Department of Health and Human Services Indian Health Service

Statement of Work (SOW) Portable Electrocardiogram (ECG) Machines

1. PURPOSE OF THE PROJECT

The Indian Health Service (IHS), a federal agency within the Department of Health and Human Services, is responsible for providing federal health services to American Indians and Alaska Natives. The mission of IHS is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level and assure that comprehensive, culturally acceptable personal and public health services are available and accessible to members of the 574 federally recognized Tribes across the United States.

The Lawton Service Unit is a Joint Commission-accredited federal facility in Oklahoma. To meet our mission, portable ECG machines are a medical modality that has been deemed necessary to augment the services as such are necessary to support and supplement health care within the hospital. The mission of the Lawton Service Unit is to deliver quality care in order to attain positive health outcomes for all our valued patients with emphasis on cultural sensitivity and human dignity.

The Lawton Indian Hospital (LIH) Emergency Department (ED) has a requirement for portable ECG systems for rapid acquisition, interpretation, storage, transmission, and integration of patient cardiac diagnostic data into the hospital’s new Electronic Health Record (EHR) system, Oracle, to support timely diagnosis and treatment.

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

2.1. The contractor shall provide all labor, supervision, materials, transportation, equipment, installation, testing, training, and documentation necessary to furnish and place into operation diagnostic ECG systems in the ED at the LIH.

2.2. The Contractor shall provide two (2) portable ECG systems like or equal to Phillips A02 Cardiac WS7000 Part Number 860441_A02 that meet the following minimum requirements below. Note: Both ECG systems are to be identically equipped with the same accessories as below:

2.2.1. Diagnostic-quality up to 18-lead simultaneous ECG acquisition capability included. Standard 12 lead plus V3R, V4R, V5R, V7, V8, V9

2.2.2. Simultaneous acquisition and analysis of all ECG leads.

2.2.3. Color display screen with touchscreen functionality with a screen size between 18 to 19 inches and screen brightness equal to or greater than 380 cd/m2

2.2.4. Guided touchscreen workflow with smartphone-like hand gestures

2.2.5. Internal storage of patient ECG records.

2.2.6. Capability to record and print diagnostic ECG reports.

2.2.7. Weight under 11kg (excluding accessories)

2.2.8. Barcode scanner compatibility or integrated barcode scanning capability.

2.2.9. Capabilities to support auto-programming (EHR-to-Equipment).

2.2.10. Gigabit ethernet connectivity with RJ-45 for transmission and storage of ECG data.

2.2.11. (4 or more) USB 3.0 ports and HDMI interface support.

2.2.12. Wi-Fi 5 or greater connectivity and WPA3-Personal security capabilities.

2.2.13. DICOM and/or HL7 interoperability capability.

2.2.14. Rechargeable battery operation and a minimum battery capacity of 6 hours without printing.

2.2.15. Mobile cart or transport configuration suitable for clinical use.

2.2.16. Patient cable assemblies and lead-wire systems.

2.2.17. Automated ECG interpretation software which includes an 18 lead interpretation algorithm with greater than 600 interpretive statements and pediatric analysis

2.2.18. ECG interpretations include borderline statement suppression with three or more configurable settings.

2.2.19. STEMI support with critical value alerts and polar ST maps

2.2.20. Pace pulse detection – detects pulses as small as 0.02mVms

2.2.21. FDA-cleared medical device suitable for clinical diagnostic use in the United States.

2.2.22. All accessories required for full operation including any accessory required for 18 lead capture and analysis.

2.2.23. Accessories like or equal to the following.

2.2.23.1. (2) Snap Tab Electrode Adaptor (like or equal to Part#860441_E06)

2.2.23.2. (2) Wireless and LAN module if required / D24 Wifi LAN (like or equal to Part#

860441_D24)

2.2.23.3. (2) H12 1D scanner (like or equal to Part #860441_H12)

2.2.23.4. (2) Trolley with adjustable height (like or equal to Part# 860453) with like or equal accessories to (2) 860453_B04, (2) Mounting arm for wireless Patient interface module (like or equal to Part# 860453_C01), (2) Sliding drawers (like or equal to Part#860453_C02), (2) Wire Baskets (like or equal to Part# 860453_C03)

2.2.23.5. (2) 12 lead cables and (2) 18 lead cables allowing for simultaneous capture of all 18 leads

2.2.24. Vendor supplied staff training including Super User Training (like or equal to Article#

860512_B24)

3. PERIOD OF PERFORMANCE

90 days from date of award

4. LEVEL OF EFFORT

4.1. The contractor shall provide two (2) portable ECG systems, including:

4.1.1. Two (2) mobile carts with adjustable height and storage compartments

4.1.2. Two (2) 12-lead ECG lead wires

4.1.3. Two (2) 18-lead ECG lead wires

4.1.4. Two (2) electrode adaptors

4.1.5. Two (2) keyboards

4.1.6. Two (2) scanners

4.1.7. Two (2) battery

4.2. Training: Contractor shall provide on-site user training for designated clinical and support personnel, including:

4.2.1. Equipment operation.

4.2.2. Patient preparation and lead placement.

4.2.3. ECG acquisition procedures.

4.2.4. Report generation and printing.

4.2.5. Data storage and retrieval.

4.2.6. Basic troubleshooting.

4.2.7. Cleaning and disinfection procedures.

4.3. The Contractor shall provide warranty coverage, a user manual, and technical documentation.

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. - (Security Clearance for on-site human services)

5.2. The USPHS Lawton Service Unit 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 Lawton Service Unit 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 Lawton

Service Unit. 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 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 contractor shall deliver to Lawton Indian Hospital at 1515 Lawrie Tatum Rd, Lawton OK 73507 with all installation instructions, warranty documents, and specifications. No deliveries can be made after 4:15pm. 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 4:30 pm, Monday through Friday.

7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

7.1. IAW FAR Part 52.245-1, The Government shall supply the facilities, supplies and the equipment of the ED and all hospital specialty/support staff. Use of government furnished facility space, equipment, supplies, and personnel are for the provision of services set forth in this contract only.

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.

9. CHANGES TO THE STATEMENT OF WORK (SOW)

9.1. 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

10.1. The contractor shall provide user manuals, technical service and warranty documentation, preventative maintenance recommendations, and software updates necessary for proper system operation.

Services delivered and completed within time frame as set forth in contract Yes or No Contractor was professional Yes or No Item delivered meets specifications of this SOW Yes or No Contractor provided a POC Yes or No Government Property inventory and inspection Yes or No

Department Supervisor Signature:_________________________

Department Director Signature:_________________________