B Statement of Work.docx

Statement of Work

Project Title: E-Control Systems Temperature Monitoring Equipment - Phoenix Indian Medical Center and Sherman Indian High School Clinic

1. Introduction and Background

The Indian Health Service (IHS), Phoenix Area Office (PAO) Department of Acquisition Management (DAM), is procuring for a Contractor to provide equipment and technical services necessary to install new E-Control Systems temperature monitoring equipment at Phoenix Indian Medical Center (PIMC) and Sherman Indian High School Clinic. This purchase includes procurement, delivery, assembly, installation, and calibration of new E-Control Systems equipment by an Original Equipment Manufacturer (OEM) certified installer and authorized dealer. This is a brand name procurement only. The requested equipment is a turnkey wireless temperature monitoring system that meets the stringent regulatory requirements of The Joint Commission (TJC), Centers for Disease Control and Prevention (CDC), and Vaccines for Children (VFC). Procurement of the E-Control Systems temperature monitoring solution provides 24/7 monitoring capability on a secure internal server and aids the local Biomedical Engineering department’s ability to fulfill monitoring requirements on enclosed environments of medical equipment including refrigerators, freezers, and blanket warmers. The E-Control Systems digital data loggers are required to provide continuous temperature monitoring of medical equipment located in the following Phoenix Indian Medical Center and Sherman Indian High School Clinic departments including: Intensive Care Unit, Inpatient, Emergency Department, Laboratory, Outpatient, Pharmacy, Specialty Clinic, Dental, and Obstetrics Ward. Multiple refrigerator and freezer units house medication and/or vaccines with strict temperature monitoring requirements to ensure safe storage and handling. Digital data loggers with continuous monitoring and reporting capabilities and a current certificate of calibration are required for all units storing Vaccines for Children (VFC) vaccines per Arizona VFC guidelines. Calibrated digital data loggers are required to stay in compliance with VFC vaccine management plan guidelines.

2. Service and Equipment Requirements

The Contractor shall provide E-Control Systems certified personnel to perform comprehensive on-site visits to Phoenix Indian Medical Center and Sherman Indian High School Clinic, in order to install E-Control Systems IntelliSense ZB hardware and software to optimal operation. The Contractor shall provide all test equipment, tools, labor, supervision, parts, travel, and any other items deemed necessary to fulfill the requirements of this statement of work. All equipment shall be installed without modifications to the existing structure of utilities. Specific tasks and requirements include the following:

2.1 – E-Control Systems IntelliSense Equipment Procurement, Delivery, and Installation:

The Contractor shall procure, install, and configure all new E-Control Systems temperature monitoring equipment to operate inside Phoenix Indian Medical Center and Sherman Indian High School Clinic. The Contractor shall deliver, install, and certify all IntelliSense temperature monitoring equipment to fully comply with all relevant E-Control Systems installation criteria and technical standards. The equipment must conform to site conditions and E-Control Systems install specifications. The Contractor shall ensure all new E-Control Systems equipment is properly installed and mounted to the monitored medical equipment. The temperature probes and/or sensors shall be installed in a buffered material (glycol) and installed in the middle of the monitored unit in compliance with Arizona Vaccines for Children requirements. The Contractor shall install, assemble, and mount the digital data logger equipment per OEM specifications requirements. All equipment and accessories shall be new condition, E-Control Systems factory assembled/configured, and include a factory warranty. Remanufactured items or items procured through non-authorized channels (gray market) will not be accepted. The Contractor shall warrant all workmanship. The Contractor shall ensure the equipment is pre-assembled at the E-Control Systems factory/manufacturer and delivered to Phoenix Indian Medical Center and Sherman Indian High School Phoenix

Area

IHS

E-Control

Systems

Temperature

Monitoring

Equipment

Procurement Phoenix

Area

IHS

Service

Units

Phoenix

Indian

Medical

Center and

Sherman

Indian

High

School

Clinic

IHS# 1454668

Clinic. It is the Contractor’s responsibility to unload, unpack, and unbox all equipment and properly remove and dispose of packing material. Hardware installation services shall be provided by E-Control Systems authorized installer (including connection of sensors). The Contractor shall remove the wrapping, transport, and physically install the equipment at all departments/locations listed herein. The Contractor shall assemble, install/adjust, and test the E-Control Systems devices and components to ensure proper operation and electrical safety. The Contractor is responsible for the repair and/or replacement of any damaged, defective, broken, or missing item/part/accessory. A complete list of all E-Control Systems equipment and services (including options/accessories/configurations) required in this procurement is listed in Section 14 – E-Control Systems Equipment and Services. The Contractor shall provide and install the following E- Control Systems IntelliSense equipment/software and services:

2.2.1 IntelliGate ZB Kit (with Power Supply, Ethernet Cable, Magnet) – Part #5011001 – Quantity 29

2.2.2 Mesh Router Kit – Incudes Mesh Router (ZB), and 5v Power Supply – Part #4021029 – Quantity 4

2.2.3 IntelliSensor TempNTC-40ZB V3 w/ Display – Includes Power Supply (Capable of Monitoring Up to 4 temps) – Quantity 65

2.2.4 IntelliSensor HumBipZB V3 w/ Display - Includes Power Supply (Temperature & Humidity Probes built into sensor) – Quantity 53

2.2.5 IntelliSensor TempNTC-22ZB V3 w/ Display – Includes Power Supply (Capable of Monitoring Up to 2 temps & 2 Digital) – Quantity 2

2.2.6 IntelliSensor TempRTD-40ZB V3 w/ Display – Includes Power Supply (Capable of Monitoring Up to 4 temps) – Quantity 2

2.2.7 IntelliSensor Analog5V-40ZB (Capable of Monitoring Up to 4 Analog Devices) – Quantity 1

2.2.8 Zip Cord Probe (-40°C + 125°C) – Quantity 3

2.2.9 Product Simulator – Glass Glycol Bottle (Including Probe): -40°C +85 °C – Quantity 68

2.2.10 ULT RTD Probe (-200 °C - + 40°C) – Quantity 1

2.2.11 CO2 Probe - 0-5% 0-5V Output – Quantity 1

2.2.12 24 V Power Supply – Quantity 1

2.2.13 3 Point Loop Calibration – 1 transmitter 1 probe – Quantity 56

2.2.14 3 Point Loop Calibration - 1 transmitter 2 probes – Quantity 8

2.2.15 3 Point Loop Calibration (ULT or LN2) 1 transmitter 1 probe – Quantity 1

2.2.16 HumBip Calibration – Quantity 1

2.2.17 Analog 5V Calibration – Quantity 1

2.2.18 Hosting fee per IntelliSensor Unit – Quantity 118

2.2.19 Setup Fee for Hosting per Measured Point (One Time Fee) – Quantity 178

2.2.20 Hardware Installation Services

2.2.21 Shipping and Delivery Services

2.3 – E-Control Systems Equipment Inspection and Performance Testing:

The Contractor shall test all E-Control Systems temperature monitoring equipment after installation to confirm proper operation in accordance with OEM requirements. The Contractor shall make physical and wireless connections in accordance with E-Control systems setup requirements. Qualified personnel shall perform calibrations and function testing of the temperature monitoring system hardware. Phoenix Area Indian Health service will accept the equipment once installation and successful verification testing has been completed and approved.

2.4 – E-Control Systems Equipment Training:

The Contractor shall provide orientation and end-user training to the Phoenix Indian Medical Center and Sherman Indian High School Clinic staff upon final installation.

2.5 – Documentation of services performed and supporting documents The Contractor shall provide a detailed service report indicating services performed and include pertinent information such as equipment identification (serial number and device type) and equipment location (department/room). Printed and digital copies of all packing slips, bills of lading, and other shipping documents shall be provided to the local Phoenix Indian Medical Center and Sherman Indian High School Clinic Property & Supply department. The Contractor shall provide all supporting documents upon request including service manuals, user manuals, and technical data sheets.

3. General Requirements

The services/work that the Contractor shall provide specifically includes those described in Section 2 or specified herein. However, the performance as described and specified shall not be deemed to constitute a detailed specification having the effect of excluding other needed work not specifically mentioned that will be necessary for the successful completion of this project as generally described. The Contractor is required to furnish all services necessary to successfully fulfill the overall objectives set forth in the contract.

Complete delivery, installation, and testing of new IntelliSense equipment shall be provided by the Contractor. The Contractor shall provide all services and technical support necessary to install and configure the E-Control Systems equipment. Full operation and final configuration of all E-Control Systems equipment shall be achieved within the period of performance of this contact. The Contractor shall clean and wipe down all equipment after installation.

The Contractor shall maintain a current list of the E-Control Systems equipment installed at Phoenix Indian Medical Center and Sherman Indian High School Clinic and shall provide an updated list to the Contracting Officer Representative (COR) upon request. This list shall include the following information: current technical specifications of the E-Control Systems devices and device information (device type, serial number, location, and current configuration). The general area shall be left in a clean and orderly condition free of any foreign material caused by the installation services.

The Contractor shall provide on-site visits for all services listed herein including installation/configuration of E-Control Systems devices, and training services. The Contractor shall furnish all necessary tools, consumables, software and test equipment to pursue the fulfillment of work performed under this Statement of Work. The Contractor shall provide the necessary parts and accessories (including mounts) to ensure all new temperature monitoring equipment is properly installed in the enclosed environments of the medical devices. All new E-Control Systems digital data loggers and sensors shall be properly mounted to the monitored device and installed in compliance with CDC and VFC requirements.

The Contractor shall provide at least one (1) site visit for installation services and at least one (1) site visit for the final review, testing, and subsequent acceptance by IHS of the E-Control Systems temperature monitoring equipment.

The Contractor shall warrant all workmanship. The Contractor shall at minimum provide a full one year warranty for parts and labor for all E-Control Systems equipment and components listed herein. The warranty shall begin at the time of IHS acceptance of equipment and after installation. All services shall be performed in accordance with E-Control Systems requirements, in order to fulfill requirements for coverage of the manufacturer warranty.

The Contractor shall provide training such that all Phoenix Indian Medical Center and Sherman Indian High School Clinic staff completing the training are qualified to operate the IntelliSense hardware and software. The Contractor shall provide remote support and training to Phoenix Indian Medical Center and Sherman Indian High School Clinic end-users on use of FusionLive software.

The Contractor shall provide all shipping and handling services necessary to deliver and install the E-Control Systems equipment. Equipment shall be delivered by standard freight and lift gate delivery service shall be provided upon request.

The Contractor shall inform the COR and local service unit point of contacts of shipping updates and provide notification of shipment within 24 hours.

The Contractor shall provide a projected schedule for the project, within 15 days of contract award addressing the following milestones: on-site survey and verification that all E-Control Systems equipment quantities and configurations are accurate, manufacture/factory assembly of all parts and/or equipment, delivery to Phoenix Indian Medical Center and Sherman Indian High School Clinic, and installation of new IntelliSense temperature monitoring equipment.

All equipment and materials provided by the Contractor shall be new and, where appropriate, shall arrive on-site sealed in original manufacturer’s containers. The Government reserves the right to refuse any items deemed to not meet this requirement. The Contractor shall provide tools, labor and any test equipment for on-site installation.

The Contractor shall provide remote software installation support and configuration services to Phoenix Area and Phoenix Indian Medical Center and Sherman Indian High School Clinic Information Technology (IT) departments. The Contractor shall provide FusionLive software packages, patches, updates, and licenses.

4. Contractor Personnel Requirements

The Contractor shall provide E-Control Systems certified service personnel with experience in maintenance, installation and testing of the IntelliSense temperature monitoring equipment types listed herein. Personnel shall be qualified to perform the required installation and training services for all listed equipment (see Section 14 – E-Control Systems Equipment and Services). In the event a service representative is unable to fulfill all services listed herein, the Contractor shall provide a senior service engineer, or like, to resolve any problems. All workmanship performed by the Contractor shall be of acceptable industry standard quality and shall be immediately rectified at no additional cost to the Government upon notification of non-acceptability by the Government. Valid documentation of E-Control Systems certification and current manufacturer’s authorization to perform technical support, installation, and maintenance on the items listed in Section 14 shall be included with the submission of offer at the time of solicitation.

5. Contractor Requirements

The Contractor shall provide all needed supplies, OEM parts, materials, equipment, and tools that are necessary for the performance of the contract requirements. The Contractor shall be held responsible for the cost of any necessary repairs or equipment replacements caused by negligence and abuse on his/her part. The Contractor shall be responsible for the cost for safeguarding all Government property that will be serviced under this contract. The Contractor shall have adequate liability insurance to cover any potential liability. In no event shall the Government release the Contractor from liability arising from acts of omission, improper repair, negligence, or deliberate or non-deliberate acts that jeopardize the health and safety of patients and/or Government employees. The rules of law governing such incidents or actions shall prevail.

The Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized Contractor reseller for the proposed equipment/system such that the OEM warranty is supported and maintained by the OEM. The Contractor shall be OEM authorized/certified to service the required E-Control Systems equipment throughout the lifecycle of the contract. If you are not the original equipment manufacturer (OEM), then an Authorized Distributor Letter is required with the submission of offer at the time of solicitation in order to be considered for the award.

The Contractor shall have an active quality system in place that at the time of solicitation and throughout the lifecycle of the contract. The Contractor shall utilize quality processes established on ISO 27001, ISO 17025, and ISO 9002 standards. The Contractor shall provide quality certificates indicating compliance to quality management system regulations upon request.

6. Reporting Requirement and Deliverables

6.1 Service Reports: The Contractor shall instruct its service representatives to obtain a signature from the COR or designee official responsible for the equipment upon completion of the installation and testing services. A copy of the signed service report shall be left with the COR or designee official responsible for the E-Control Systems equipment. The Contractor shall also forward copies of the Installation and Testing Service Reports to the COR by the 7th day after service is performed. However, Emergency Maintenance Service Reports shall be forwarded to the COR within 10 working days after completion of the service. At a minimum, Service Reports should include the following information:

6.1.1 Device type

6.1.2 Model Number

6.1.3 Serial Number

6.1.4 Location(department/room number)

6.1.5 Configuration/settings on device

6.1.6 Serial Number, Make, Model and Last Calibration Date of all Test, Measurement, and Diagnostic Equipment (TMDE) used. All equipment shall be NIST traceable.

6.1.7 Testing Results

6.1.8 Technician Comments.

6.2 Original Equipment Manufacturer’s Supporting Documentation

6.2.1 The Contractor shall provide hard copies and digital copies of the latest versions of the manufacturer’s manuals for operation, maintenance, inspection, and repair. Documents shall include User’s Manuals, Service Manuals, Operator’s manuals, etc.

6.3 Invoice Instructions:

Invoicing will be completed electronically at www.ipp.gov or any successor site. Note: The IPP Helpdesk is itservicedesk@fiscal.treasury.gov

HHSAR Clause 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022)

(a) Definitions. As used in this clause -- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘Content of Invoices’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

Contracting Officer Representatives (COR): Zachary Navarro, zachary.navarro@ihs.gov Contract Specialist/Administrator: Donovan Conley, Donovan.Conley@ihs.gov

6.4 Training: The Contractor shall schedule and provide operator and in-service training for the Phoenix Indian Medical Center and Sherman Indian High School Clinic staff. The in-service trainings shall be provided by the Contractor:

6.4.1 Provide operational and problem identification training to biomedical engineering staff on-site at Phoenix Indian Medical Center and Sherman Indian High School Clinic.

6.4.2 Provide remote FusionLive software support to Phoenix Indian Medical Center and Sherman Indian High School Clinic staff.

6.4.3 Available E-Control Systems training resources such as operator’s guides and quick reference sheets shall be provided in hard copies and digital copies.

7. Conformance standards

The Contractor shall install and service the E-Control Systems equipment covered by this contract in accordance with the following standards:

7.1.1 Original Equipment Manufacturer’s (OEM) specification requirements

7.1.2 American National Standard (ANSI)

7.1.3 Arizona Vaccines for Children (VFC)

7.1.4 Centers for Disease Control and Prevention (CDC)

7.1.5 The Joint Commission Standard (EC.02.04.03)

7.1.6 Association for the Advancement of Medical Instrumentation (ANSI/AAMI EQ56:2013)

7.1.7 International Organization for Standardization (ISO)

7.1.8 Occupational Health and Safety Association

7.1.9 Federal, Tribal, and local regulatory guidance and ordinances in regards to bio hazardous waste, disposal, and applications

8. Inspection and Acceptance Criteria

The Government will monitor the Contractor’s performance under this contract and shall retain the right to perform unscheduled inspections, as it deems necessary. Furthermore, the Government retains all rights provided by the FAR (Federal Acquisition Regulations) clause entitled “Inspection of Services – Fixed Price” and any other inspection clause, which may be specified in the contract. The Government will conduct an acceptance inspection following the completion of the E-Control Systems equipment installation. The inspection will be performed by the Phoenix Indian Medical Center Biomedical Engineering staff. Contractor shall correct any deficiencies noted within 30 days following the inspection.

The Contractor shall have a prior successful history in providing E-Control Systems equipment installation services and present full ability to perform all services during the lifecycle of the contract. The Contractor shall investigate all deficiencies, complaints, and suspected issues involving services performed that do not conform to the expectation listed within the Statement of Work. In the event an identified issue is not remediated in a timely manner, an independent qualified consultant shall be retained at the Contractor’s expense.

The COR will monitor the Contractor’s activities and accomplishments and will indicate acceptance or non-acceptance of the deliverable. The deliverables identified within this Statement of Work will be inspected and either approved or, if they are not acceptable, rejected by the COR. The Contractor shall establish an inspection system covering the equipment stated in this Statement of Work. The Contractor shall maintain a history file on all installations, testing, repairs, relocations and inspections conducted. The history file shall be the property of the Government and shall be maintained by the Contractor and turned over to the COR upon completion of the contract.

9. Safety Precautions/ Bio-Hazard Safety

All system, either mechanical or electrical that must be deactivated before servicing shall be rendered by whatever disconnect or shut-off means are provided. Each deactivated system shall be properly “tagged-out” to prevent accidental reactivation. The Phoenix Indian Medical Center Biomedical Engineering Department will furnish “tag-out” procedures and tags. The Government shall be responsible for removing the contents of any equipment and ensuring it is biologically safe. If applicable, the Contractor shall notify the Phoenix Indian Medical Center and Sherman Indian High School Clinic Biomedical Engineering Department and Safety Officer before removing any bio-hazardous material. If applicable, the Contractor is responsible for removing and disposing of all hazardous materials/sources. The Contractor shall take the necessary precautions to safeguard all medication, vaccines, specimens, and reagents stored in environmentally controlled units including refrigerators, freezers, and chambers.

10. Schedule and Notification, Government Responsibility

The contractor shall provide all services during normal operating hours Monday through Friday from 8:00 a.m. to 4:30 p.m. during the week, unless otherwise specified. Any install services outside of the normal work schedule shall be arranged with the facility Point of Contact at no additional expense to the Government. Service schedule shall be agreed to by the contractor and the designated COR. The Contractor personnel shall check-in with the Phoenix Indian Medical Center and Sherman Indian High School Clinic Biomedical Engineering Department or Facilities Engineering Department before beginning any work. The Contractor shall call or email the Phoenix Indian Medical Center and Sherman Indian High School Clinic Service Unit staff and coordinate with the department leads during project implementation. The Contractor shall acquire approval for all scheduled dates for services and deliveries, no less than one (1) week in advance.

Contractor shall comply with IHS visitation policy.

10.1 Before performing services the Contractor personnel shall report to the Security Department and local Facilities Engineering or Biomedical Engineering Department at the beginning and end of their entire visitation at the facility, to sign-in and receive a facility “Guest” badge.

10.2 The Contractor shall report to the Facilities and/or Biomedical Department at the beginning of each visitation for a wellness screening prior to start of work due to COVID-19 response. The Contractor’s personnel shall comply with all visitation requirements prior to entering the facility.

10.3 The Contractor shall be authorized to park only in areas opened to the public.

10.4 The Contractor shall be allowed minimal use of government space to store supplies and/or equipment as required under this contract.

10.5 The Contractor shall be responsible for any repair or damage incurred to the building system as a result of contractor errors or poor workmanship.

11. Performance Period

The Period of Performance for this contract is three months from the issuance of award.

12. Submission of Offer

The Contractor shall provide the following documentation with the submission of offer at the time of solicitation:

12.1 Documentation of the manufacturer of the IntelliSense temperature monitoring equipment

12.2 Documentation and/or technical specification sheets of the E-Control Systems equipment

12.3 E-Control Systems Authorized Distributor Letter and E-Control Systems Certified/Trained Personnel (Documentation confirming Contractor is OEM authorized dealer/installer)

12.4 Information detailed in submitted offer shall include clear description of equipment and services by line item (Reference Section 14):

12.4.1 IntelliSense equipment information (Manufacturer Item #, Device Description, Quantity, and Cost)

12.4.2 Description of all delivery/transport, and installation services

12.4.3 Warranty and support provisions: Information on all parts and labor provided by the Contractor post- installation and time period of coverage.

12.4.4 Post-Warranty Support: The Contractor shall provide a detailed list of services available to Phoenix Indian Medical Center and Sherman Indian High School Clinic after warranty period ends. The Contractor shall include pertinent information such as description of on-site maintenance/repair services available, number of technicians available to Phoenix Area, and warranty period for repair services (including associated parts, service, and clinical components).

13. Location

The Contractor shall deliver all equipment and services to the following location:

13.1 Phoenix Indian Medical Center 4212 N 16th St

Phoenix, AZ 85016

13.2 Sherman Indian High School Clinic 9010 Magnolia Avenue

Riverside, CA 92503

14. E-Controls Systems Equipment and Services

The Contractor shall procure, deliver, and install all E-Control Systems IntelliSense equipment and provide all services listed in the table below. The Contractor shall reference all E-Control Systems Manufacturer item numbers in the submission of offer at the time of solicitation.

Item

Quantity

E-Control Systems Equipment Description (Including Options/Accessories/Configurations) Manufacturer Item #

IntelliSense ZB Hardware

IntelliGate ZB Kit (Includes Power Supply, Ethernet Cable, Magnet)

5011001

Mesh Router Kit – Incudes Mesh Router (ZB), and 5v Power Supply

4021029

IntelliSensor HumBipZB V3 w/ Display - Includes Power Supply(Temperature & Humidity Probes built into sensor)

IntelliSensor HumBipZB V3

Sensors and Parts

Product Simulator – Glass Glycol Bottle (Including Probe): -40°C +85 °C

N/A

Calibration Services

3 Point Loop Calibration Services – 1 transmitter 1 probe

N/A

Enterpise Software License

Setup Fee for Hosting per Measured Point (One Time Fee)

N/A

15. Phoenix Indian Medical Center and Sherman Indian High School Clinic Monitored Equipment

The Contractor shall install all E-Control Systems IntelliSense sensors in the departments/equipment listed below.

Department/Location

Quantity

Microbiology

Probe

Incubator CO2 (5 to 10%CO2) / Temperature NTC - 22, Zip Cord Probe, Analog 5V, CO2 Probe, Power Supply

Blood Bank

Chemistry

Laboratory Hallway

Hematology

Laboratory Hallway

Phlebotomy

Pathology

Morgue

PCMC - Pharmacy

PCMC South

PCMC North

Specialized Care

ED Med Room

ICU Med Room

Same Day Surgery

Pharmacy 2FL

Podiatry

Compounding

Pharmacy 3FL

West OB

East OB

Pediatrics

Specialty Clinic

BSMT Room

Dental

Dental Annex

Vaccine Clinic

Food Service

Sherman Indian High School Clinic