Attachment 1 Statement of Work 3.12.24 COTS Radiography Xray Retrofit.pdf

FEDERAL AVIATION ADMINISTRATION

CIVIL AREOSPACE MEDICAL INSTITUTE

Acquisition of

Digital Retrofit for X-Ray Room & Installation

STATEMENT OF WORK

February 13, 2024

Page ii

Table of Contents

1 BACKGROUND

1.1 OVERVIEW

1.2 ACRONYMS AND ABBREVIATIONS

2 APPLICABLE DOCUMENTS

2.1 FAA DOCUMENTS

2.2 OTHER DOCUMENTS

3 REQUIREMENTS

3.1 PROGRAM MANAGEMENT

3.1.1 Program Administration

3.1.2 Quality Assurance

3.2 PROCUREMENT OF HARDWARE AND SOFTWARE

3.2.1 Hardware

3.2.1.1 Workstation/server

3.3 PRE-INSTALLATION ACTIVITIES

3.3.1 Factory Acceptance Test Planning

3.3.2 Site Acceptance Test Planning

3.3.3 Pre-Installation Preparation

3.4 INSTALLATION, INTEGRATION AND ACCEPTANCE TESTING

3.4.1 Installation and Integration

3.4.2 Site Acceptance Testing

3.5 POST-INSTALLATION ACTIVITIES

3.5.1 Software and Documentation

3.5.2 Decommissioning of Equipment

3.5.3 Training Program

3.6 Supply Support

3.6.1 Packaging, Handling, Storage, and Transportation (PHS&T)

3.6.5 Contractor Maintenance

3.6.5.1 Operational Hardware Maintenance Services

3.6.5.4 Software Maintenance

3.6.5.6 Contractor Contact Procedure

3.6.5.7 Support Facilities

1 Background

1.1 Overview

The Federal Aviation Administration (FAA) Civil Aerospace Medical Institute (CAMI) Occupational Medicine Health Clinic Division (AAM-700) requires a Firm Fixed Price (FFP) and installation for a Commercial-Off-The-Shelf (COTS) Radiography X-ray Retrofit. As part of FAA CAMI AMEN Technical Refresh ACAT V Program, approved 10/19/17, AAM-700 has initiated this new request for Delivery and Installation of the following equipment:

a. Digital Radiography (DR) Detector retrofit to current radiology room.

b. Windows 10 operating system-based workstation with operating software.

AAM-700 executes the FAA’s Aeromedical Occupational Health Clinic support for local MMAC employees and the FAA employees who attend training, which focuses on providing occupational and non-occupational medical support to those students and federal employees of MMAC. This program involves urgent care, medical exams, and OSHA mandated exams provided by both physicians and mid-level providers. The AAM-700 group supports ongoing operational safety functions through its provisions of medical services.

1.2 Acronyms and Abbreviations

CAMI Civil Aerospace Medical Institute COR Contracting Officer Representative COTS Commercial Off the Shelf FDA Federal Drug Administration MMAC Mike Monroney Aeronautical Center OSHA Occupational Safety and Health Administration SOW Statement of Work

2 Applicable Documents The following specifications, handbooks, orders, standards, and drawings form a part of this SOW and are applicable to the extent specified herein. The latest version of these documents as of the contract date must apply. Copies of the referenced documents may be obtained as follows:

• Copies of FAA specifications and interface documents may be obtained from the Federal Aviation Administration, Headquarters Public Inquiry Center APA-230, 800 Independence Avenue SW, Washington, DC 20591, 202-267-3484. Requests should fully identify material desired and cite the solicitation or contract number.

• Requests for copies of documents not covered in the preceding paragraph should be addressed to the Contracting officer. Requests should fully identify material desired and cite the solicitation or contract number.

• Copies of the Acquisition Management System Test and Evaluation Process Guidelines are available in the FAA Acquisition System Toolset (FAST). The on-line internet address of FAST is: http://fast.faa.gov.

http://fast.faa.gov/

2.1 FAA Documents

Document Subject

FAA D 2404B Technical Instruction Book Manuscript: Electronic, Electrical, and Equipment, Requirements For Preparation of Manuscript and Production of Books

FAA ORDER 1600.54B FAA Automated Information Systems Security

Handbook

FAA-STD-025D Preparation of Interface Documents (10/95)

FAA-STD-020B Transition Protection, Grounding, Bonding, And Shielding (5/11/92)

FAA-STD-028B Contract Training Programs (5/1/93)

FAA-HDBK-004 National Airspace System Internet Protocol

Suite (1997)

FAA Guidance FAA Green Procurement Plan (10/11)

2.2 Other Documents

Document Subject FORM FDA 3881 Indications for Use

FORM FDA 510k Premarket Certification of Intent to Market the Device

ASTM-D-3951-95 Standard Practice for Commercial Packaging

NFPA-70 National Electric Code (NEC)

EO13423 Executive Order 13423: Strengthening Federal

Environmental, Energy, and Transportation Management (1/07)

EO13514 Executive Order 13514: Federal Leadership in

Environmental, Energy, and Economic Performance (10/09)

3 Requirements

3.1 Program Management

3.1.1 Program Administration

The Contractor must implement and document a Management Program. The MP must identify the Contractor's management, organization, authority, responsibility, controls, and the extent to which these apply to the DR Detector Retrofit and Installation. At a minimum, the Contractor must perform the following tasks in managing the delivery and installation of retrofit detector and workstation system units and their corresponding equipment:

• Produce the schedules of work that reflect and track the delivery of products as specified by this

SOW.

• The Contractor must survey the location before the installation to make sure there is proper power and data ports available and give any information regarding necessary changes if needed by the government facilities services.

• Designate a Program Manager (PM) who is responsible for integrating and maintaining the total Contractor effort as described in this SOW. The PM must be always prepared, given reasonable notice, to present and discuss with the FAA the status of contract activities.

3.1.2 Quality Assurance

The Contractor must provide and maintain a documented quality system as a means of assuring compliance with the hardware and software requirements of the contract. The quality system should be established and maintained in accordance with ISO 13485, U.S. Quality System Regulator - QSR) and must be documented in the Quality System Plan.

3.2 Procurement of Hardware and Software

The Contractor must procure the commercial off-the-shelf (COTS) products to retrofit equipment specified in Section 3.2.1 into an existing X-RAY room outfitted with a ICRco CR 3600 scanner and processor (See Figure 1). In order to comply with Executive Orders 13423 and 13514, and the FAA Green Procurement Plan (GPP), the Contractor must survey the area and provide installation and an initial technical setup, manuals, instruction books, and training support materials available from the COTS product vendors for the product. The Contractor must identify and report all license, copyright, and proprietary restrictions that affect the FAA's ability to maintain the COTS products. Maintenance warranty and drop warranty must be available for purchase.

3.2.1 Hardware

All equipment delivered must be new, manufactured in the USA, and installed by the vendor.

This effort will acquire a radiography x-ray retrofit DR detector and workstation in the following configuration:

DR Detector image plate

The detector components must include detector specifications, detector interfaces, detector environmental, detector mechanical, detector battery and detector battery charger.

Full exposure parameters can be set manually, or AEC (automatic exposure control) can be used. Anatomical programming can be set for a variety of examinations.

The contractor’s DR Detector imaging plate must use to capture the image after the x-ray has passed through the patient. Once acquired, the detector must send the image to the Image view workstation wirelessly through the closed wireless network supplied by contractor.

Higher DQE (Detected Quantum Efficiency) enabling the potential for lower dose and improved image quality.

Advanced enclosure design with an IP57 rating for better protection against ingress of dust and water.

Compatible with current wall and table Bucky that is equipped to handle up to a 17” plate/detector.

Imaging Windows 10 or newer based Workstation

The contractor’s workstation must include all supporting equipment to be used by the radiology technologist to set up views and exposure techniques for the patient exams, review and notate, add markers for radiologist reviews and then transmit images to Radiologists for review.

The data must transmit through the facilities network via a wired network connection including:

System administrative (create/modify user logon and password; create/modify output printer configurations; manage image output queue; re-send image output; manage local database [view/delete patient image files]; protect selected patient/image files from reclamation; create/modify technologist comments; perform detector array calibration;

generate test pattern images for output device QC).

Single Console:

Software, image processing, and DICOM and/or HL7 output Computer with a minimum of Intel Core i7-13700T 16 GB Memory 512 GB Solid State Drive DVD-RW and/or USB enabled drive(s) Microsoft Windows 10 Pro or newer Energy Star Qualified

Remote diagnostic service capability via internet connection

Selection of Exposure: Allow for full exposure parameters to be set manually, or AEC

(automatic exposure control) can be used.

Interface with the detector and the x-ray exposure equipment to acquire and transmit patient, exam, and image data in digital format.

Image Storage Capacity: Images must be able to be saved to removable media on a DVD-

RW and or USB enabled drive. Minimum of 500 images able to be saved for retransmission or reprocessing.

Must be able to operate without access to a Picture Archive and Communication System

(PACS).

Acquisition and distribution of data: Operator input; log on/log off; patient demographics (add / edit patients); patient accession number, study selection; search by patient name, ID, or visit number; and output setup selection (workstations, archives, printers).

Full exposure parameters must be able to be set manually, or AEC (automatic exposure control) can be used. Anatomical programming can be set for a variety of examinations.

Exposure factors for each exam view (programmed default factors with manual overrides; small/medium/large patient size selection; manual technique selection; tube warm-up capability; detector calibration).

Automatic exposure control (AEC) (ion chamber selection; manual control, AEC on/off);

detector array; detector rotation indicator (for wall stand only); exposure button (prep/exposure control button; audible/visible exposure indicator); and generator on/off.

Exposure and image capture:

Exposure factors for each exam view (programmed default factors with manual overrides; small/medium/large patient size selection; manual technique selection; tube warm-up capability; detector calibration).

Acquire and process digital images: Optimize grayscale display and apply examination specific nonlinear edge enhancement with perceptual tone-scale processing (PTS) preferred.

Display preview image (apply image cropping; apply image multi-formatting; add image markers, flip, and rotate image, enter technologist comments; accept/reject image).

Image Data Output: minimum 12-bit log

Wireless Access Point

Imaging Station Preview Monitor: Minimum of 24” with appropriate resolution capability for full image viewing.

3.2.1.1 Workstation

The Contractor must provide one (1) workstation PC, monitor, and software that meet the minimum specifications outlined in 3.2.1.

3.3 Pre-Installation Activities

3.3.1 Factory Acceptance Test Planning

The Contractor must prepare a Factory Acceptance Test (FAT) plan and a FAT procedure to validate the hardware acquired under this contract. The FAT plan and procedure must address all testing issues, including how vendor hardware and software upgrades will be integrated and tested. The FAT plan and procedure must be submitted 30 DACA.

3.3.2 Site Acceptance Test Planning

The Contractor’s Applications Consultant must be onsite for all installation services. The Contractor’s Consultant must work with the radiology team to develop a database of approved protocols and techniques and customize the system features to maximize the site’s individual workflow needs. The Contractors must train the staff and support the team as they begin to use the system with patients, as well as ongoing product technology assistance and user needs.

The Contractor must prepare a Site Acceptance Test (SAT) plan and a SAT procedure to verify and certify that all COTS hardware and all software installed and integrated at operational sites perform to vendor and FAA requirements. The Contractor must submit these documents 30 days prior to conducting the SATs.

3.3.3 Pre-Installation Preparation

The Contractor must manage the procurement actions and interfaces with the vendor(s) and must further ensure that procured hardware and software is made available on schedule, is operating to vendor specifications at delivery, and is of the same model of hardware and release of software for each type of equipment. The contractor must check all COTS products to ensure the equipment is fully functional according to vendor specifications prior to shipping to the operational sites. This includes, but is not limited to, the following actions:

- The Contractor must provide the necessary facilities and services to check the COTS products.

- The Contractor must conduct FATs to validate the workstation configuration acquired under this contract.

- The FAT must be conducted in accordance with the FAT plan and procedure (see Section 3.3.1) .

- The Contractor must pre-load all software identified by the FAA.

- The Contractor must coordinate the preparation of each workstation with the FAA Technical officer to ensure the proper version of the application software is loaded before equipment is shipped to the site.

- The Contractor must pre-configure all communications equipment, to include router parameters and NAS addressing assignments.

- The Contractor must configure the workstations to reflect the installed configuration at the operational sites and validate the workstation configuration and operation.

- The Contractor must transport all components, equipment, and spares by the most economical means possible, considering dependability, safety, urgency of need, and traceability. All materials must be shipped FOB destination, inside delivery. All shipments must be made in accordance with ASTM-D3951-95.

- Equipment and software must be shipped to arrive on-site not earlier than one week before installation or as specified by the FAA. Packing must be in accordance with standard commercial packing as specified in ASTM-D3951-95.

- The delivery must include tools and test equipment, fastening components, support equipment, special tools, and all documentation necessary to accomplish the installation and integration.

3.4 Installation, Integration and Acceptance Testing

The Contractor must coordinate system implementation with the FAA COR. The FAA will provide space, lighting, heating, ventilating, air conditioning and power to the extent necessary for the DR retrofit installation. The Contractor must install, integrate, and test all delivered hardware and software in accordance with the SIIP and the following sections.

3.4.1 Installation and Integration

The Contractor must install all equipment in accordance with manufacturer specifications and recommendations, and the provisions of FAA-STD-020b (as applicable). Contractor installations must include physical placement of equipment, mechanical connections, equipment grounding and bonding, installation of power cables and connectors, and installation of all signals, communication, LAN and interface cabling. The Contractor must remove all packaging and wrapping material immediately after unpacking the equipment. The Contractor must configure all communications components, in hardware and software, as needed to meet FAA requirements. If dismantling of existing facilities or equipment or other measures are necessary to complete the installation, full restoration to pre-installation conditions must be the responsibility of the Contractor. Workstations, cable and non-workstation equipment items being replaced must be de-installed and removed.

The Contractor must integrate all system components, ensuring proper operation when connected to existing system components, and demonstrating system readiness to perform real-time flow management tasks. Installation and testing of the equipment must not disrupt or interfere with, nor cause any disruption or interference with the FAA ATC operations in any way.

3.4.2 Site Acceptance Testing

The Contractor must complete all integration testing prior to scheduling or conducting operational site acceptance testing activities in accordance with Section 3.5.1. The Contractor must conduct Site Acceptance Testing of the all installed equipment in accordance with the Government approved SAT plan and SAT procedure.

3.5 Post-Installation Activities

3.5.1 Software and Documentation

The Contractor must deliver the documents required for the appropriate function of each instrument.

3.5.2 Decommissioning of Equipment

The Contractor must remove outdated ICRco CR 3600 scanner and processor equipment from the site, identify and divert those materials that can be recycled or reused through an R2 certified facility, and dispose of the remaining equipment or materials using FAA disposal procedures.

3.5.3 Training

The Contractor must provide familiarization training and associated materials in accordance with the requirements specified herein. The Contractor must conduct familiarization training of FAA personnel in system administration and hardware fault isolation of hardware procured and installed under this contract.

The Contractor must develop/modify and perform familiarization training in accordance with best commercial practices.

3.6 Supply Support

3.6.1 Packaging, Handling, Storage, and Transportation (PHS&T) During the Interim Contractor Maintenance and Logistics Support (ICMLS) period, ASTM-D-3951, Standard Practices for Commercial Packaging, must apply.

3.6.2 Contractor Maintenance

The Contractor must maintain all COTS products and all applications software.

3.6.2.1 Operational Hardware Maintenance Services

The Contractor must provide maintenance services and supply support for all workstation and related hardware/software installed at each operational site.

The Contractor must obtain concurrence prior to taking any maintenance action. The Contractor must notify the FAA site representative at the completion of maintenance activities and provide an assessment of equipment status.

The Contractor must identify and perform preventive maintenance required or recommended by the manufacturer. This maintenance must be scheduled and coordinated with site personnel and performed on a non-interference basis.

3.6.2.2 Software Maintenance

The Contractor must provide a toll-free telephone contact for sites to report software problems and/or to obtain assistance for all COTS software acquired and installed under this contract. The Contractor must provide vendor license agreements, and software and documentation updates. The Contractor must assess the impact of changes on the installed system and recommend a course of action to accept and implement or defer the new product.

3.6.2.3 Contractor Contact Procedure

The Contractor must create a process for reporting problems and processing corrective actions. The Contractor must maintain a toll-free telephone contact for sites to report equipment problems and/or to obtain assistance through telephone support to resolve problems that can be resolved remotely. This contact must compliment the overall Instrument support help desk. This toll free number must be accessible and responsive 24-hours per day 365 days per year.

3.6.2.4 Support Facilities

The Contractor must provide all support facilities required for storage and repair/overhaul of workstations and peripheral equipment.

Figure 1:

Current processor: ICRco- CR 3600 Xray Control: MFR: Mleistone, Model#: MS 325 HF, Date of MFR: 2/1/200, Serial: I07-024 Xray Tube: MFR: Toshiba, Model#: E7239FX, Serial#: 08M243, Tube inserts#: e7239, Insert#: 8M0070