Clinical Engineering PWS_Draft.docx

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Biomedical Clinical Engineer
Solicitation number
FA800321C0021
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This is a Performance Work Statement (PWS) for Air Force Medical Command (AFMEDCOM) Clinical Engineering support services under Solicitation Number FA800321C0021. The requirement is for a Biomedical/Clinical Engineer V to provide lifecycle program management support for contingency, expeditionary, and war reserve medical equipment for the AFMEDCOM A4/10E Division located at Fort Detrick, Maryland (693 Neiman Street and 1270 Montevue Lane). The work is performance-based and non-personal services involving technical and engineering analysis, market research, program management, and advisory services related to medical device acquisitions and sustainment.

The contractor must provide comprehensive support including: identifying Original Equipment Manufacturers (OEMs) and available contracting agencies through market analysis; liaising between OEMs and cybersecurity approval offices; reviewing medical maintenance data and identifying trends; assisting with total cost of ownership calculations; supporting contracting actions and budgetary decisions; and providing engineering recommendations for contingency and expeditionary medical equipment. The position requires a Bachelor of Science in Engineering (or higher) with specialized coursework in fundamental engineering science, or an equivalent degree with current Certification in Clinical Engineering (CCE). The candidate must possess three years of experience in healthcare technology management, clinical engineering analysis, device/system lifecycle analysis, project management, requirements management, market research, technical evaluations, and installation requirements reviews. The contractor must maintain 100% staffing within 15 days of contract start, preserve a 95% overall filled rate, and limit turnover to less than 30% across all positions. Additional requirements include Tier 1 security clearance, annual DoD Cyber Awareness and HIPAA/Privacy Act training, monthly status/financial reporting, quarterly meetings with the Government team, and periodic travel to conferences and military medical exercises (estimated 14-29 days annually). The contract involves an estimated 250 monthly events supporting approximately 500 customers throughout AFMS and the Military Health System. Work location is Fort Detrick, Maryland, with normal duty hours of 7:30 a.m. to 4:30 p.m., Monday through Friday, and ad-hoc telecommuting authorized upon written Government approval.

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Solicitation Number / Contract Number TBD Insert Date, Mod #

PERFORMANCE WORK STATEMENT

for

AIR FORCE MEDICAL COMMAND

(AFMEDCOM)

AFMEDCOM Logistics and Installation Support A4/10E Clinical Engineering Contingency Equipment Material Support Solicitation/Contract Number TBD

Date (XX Month Year)

(Version Control Date: 23 Jul 2025)

Table of Contents Section Page Number

1.DESCRIPTION OF SERVICES5
1.1.Background.5
1.2.Scope.5
2.GENERAL INFORMATION5
2.1.Contractor Identification.5
2.2.Contractor Training.5
2.3.Contractor/Government Communication.5
2.4.Monthly Status/Financial Report.6
2.5.Place of Performance.6
2.6.Travel Requirements.6
2.7.Mission/Emergency Essential.7
2.8.Duty Hours.7
2.9.Telecommuting.8
2.10.Federal Holidays.8
2.11.Facility Closures.8
2.12.Conduct of Contractor Personnel.8
2.13.Controlled Unclassified Information (CUI).9
2.14.Personnel Staffing:9
3.CONTRACT REQUIREMENTS10
3.1.Support Services.10
3.2.Minimum Qualifications:10
3.3.Security Requirements. (For Unclassified Contracts)10
3.4.Service Contract Reporting (SCR)11
3.5.Quality Control Plan (QCP):11
3.6.Post-Award and Initial Contract Performance Meeting.11
4.PERFORMANCE OBJECTIVES11
4.1.Services Summary (SS)11
5.GOVERNMENT FURNISHED PROPERTY (GFP)12
6.DELIVERABLES12
Appendix A13
ACRONYMS13

PERFORMANCE WORK STATEMENT (PWS)

AFMEDCOM Logistics and Installation Support A4/10E Clinical Engineering Contingency Equipment Materiel Support

1. DESCRIPTION OF SERVICES

1.1. Background. The mission of the Air Force Medical Command (AFMEDCOM) is to generate medically ready forces, deploy expeditionary medics, and improve the health of all we serve - anytime, anywhere. Air Force Warrior Medics are Mission Focused, Excellence Driven, ensuring a medically ready force to fly, fight and win with four main strategic imperatives for the Air Force Medical Service (AFMS): 1. Deliver Department of the Air Force (DAF) Integrated Operational Capability, 2. Enhance Joint Force Readiness Support, 3. Drive Advance Medical Force Development, and 4. Provide a Medically Ready Force. The Clinical Engineering and Equipment Sustainment (AFMEDCOM A4/10E) Division of Air Force Logistics and Installation Support (AFMEDCOM A4/10) Directorate provides operational support, analysis, and program management to our warfighters, AFMS enterprise-level, and the Military Health System (MHS) contingency and expeditionary medical equipment. This position will be utilized to support lifecycle program management of medical technologies from initial requirement identification through operational testing to contracting through delivery, sustainment and disposal for contingency and expeditionary operations. The support will include, but is not limited to: identifying Original Equipment Manufacturers (OEMs) currently existing on the market through market analysis and available contracting agencies, noting concerns to the Senior Clinical Engineer regarding equipment or facility requirements for deployed environments, liaising between the OEM and cybersecurity approval offices, requirement owners, contracting agencies or others, reviewing medical maintenance data and identifying trends, reviewing available medical maintenance plans or training options and providing recommendations to the Senior Clinical Engineer on the courses of action, assisting with the development of total cost of ownership calculations for contingency medical equipment, identifying equipment concerns based on staffing expertise/levels, supporting the program managers for contracting actions and budgetary actions, and providing sound engineering recommendations to the Senior Clinical Engineer for contingency, expeditionary, and war reserve medical equipment.

1.2. Scope. This Performance Work Statement (PWS) defines the general tasks for non-personal services including professional support, studies, analyses, evaluations, engineering and technical services. This is a performance-based, non-personal services requirement to provide the labor necessary to perform tasks in the functional area of Biomedical/Clinical Engineer V by providing support for the AFMEDCOM mission and specifically contingency, war reserve material (WRM), and expeditionary medical equipment. The Contractor shall assist, support, and advise the AFMEDCOM A4/10E Division with the technical and engineering aspects of lifecycle program management of medical technologies from initial requirement identification through operational testing to contracting through delivery, sustainment and disposal for contingency and expeditionary operations. The support will include, but not limited to: identifying Original Equipment Manufacturers (OEMs) currently existing on the market through market analysis and available contracting agencies, noting concerns to the Senior Clinical Engineer regarding equipment or facility requirements for a deployed environments, liaising between the OEM and cybersecurity approval offices, requirement owners, contracting agencies or others, reviewing medical maintenance data and identifying trends, reviewing available medical maintenance plans or training options and providing recommendations to the Senior Clinical Engineer on the courses of action, assisting with the development of total cost of ownership calculations for contingency medical equipment, identifying equipment concerns based on staffing expertise/levels, supporting the program managers for contracting actions and budgetary actions, and providing sound engineering recommendations to the Senior Clinical Engineer for contingency, expeditionary, and war reserve medical equipment. All will be accomplished in accordance with applicable statutes and regulations for contingency and expeditionary medical equipment within the AFMS.

While Government will not supervise Contractor personnel, Contractor performance will be monitored to ensure adherence to PWS and successful performance. Under no circumstances shall the Government assign tasks to prepare work schedules for Contractor personnel. It shall be the responsibility of the Contractor to manage its personnel and to guard against any actions that are personal services or give the perception of personal services. If the Contractor feels any actions constitute or are perceived to constitute personal services, notify the Contracting Officer (CO) immediately. These services shall not be used to perform work of a policy/decision making or management nature, i.e., inherently Governmental functions. All decisions relative to programs supported by the Contractor shall be the sole responsibility of the Government.

2. GENERAL INFORMATION

2.1. Contractor Identification.

All Contractor/Subcontractor personnel shall identify themselves as Government Contractor personnel during all forms of communication such as business meetings, telephone conversations, electronic mail, attendance sheets, coordination documentations, reports, and the signature blocks utilized in all correspondence. If a contract requires Government workspace, the Contractor/Subcontractor personnel shall wear a picture identification badge and identify their workspace area with their name and company affiliation.

2.2. Contractor Training.

Table 1-Contractor Training

Training
Form
Frequency
Department of Defense (DoD) Cyber Awareness Challenge.
Web-based
Annual
Health Insurance Portability & Accountability Act (HIPAA) and Privacy Act Training
Web-based
Annual

2.3. Contractor/Government Communication.

2.3.1. The Contractor shall designate a Focal Point to be the single point of contact for all Contractor and Government correspondence. The Focal Point shall provide clear and consistent written and verbal response to Government within 24 hours of Government initiated communication (e.g., return phone calls, emails or other communication).

2.3.2. The Contractor’s Focal Point shall meet with the Government team at least quarterly. Additional meetings may be requested by the Government or the Contractor as necessary. The Contracting Officer (CO), Contractor Focal Point, CORs and/or other designated representative will provide monthly performance feedback to the Contractor. The Contractor shall provide an agenda and minutes IAW Contract Data Requirements List (CDRL) A001 and A002 and corresponding DID.

2.4. Monthly Status/Financial Report. The Contractor shall prepare and submit a monthly status/financial report identifying all tasks performed, status, issues, and anticipated actions consistent with the PWS. The Contractor shall provide the Monthly Status/Financial Report IAW CDRL A003 and associated DID.

2.5. Place of Performance. The work to be performed under this contract will be performed at 693 Neiman Street, Ft. Detrick, MD 21702 and Ft. Detrick Area B, 1270 Montevue Lane, Ft. Detrick, MD, 21702.

2.6. Travel Requirements.

Table 1 Trip Purpose

Conferences
Projected Dates
Travel Location
# Days
#Travelers
RSNA
Late Nov/Early Dec
Chicago, IL
5 days
1
AMSUS
February/March
National Harbor, MD
4 days
1
MHSRS
August/September
Kissimmee, FL
5 days
1
MRA/CSDC Visit
Semi-Annually
TBD, CONUS
3 days
1
MRA/CSDC Visit
Semi-Annually
TBD, CONUS
3 days
1
Assist with First Article Test
Semi-Annually
TBD, CONUS
5 days
1
Military Medical Exercise/Planning Meeting Advisor
Annually
TBD, CONUS
5 days
1
Device Deployment
Annually
TBD, CONUS
3 days
1

2.6.1. Contractor personnel may periodically be required to travel as described in but not limited to PWS Travel Table 1: Travel Schedule.

2.6.2. Prior to travel the Contractor shall coordinate with and receive authorization from the COR for all travel. The Contractor shall be responsible for obtaining all passenger transportation, lodging, and subsistence at the best value for the Government. Reimbursement of travel costs shall be IAW FAR 31.205-46, Travel Costs.

2.6.3. The Contractor shall submit a travel report to the COR 5 business days after each trip completion. Travel report format shall include a minimum of the following: dates of travel, destination, purpose, individuals contacted, brief synopsis, issues and challenges, recommendations, and the traveler’s signature. The Contractor shall provide the Travel Report IAW CDRL A004.

2.7. Mission/Emergency Essential. None of the services listed in this PWS are mission/emergency essential.

2.8. Duty Hours. Normal duty hours (for that location) are 7:30 am to 4:30 pm (time may be adjusted accordingly), Monday through Friday (excluding Federal Holidays) with increased flexibility for telecommuting during Military Pass days when published.

2.9 Telecommuting.

2.9.

2.9.1. Telecommuting is authorized on an ad-hoc or situational basis for this contract. Routine, recurring telecommuting (3 or less days per week) may be authorized upon the written approval of the CO/COR provided the contractor is accomplishing value-added work IAW this PWS. The COR shall have final approval of telecommuting schedules. In the event telecommuting is authorized, a laptop with a Virtual Private Network account and Common Access Card (CAC) accessibility shall also be provided and supported by the government in locations referenced in Section 2.5. In the event of unplanned closure of the facility due to natural disasters, military emergency or severe weather, the contractor may propose an alternate work location subject to the prior coordination of the contractor’s focal point and COR. Contractors shall complete the telework training course, and a signed agreement shall be in place and provided to the COR/PM prior to telecommuting. The contract personnel telecommuting will ensure continuity and timeliness in completing tasks.

2.9.2. While telecommuting, contractor personnel must respond to any inquiries from the COR or designated government official within 2 hours. In the event the contractor personnel are unable to log onto their laptop due to VPN or CAC issues, the contractor employee shall either take leave following company policies, or report to an alternate location where meaningful work can be accomplished. The contractor may not charge the Government for work not performed or travel time a contractor employee may require locating a suitable alternative location. Teleworking arrangements may be revoked by the Contracting Officer through written correspondence; contract personnel will be required to return to work on the next business day.

2.10. Federal Holidays. Federal offices are closed on federal holidays as established by Federal law (5 U.S.C. 6103) and any other holidays declared by executive order. Holidays are documented by year on the Office of Personnel Management website for Federal employees located at: https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview.

2.11. Facility Closures. The Government will notify the Contractor of anticipated closure of the facility, (i.e., training, holidays, administrative leave granted to the entire staff, or other closure including down days) five (5) business days in advance or as soon as possible. A Military Pass Day is a day that the United States Air Force (USAF) leadership designates as a minimal manning/liberal leave day. The employee may take leave following their company’s policies or work from an alternate location. In the event of unplanned closure of the facility due to natural disasters, military emergency or severe weather, the Government will notify the Contractor in the same manner as the Government notifies Washington D.C. area civilian personnel.

2.12. Conduct of Contractor Personnel.

2.12.1. Reference FAR 3.1002(a) The CO or designated Government representative may require Contractor personnel working under this contract be removed from the job site. Removal from the job site or dismissal from the premises shall not relieve the Contractor of the contract requirements.

2.12.2. Contractor personnel shall observe Government facility parking, safety and traffic regulations that apply to all facility employees.

2.12.3. Alcoholic beverages on the job are prohibited.

2.12.4. There shall be no loud, profane or abusive language used on the job.

2.12.5. Contractor personnel shall present a neat well-groomed appearance. Neat, clean, business casual or business attire clothing shall be worn.

2.13. Controlled Unclassified Information (CUI).

2.13.1. CUI is Government created or owned UNCLASSIFIED information that must be safeguarded from unauthorized disclosure.

2.13.2. Information requiring specific security measures indexed under one system across the Federal Government DoD Instruction 5200.48, “Controlled Unclassified Information,” established DoD CUI policy on March 6, 2020.

2.13.3. All information produced as a result of contract performance shall be reviewed prior to dissemination to determine if CUI is identified, and if so refer to DoDI 5200.48 for additional instructions regarding designation, handling, and decontrolling of CUI (including CUI identification, sharing, marking, safeguarding, storage, dissemination, destruction, and records management).

2.14. Personnel Staffing:

2.14.1. The Contractor shall accomplish, at a minimum, the following personnel staffing performance management outcomes:

2.14.1.1. Ensure positions are filled 100% and are present for duty within 15 days after the start of the period of performance (POP) in the contract.

2.14.1.2. Ensure continuation of services during personnel absences due to sickness, leave, and voluntary or involuntary termination from employment such that impact to the Government is minimal and position vacancies do not exceed 10 calendar days. The Contractors shall maintain an overall filled rate of 95%.

2.14.1.3. The substitute/replacement personnel shall begin work no later than 10 calendar days after notification or immediately after departure of the incumbent personnel, whichever is earlier.

2.14.1.4. The Contractors shall promptly notify the contracting officer and COR within five (5) calendar days of a projected vacancy exceeding 10 calendar days.

2.14.1.5. Provide a stable workforce with less than 30% turnover across all contracted positions. A turnover is recorded when a worker leaves a position for any reason, and the Government still has a requirement for that position.

2.14.1.6. The Government will not pay for services not rendered if a vacancy exceeds 10 business days

3. CONTRACT REQUIREMENTS

3.1. Support Services.

3.1.1. Biomedical/Clinical Engineer V.

3.1.2. The Biomedical/Clinical Engineer V must have three (3) years of experience in healthcare technology management and clinical engineering analysis of a wide range medical device requirements. Experience must include device/system lifecycle analysis, project management, requirements management, market research, technical capabilities evaluations, clinical human factors analysis, and installation requirements reviews (i.e. electrical, plumbing, basic construction, information technology (IT), cybersecurity, structural, Heating, Ventilation and Air Conditioning (HVAC), environmental factors, and integration). The Biomedical/Clinical Engineer V shall have consulting or customer relationship interaction experience in which he/she demonstrated critical thinking skills to solve a wide variety of problems. The Biomedical/Clinical Engineer V shall have demonstrated consistent attention to detail in the development of high-quality work products, with the ability to clearly communicate findings to Government and DoD personnel. The Biomedical/Clinical Engineer V shall have demonstrated leadership and/or peer-leadership on inter-disciplinary healthcare teams, while balancing conflict resolution, multiple responsibilities, priorities, task deadlines, organizational problems, and implementation of efficient and effective solutions.

3.1.3. Roles and Responsibilities. The Biomedical/Clinical Engineer V shall:

3.1.4.1. Provide comprehensive engineering support to AFMEDCOM/A4/10E Division, in the planning and execution of AFMS medical equipment lifecycle management for contingency and expeditionary medical equipment.

3.1.4.2. Provide comprehensive engineering support to AFMEDCOM/A4/10E Division on deployable medical equipment and related technologies found in War Reserve Materiel (WRM) and Manpower and Equipment Force Packaging System (MEFPAK) assemblages. Types of devices found within WRM, or contingency operations include, but are not limited to: Computed Tomography (CT) scanners, digital fixed and mobile X-ray (Digital Radiography), ventilators, lab analyzers, electrical generators, environmental control units (ECUs), oxygen generators and storage units, sterilizers, Operating Room tables, dental devices, patient monitoring, etc.

3.1.4.3. Provide technical and administrative support to the AFMEDCOM/A4/10E Division for contingency, expeditionary and WRM.

3.1.4.4. Provide project management and expert engineering guidance as it relates to various medical devices and systems deployed by AFMEDCOM, Air Combat Command (ACC), Air Mobility Command (AMC), Air Force Special Operations Command (AFSOC), and other Air Force Major Commands (MAJCOMs). Shall provide technical expertise and input to AFMEDCOM A4/10E supporting a variety of medical device and system acquisitions. Shall support various medical device and system acquisitions with technical expertise. Shall be familiar with medical device principles and operations.

3.1.4.5. Assist in the development of life cycle medical equipment requirements.

3.1.4.6. Advise the Senior Engineer of any medical equipment concerns related to current AFMEDCOM A4/10E budgetary constraints, current staffing/expertise levels that would support equipment downrange, necessary supplies needed for operation of contingency, expeditionary, and WRM equipment.

3.1.4.7. Recommend policies and/or directives to the AFMEDCOM/A4/10E Division related to AFMS contingency, war reserve material, and expeditionary healthcare technology management, and provide initial drafts.

3.1.4.8. Provide technical assessments on engineering and project management aspects of the AFMS contingency and expeditionary equipment replacement and modernization requests to ensure all feasible lifecycle considerations (technical, clinical, facilities, training, IM/IT, cyber) for use in a deployed environment or storage location have been addressed and coordinated with AFMEDCOM/A4/10E prior to purchase. The equipment request shall be assessed, and the results shall be shared with AFMEDCOM/A4/10E within two (2) weeks of being assigned. This shall include review of existing operational equipment historical maintenance data found in the Joint Medical Asset Repository (JMAR), Defense Medical Logistics Standard Support (DMLSS), and/or Defense Medical Logistics – Enterprise Solution (DML-ES) systems. This review will ensure replacement of a medical device is financially responsible, necessary to maintain a standard of patient care, and aligns with AFMS, MAJCOM, and MEFPAK Responsible Agency (MRA) priorities, and can be used effectively in a deployed location.

3.1.4.9. Assist Government Representatives with technology review, engineering assessments, and/or site surveys and provide technical expertise and inputs to AFMEDCOM/ A4/10E for contingency, expeditionary and war reserve equipment.

3.1.4.10. Supports the tracking of on-going projects and deliveries/installations for any of the centrally procured or centrally assisted medical device procurements for the MEFPAK Responsible Agencies or Consolidated WRM Storage and Deployment Centers (CDSCs). Notifies AFMEDCOM/A4/10E of any slippage or delays in projects.

3.1.4.11. Identifies whether a medical device is currently in compliance with Risk Management Framework (RMF) cybersecurity requirements or other interface requirements using an online system or by contacting the appropriate approval office. Acts as a liaison between the Original Equipment Manufacturers (OEM) and cybersecurity office and other requirement owners to identify any issues to AFMEDCOM A4/10E concerning a medical device ability to connect to the network or receive updates while in the deployed environment or in a storage facility during life cycle planning.

3.1.4.12. Provides recommendations to AFMEDCOM A4/10E and MEFPAK Responsible Agencies for enterprise-wide replacement/upgrade plans for contingency, expeditionary, or WRM equipment. Reviews current operational inventory records to identify trends in maintenance data that would trigger a replacement. Assists with the development of total cost of ownership calculations for contingency medical equipment. Reviews available medical maintenance plans or training options and providing recommendations to AFMEDCOM A4/10E on the courses of action.

3.1.4.13. Provides sound engineering recommendations to the AFMEDCOM A4/10E on operational equipment needs or trends in maintenance history to support AFMEDCOM A4/10E on the development of a prioritization matrix.

3.1.4.14. Supports the market research and analysis of a wide range of medical devices, identifying Original Equipment Manufacturers (OEMs) currently existing on the market, identifies available contracting agencies. Advises AFMEDCOM A4/10E on the results of this research. Assists with the collection of budgetary quotes requested by Government personnel and makes sound engineering recommendations to AFMEDCOM A4/10E and/or other Government representatives on whether the product meets the requirements. Makes engineering recommendations and assists with drafting contracting packages for medical devices and technology to AFMEDCOM A4/10E.

3.1.4.15. When directed, communicate with vendors to set up product demonstrations for AFMEDCOM A4/10E.

3.1.4.16. Assist in the development of medical materiel procurement and sustainment packages for respective sources of supply of operational equipment. Organizes medical materiel purchase and sustainment requests, as well as contracting packages, for approval by AFMEDCOM A4/10E for WRM, contingency, and expeditionary medical equipment.

3.1.4.17. Research and advise on upcoming industry changes in developing medical devices that may significantly improve or impact warfighter care.

3.1.4.18. As requested, assists with the preparation of Business Case Analyses (BCAs) comparing various operational healthcare technology lifecycle management courses of action (COAs) and submits to AFMEDCOM A4/10E by the deadline indicated.

3.1.4.19. Participate in and provide subject matter expertise for first article tests.

3.1.4.20. Estimated Workload. The quantities, as stated herein Table 2, are estimates and, as such, are subject to variations. These estimates are not conclusive. These estimates are provided for the Contractor to understand the potential full scope of workload to be performed; complete requirement descriptions are outlined further throughout this PWS. There are an estimated 500 customers requiring support (i.e., 500 users that are spread out throughout AFMS and MHS). The column titled “Number of Events” represents the number of occurrences of that event within a month. The Contractor shall be responsible for providing feedback to the Government if these workload estimates are found to have a range variation of greater than 15%. Negotiations for an equitable estimated cost adjustment may be initiated by either party if a variation over 15% is found to exist. These figures are based on historical data and are not intended to alter the firm fixed priced nature of performing this work.

Table 2

Description of Events for the Biomedical/ Clinical Engineer V
Number of Events (Per Month)

Analyze and advise AFMEDCOM A4/10E on Vendor equipment; Supports the collection of budgetary quotes and makes sound engineering recommendations for operational, contingency, expeditionary, and WRM equipment to AFMEDCOM A4/10E and/or other Government representatives on whether the product meets the requirements.

Supports the tracking of ongoing projects and installation timelines and advises AFMEDCOM A4/10E of any potential delays; Provides sound engineering recommendations to AFMEDCOM A4/10E on operational equipment needs or trends in maintenance history to support AFMEDCOM A4/10E on the development of a prioritization matrix.

Supports the market research and analysis of a wide range of medical devices, identifying Original Equipment Manufacturers (OEMs) currently existing on the market, identifies available contracting agencies. Advises AFMEDCOM A4/10E on the results of this research. Assists with the collection of budgetary quotes requested by Government personnel and makes sound engineering recommendations to AFMEDCOM A4/10E and/or other Government representatives on whether the product meets the requirements; Makes engineering recommendations and assists with drafting of contracting packages for medical devices and technology to AFMEDCOM A4/10E.

Liaise w/ CSDCs, MRAs, and AFMEDCOM A4/10E, and other requirement owners to provide engineering input for Government consideration.

Provides comprehensive engineering support to AFMEDCOM A4/10E, in the planning and execution of AFMS medical equipment lifecycle replacement and modernization; Assists in the technical development and refinement of assemblage allowance standard medical equipment requirements in advance of lifecycle replacement. Assist in the development of all contingency equipment Lifecycle management plans.

Assists in preparation of Business Case Analyses (BCAs) comparing various operational healthcare technology lifecycle management courses of action (COAs) and submits to AFMEDCOM A4/10E by the deadline indicated.

Recommend engineering policies and/or directives to the AFMEDCOM A4/10E Division related to AFMS operational healthcare technology management and provide initial drafts.

Research and technically advise/brief on upcoming industry changes in developing medical devices that may significantly improve or impact warfighter care.

Provides engineering recommendations and technical advice to AFMEDCOM A4/10E concerning operational requirements compared to the medical devices on market and liaison with vendors as directed by the Government. Communicate with vendors to set up product demonstrations with AFMEDCOM A4/10E.

Participate in and provide SME knowledge for first article tests.

Total Number of Events:
250

3.2. Minimum Qualifications:

3.2.1. Education and Certifications. The Biomedical/Clinical Engineer V shall have a Bachelor of Science in Engineering or higher (Master’s or higher preferred but not required) from a school accredited by the Accreditation Board for Engineering and Technology (ABET) as a professional engineering curriculum that includes differential and integral calculus and courses (more advanced than first-year) in five (5) of the following seven (7) areas: (a) statics and dynamics; (b) strength of materials (stress-strain relationships); (c) fluid mechanics, hydraulics;

(d) thermodynamics; (e) electrical fields and circuits; (f) nature and properties of materials (relating particle and aggregate structure to properties) and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics. Examples of acceptable engineering degrees include Biomedical Engineering, Clinical Engineering, Bioengineering, Biomechanical Engineering, Electrical Engineering, Mechanical Engineering, and Biochemical Engineering. Titles may vary from educational institutions and change over time. The Biomedical/Clinical Engineer V may also have a bachelor’s degree not listed above while also being currently Certified in Clinical Engineering (CCE) from the American College of Clinical Engineering (ACCE).

3.2.2. Experience. The Biomedical/Clinical Engineer V must have three (3) years of experience in healthcare technology management and clinical engineering analysis of a wide range medical device requirements. Experience must include device/system lifecycle analysis, project management, requirements management, market research, technical capabilities evaluations, clinical human factors analysis, and installation requirements reviews (i.e., electrical, plumbing, basic construction, information technology (IT), cybersecurity, structural, Heating, Ventilation and Air Conditioning (HVAC), environmental factors, and integration). The Biomedical/Clinical Engineer V shall have consulting or customer relationship interaction experience in which he/she demonstrated critical thinking skills to solve a wide variety of problems. The Biomedical/Clinical Engineer V shall have demonstrated consistent attention to detail in the development of high-quality work products, with the ability to clearly communicate findings to Government and DoD personnel. The Biomedical/Clinical Engineer V shall have demonstrated leadership and/or peer-leadership on inter-disciplinary healthcare teams, while balancing conflict resolution, multiple responsibilities, priorities, task deadlines, organizational problems, and implementation of efficient and effective solutions.

3.3. Security Requirements. (For Unclassified Contracts)

3.3.1. Personnel Clearance: The Contractor personnel shall have a Tier 1 (NACI) investigative clearance/background investigation prior to performing work on this contract. The Contractor shall request personnel security clearances to include fingerprinting, and all associated clearance tasks, at the company’s expense. The Contractor shall provide documentation received from the appropriate Government agency as to the verification of contract personnel’s Tier 1 certification. Due to costs involved with security investigations, requests for personnel security clearances shall be kept to the minimum required to fulfil contract requirements.

3.3.2. Facility Clearance: The Contractor shall possess or obtain an appropriate facility security clearance (Secret) prior to performing work on a classified Government contract. If the Contractor does not possess a facility clearance the Government will request one. The Government assumes costs and conducts investigations for Top Secret, Secret, and Confidential facility security clearances. The Contractor shall request a facility clearance, at the company’s expense.

3.3.3. Local Area Network (LAN). All Contractor employees requiring access to the Government unclassified computer network shall have a valid Tier 1 investigation verified through JPAS. No Contractor employee will be provided access to unclassified computer network or its inherent capabilities (i.e., internet access, electronic mail, file and print services) without a valid Tier 1 investigation. The Contractor shall be aware of and abide by all Government regulations concerning the authorized use of the Government’s computer network including the restriction against using the network to recruit Government personnel or advertise job openings.

3.3.4. Disclosure of Information. In the performance of this contract, the Contractor may have access to data and information proprietary to a Government agency or to another Government Contractor, or of such nature that its dissemination or use, other than as specified in this contract, would be illegal or otherwise adverse to the interests of the Government or others. The Contractor and its personnel shall not divulge, or release data or information developed or obtained under performance of this contract, except to authorized Government personnel or upon written approval of the CO. The Contractor and its Contractor personnel shall not use, disclose, keep for personal use or reproduce proprietary information bearing a restrictive legend, other than as specified in the contract.

3.3.5. Non-Disclosure Agreement (NDA). All Contractor employees shall sign the non-disclosure statement provided at Appendix B and submit to the CO prior to beginning performance on this contract.

3.4. Service Contract Reporting (SCR) The Contractor shall report manpower data IAW the current Guidebook for Service Contract Reporting in the SAM. User Manuals: Additional guidance can be found in the Guidebook for Service Contract Reporting in the System for Award Management.

3.5. Quality Control Plan (QCP): The Contractor is responsible for Contract Management and Quality Control, not the Government. The Contractor shall submit a Quality Control Plan (QCP) (10) business days after contract award and maintain/update it thereafter.

3.6. Post-Award and Initial Contract Performance Meeting. The Contractor shall participate in the post-award meeting scheduled by the Government.

4. PERFORMANCE OBJECTIVES

4.1. Services Summary (SS).

The Contractor services requirements are summarized as performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service for each requirement. These thresholds are critical to mission success.

Services Summary Table

Item #
Performance Objective
PWS Paragraph
Performance Standard
AQL/Performance Threshold

(This is the maximum error rate.)

Method of Surveillance

#01
Provides sound engineering recommendations to Medical Logistics AFMEDCOM A4/10E on operational equipment needs or trends in maintenance history to support Medical Logistics AFMEDCOMA4/10E on the development of a prioritization matrix.
3.1.4.18.
All personnel meet specified requirements
Exceptional: 100% compliance

Very Good: 95-99% compliance

Satisfactory: 90-94% compliance

Marginal: 85-89% compliance

Unsatisfactory: <85% compliance Review of personnel records and qualifications through Periodic Surveillance by COR

#02
Supports the market research and analysis of a wide range of medical devices, identifying Original Equipment Manufacturers (OEMs) currently existing on the market, identifies available contracting agencies. Advises AFMEDCOMA4/10E on the results of this research.
3.1.4.14.
Required staffing levels maintained with minimal disruption
Exceptional: 100% staffing levels maintained

Very Good: 95-99% staffing levels maintained

Satisfactory: 90-94% staffing levels maintained

Marginal: 85-89% staffing levels maintained

Unsatisfactory: <85% staffing levels maintained Review of monthly staffing reports through Periodic Surveillance by COR

#03
Identifies whether a medical device is currently in compliance with RMF cybersecurity requirements or other interface requirements using an online system or by contacting the appropriate approval office.
3.1.4.11.
All deliverables submitted on time and in correct format
Exceptional: 100% on time, correctly formatted

Very Good: 95-99% on time, correctly formatted

Satisfactory: 90-94% on time, correctly formatted

Marginal: 85-89% on-time, correctly formatted

Unsatisfactory: <85% on time, correctly formatted 100% inspection of deliverable submissions

#04
Track, using established systems, receipt of equipment procured through AFMEDCOM A4/10E. Monitor training as indicated by the procurement contracts.
3.1.4.10.
Accurate and timely submission of hours worked reports
Exceptional: 100% accurate and on-time

Very Good: 1-2 minor errors or delays per month

Satisfactory: 3-4 minor errors or delays per month

Marginal: 5-6 minor errors or delays per month

Unsatisfactory: >6 minor errors or delays, or any major errors Random Sampling and Periodic Surveillance

#05
Assists in the technical development and refinement of assemblage allowance standard medical equipment requirements in advance of lifecycle replacement.
3.1.4.12.
Full compliance with all applicable regulations
Exceptional: Zero non-compliance issues

Very Good: 1-2 minor non-compliance issues per year

Satisfactory: 3-4 minor non-compliance issues per year

Marginal: 5-6 minor non-compliance issues per year

Unsatisfactory: >6 minor or any major non-compliance issues Periodic compliance audits and reviews through Periodic Surveillance and Customer Feedback

#06
Participate in and provide SME knowledge for first article tests.
3.1.4.20
Successful completion of all required tasks
Exceptional: All tasks completed on time with excellent quality

Very Good: 95-99% tasks completed on time with good quality

Satisfactory: 90-94% tasks completed on time with acceptable quality

Marginal: 85-89% tasks completed on time or with quality issues

Unsatisfactory: <85% tasks completed on time or significant quality issues Program reviews and task completion report assessments through Periodic Surveillance and Customer Feedback

#07
Assists in the preparation of Business Case Analyses (BCAs) comparing various operational healthcare technology lifecycle management courses of action (COAs) and submits to AFMEDCOM A4/10E by the deadline indicated.
3.1.1.3.
All technical support and maintenance tasks are performed IAW OEM standards and schedules
Exceptional: 100% compliance with PMCS schedules

Very Good: 95% compliance

Satisfactory: 90% compliance

Marginal: 85% compliance

Unsatisfactory: Less than 85% compliance 100% Inspection of maintenance records and logs by the COR

#08
Provides input on engineering policies and/or directives to the AFMEDCOMA4/10E Division related to AFMS operational healthcare technology management and provides initial drafts.
3.1.1.4.
Upgrades are performed as they become available, or as requested
Exceptional: 100% of upgrades performed timely

Very Good: 95% timely upgrades

Satisfactory: 90% timely upgrades

Marginal: 85% timely upgrades

Unsatisfactory: Less than 85% timely upgrades Periodic Surveillance by the COR.

5. GOVERNMENT FURNISHED PROPERTY (GFP) The Contractor’s responsibilities for the GFP are outlined in the Government Property clause 52.245-1

6. DELIVERABLES

6.1. The Contractor shall submit all deliverables as specified in this PWS and contract Exhibit A, Contract Data Requirements List (CDRL).

6.2. All deliverables shall be submitted electronically to the COR(s) unless otherwise directed.

6.3. The Contractor shall provide informal reports by e-mail as requested by the COR.

Appendix A

ACRONYMS

Acronyms and Definitions

ACRONYM
DEFINITIONS
AF
Air Force
AF/SG
Air Force Surgeon General
AFFARS
Air Force Federal Acquisition Regulation
AFI
Air Force Instruction
AFMEDCOM
Air Force Medical Command
AFMS
Air Force Medical Service
AIS
Automated Information System
AMC
Air Mobility Command
AT
Anti-Terrorism
AT/CUD
Acceptance Testing/Clinical Use Determination
CAC
Common Access Card
CDRL
Contract Data Requirements List
CE
Clinical Engineering
CONUS
Continental United States
COR
Contracting Officer Representative
CPAR
Contractor Performance Assessment Reports
DFARS
Defense Federal Acquisition Regulation
DHA
Defense Health Agency
DIACAP
DoD Information Assurance Certification and Accreditation Process
DLA
Defense Logistics Agency
DMLSS
Defense Medical Logistics Standard System
DML-ES
Defense Medical Logistics – Enterprise Solution
DOB
Date of Birth
DoD
Department of Defense
DoDD
Department of Defense Directive
DoDI
Department of Defense Instructions
DSA
Data Service Agreement
DUA
Data Use Agreement
ECUs
Environmental control units
FAR
Federal Acquisition Regulation
FDA
Federal Drug Administration
FOUO
For Official Use Only
FTE
Full Time Equivalent
FY
Fiscal Year
HIPAA
Health Insurance Portability and Accountability Act of 1996
HQ USAF/SG
Headquarters United States Air Force Surgeon General
HTM
Healthcare Technology Management
HVAC
Heating, Ventilation and Air Conditioning
IA
Information Assurance
IAW
In Accordance With
IM
Information Management
IT
Information Technology
IV&V
Independent Verification and Validation
JMAR
Joint Medical Asset Repository
JKO
Joint Knowledge Online
CO
Contracting Officer
CT
Computer Tomography scanners
LAN
Local Area Network
MEFPAK
Manpower and Equipment Force Packaging System
MHS
Military Health System
NACI
National Agency Check with Inquiries
NACLC
National Agency Check with Local Agency Check and Credit Check
NDA
Non-Disclosure Agreement
NLT
no later than
NOPP
Notice of Privacy Practices
OCI
Organizational Conflict of Interest
OCONUS
Outside the Continental United States
ODC
Other Direct Cost
OEM
Original Equipment Manufacturer
OHTM
Operational Healthcare Technology Management
OMT&E
Operational Medicine Test & Evaluation
PAR
Performance Assessment Report
PD2
Procurement Desktop-Defense
PHI
Protected Health Information
PII
Personally Identifiable Information
PIT
Platform Information Technology
PKI
Public Key Infrastructure
PM
Program Manager
PMO
Program Management Office
PMP
Project Management Professional
POC
Point of Contact
PWS
Performance Work Statement
QC
Quality Control
QCP
Quality Control Plan
RFP
Request for Proposal
RMF
Risk Management Framework
SCR
Service Contract Reporting
SG
Surgeon General
SIPRNET
Secret Internet Protocol Router Network
SLA
Service Level Agreement
SORNS
System of Record Notices
SOW
Statement of Work
SS
Service Summary
TDY
Temporary Duty
VGSA
Visitor Group Security Agreement
VPN
Virtual Private Network
WRM
War Reserve Materiel

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File details come from the government source that posted it. Updated .