A2 Digitial Radiology SOW (18 Nov 20).pdf

STATEMENT OF WORK

FOR

Digital Radiographic (DR) System – Thule AFB

Prepared By:

Medical Logistics Clinical Engineering Air Force Medical Readiness Agency DATE: 18 Nov 20

REVISION NUMBER: #1.4

Statement of Work for: Digital Radiographic (DR) System – Thule AFB

Table of Contents

1 SCOPE

1.1 Background

2 APPLICABLE DOCUMENTS

2.1 Department of Defense (DoD) Standards

2.1.2 Availability of DoD Documents

2.2 Other standards and publications

2.2.1 Availability of Other standards and publications

3 REQUIREMENTS

3.1 General

3.2 Detail Tasks

3.2.1 Request for Offers (RFO) Overall Minimum Requirements

3.2.4 Maintainability/Maintenance Support

3.2.5 Removal

3.2.6 Extended Installation, Turnkey or Incidental Services

3.3 Program Planning and Management

3.3.1 Site Management

3.3.2 Site Information

3.4 Deliverables

3.4.1 Language and measurements

3.4.3 Material Submittal

3.4.4 Project Schedule

3.4.5 Final Records

3.6 DHA IA/RMF Requirements

3.7 Pictures of Current Room

3.8 Deleted

3.9 Current DR Room Schematics

1 SCOPE

This Statement of Work (SOW) defines the effort required for replacing a Digital Radiographic (DR) System at Thule AB.

1.1 Background

The Digital X-ray project has been initiated to replace the GE proteus unit that will fulfill the radiology and orthopedic clinic requirements as specified in this statement of work.

2 APPLICABLE DOCUMENTS

The following documents apply to this SOW to the extent specified herein.

2.1 Department of Defense (DoD) Standards

• Final Governing Standards (FGS-GL) 2003 Edition

GreenlandFGS-July20 03.pdf

• Hazardous Waste Management Plan (A068) 2018 Edition

A068 (1 Feb 18) Hazardous Waste Ma

• Solid Waste Management Plan (A071) 2017 Edition

02 - A071 (30 March

18) Solid Waste Mana

2.1.2 Availability of DoD Documents

Unless otherwise indicated, copies of documents listed above are available from:

• Executive Services Directorate, DoD Directives Division: http://www.esd.whs.mil/DD/

• Air Force E-Publishing: http://www.e-publishing.af.mil/

• Department of Defense Instruction (DoDI) 8510.01 Risk Framework (RMF)

2.2 Other standards and publications

• Unified Facilities Criteria (UFC) 3-600-01 Fire Protection Engineering For Facilities, Change 1, 14 July 2009

• UFC 3-301-01 Structural Engineering, Appendix F, Table F-1 for Climatic Loading Data and Table F-2 for Earthquake Loading Data

• International Building Code (IBC), 2012 Edition

• National Fire Protection Agency (NFPA) 101 – Life Safety Code, 2012 Edition

• National Information Assurance Partnership (NIAP) Common Criteria Cybersecurity

Evaluation and Validation Scheme (CCEVS) evaluation (https://www.niap-ccevs.org)

2.2.1 Availability of Other standards and publications

Unless otherwise indicated, copies of documents listed above are available from:

• www.wbdg.com

3 REQUIREMENTS

http://www.e-publishing.af.mil/

3.1 General

The work required by this contract shall be performed in accordance with this Statement of Work (SOW). The Contractor shall provide all materials, plans, labor, equipment, and supervision necessary to accomplish the work requirements. The contractor shall install the DR system in accordance with the detailed requirements below. The contractor shall provide all materials, plans, labor, equipment, and supervision necessary to do the work requirements.

Only equipment and part numbers that are FDA approved, have an existing Defense Health Agency Risk Management Framework Authority to Operate, and commercially available at the time of quote submission, may be offered under this requirement.

3.2 Detail Tasks

3.2.1 Request for Offers (RFO) Overall Minimum Requirements

3.2.1.1 Generator

• At least a 65kw generator. All power at Thule is in the US standard 60 Hz. There is no noise dB limitation. If the noise is excessive, hearing protection or other contingencies will be instituted. Note: An fully functional GE generator is already on-site and compatible with the current system. It is available for use by the contractor at their own risk. Further details can be provided upon request.

3.2.1.2 Detector Plates

• Shall be a two plate Direct Radiography system: two portable wireless detectors with table-top functionality of at least 35 x 43 cm. Each wireless detector shall include a spare battery.

3.2.1.3 Wall Stand

• Shall include a wall stand.

3.2.1.4 Automatic Exposure Controls (AEC) Fields

• Shall have automatic Exposure Control for both the vertical and table buckys with a minimum of 3 AEC Fields.

3.2.1.5 Tube Head

• Shall have ceiling-mounted tube-head adjustable to accommodate weight-bearing lower extremity studies.

3.2.1.6 Table

• Shall have a fixed mounted elevating table with four-way floating tabletop design supporting at least 450lbs at the center with movement.

3.2.1.7 Positioning Devices

• Shall include automated image capture and includes any required positioning devices.

3.2.1.8 Weight Bearing

• Shall include weight-bearing extremity steps/stand with a maximum step height of 24” and capable of bearing patient weight of at least 450 lbs. The detector shall include a weight-bearing protective case for patients to stand on. The system shall include all software to complete weight-bearing exams. Shall include all software to complete these exams.

3.2.1.9 Wall Bucky

• Shall include a motorized auto-tracking, folding & tilting wall bucky that will maintain bucky/tube alignment if one is moved.

3.2.1.10 Integrated Workstation (Qty. 1)

• Shall include all software for orthopedic and radiology clinics to include weight-bearing, dose reporting, and scoli software.

• Shall have integrated independent and secure wireless capability integrating image preview at the workstation

• Shall include integrated Workstation with exam protocols and technique presets that are customizable at the time of applications training

• Shall include integrated 1-2 monitors to manage workflow, image acquisition preview, and post-processing functions. The size of the monitors should be at least 19”.

• Shall include post-processing tools at Workstation for annotation and image manipulation

3.2.1.11 Variable Grid

• Shall have a variable grid for both wall bucky/table bucky Max MA station of at least 800 mA

3.2.1.12 Charging Station

• Shall include at least one charging station and a second set of batteries for each detector.

3.2.1.13 Dose Reporting

• Shall include dose reporting software.

3.2.1.14 Repeat/Reject

• Shall include repeat/reject analysis applications program.

3.2.1.15 Manual Technique

• Manual technique selection shall be possible for all exams.

3.2.1.16 Table

• The system shall be capable of taking images of patients in wheelchairs and gurneys when patient movement to a table is not possible.

3.2.1.17 Radiologist Technician Training

• Shall include on-site/in-person user training for all components and accessories for 2 technologists at time of installation.

3.2.1.18 Acceptance Testing

• Acceptance Testing shall occur immediately after installation (on the same trip). The vendor will need to be onsite as well as the physicist.

• Lodging cost is estimated to be $185 per night per person. Air transportation will be provided by the Government from Copenhagen, Denmark to Thule Air Base.

• Vendors shall provide Maj Clifford Souder (clifford.c.souder.mil@mail.mil) and Mr.

Claudy Philemon (claudy.j.philemon.ctr@mail.mil) a finalized schedule.

3.2.1.19 Digital Imaging and Communications in Medicine (DICOM)

• Must be able to burn/export studies into a DICOM format from the workstation and include any peripherals required to do so.

• Shall include DICOM Worklist integration with the Composite Health Care System

(CHCS)

• Shall include a CD burner.

3.2.1.20 RMF

• Vendors shall only quote items that already have an Authorization to Operate (ATO)/Authorization to Connect (ATC).

• The unit shall utilize Windows 10 or Linux.

• All major component software applications (SQL, IIS, .Net, etc.) have current commercial support.

• Failure to provide ATO or ATC equipment shall result in rejection of the vendor's quote.

3.2.1.21 Vertical Cassette

• The unit shall have a vertical cassette holder (w/bucky), scoliosis holder, and protector for the 35x43cm detector for weight-bearing exams.

3.2.1.22 Power Requirements

• The system shall operate on the following: 480V. All power at Thule is in US standard 60 Hz. No UPS required for this equipment.

3.2.1.23 Phantoms

• The vendor shall provide a phantom to use during quality control testing by the radiologist technician.

3.2.4 Maintainability/Maintenance Support

3.2.4.1 Maintenance Contract

• Vendors shall only quote items that will be able to be placed on a full-service maintenance contract.

3.2.4.2 Service Personnel

• Location of nearest service personnel shall be provided as well as the option for remote support.

3.2.4.3 Operator Manuals

• The unit shall include 2 sets of operator user manuals and 2 sets of service manuals. All manuals shall be in electronic form.

3.2.4.4 Warranty

• Shall include a 1-year warranty

3.2.5 Removal

3.2.5.1 De-Install

• The current equipment shall be de-installed and removed from the facility. The equipment should be packed and ready for shipment out by sea the next port season and moved to either the DLA Disposition Services (DRMO) lot. De-install is soley the responsibility of the vendor.

3.2.6 Extended Installation, Turnkey or Incidental Services

• The final quote must include all equipment and all site prep/construction/incidental services required to provide a fully operational system that meets all minimum requirements/essential characteristics. If the system requires drilling into the floor, the floor tiles will be replaced with similar or contrasting colors approved by the Thule facility manager. If the system requires ceiling/wall patches, they shall be painted with a closely matching color.

• Vendors must provide with their quote a detailed statement of work and pricing for the installation/site work.

3.3 Program Planning and Management

3.3.1 Site Management

• The contractor shall perform a final cleanup and repair of the work area, including any damage done to adjacent grounds, pavements, or structures. Any damage shall be repaired and returned to conditions matching those before the contractor began work on this project.

3.3.2 Site Information

• Physical name of building/facility: 118 Thule AB Clinic

• Physical address of project: PSC 1501 Unit 82501 APO AE 09704

• Personnel working on the project need Foreign Visitor Request entry approval and dispensation from the Danish Ministry of Foreign Affairs unless if they are from the US, Denmark, or Canada. No US Passport is required if traveling from Denmark. Danish vendors will have to get prior authorization to get on the plane from Copenhagen.

• Note: Danish or Greenlandic authorities do not need to approve anything when entering the country.

• If the contractor has any hazardous materials, the contractor needs to submit MSDS info to our environmental specialists for approval before shipping – please use this email SHR-THU-ENVSHR-THU-ENV@vectrus.com.

3.3.3 Work Items

3.3.3.1 Water Disposal

• Water disposal from this product will be handled by the Base Maintenance Contractor according to hazardous waste procedures.

• Waste products from this project should be disposed of in Base DRMO.

3.3.3.2 Work hours

• The facility hours of operation are 7:30 am-4:30 am ET.

• Contractors can work before/after hours. Access badges would need to be acquired from

821 SPTS.

• Contractors can work weekends. Access badges would need to be acquired from 821

SPTS.

3.3.3.3 Permits and Outages

• The contractor shall obtain all applicable work permits including but not limited to AF Form 103 Work Clearance Request and utility prints for the worksite, welding; burn permit, and any permits or licenses required for the removal of hazardous materials.

• To obtain a hot work permit AF Form 592, when onsite, you will need to contact our Fire Chief Mr. Aage Johansen, ext. 3249. The Fire Chief will then issue a hot work permit for you.

• To obtain above ceiling permits, the contractor will need to submit an AF Form 103 for approval seven (7) days in advance of any work to be performed.

• An approved AF Form 103 and coordination with 821 SPTS and Medical Clinic Staff is required for above ceiling work and dealing with electrical, med gas, sprinkler, alarm, plumbing, etc. outages.

• Check UFC and NFPA requirements for additional information on the process for outages.

3.3.3.4 Facility Required Inspections

• Check UFC and NFPA requirements for information on inspection requirements for electrical, medical gas, sprinkler, plumbing, framing, etc.

3.3.3.6 Environmental

• Wildlife and arctic weather conditions are known environmental concerns or hazards at the site.

• The site is a seismic rated building. Please follow the directions of UFC 3-301-01 Table F-3, Greenland, Thule AB. The site is not an “event” rated building.

3.4 Deliverables

mailto:SHR-THU-ENVSHR-THU-ENV@vectrus.com

3.4.1 Language and measurements

All literature, measurements, and received measurements shall be in English, and utilize where possible Society of Automotive Engineers (SAE) units of measure. Unit of measure exceptions shall only be accepted for filtering measurements, water chemistry, and equipment literature that was originally written with metric measurements.

3.4.3 Material Submittal

Provide all equipment manuals and installation documentation not supplied by the Government.

3.4.4 Project Schedule

Provide a detailed project schedule showing at a minimum: major milestones towards project completion, task durations and dependencies, cargo transport requirements, and personnel travel needs. If during the period of performance of the contract there are changes to the schedule, an updated schedule would need to be provided so that a modification can be made to the contract.

3.4.5 Final Records

Provide final redline/as-built drawings, system specifications, and operational/maintenance manuals and any other documentation needed for the Base Maintenance Contractor to complete DD Form 1354. Documents shall show actual installation conditions, wiring, and warranty as applicable.

3.6 DHA IA/RMF Requirements

DHA IA_RMF

Requirements.pdf

3.7 Pictures of Current Room

DR Room Pictures.zip

3.8 Deleted

3.9 Current DR Room Schematics

118 Floor Plan.pdf

Building 118 Room No. 169.pdf

Celing height room

no. 169.pdf