stevi highlights Final SOW (003).pdf

Department of Health and Human Services Indian Health Service

Clinton Indian Health Center

Statement of Work (SOW) Radiographic System

Definium Tempo Pro or equal to

1. PURPOSE OF THE PROJECT

The Clinton Service Unit (CSU) – Clinton Indian Health Center (CIHC) Indian Health Services (IHS) has a need for which includes all hardware, software, service, and installation requirements for procurement of a Digital Radiographic System. Descriptions herein describe the minimum System requirements to be provided by Contractor, which if properly configured and installed, shall utilize the source of ionized radiation to obtain diagnostic radiographs in the medical treatment plan for the patient. This System shall be utilized by Registered Technologists in Radiography. Our existing x-ray system is approaching the end of its operational lifespan and will need to be replaced, as the detectors have already reached their EOSS (end of service support). By upgrading to a new x-ray system, Clinton will be able to offer our patients the latest advancements in x-ray technology. This initiative involves acquiring a new machine, overseeing its installation, providing applications training, as well as removing and trading in the current equipment. Additionally, it includes ongoing preventive maintenance and support. Below are the dimensions for the x-ray room and then the x-ray room with the control room.

1.1. Radiology contractual service support is required to maintain equipment in proper and safe operating condition. This support is required to assure federal compliance to 21 CFR, sub-chapter ”J”, parts 1020.30, 1020.31 and 1020.32; and I H S compliance to Joint commission Environment of Care.

X-ray room only

Clinton Indian Health Center

X-ray room with control room attached

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

The contractor shall provide the Clinton Indian Health Center a new Definium Pro system or brand equal to. The contractor shall provide the following setup and installation services:

Overhead Tube Suspension (OTS) Generator Table Software and Control Panel (CPU) X-Ray Tube Tube Collimator Training

Clinton Indian Health Center

Minimum System Requirements

2.1. Overhead Tube Suspension (OTS)

2.1.1.1. Ceiling-mount tube system utilizing the existing UNISTRUT configuration

2.1.1.2. 12-inch tube head touch screen console with full acquisition workflow functionality enabling in-room workflows.

2.1.1.3. OTS Bridge and Cable Management

2.1.1.4. Cable Storage U-bolt for Cabinet

2.1.1.5. Wireless kit

2.1.1.6. Radiology Control Interface Module (RCIM2)

2.1.1.7. Standard 21 CFR Subchapter J Labeling

2.1.1.8. Wall Stand Cable Select

2.1.1.9. Wall stand Left/Right Insert Select

2.1.1.10. Wall Stand Grid - 100-180 cm (40-72 in)

2.2. Generator

2.2.1.1. 80kW High Frequency Generator

2.2.1.2. 3-phase generator

2.2.1.3. Tube arch protection

2.2.1.4. 25 KAIC X-Ray Main Disconnect Panel 80 Amp, 480 V / 208 V

2.3. Table

2.3.1.1. Weight limit over 750lbs

2.3.1.2. 4-way floating table top

2.3.1.3. Table Cable Select

2.3.1.4. Rear Foot Pedal - Performance Table

2.3.1.5. Table Grid - 100 cm (40 in)

2.3.1.6. Two (2) FlashPad HD Detectors: 43x43 cm (17x17 in) & 35x43 cm (14x17 in)

2.3.1.7. Two (2) and Three (3) Detectors Configuration

2.3.1.8. Detector Grip Sticker for both HD FlashPads

2.3.1.9. Weight Bearing Cover for FlashPad HD Detector

2.3.1.10. Grid Holder - Wall Mountable

2.3.1.11. Lateral Detector Holder - Table Mount

2.4. Software and Control Panel CPU

2.4.1.1. Dual Energy Subtraction

2.4.1.2. Auto Grid

2.4.1.3. IQST Phantom

2.4.1.4. AutoRad Package

2.4.1.5. Infrared Remote Control

2.4.1.6. Uninterruptible Power Supply (UPS)

2.5. X-ray Tube:

2.5.1.1. Small and large focal spot;

2.5.1.2. 350 KHU;

2.5.1.3. Cast rotating anode assembly;

2.5.1.4. High load capacity;

2.5.1.5. High heat capacity.

2.5.1.6. Minimum tube angulations -/+ 180 degrees (detent 0 and 90 degrees);

2.5.1.7. Minimum tube rotations -/+ 120 degrees;

stebrown Highlight stebrown Highlight jblackmon Highlight ronburns Highlight ronburns Highlight

Clinton Indian Health Center

2.5.1.8. Automated vertical and longitudinal tracking

2.5.1.9. Extensive/long vertical travel - enough to accommodate weight-bearing knees using wall Bucky;

2.5.1.10. Vertical tracking feature with Wall stand and Table (auto centering).

2.6. Tube Collimator:

2.6.1.1. Manual and Automatic Collimator;

2.6.1.2. Rectangular shutters;

2.6.1.3. Laser Center Light;

2.6.1.4. Inch scale;

2.6.1.5. Display SID, angle, and area of collimation;

2.6.1.6. Lock release: free movement and restricted;

2.6.1.7. Rotation +/-180 degrees or 360 degrees;

2.6.1.8. Detent at 90 degrees;

2.6.1.9. Cross hair centering light;

2.6.1.10. Equipped with Positive Beam Limitation (PBL).

2.7. Training

2.7.1.1. Applications Training Program on awarded system

2.8. PM at Clinton will be on the awarded system and 2 wireless HD detectors.

2.9. Provide a 97% percentile of guaranteed equipment up-time status operating according to manufacturer design specifications.

2.10. Provide local FE technical phone support for radiology department at no charge Monday through Friday 8am-5pm.

2.11. Provide an in-site on-line diagnostic network with manufacturer engineers for technical and diagnostic support services available all hours at no charge.

2.12. Contractor’s replacement parts shall be original equipment manufacturer parts.

2.13. System software applications shall be license patented.

2.14. Trade in existing Optima 646 and 2 flash pad detectors with credit toward awarded system and HD detectors

3. PERIOD OF PERFORMANCE

The base year Period of Performance will be 12 months from date of award or until the end of warranty expiration.

4. LEVEL OF EFFORT

4.1. The contractor shall offer a one-year warranty for preventative maintenance and repairs at the Clinton Indian Health Center following the installation of the new machine.

Clinton Indian Health Center

4.2. The contractor shall perform services compatible with the Clinton Indian Health Center Radiology Department patient schedules and availability.

4.3. The contractor shall provide a test/function report within seven (7) business days of completed installation.

4.4. Training: The purpose of this section is to understand the supplemental vendor Training Program fees throughout and after this procurement. The training audience shall include Radiographic Technologists and supporting imaging staff at the Clinton Indian Health Service. Onsite training that follows the initial equipment install, in addition to the supplemental training required during major equipment component upgrades shall be provided for the facility after equipment is installed. Other additional training options that may be considered include distance learning, Computer-Based Training, and/or web meetings. Proposed quotes above the minimum requirements (i.e., training options) shall be at Bidder’s expense.

4.4.1. Contractor training programs include the following minimum requirements:

4.4.1.1. Imaging staff and biomed onsite training of the System and all components following the initial installation and acceptance testing;

4.4.1.2. Imaging staff and biomed onsite training of the System and all components following integration to Radiology Information System (RIS) and Picture Archival Communication System (PACS)

5. SPECIAL REQUIREMENTS

5.1. In accordance with HHSAR 304.1300(b) non-routine contractor employees shall comply with OPDIV DHHS/SE Region – Human Resources, Security Clearance Guidance – Visitors (3/29/12) policy for contract performance period. Contractor employees will be required to obtain a visitor’s pass upon arrival for services from Facilities Management.

5.2. The US PHS Clinton Indian Health Center is a tobacco/smoke free environment (buildings and grounds). No tobacco/smoking use will be tolerated during service.

5.3. Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises, where the work shall be performed shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by Clinton Indian Health Center official, presenting valid identification, smoking restriction and any safety procedures.

5.4. The contractor shall not disclose or cause to disseminate any information concerning operations of Clinton Indian Health Center. Such action(s) could result in violation of the contract and possible legal actions.

5.4.1. All inquiries, comments, or complaints arising from any matter observed, experienced or learned of as a result of or in connection with the performance of the contract, the resolution of which may

Clinton Indian Health Center require the dissemination of official information, shall be directed to the government’s designated representative.

6. DELIVERABLES AND REPORTING REQUIREMENTS

6.1. Delivery: The contractor will coordinate the delivery, installation and training date with the designated government employee. The government will provide the contractor with dock access and building access for this sole purpose. The designated government employee will work with the pertinent government agency to secure the needed dock access. No deliveries can be made after 4:00pm. Driver needs a valid ID.

6.2. Contractor Point of Contact: The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of supplies, delivery, and/or maintenance. The POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract.

6.3. Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered during at least eight working hours, between 8:00 am and 5:00 pm, Monday through Friday.

6.4. Personnel Qualifications: Service and Maintenance shall be performed by certified, experienced training Field Engineers (FE’s). FE stays up to date on all required CE’s, equipment training and advances in technology per manufacturer requirements.

7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

7.1. The Government shall supply no property or services. Facility usage is at the discretion of the Radiology Supervisor as applicable. The vendor shall have a designated chaperone at all times while in the facility.

8. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

8.1. Required personnel, materials, supplies and equipment: The contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the contract, to include but not limited to:

8.1.1.1. Providing radiology supervisors and biomedical technicians, with electronic PM service and repair reports per each site visit on all systems covered by this contract.

8.1.1.2. After completion of requested or scheduled contracted services, the FE shall provide a briefing of field service visit to the radiology supervisor, biomedical equipment technician or designated persons, prior to site departure.

Clinton Indian Health Center

8.1.1.3. The service unit shall provide an ongoing method of monitoring and evaluating services set forth in this contract.

9. CHANGES TO THE STATEMENT OF WORK (SOW)

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

10. DELIVERABLES/PERFORMANCE MATRIX

Measureables to be evaluated at the conclusion of awarded contract:

Performance is acceptable. YES NO N/A

Responsibilites of contractor have been fulfilled, including equipment that arrives and is installed within the designated timeframe.

YES NO N/A

Contractor Invoicing was accurate and submitted in a timely manner.

YES NO N/A

Equipment provided met the technical specifications as defined within the SOW.

YES NO N/A

Quality Control measures were utilized by Contractor personnel.

The contractor met all reporting requirements as designated within the SOW.

YES NO N/A

Training - training sessions for staff on the new equipment.

Competency assessments were completed for each participating staff member.

YES NO N/A

Comments:

Department Supervisor Signature:_________________________

Administrative Officer Signature:_________________________

STEVI M.

BROWN -S

Digitally signed by STEVI M.

BROWN -S

Date: 2025.06.04 09:04:41 -05'00'

Tina M. Scott -S Digitally signed by Tina M.

Scott -S Date: 2025.06.04 11:25:02 -05'00'