N68335-17-R-0192_STATEMENT_OF_WORK_RevC_-_FedBid.pdf

Computed Tomography (CT) X-Ray NDI System

Statement of Work 10 July 2018

1. Scope

1.1. Purpose

The primary purpose of this Statement of Work (SOW) is to identify the requirements for the CT X-Ray System to be installed at NAWCAD Lakehurst, NJ. The CT X-Ray System will provide cross competency support for the NAWCAD LKE mission in the areas of SE and ALRE Design/In-Service Engineering, Production and Quality Assurance, and Materials Engineering. In addition, this technology will allow the Navy to develop inspection and reverse engineering capabilities that can be expanded across multiple projects and fold into the Enterprise Qualification / Certification Solutions needed to operationalize additive manufacturing solutions.

The CT X-Ray System shall be in accordance with Federal radiation regulations and equipment specification. This requirement also includes preventative maintenance, software maintenance, spare parts and a service kit. The system shall be delivered to and installed at the Naval Air Warfare Center Aircraft Division, Building 332, Lakehurst, NJ 08733.

2. References

3. Technical Requirements

3.1. Computed Tomography (CT) X-Ray NDI System

The CT X-Ray NDI system shall be in accordance with the above referenced equipment specification. Products such as a prototype unit, pre-production model, or experimental unit do not qualify as meeting the requirements specified herein.

3.2. Installation and Equipment Requirements

Within one (1) week after contract award, the contractor/manufacturer shall submit a document identifying any installation requirements for the equipment. The contractor/manufacturer shall identify all major components of the CT X-Ray System and provide detailed facility requirements for each component. All utility requirements, ventilation requirements, structural and any other requirements shall be identified. The contractor/manufacturer shall also identify the electric loading (power, voltage, amperage, phase, etc.) requirements for their equipment. The submitted document shall be in accordance with Contract Data Requirements List (CDRL) A001 - Installation and Equipment Requirements.

3.2.1. Post-Award Kickoff Meeting

Within four (4) weeks after contract award, there shall be an in-person meeting at NAWCAD Lakehurst between the contractor/manufacturer and appropriate representatives from the Government to discuss the contractor/manufacturer’s proposal in further detail, review the Installation and Equipment Requirements, and discuss the terms and conditions of the

[1] NAVAIR, A Computed Tomography (CT) X-Ray Non-Destructive Inspection (NDI) System Specification, 10 July 2018.

awarded contract.

3.2.1.1. Observation

During this visit, the Government will provide access to the location the CT X-Ray System will be located. The contractor/manufacturer shall, at their own expense, be responsible for conducting a site survey, taking measurements, and ensuring that the proposed machine will be able to be delivered and installed in the proposed location.

This includes moving to the final placement location, as well as maintaining clearance around the machine in its final location. If any issues or concerns arise the contractor/manufacturer shall immediately bring it to the Government’s attention.

3.2.1.2. Installation Schedule

The installation shall be discussed at the Post-Award Kickoff Meeting. The contractor/manufacturer shall construct the installation schedule based on the discussion at the Post-Award Kickoff Meeting. This schedule shall include, but is not limited to, the identification of the system requirements, the delivery and installation of the system, any calibration required and contractor provided training. The contractor/manufacturer shall adhere to this schedule unless otherwise noted.

3.2.1.3. Deliverables

The contractor/manufacturer shall be responsible for the schedule and meeting minutes which shall be submitted 30 days after the Post-Award kickoff meeting is held in accordance with CDRL A002 - Kickoff Meeting Minutes and Installation Schedule.

Official changes to this schedule shall only be applied upon agreement between all parties.

3.2.2. Machine/Installation Documentation

Within 30 days after contract award, the contractor/manufacturer shall supply three (3) sets of hard copy manuals and one (1) set of digital preliminary machine/installation documentation, which includes standard manuals for the equipment. If changes to parts or materials occur before System Installation, update(s) will be submitted within 15 days of change with Government approval. At System Installation, the contractor/manufacturer shall supply three (3) sets of hard copies and 1 set of digital manuals detailing procedures for:

machine installation and removal, machine maintenance, configuration, operation (all actions that would be performed during operation), accident prevention, and emergency management in accordance with CDRL A003 - Machine Documentation.

3.2.3. Installation Drawings

Within 30 calendar days after the Post-Award Kickoff Meeting, the contractor / manufacturer shall supply drawings of the proposed machine layout within the area identified in Appendix A of the referenced equipment specification. The drawings shall be of sufficient detail to allow maintenance personnel to move, install, and perform regular maintenance and repairs on the machine in accordance with CDRL A004 - Installation Drawings. All dimensions shall be provided in English units. The Government shall review all drawings and documents and identify within 15 days whether or not they are acceptable. If disapproved, the contractor / manufacturer shall correct the documents and resubmit within 2 weeks.

3.2.4. Machine Installation/Logistics

The contractor/manufacturer shall be responsible for all shipping, delivery, installation, initial configuration and calibration of the CT X-Ray NDI system. The contractor/manufacturer shall notify the Government point of contact (POC) of the dates in which they need to have their personnel in the Government facility. The contractor/manufacturer shall provide all equipment and personnel to move the system to the required location. The Government shall supply utilities for the machine as required. However, these utility requirements shall not exceed those specified in the referenced equipment specification. The contractor / manufacturer shall be responsible for all utility hookups.

3.2.4.1. Validation and Verification

3.2.4.1.1. Post-Installation Inspection

Within 24 hours after the installation of the CT X-Ray System is complete, the contractor/manufacturer shall, inspect the machine for overall alignment, fit-ups, radiation cabinet leaks and proper operation of safety interlocks features. If any deficiencies are found through these inspections and tests, the contractor shall be responsible for correcting them before the Government accepts the machine.

3.2.4.1.2. Pre-Operational Test

Prior to operating the machine, the contractor/manufacturer shall contact the on-site Government representative and NAWCAD Lakehurst Radiation Safety Officer to monitor initial power-up and testing of the equipment.

3.2.4.1.3. Operational/Radiation Test

The contractor/manufacturer shall perform alignment, accuracy, radiation surveys and operational testing to demonstrate that the machine meets all of the requirements described in paragraph 3.2 of the System Specification for both Stainless Steel and Titanium. All test results shall be documented by the contractor/manufacturer and witnessed by the Government and NAWCAD Lakehurst Radiation Safety Officer; all test results shall be submitted within 30 days after the execution of these tests in accordance with CDRL A005 - Operational /Radiation Test Results. All material for these tests shall be supplied by the contractor.

3.2.4.1.4. Material Disposal

The contractor/manufacturer shall be responsible for the proper disposal of all installation waste material. This includes but is not limited to: shipping materials, packing materials, tarps, pallets, radiation waste material, etc…

3.3. Radioactive Material

3.3.1. Radioactive Material Transfer

The contractor/manufacturer shall document the receipt of sources of radioactive material on-site and notify NAWCAD Lakehurst Radiation Safety Officer for record keeping.

3.3.2. Radioactive Material Source Information

The contractor/manufacturer shall provide documentation to NAWCAD Lakehurst Radiation Safety Officer stating that exempt quantity radiation sources are used as prescribed in 10 CFR Parts 19-20 and 30-31.

3.3.3. Radiation Survey

The contractor/manufacturer shall perform a radiation survey after installation. All test results shall be documented by the contractor/manufacturer and witnessed by the Radiation Safety Officer; the test results shall be submitted within 30 days after the execution of these tests in accordance with CDRL A011 – Radiation Survey Results. All initial radiation survey documentation shall be supplied by the contractor to the NAWCAD Radiation Safety Officer.

3.4. Safety Data Sheets

At System Installation, Safety Data Sheets (SDS) shall be provided for all materials specified within the Machine Specification by the contractor in accordance with CDRL A006 - Safety Data Sheets (SDS).

3.5. Software

The contractor/manufacturer shall install all required software for machine operation and data analysis on any computer that is part of the CT X-Ray NDI system. The contractor/manufacturer shall also provide a second (separately licensed, if applicable) copy of the software that may be installed on a Government provided IT asset. All software shall be compatible with the two latest major releases of Microsoft Windows. The contractor/manufacturer shall provide a minimum of two (2) backup copies of all software used in the CT X-Ray NDI system on Compact Discs (CDs) no less than one week prior to installation in accordance with CDRL A007- Software. Portable hard-drives or thumb drives are not acceptable mediums. Additionally, the CT X-Ray NDI system will not have access to network resources (i.e. the internet).

All software supplied by the contractor/manufacturer that requires license keys with expiration dates for the CT X-Ray NDI System shall co-terminate and be supported for at least two (2) years.

3.6. Training

The contractor/manufacturer shall provide Operator/Radiation Safety training and training materials at the Government's facility. Training shall occur on a schedule that is consistent with the minimum requirements listed below and has been agreed upon by both the contractor and the Government at the Post-Award Kickoff Meeting. The following shall be provided:

3.6.1. Training Materials

Seven (7) days prior to the scheduled training, the contractor/manufacturer shall provide all relevant training materials for the applicable training in accordance with CDRL A008 - Training Materials. The training materials shall be comprehensive, detailing all required and best practice procedures that are necessary for radiation producing machine operations.

The Government shall have the right to use, modify, reproduce, and release these documents within the Government.

3.6.2. Radiation Safety Training

The contractor/manufacturer shall provide initial Radiation safety training with up to five (5) personnel. The training shall include instruction in the event of radiation emergency situations and recommended action when responding to a radiation incident in or around the equipment. The training shall occur prior to any on-site operation of the machine. The contractor shall document the training and provide the Government training course material completion certificates for those personnel receiving Radiation Safety Training in accordance with CDRL A008 – Training Materials.

3.6.3. Basic Training

The contractor/manufacturer shall provide training to operate all equipment and perform all tasks under Section 3 of the specification including, but not limited to: digital radiography, computed tomography, and operation/maintenance/safety of the delivered CT system operation. This training session shall be 4-5 days and shall be for five (5) participants immediately after the machine has been installed and safety training has been performed.

The contractor/manufacturer shall document the training and submit the briefing in accordance with CDRL A008 – Training Materials.

3.6.4. Basic Operator/Radiation Safety Training Follow-up

Between 60 and 120 days after the Government accepts receipt of the equipment, the contractor/manufacturer shall provide follow up training to the operator/radiation safety training to refresh the operator personnel with the concepts learned in the basic training.

Follow up shall be for two (2) days with five (5) participants. The contractor/manufacturer shall document the training and submit the briefing in accordance with CDRL A008 – Training Materials.

3.6.5. Digital Radiography & Intro to CT Training Course

The Vendor shall provide a 40 hour ASTM/ASNT Certified DR/CT training course with up to five (5) personnel, held at the vendor’s site. This course follows the recommended curriculum of FWG-IDR, MAI, ASTM and ASME in a format for compliance with NAS 410 and SNT-TC-1A type Qualification/Certification programs. The Contractor/manufacturer shall document the training and submit the briefing in accordance with CDRL A008 – Training Materials.

3.6.6. Advanced CT Training

The contractor/manufacturer shall provide an Advanced CT Training with up to five (5) personnel as a 4-day class at the contractor/manufacturer’s site that addresses the advanced capabilities of the Industrial CT technology. The course shall include, but not be limited to the following topics: CT Technique Development training, CT Reconstruction. The contractor / manufacturer shall document the training and submit the briefing in accordance with CDRL A008 – Training Materials.

3.7. Maintenance

The contractor/manufacturer shall provide maintenance and periodic calibration as required in accordance with the original equipment contractor/manufacturer's preventative and reactive maintenance plan. This Maintenance Plan shall include all parts and labor to repair the CT

X-Ray System in the event a failure occurs. Any modification of the cabinet of the CT X-Ray System previously certified pursuant to the 21 CFR 1010.2 as a result of maintenance or repairs shall be construed as manufacturing if the modifications affect any aspect of the applicable requirement. The contractor/manufacturer’s qualified technical representative who performs such modifications shall re-certify and re-identify the systems in accordance with the provisions of 21 CFR 1010.2 and 1010.3. The contractor/manufacturer shall be responsible for the acquisition and installation of version upgrades to any installed software on the CT X-Ray System’s computer. In the event of a version upgrade, all required installation files shall be provided to the Government no less than one week prior to installation in accordance with CDRL A007 - Software. The CT X-Ray NDI system may not have access to network resources (i.e. internet connection).

3.7.1. Maintenance Agreement

12 Month Hardware Warranty The contractor/manufacturer shall replace or repair any system hardware components that fail within 12 months of the Government acceptance of the fully installed and operational system at no additional cost to the Government. The contractor/manufacturer shall identify any consumable items that are not covered under this warranty.

5-Year Preventative Maintenance Services The contractor/manufacturer shall provide at least five (5) preventative maintenance visits to NAWCADLKE to verify and optimize system performance and to perform any system maintenance required. The contractor/manufacturer shall include the scope for this maintenance in their proposal. The maintenance schedule shall include at least one visit per year for the first five (5) years after Government acceptance of the fully installed and operational system, as separate line items.

5-Year Software Maintenance/Updates The contractor/manufacturer shall provide all software updates released within five (5) years of Government acceptance of the fully installed and operational system, as separate line items.

3.8. Spare Parts and Service Kit

The contractor/manufacturer shall provide a list of all common consumables, replacement parts and items necessary to perform preventative maintenance in accordance with CDRL A012 - Replacement Parts List. The list shall include a commercial part number, specification (if applicable), quantity concurrently used, and typical frequency of replacement (e.g. 1 every 100 machine hours, 1 every 6 months). The contractor/manufacturer shall also provide a spare parts and service kit. The quantity of spares shall include common consumables and all items necessary to perform preventative maintenance. At a minimum, at least 10 spare filaments and spare O-rings should be included. In addition, the contractor/manufacturer shall include at least Qty: 1 EA spare tubes and detectors to be used with the CT X-Ray NDI System as separate line-items that can be executed in each year of the contract. All spare parts must conform to the equipment specifications. A digital copy of the certification shall be provided at the time of shipment or a hard copy shall be included with the shipment.

3.9. Communication

A primary POC who can obtain and provide any required information for their party shall be established at this time for each party to streamline the communication process. All parties shall provide the appropriate contact information for each of their POCs, which shall include but is not limited to: Office Telephone Number, Business Mailing Address, Email Address, Cellular Phone

Number, and the same information for an alternate POC. It shall be the contractor's responsibility to keep in contact with the appropriate Government representatives in order to maintain consistency and transparency of every process in the planning, fabrication, delivery, and installation of the machine. All communication subsequent to the Post-Award Kickoff Meeting should be in the form of e-mail and/or telephone, unless other forms are necessitated by the nature of the information being transferred (e.g. mailing drawings). Any requests for official changes or deviations from the contract shall only be implemented after being submitted through the Procurement Contracting Officer (PCO) for approval. Communication shall exist only between the established POCs.

3.10. Contractor Workforce Qualification and Licensing

The contractor/manufacturer shall ensure that all personnel involved with on-site activities are fully qualified and licensed to perform their particular functions in the state of New Jersey.

3.11. Safety Requirements

During the performance of all work under this contract, the contractor/manufacturer shall strictly adhere to industry and Federal radiation safety regulations at all times including the use of proper safety/ radiation equipment and attire. All contractor personnel shall comply with the Safety/Health and Radiation requirements in the standards and directives listed below:

a. National Electric Code (NEC 2011)

b. International Electrical Testing Agency (NETA)

c. The Institute of Electrical and Electronics Engineers standards (IEEE)

d. Current Occupational Safety and Health Regulations (OSHA)

e. National Safety Council, Accident Prevention Manual for Industrial Operations

f. Applicable Federal, state, and local safety operating procedures

g. National Safety Code (ANSI C2)

h. National Fire Protection Association (NFPA 101) Life Safety Code

i. Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter J, Part

1020.30 Diagnostic X-Ray Systems and their Major Components

j. Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter J, Part

1020.31 Radiographic Equipment

k Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter J, Part 1

020.33 Computed Tomography (CT) equipment

l. Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter J, Part

1020.40 Cabinet X-Ray Systems

m. Nuclear Regulatory Command (NRC) Regulations (10 CFR), Part 19 - Notices, Instructions and Reports to Works: Inspection and Investigations

n. Nuclear Regulatory Command (NRC) Regulations (10 CFR), Part 20 - Standards for Protection against Radiation

o. Nuclear Regulatory Command (NRC) Regulations (10 CFR), Part 30 – Rules of

General Applicability to Domestic Licensing of Byproduct Material

p. Nuclear Regulatory Command (NRC) Regulations (10 CFR), Part 31 – General

Domestic Licenses for Byproduct Material

q. ASTM E2597: Standard Practice for Manufacturing Characterization of Digital

Detector Arrays

r. DODI 8500.2, Information Assurance (IA) Implementation

s. DODI 60.55.8, Occupational Ionizing Radiation Protection Program

t. Radiological Affairs Support Program Manual, NAVSEA 0420-AA-RAD-010

u. NAVAIRWARCENACDIVINST 5104.1C Radiation Safety Program

v. Department of the Army; Corps of Engineers Manual entitled "Safety and Health

Requirements Manual." EM385-1-1

3.12. Safety Plan

The contract shall be governed by the requirements set forth in the Department of the Army;

Corps of Engineers Manual entitled "Safety and Health Requirements Manual." EM385-1-1. The contractor/manufacturer shall use a qualified person to prepare the written site specific Accident/Radiation Safety Prevention Plan (APP). This Safety plan shall be provided within 30 days after contract award in accordance with CDRL A010 - Accident Prevention Plan. Prepare the APP in accordance with the format and requirements of USACE EM385-1-1 Appendix A, "Minimum Basic Outline for Preparation of Accident Prevention Plan." The APP shall be job specific and shall address any unusual or unique aspects of the project or activity for which it is written. Included in the APP shall be an Activity Hazard Analysis, identifying job specific hazards (radiation) and how the contractor/manufacturer intends to deal with these hazards. If a crane is to be used, certification of the crane and operator's license shall be submitted with the safety plan. If required for installation, the contractor/manufacturer shall obtain a hot permit by contacting either 732-323-7578 or 732-323-7580.

3.12.1. Toxic and Hazardous Substances

The contractor/manufacturer shall submit a Safety Data Sheet (SDS) in accordance with CDRL A006 for each toxic or hazardous substance to be utilized on Joint Base MDL - Lakehurst. Toxic and hazardous substances are defined in CFR 29 Part 1910 Subpart Z.

The SDSs shall be submitted within 30 days after contract award. All approved toxic and hazardous substances must be labeled in accordance with CFR 29 Part 1910.1200.

3.12.2. Interruption of Utilities

The contractor/manufacturer shall perform the work under the contract with a minimum of outage time for all utilities. The contractor/manufacturer shall give written notification to designated Government personnel at least 14 working days in advance of their need for a proposed major utility outage (i.e. turning off the main supply to a building). The contractor/manufacturer shall give five (5) business days’ notice of their need for a minor outage (i.e. turning off power to an area internal to a building). The contractor/manufacturer shall provide temporary heat and/or domestic hot water if outage is expected to be longer than 8 hours of continuous duration. This time period shall include start-up and cool-down periods. The utilities may be interrupted only when approved in writing by the designated Government personnel. Because of mission requirements, utility interruptions may have to be scheduled at a time other than that requested by the contractor/manufacturer.

3.13. Security

3.13.1. Facilities Access Restrictions

The contractor/manufacturer shall note that only United States citizens will be permitted access to the facility. All personnel entering the facility will be required to provide date of birth, valid photo ID, and social security number. Current vehicle registration and proof of insurance will be required of each vehicle entering the facility. No weapons of any kind will be allowed on base.

No animals are allowed on base with exception of documented service animals. Vehicles and personnel entering the base will be subject to search. The contractor/manufacturer shall perform installation and training during normal hours of operation. Joint Base MDL Lakehurst operates on a compressed work schedule. Normal hours of operation are Monday through Thursday from 7:00AM to 4:30PM. Friday hours are 7:00AM to 3:30PM every other week. The Base is closed on alternating Fridays. The contractor/manufacturer shall be notified of the base operational schedule along with holidays and shop-closings, in advance, prior to the start of the job.

In case there is any snow or ice accumulation, it is the responsibility of the contractor / manufacturer to contact the Snow Line (732-323-7669) to check for base closures.

3.13.2. Pictures

The contractor/manufacturer shall not take any pictures in or around the facility. If pictures care required, the contractor shall notify the Government and a Government representative will take the necessary pictures. These pictures shall be turned over to the contractor / manufacturer only if they have been cleared for public release by Government security personnel.

3.13.3. Contractor’s Parking

The contractor/manufacturer's personnel shall park in the designated parking lots. No personally owned vehicles shall be parked in any restricted areas.

3.13.4. Contractor’s Employee Restrictions

The contractor/manufacturer's employees shall be restricted to areas within this scope of work plus direct routes to and from the site.

3.13.5. Subcontracting

The contractor/manufacturer shall be responsible for ensuring that all subcontractors comply with the contract requirements.

3.14. Security Force and Fire Protection

The Base Security Police telephone number is 732-323-4000 and the Base Fire Department telephone number is 911 for reporting a fire.

3.15. Emergencies

In case of an emergency, the Commanding Officer, Radiation Safety Officer, Security Forces personnel, Base Fire Dept, Safety personnel or their representatives, shall have the authority to order the contractor/manufacturer to stop work and clear the area of personnel and equipment.

The contractor/manufacturer shall comply with such an order with all possible speed. After clearing the work site as instructed, the contractor/manufacturer shall immediately inform the contracting officer of all verbal or written stop work orders. In the case of being halted by Security Forces personnel, Fire Dept, Radiation Safety Officer or Safety personnel, the contractor/manufacturer shall notify the contracting officer in writing and provide explanation for the stoppage.

3.16. Failure to Comply

If the contractor/manufacturer fails to comply with the specifications herein, it may result in the cancellation of this contract and/or the work herein.

3.17. Unforeseen Conditions

Should unforeseen conditions arise during the course of work, the contractor/manufacturer shall immediately notify the Contracting Officer and await their direction. If the contractor / manufacturer resolves the unforeseen condition without proper notification and direction by the Contracting Officer, they do so at their own risk and thereby relieves the Government of any request for equitable adjustment(s) and/or liability for payment if additional costs are incurred.