Attachment 1_STATEMENT OF WORK _CT Trailer Rental.pdf

STATEMENT OF WORK

FOR

RADIOLOGICAL COMPUTERIZED

TOMOGRAPHY SYSTEM

AT 35 MDG, MISAWA AIR BASE JAPAN

35 MEDICAL SUPPORT SQUADRON

MISAWA AIR BASE

8 FEB 2022

1. SCOPE: The contractor will provide one (1) Computerized Tomography (CT) trailer with a Toshiba

Cannon Aquilion 64/128 VeloCT system installed, and one (1) generator for the trailer.

1.1. DELVERY OF EQUIPMENT:

1.1.1. The CT trailer and a generator must be delivered to the location as indicated below. Generators, Equipment setup and verification must be provided and completed by the vendor personnel no later than 19 May 2022 to ensure that the equipment is fully operational on 20 May 22. During the initial implementation, an English-speaking technical representative must be available by telephone 24 hours.7 days a week. All equipment displays and supporting documents must be in the English language. The trailer and a generator shall be in need of operational at the 20 May 2022 thru 19 September 2022 for 4 months (The rental period is subject to change).

1.1.2. PRIMARY LOCATEION OF COMPLETE SYSTEM

1.1.2.1 The system shall be delivered and installed

At: 35th Medical Group Unit 5024 Bldg 99

Misawa Air Base, Japan 96319-5024

1.1.2.2 Exact installation location at the primary location shall be coordinated by the contactor with the point of contacts listed below.

Facility Manager, 35 Medical Group

011-81-176-77-6095

1.2. CLASSIFICATION:

1.2.1. This equipment shall include delivery, installation, all calibrators/standards, and quality control materials needed to perform the specified testing. For the purpose of this SOW the CT system includes at a minimum.

Computerized Tomography System: Aquilion Gantry, Couch, Console, and one Forty foot power cord.

1.2.2. The contractor shall provide operators and maintenance manuals in the English language. The level of detail required of the appropriate instrument maintenance manuals extends only to the routine maintenance procedures performed by the users. All instruments specified is non-government owned equipment that is serviced and maintained by the Contractor.

1.2.3 The Contractor shall be responsible for the collection and transportation of the equipment upon expiration or termination of the contract.

1.2.4. The power requirements for the unit are as follows. A generator that can output 480 Volts AC, 60 Hertz +-/

.5Hz, 3 Phase, 3 wire underground delta with case to earth ground, or Wye star with case to earth ground. The voltage variation is from 455V to 504V. The unit needs a dedicated 125 KVA circuit. It requires a 150 amp circuit, and requires to have power delivered at 60 hertz.

1.2.4.1. The generator fuel usage is monitored by the Government once it’s installed and ready to use. Contractor is not required to monitor them.

1.2.5. English programs, keyboard, and displays.

1.3. COMPUTERRIZED TOMOGRAPY SYSTEM:

1.3.1. The Computed Tomography system must be a Toshiba Cannon Aquilion Computed Tomography system capable of 64/128 VeloCT. The unit will need to have a large-aperture slip-ring gantry and extra-wide couch. It is required to have a High Frequency X-ray generator and high-heat-capacity X-ray tube. It will need to run on windows XP operating system. The aperture size needs to be 72cm, and needs to have 18, 24, 32, 40, and 50 cm fields of view. The gantry needs to have operating controls on both sides and a patent positioning light. The couch needs to be 47 cm wide and have a metal free couch top. The couch top needs to support up to 450 pounds of weight while maintaining an accuracy of +/- .25mm.

1.3.2. The CT trailer must not require any changes to the facility infrastructure beyond electrical.

1.3.3. The CT systems, displays, and supporting literature will need to be in the English language.

1.3.4. The CT system must be capable of interfacing with the military hospital computer system.

1.3.5. The CT system must utilize a window operating system. A minimum of Windows XP.

1.3.6. The CT system must be capable of interfacing with our current Picture Archiving and Communications

Systems (PACS).

1.3.7. All software shall be the most current version, be fully supported by the software manufacturer and be current with all security updates. Software updates will be provided at no additional cost to the government throughout the term of the contract.

1.3.8. The equipment must arrive in a serviceable and well maintained.

1.4. MAINTENANCE:

1.4.1 The Contractor shall ensure the trailer meets or exceeds the following minimum maintenance standards at the time of acceptance and throughout the lease period.

-The Contractor is responsible for all scheduled and unscheduled maintenance of the trailer.

-The Contractor shall provide all parts and labor necessary to complete required maintenance tasks; however, the maintenance does not include cases of intentional or accidental damage caused by the user.

-Maintenance shall be performed according to the manufacturer’s recommended maintenance schedule.

1.5. DAMAGES:

1.5.1 The Government shall not be responsible for acts of God that may result in damage to the trailer (i.e. hail storms, thunderstorms etc.). In addition, the Government shall not be responsible for normal depreciation to the trailer. For purpose of this contract, “normal depreciation” is defined as the wear and tear that can reasonably be expected to result given the trailer’s normal use. The Government will only be responsible for damage in excess of normal wear that results from negligence, neglect, or similar acts of the Government. All contractor claims for damage by the Government shall be submitted to the contracting officer for consideration in accordance with FAR

Subpart 33.2 Disputes and Appeals.

2. GENERAL REQUIREMENTS

2.1 CONTRACTOR PERSONNEL:

2.1.1. Contract Manager. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the contractor when the manager is absent, shall be designated in writing to the contracting office and Medical Equipment Repair

Shop.

2.1.1.1. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to the daily operation of this contract.

2.1.2. Contractor Employees. The contractor shall not employ persons for work on this agreement in such employee is identified to the contractor by the contracting officer as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population.

2.1.2.1. Contractor personnel shall present a neat appearance and be easily recognized as contractor employees.

Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their cloths while performing any service at any U.S. Government facility.

2.2. PHYSICAL SECURITY: The contractor shall be responsible for safeguarding all government property provided for the contractor’s use or access.

2.3. HOURS OF OPERATION:

2.3.1. Normal hours of operation. The contractor shall perform the services required under this contract during the following hours: Monday through Friday between the hours of 0730 – 1630.

2.3.2. The Contractor shall provide service/direct customer service and support 24 hours/7 days a week, to include hotline telephone service to assist operators in correcting equipment operations problems.

2.3.3. Legal Holidays. The following legal holidays will be observed by the Government:

New Year’s Day 1 January

Martin Luther King’s Birthday Third Monday of January

President’s Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth (observed) 18 June

Independence Day 4 July

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day 11 November

Thanksgiving Day Fourth Thursday in November Christmas Day 25 December

NOTE: any of the above holidays falling on a Saturday will be observed on the preceding Friday, holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above.

2.4 RECORDS: The contractor shall maintain all records necessary to comply with the regulatory requirements and FDA standards. The contractor shall be responsible for creating, maintaining and disposing of only those Government required records that are specifically cited in this SOW or required by the previsions of a mandatory directive listed in section 5.4, Applicable publications and forms. If requested by the Government, the contractor shall provide the original record or a reproducible copy of any such records within five working days of the receipt of the request.

2.5. REMOVAL OF EQUIPMENT: The contractor shall not remove any equipment from the Government work site without prior approval of the POC or his/her designate representative.

2.6. SPECIAL SECURITY REQUIREMENTS: The contractor shall comply with all Misawa AB security and HPCON access requirements. The government will provide escorts for the contractor, as required.

2.6.1. BASE PASSES. The contractor shall obtain the following pass and identification items and adhere to the rules regarding the passes set forth:

(1) Prior to the start of on-site work, the contractor shall submit applications for base passes (listed below) to 35 SFS/S-5 via 35 CONS/PKB, for all employees including subcontractor employees, and vehicles requiring access to Misawa Air Base in order to perform services under this purchase order.

(a) 5 AF Form 99, Application for Base Pass, for employees.

(b) 35 FW Form 54, Application for Vehicle Registration.

(2) The contractor, in conjunction with sponsoring unit/agency, will periodically cross-reference current employees against the base pass listing maintained by the Visitor Control Section, 35 SFS/S-5, Bldg. 301, to ensure accuracy and to verify employment status of assigned personnel. The contractor will immediately report any changes in employment status such as termination, retirement, or resignation of employed personnel in possession of base and/or vehicle passes to the sponsoring unit/agency and/or the base contracting office. The contractor will be responsible for collection of the base and/or vehicle pass turn-in to the sponsoring unit/agency within three (3) working days of the employee’s termination.

(3) Upon completion of this contract, the contractor shall return all employees and vehicle passes to the Visitor

Control Section, 35 SFS/S-5, Bldg. 301, and obtain a Certification of Receipt then submit to 35 CONS/PKB. Final payment will be withheld until the contractor has accomplished required clearances.

2.6.2. RANDOM ANTITERRORISM MEASURES (RAMS). RAMS are conducted on Misawa Air Base at varying times during a 24-hour period and may consist of measures such as spot checks of identification credentials, random vehicle searches, and site security sweeps. The contractor is subject to participating and cooperating with RAMS as directed by competent authority. Anticipate increased RAMS during implementation of elevated Force Protection Conditions (FPCONs).

2.6.3. REPORTING SUSPICIOUS ACTIVITY. It is the responsibility of all personnel working and residing on

Misawa Air Base to be alert for detecting and reporting suspicious criminal or terrorist activity. The contractor shall immediately report any on-base observed suspicious activity to the 35 SFS/BDOC, Bldg. 646. All contractor-employed personnel shall be familiar with suspicious activity reporting numbers and procedures. The primary number for reporting suspicious activity on Misawa Air Base is 911 from a base phone or 0176-53-1911 from a mobile phone or off-base.

2.7. PROJECT SITE REQUIREMENTS:

2.7.1. Suspension of Utilities. N/A

2.7.2. Special Safety Precaution. All work shall be conducted in a safe manner and shall comply with the current

Safety and Health Requirements. The Contractor shall provide all necessary safety protective equipment, and follow all necessary procedures. The contractor shall notify the contracting officer of all mishaps involving Air Force property or personnel immediately.

2.7.3. Material Approval Submittal. The contractor shall submit a Safety Data Sheet (SDS) for chemicals, if used in this service, accompanied by AF Form 3000, Material Approval Submittal, to the CO for approval prior to use, and supplies shall not be changed without approval after contract start date. Submission of chemical samples may be requested along with the SDS.

2.8. MISAWA AIR BASE FIRE PROTECTION. The contractor shall be responsible for fire prevention in all contracted area, and be free from any potential fire hazards. The contractor shall comply with the following fire prevention guidance.

2.8.1. FIRE REPORTING:

(1) The primary emergency reporting number on Misawa Air Base is 911 or 0176-53-1911 from off base. Fire

Department operations take place out of building 947 and 3003 for main base.

(2) On-base telephone if any, in the on-base warehouse(s) shall have “911”stickers.

(3) All contractor-employed personnel shall be familiar with fire reporting numbers and procedures, and shall put the number “0176-53-1911” into his or her mobile phone.

2.8.2. VEHICLES:

(1) Access for fire fighting vehicles must be maintained at all working sites.

(2) Contractor’s vehicles shall not be parked within 15 feet of any fire hydrant or Fire Department connection.

(3) Contractor’s vehicles shall give the right-of-way to responding fire/emergency vehicles.

2.8.3. ELECTRICAL HAZARDS:

(1) All the contractor’s electrical tools and equipment shall be in good (original) working condition and its maintenance shall be done properly in compliance with manufacturer’s maintenance instructions.

(2) All extension cords used shall be equipped with circuit breakers and plugged directly in the outlets (not other extension cords).

(3) Building utility panels shall not be blocked by contractor tools/supplies.

2.8.4. STORAGE:

(1) Flammable liquids shall not to be stored inside the warehouses, next to the buildings, or near exit ways.

(2) Fire protection system shall not be obstructed at any time. Carpet storage shall be neat in a manner which does not present fire/safety hazards and not to block the access to where fire-extinguishers are mounted.”

2.9. CONTRACTOR SITE REQUIRMENTS. If the contractor requires storage for any material or chemicals, a storage area can be arranged by the Authorized Caller or Contracting Officer.

2.10. SPECIAL CONTRACT REQUIREMENTS.

2.10.1. DISPOSAL MATERIAL. Except as specified elsewhere in this contract or this SOW, all residue and scrap generated by the contractor during the performance of this purchase order shall be disposed of outside the confines of Misawa Air Base in accordance with all Japanese Laws unless otherwise directed by the CO.

2.11. CONTRACTOR EQUIPMENT.

2.11.1. VEHICLES. The contractor shall operate vehicles to comply with Japanese and base traffic regulations.

All contractor vehicles shall comply with Japan Licensing, Registration, and Vehicle Safety Inspection requirements. All vehicles must be in operating condition.

2.11.2. REQUIRED INSURANCE:

(This paragraph applies only when contractor’s owned vehicles are being operated on Misawa Air Base)

(1) The contractor shall procure and maintain during the entire period of his/her performance under this contract, the following minimum vehicle insurance:

Property Damage – ¥2,000,000

(2) Prior to the commencement of work hereunder, the contractor shall furnish to the CO a certificate or written statement of the above required insurance. The contractor is required to notify the CO immediately upon cancellation or of any material change in the policies adversely affecting the interests of the Government.

(3) The contractor agrees to insert the substance of this clause including this paragraph c, in all subcontracts hereunder.

2.12. PHYSICAL SECURITY/LIABILITY. The contractor shall provide appropriate protection to surrounding work areas. The contractor is responsible for safeguarding all contractor equipment and personnel from damage and injury. The contractor shall be responsible for any damage caused by the contractor to the government and contractor property, or for any injuries caused by the contractor to government personnel or contractor’s employees, which may arise from or be incident to the contractor’s use and occupation of government facilities or contractor’s performance.

2.12.1. The contractor shall exercise care to avoid any damages to the facility, furniture, and equipment. The contractor shall at no cost to the government, repair or replace any damages to facility, furniture, or equipment determined to have been caused by the contractor.

2.12.2. The contractor shall notify the CO and the government representative as soon as possible on any damage occurs in the work area.

2.13. GOVERNMENT REMEDIES. If a defect has not been corrected within a reasonable time frame, the CO shall follow FAR 52.212-4, Contract Terms and Conditions – Commercial Items (a) Inspection/Acceptance, for contractor’s failure to perform satisfactory service or failure to correct non-conforming service.

2.14. PERFORMANCE OF SERVICES DURING CRISIS DECLARED BY THE NATIONAL COMMAND

AUTHORITY OR OVERSEAS COMBATANT COMMANDER. This service is not determined to be essential for performance during crisis. In the event of crisis, the contractor will be notified by the CO of the need to discontinue services due to base closure or other causes.

3. GOVERNMENT-FURNISHED FACILITES, EQUIPMENT, MATERIAL, AND SERVICES

3.1. GENERAL: The Government will provide, without cost to the contractor, the facilities, equipment, materials, and services listed below.

3.1.1. FACILITIES: The Government will furnish the facilities for set-up and operation of the CT system. The contractor shall not alter the facilities without written approval of the Contracting Officer. The contractor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for performance of this contract

3.1.2. Equipment: Contrast Injector Manufacturer: Medrad INC. Model: Stellant D Equipment Control Number

(ECN): 009530 will be provided for use in the CT trailer. This is the only equipment item that will be provided for use.

3.2. MATERIALS: Contrast media will be provided for use with the contrast injector that we are providing for use in the CT trailer. This is the only material that we will be providing.

3.3. SERVICES: Security police and Fire Protection, as is provided to all other personnel on the installation.

3.4. UTILITIES: The contractor may utilize existing government sources of electricity, water, and sewer needed to perform the services required by this SOW. The contractor shall provide own utilities where utilities are unavailable. The contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operation under conditions that prevent waste of utilities.

3.5. SANITARY FACILITIES: Toilet facilities are available for the contractor’s use.

3.6. SECURITY FORCES AND FIRE DEPARTMENT: Government telephones are located throughout the base. The only time the contractor or their employees are authorized to use these telephones is to contact the Base

Security Forces and the Base Fire Department. The emergency phone number is 911.

3.7. GENERAL: Except for those government furnished items and services specified in section 3, the contractor shall furnish all items and services required under this contract.

3.8. TRANSPORTATION: Transportation is the responsibility of the contractor. The Government will not provide transportation.

3.9. NAMETAGS: The contractor shall furnish a nametag for each employee. The nametag will contain the name of the company and the employee.

3.10. SAFETY DATA SHEETS (SDS): The contractor shall provide SDS for each item delivered under this contractthat is considered to be hazardous material by its representative government. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the

English language and shall contain as a minimum the following information: identification of the specific hazard, the required practices for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

4.1. SPECIAL REQUIREMENTS FOR PROTECTED HEALTH INFORMATION:

4.2. Whenever a contactor (in this case contract) is awarded that requires the vendor to collect, use, copy, access, or store Protected Health Information (PHI) in commercial office space, The contractor must:

4.3. Notify the MTH HIPAA Security Manager.

4.4. Follow the DUA and DoD requirements for secure disposal, destruction, and/or sanitization of all equipment that contained PHI.

5. REGULATORY REQUIREMENTS.

5.1. GENERAL: Applicable documents - The latest practicable national (US) technical regulations are applicable for the manufacturing of the system. Contractors will comply with all U.S. laws pertaining to medical equipment. Contractors will also comply with all Department of Defense (DoD), Department of the Air Force regulations and policies pertaining to medical equipment. Publications and forms not on the internet can be obtained from the MTF. These regulations include but are not limited to the following.

5.2. The publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to this mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance

5.3. PUBLICATIONS:

5.3.1. MANDATORY:

Public law 91-562 29 Dec 70-Occupational Safety and Health Administration

Public Law 104-191 (2013) Health Insurance Portability and Accountability Act of 1996 Current edition of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO).