIONS, ACRONYMS, REFERENCES:10
10.1 General Definitions10
10.2 Acronyms:12
10.2 References12
ATTACHMENT 1: QUALITY ASSURANCE SURVEILLANCE PLAN14

1.0 INTRODUCTION/BACKGROUND

The Federal Aviation Administration (FAA) is the element of the U.S. government with the primary responsibility for the safety of civil aviation. The FAA’s mission is to provide a safe, secure, and efficient National Aerospace System (NAS) as directed by Federal Statutes, Federal Aviation Regulations and FAA Orders. As the leading authority in the international aerospace community, the FAA is responsive to the dynamic nature of the aerospace industry, customer needs, economic conditions, and environmental concerns.

Within the FAA, the Federal Air Surgeon (FAS) and Office of Aerospace Medicine (AAM) protect pilot/pilots, air travelers and the public welfare through processes for pilot medical certification and FAA Air Traffic Controller Specialist (ATCS) medical clearance. A person found qualified under the FAA pilot medical standards may be medically certificated, in accordance to the class of medical certificate issued, to operate aircraft ranging from private general aviation aircraft to commercial airliners. Similarly, a person found qualified under the FAA ATCS medical standards may be medically cleared to perform air traffic control duties. Annually, the FAS/AAM makes medical determinations for approximately 385,000 pilot and over 15,000 ATCS incumbent controllers and applicants. The estimated number of cases subject to Behavioral Health review range from 544 to 572. Determinations must be effective, efficient and timely to fulfill the FAA safety mandate.

The FAS/AAM must make determinations on pilot/ATCS cases ranging across the entire spectrum of medical conditions and diagnoses. A significant number of cases involve behavioral health conditions (psychiatric) requiring physician psychiatrists with expertise across the spectrum of mental and behavioral health conditions and application to aeromedical determinations. Specialized knowledge of these psychiatrists is also important for supporting other tasks related to FAS policies and procedures, including literature reviews, policy/protocol development, educational activities, expert summit meetings, etc.. These experts provide reasoned and comprehensive analyses of the risks, mitigations, complex interactions and variables associated with behavioral health conditions related to pilot and ATCS performance of safety sensitive duties. Specific behavioral health areas include eligibility under the Selective serotonin reuptake inhibitors (SSRI) antidepressant medication protocol, substance use disorders, cognitive disorders, and the Human Intervention Motivation Study (HIMS) program.

The FAS depends on internal AAM behavioral health specialists, augmented by external consultants, knowledgeable in the FAA standards and the unique culture of the professional/private pilot and their aviation environment. External consultants are required, and the need for these services is not a new requirement. We seek through this contracting effort to develop a more robust capacity for reviewing behavioral health cases, a more cogent process of succession planning, and improved consistency and application of the aeromedical standards. The requiring organization has researched and identified a small cadre of supporting psychiatrists that may be interested in becoming contract consultants, with robust experience and expertise to support the FAA.

2.0 SCOPE OF WORK

The intent of this acquisition is establish a multiple award of Indefinite Delivery/Indefinite Quantity (IDIQ) Contracts with a limited number of providers (3-4) who meet the qualifications for Behavioral Health Consultant services for the FAA Offices of Aerospace Medicine. Annual task orders to be issued in support of subject matter expertise by review Behavioral Health Consultants (e.g. Psychiatrists) The Contractor must provide all labor, facilities (including utilities and Internet Access), materials & supplies. The Contractor must meet all the qualification requirements in Section 6.0 and ensure it is capable of providing the necessary services and deliverables to support FAA.

2.1 Services:

The FAA requires a Multiple Award Contract for Contract Behavioral Health Subject Matter Experts (SME) to provide a professional review of records. The Contractor must independently review records for each identified pilot/ATCS including but not limited to medical applications and all pertinent medical documentation. The report must provide medical interpretation supported by the evidence found in the review, identify aeromedically significant behavioral health issues and formulate recommendations in accordance with the Code of Federal Regulations (14 C.F.R.§ Part 67), and procedural guidance from AAM. Reports must be provided for review through the government access to Huddle (https://www.huddle.com).

2.2 Behavioral Health SME Tasks

2.2.1 Case Reviews:

Contractors must:

· Receive documents, process and review cases involving pilots and air traffic controllers, and provide reports via electronic means (e.g. such as Huddle or other relevant system) as prescribed by the FAA.

· Be available to communicate when required with FAS/AAM medical officers/staff or other treating/evaluating providers related to the review of behavioral health cases, via phone call, email, teleconference or other means.

· Provide within 30 days of receipt a complete case analysis report for review plus other documentation prescribed by the FAA for case tracking and record keeping.

· Contractors should make best efforts to submit completed reports to FAA as promptly as possible to maximize efficiencies for both the contractor and FAA.

· Reports must:

· Comprehensively review documents, reports, studies, etc.

· Provide expert professional / technical advice within the scope of the Consultant’s professional qualifications, licensure, and expertise for aeromedical behavioral health cases to include:

· Assessment of the risk (e.g., likelihood of sudden or subtle incapacitation) from conditions and/or treatments.

· Assessment of efficacy of risk mitigation to include prescribed treatment and monitoring plus any additional recommendations.

· Note any new conditions or other concerns the Contractor might identify that the FAA/AAM may not have recognized and/or may be outside of the Contractor’s expertise or scope of review.

· Must formulate opinions and recommendations reflecting and consistent with 14 CFR Part 67 (pilots), FAA Order 3930.3 series (FAA ATCS), the AME Guide, other FAS/AAM guidance, and (as appropriate) best available published medical literature/evidence.

· If appropriate, provide citations from the medical literature.

· If reviewing HIMS-specific cases accompanied by a HIMS AME Data Sheet, review the Data Sheet for accuracy and handle as prescribed by the FAA.

2.3 Period of Performance:

The period of performance is for five (5) years. (One-year Base beginning from the date of award with four (4) One-Year Options) beginning from date of award.

The Government's primary operational hours are Monday through Friday 6:00 AM to 6:00 PM. EST. Normal office hours are Monday through Friday from 8:00 AM to 4:30 PM EST. No work shall occur on federal holidays or any other day(s) designated by Federal Statute, Executive Order, or Presidential Proclamation. No deferential pay or overtime rates will be authorized.

The Contract Behavioral Health Consultant(s) contracted for their services need to be aware of normal office hours for coordination purposes with Government points of contact (POC) as needed, but need not comply with the same operation and office hours as the Government.

2.5 General Requirements

· Contractors are expected to work remotely (offsite).

· Onsite work may be approved on a case by case basis.

· Contractors may be required to travel/if when a need arises.

· Contractors must comply with the security requirements outlined in Section 4.0 – Security.

· Contractors will be assigned cases by the Government via Huddle (https://login.huddle.com/) or other system as prescribed

· Contractors must provide and maintain a schedule of availability to the COR

· Contractors are not authorized to review pilot disability cases outside of those assigned

3.0 CONTRACT EQUIPMENT

3.1 Government Furnished Equipment (GFE)

The Government will provide all pilot case material through Huddle software (https://login.huddle.com/) or relevant system designated. Huddle is a privately held cloud-based collaboration software company secured by the government as the platform developed for the U.S. government agencies and organization via a strategic partnership and technology development agreement. Huddle enables the U.S. government community to securely access data and in this case, provide access to pilot records for Behavioral Health and other panel reviews. Upon contract award the government will secure and maintain access rights to huddle for the Consultants throughout contract.

3.2 Contractor Furnished Equipment (CFE)

The contractors must provide all working space, office furniture, equipment, supplies, and materials necessary to successfully accomplish the requirements outlined in this PWS. The Government will not assume responsibility, nor be liable for the Contractor’s own property.

4.0 SECURITY

The contractor shall ensure that employees observe and comply with all FAA policies, regulations and procedures concerning; fire, safety, environmental protection, sanitation, identification, security, traffic, parking, limited access areas, gratuities, and conduct. Contract employees working in government facilities shall 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 shall be responsible for safeguarding all Government property issued for contractor use. The Contract personnel are required to perform services in secure facilities. Entrance into the Government provided working space requires Government issued key card. The Contractor employees may not begin work until forms are submitted and have been reviewed and authorized by local security offices of the FAA.

4.1 Safe Guarding Pilots Sensitive But Unclassified (SBU) Information The Contractor must have established quality control procedures upon contract performance. Quality assurance procedures must include:

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

· Procedures for assuring all documents are secured at all times and are never left unattended;

· Procedures to prevent discussion outside the immediate work area of information contained on any medical document;

· Procedures to prevent information from being disseminated to anyone regarding a specific individual

· Signed Non-Disclosure Agreements for all employees working with FAA Medical Records (including paper and electronic records)

5.0 QUALIFICATION(S)

It is imperative that Behavioral Health Consultants have the experience and training necessary to perform the requirements of this PWS.

The Contractor must meet the following requirements:

· Physician (Doctor of Medicine/M.D., or Doctor of Osteopathic Medicine/D.O.)

· Current state licensure within the United States,

· Board certification in psychiatry

· Provide a current Curriculum Vitae (CV) and/or other documentation as requested by the government that demonstrates expert knowledge and experience in the detection, diagnosis, treatment and prognosis of aviation behavioral health conditions and disorders.

· Possess extensive knowledge and experience in aerospace behavioral health/psychiatry for determining eligibility for pilot medical certification/ATCS clearance, to include understanding the culture and working conditions of the aviation professionals (pilots, air traffic controllers).

· Demonstrate knowledge and experience in reviewing and summarizing psychiatric material, to include providing comprehensive review analysis and psychiatric case reports in the context of Code of Federal Regulation (CFR) Title 14, Part 67 (Aviation Medical Certification), FAA Order 3930.3 series (Air Traffic Control Specialist Health Program), the Aviation Medical Examiner (AME) Guide, and other prescribed guidance.

· Acknowledge understanding that the Contractor may also be requested to provide additional services under this contract or other agreement to include: 1) provide expert witness testimony involving cases previously reviewed or requiring new independent review; 2) participate in the Federal Air Surgeon’s Behavioral Health Panel; 3) participate in other tasks related to FAS policies and procedures to include literature reviews, medication/therapy reviews, policy/protocol development, educational activities, expert summit meetings, etc.

Highly desired but not required requirements include the following:

· Additional sub-specialty certification/qualification e.g., addiction psychiatry, forensic psychiatry), Human Intervention Motivation Study (HIMS) program training and experience.

Note: Contractors reviewing cases specifically for the HIMS program should also be certified/qualified in addiction.

6.0 CONTRACT DELIVERABLES

For each Case Review, the Contractor must deliver the following:

Contract Data Requirement List (CDRL)
Description
Due Date
1
Proof of Contractor Liability Insurance
30 days after contract award
2
Case Review Reports must:

A) Provide comprehensive review/summary (see section 3.1).

B) Provide professional recommendation regarding eligibility for medical certification, with supporting rationale based on the information reviewed and communicated.

C) Be submitted in electronic form, with printed version if required by the COR.

D) Be signed and dated (electronic signature acceptable).

E) Be accompanied by all supporting communication (i.e. verbal, written, and electronic) with all relevant parties and FAA officials in support of the consultative processes.

Reports must be submitted within 30 calendar days via Huddle/ AAM-100 Technical Expert/Designee and to the COR (or COR designee) in monthly batches to accompany the Monthly Invoice Reports (MIR).

2
Monthly Invoices
Invoices for each month must be submitted by the 7th day of the following month.
4
Monthly Invoice Report: The Contractor must prepare and submit Monthly Invoice Reports (MIRs), with invoices for individual reports, and any other required reports, based on the deliverable identified in this PWS in Contractor Format Memo. The MIR and Invoice must include the following information:

A) Number of cases reviewed in the month of invoice by category and CLIN.

B) Current cases in review but not completed C) An Invoice must be submitted monthly detailing the cases processed offsite, including the names and hours worked on site.

D) A redacted copy of the Invoice listing only the case number worked in each category must also be submitted.

Monthly Invoice Reports must be submitted by the 7th day of the following month through Huddle the CO and COR to accompany invoices submitted to government payable system.

7.0 Travel

Currently, the Government does not anticipate travel requirements, however, travel may be required as deemed necessary by the Government. All travel requirements, to the greatest extent possible will be scheduled 30 days in advance and funded through bi-lateral modification.

Contractors must be able to travel IAW the services outlined in this PWS to support this Behavior Health Review project, and will be subject to restrictions of the Integrated Management Team (IMT) and Center for Disease Control (CDC) recommendations. All travel on this contract must be IAW Federal Travel Regulations (FTR), contractually funded, and authorized in writing by the CO/COR of record.

8.0 Over and Above (O&A)

Additional services may be necessary to support the Behavior Health Consultant Contract. The CO may request a proposal from the Contractor should the need for additional support arise such as Expert Witness Testimony. All O&A’s must be incorporated into the contract via a modification that is bilaterally signed.

9.0 Quality Assurance

9.1 Quality Assurance Surveillance Plan

The Government intends to utilize the attached Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance under this contract. The oversight provided for in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract’s period of performance. Further, the QASP will provide the Government with a way to track performance and will provide verifiable input to the selection of work among the participating contractors for this program. The QASP is provided as Attachment 1 to this PWS. The QASP is a living document and may be unilaterally updated by the Government as necessary.

The Contractor must provide quality assurance to the highest level to ensure the safety of the National Airspace System. This includes following all Security Requirements outlined in PWS Section 4: Security and Attachment 1: Quality Assurance Surveillance Plan (QASP).

10.0 DEFINITIONS, ACRONYMS, REFERENCES:

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

10.1 General Definitions

Acceptable Quality Level (AQL)
The standard at which service is considered satisfactory as agreed upon by the Contractor and the Government.
Aerospace Medical Certification Subsystem
The web application used by Aviation Medical Examiners and their staff to transmit FAA flight physical data to the FAA
Alternative Dispute Resolution (ADR)
Process for the resolution of disputes regarding work determined to be unsatisfactory.
Pilots/Pilot
Terms used to mean the same
Aviation Safety (AVS) Quality Management System (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. (https://employees.faa.gov/org/linebusiness/avs/programs/qms/)
Contractor
The term Contractor (Physician Psychiatrist Consultant) as used herein refers to both the prime Contractor and any subcontractors. The prime Contractor shall ensure that his subcontracts (if any) comply with the provisions of this contract.
Contracting Officer (CO)
One with authority to enter into, administer, and/or terminate contracts and make related determinations.
Contracting Officer’s Representative (COR)
The person designated and authorized in writing by the CO to be responsible for surveillance/monitoring of the Contractor's performance.
Document Imaging Workflow System (DIWS)
AMCD software that automates the FAA certification document control systems, the certification approval processes, and streamlines document control, review and routing throughout pilots medical certification by converting paper and medical documents into digital images. These converted images are used by the Government Legal Instrument Examiners, AMCD staff physicians, call center staff, Regional Offices, etc. to support pilots medical certification.
Government Owned Property
All property owned by, leased to the Government, or acquired by the Government under the terms of the contract. Government property included both Government furnished property and Contract acquired property 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 Assurance Surveillance Plan (QASP)
An organized, written, "living" document outlining the Government's methodology for monitoring Contractor performance.
Quality Control (QC)
Those actions taken by the Contractor to ensure Contractor performance meets the requirements of the contract.
On-Site Supervisor
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 work force. Assigned by the Contractor to manage the services outlined in the PWS.
Sensitive But Unclassified (SBU)
All material that contains pilots identification and medical records or an "Official Use Only" designation.

10.2 Acronyms:

AMCD
Aerospace Medical Certification Division
AMCS
Aerospace Medical Certification Subsystem
AME
Aviation Medical Examiner
AMED
Aerospace Medical Education Division
AMS
Acquisition Management System
AVS
Aviation Safety (FAA)
CAMI
Civil Aerospace Medical Institute
CFR
Code of Federal Regulations
CO
Contracting Officer
COR
Contracting Officer’s Representative
DIWS
Document Imaging Workflow System
CV
Curriculum Vitae
FAA
Federal Aviation Administration
FFP
Firm Fixed Price
FAS
Federal Air Surgeon
FOIA
Freedom of Information Act
HIMS
Human Intervention Motivation Study
LIE
Legal Instrument Examiner
ODC
Other Direct Cost
MIR
Monthly Invoice Report
NAS
National Airspace System
PA
Privacy Act
PWS
Performance Work Statement
QA
Quality Assurance
QC
Quality Control
QMS
Quality Management System
SBU
Sensitive But Unclassified

10.2 References

The Contractor must ensure all work is in full compliance with regulations expressed in the following procedures, orders, and programs unless otherwise directed by the Contracting Officer’s Representative (COR):

· Title 14 of the Code of Federal Regulations (CFR), Part 67

· Office of Aerospace Medicine (AAM) Quality Management System (QMS): https://my.faa.gov/org/linebusiness/avs/programs/qms/qms_homepages/aam.htm

· Guide for Aviation Medical Examiners

· FAA Acquisition Management Policy: http://fast.faa.gov/AMP_TOC.cfm

· FAA Acquisition Toolset: http://fast.faa.gov/

· ID Badge Online Application: https://employees.faa.gov/org/staffoffices/ash/id_badge/

· Contractor & Industrial Security Program: http://www.faa.gov/regulations_policies/orders_notices/index.cfm/go/document.information/documentid/15573

· Orders and Notices: http://www.faa.gov/regulations_policies/orders_notices/index.cfm/go/document.list/parent TopicID/184

· Forms: http://www.faa.gov/library/forms/

ATTACHMENT 1: QUALITY ASSURANCE SURVEILLANCE PLAN

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1) Work Requirement: Contractor efforts under this contract are defined within the Performance Work Statement (PWS).

2) Performance Standards: “Task Order Performance Evaluation”, the contractor’s performance will be monitored in the following areas:

a. Technical Performance

b. Schedule Compliance

c. Deliverable Quality

d. Cost Control

e. Responsiveness to Customer Requirements

3) Method of Surveillance: The Method of Surveillance is specified under section 5. Below.

4) Performance Requirements Summary Matrix: The following table provides the performance factor, standard, acceptable quality level, method of surveillance and incentive.

Performance Area
Standard
Acceptable Quality Level
Method of Surveillance
(a) Technical Performance
All task requirements met with little to no re-work/re-performance required and with few minor or no significant problems
No significant rework or re-performance required during reporting period. Any minor issues successfully addressed.
Periodic inspection of contractor performance, status reports and invoices.
(b) Schedule Compliance
Contractor provides deliverables on or before due dates and meets or exceeds project milestones or schedules.
No more than one minor deliverable submitted late per reporting period. No significant late deliveries or missed milestones.
Inspection of deliverable and milestones against schedule.
(c) Deliverable Quality
Deliverables are complete, accurate and compliant with task order requirements.
No more than one minor rejected deliverable per reporting period. No significant deliveries rejected or missed milestones.
Review and acceptance procedures for deliverables and accomplishment of milestones per task order criteria.
(d) Cost Control
Successful delivery of all contract requirements within budgeted cost
Vendor is aware of budget limitations and will continue to operate within those limits No requests for additional funding per reporting period beyond budget without notifying FAA prior.
Contractor correspondence with the Contracting Officer.
(e) Responsiveness to Customer requirements.
No significant Customer concerns received regarding Contractor’s performance
No more than one minor concern per quarter. No major concerns per reporting period.
Observation and written or concerns.

5) Acceptable Quality Level (AQL): The AQL for this project is defined in the table above for each performance area.

6) Evaluation Method: The Government will monitor the contractor’s performance in accordance with the method of surveillance noted above. The Government will review all activities cited in the table above to ensure accuracy, completeness, and quality of services provided. Contract evaluations will be accomplished by the FAA staff.

Incentives (Positive and/or Negative): The contractor’s performance, both positive and negative, will be a consideration in the Program Office Task Order award process.

PWS DATE

Prepared by Katharine T. McCauley image1.png

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