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Phoenix Area IHS Audiology Equipment Phoenix Area IHS Service Units

IHS#1454895

Statement of Work

Project Title: Phoenix Area Audiology Equipment – FY2022 Procurement

1. Introduction and Background

The Indian Health Service (IHS), Phoenix Area Office (PAO) Department of Acquisition (DAM), is procuring for a Contractor to provide equipment and technical services necessary to install and configure new audiology field equipment at Phoenix Indian Medical Center. Audiology equipment aids in the diagnosis of otologic and/or neurologic hearing loss and selection of therapy. The required audiology equipment types require specialized installation services by certified technicians to ensure that the acoustical, electrical, and mechanical properties are correct and devices are configured to meet manufacturer’s requirements. The Indian Health Service PAO intends to procure new audiology equipment and installation services by original equipment manufacturers (OEM) certified/trained audiology equipment specialists that meet manufacturer specifications, National Association of Specialized Equipment Dealers (NASED) specifications, and current American National Standards Institute (ANSI) standards.

2. Service Description

The Contractor shall provide NASED certified personnel to perform comprehensive on-site visits to Phoenix Indian Medical Center, in order to install new field equipment and software and configure the audiology instruments to optimal operation. Specific tasks and requirements include the following:

2.1 - Delivery, installation, and configuration of the new condition audiology equipment:

The Contractor shall install and configure all new audiology devices to operate inside Phoenix Indian Health ServiceMedical Center and fully comply with all relevant Interacoustics installation criteria and technical standards.

he Contractor shall deliver, install, and certify all devices to fully comply with all relevant acoustic criteria and technical standards. All devices shall be new condition, factory assembled and configured, and include a factory warranty. Remanufactured items or items procured through non-authorized channels (gray market) will not be accepted. It is the Contractor’s responsibility to unload, unpack, and uncrate all equipment and properly remove and dispose of packing material. The Contractor shall remove the wrapping, transport, and physically install the equipment at the audiology department location. The Contractor shall assemble, install/adjust, and test the audiology 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. All applicable licenses, training, shipping/handling fees and software modules shall be included in this procurement. The Contractor shall provide and install the following audiology equipment:

2.1.1 Interacoustics Callisto AUD/REM/VSP DD450 - Part #8531142 – QTY 5 Package shall include the following options/accessories:

- Transducers: IP30 insert phones -DD450 (standard freqs only) -B81 bone oscillator -HW: REM speaker & cables

-SW: AC440/REM440/VSP440

-Accessories: mic/monitor headset; pt resp switch; binaural probe mic assembly; probe tubes; USB cable; carry case -Features: QuickSIN; MHA; wave files recorded speech tests

2.1.2 Wheeled Trolley - Part #8004678 – QTY 5

2.1.3 Interacoustics VIOT Video Otoscope - Part #8513389 – QTY 5 Package shall include the following options/accessories:

- VO w/ charging stand; USB cable

-SW: VIOT Suite

-Accessories: speculum starter kit

2.1.3 Precision Yellow Probe Tubes-120/pkg - Part #1330090 – QTY 10

2.1.4 4.0mm Speculum stacked - Part #8511728 – QTY 10

2.1.5 2,5 mm Speculum stacked - Part #8515083 – QTY 10

2.1.6 Installation Services – Install and configure NOAH, Calisto and VIOT software

2.1.7 Shipping and Handling Services

2.2 – 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. 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 service necessary to successfully fulfill the overall objectives set forth in the contract.

Complete installation, configuration, testing, and programming services shall be provided by the Contractor for all audiology devices procured in this award to ensure full operation of the audiology equipment..

The Contractor shall maintain a current list of the audiology devices installed at Hopi Health Care Center and provide an updated list to the Contracting Officer Representative (COR) upon request. This list must include the following information: current technical specifications of the audiology devices, current software versions, and device information (device type, serial number, location, and current configuration).

Contractor personnel shall check-in with the PAO Service Units Biomedical Engineering Department before beginning any work. Contractor shall call or email PAO Service Unit to identify installation locations.

The contractor shall provide all services during normal operating hours Monday through Friday from 8:00 a.m. to 4:30 p.m. excluding the weekend and federal holidays. Service schedule shall be agreed to by the contractor and the designated

COR.

The Contractor shall remove all trash, discarded parts, dunnage, and other material from areas immediately after completion of installation or repair. Government-owned dumpsters may be used for disposal of this nonhazardous waste material. The general area shall be left in a clean and orderly condition free of any foreign material caused by the installation or repair activities.

The contractor shall provide a minimum of one (1) on-site visit for all services listed herein. 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 warrant all workmanship. The warranty will remain free from defects as follows: at a minimum, standard warranty is 1 year parts and labor unless otherwise specified in the product manual and/or Seller’s quotation.

The contractor shall provide training such that all patient care providers and biomedical equipment technicians completing the training are qualified to operate and identify problems in the operation of purchased equipment

The Contractor shall provide all shipping and handling services necessary to deliver and install the audiology equipment.

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 audiology equipment quantities and configurations are accurate, manufacture/factory assembly of all parts and/or equipment, delivery to Phoenix Indian Medical Center, and installation of new audiology 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 installation and removal of old equipment from the premises.

4. Contractor Personnel Requirements

The Contractor shall provide NASED certified personnel with experience in maintenance, installation and testing of the audiology equipment types listed herein. Personnel must be qualified to perform the required installation services for all listed equipment (see Section 2). In the event the 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 Interacoustics, and Hearing Instrument Manufacturers' Software Association certification and current manufacturer’s authorization to perform technical support, installation, and configuration on the items listed in Section 2 shall be included with the submission of offer at the time of solicitation.

5. Contractor Requirements

The Contractor shall provide all needed supplies, 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 repairs cause 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. If applicable, the Contractor shall be responsible for replacing, purchasing, and disposing of bio-hazardous sources, and shall consider such services a regular part of this contract.

6. Reporting Requirement and Deliverables

1. Service Reports – Delivery Tickets: The Contractor shall instruct its service representatives to obtain a signature from the COR or designee official responsible for the equipment on a service report upon completion of the installation. A copy of the signed service report shall be left with the COR or designee official responsible for the audiology equipment. The Contractor shall also forward copies of the Installation, Programming, 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:

A. Device type, Model Number, Serial Number, Location, Configuration/settings on device, Testing

Results, and Technician Comments.

7. Conformance standards

The Contractor shall install and service the audiology equipment covered by this contract in accordance with the following:

9.1 Original Equipment Manufacturer’s (OEM) specification requirements

9.2 National Association of Specialized Equipment Dealers (NASED) requirements

9.3 National Fire Protection Association (NFPA) 99 (2012 Edition), 101 (2012 Edition), 70E (2012 edition)

9.4 The Joint Commission Standard (EC.02.04.03)

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

9.6 Occupational Health and Safety Association

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

8. Quality Assurance

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.

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 PAO Service Unit 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 PAO Service Unit Bio-Medical 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.

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 de-install or 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 Biomedical Engineering Department or Facilities Engineering Department before beginning any work.

Contractor shall call or email the Phoenix Indian Medical Center 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 week in advance. The Contractor shall comply with IHS visitation policy.

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

2. The contractor shall report to the Facilities and/or Biomedical Department at the beginning of each visitation for a verbal wellness screening prior to start of work due to Covid-19 response.

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

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

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. Inspection and Acceptance Criteria, Government Responsibility

The COR will monitor the Contractor’s activities and accomplishments and will indicate acceptance or non-acceptance of the deliverable. The deliverables identified above will be inspected and either approved or, if they are not acceptable, rejected by the COR. Such inspections will occur within five workdays after the COR receives the deliverable.

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, programming, 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.

12. Location

12.1 Phoenix Indian Medical Center

4212 N 16th St Phoenix, AZ 85016

13. Audiology Equipment and Services

The Contractor shall procure, deliver, and install all audiology equipment and provide all services listed in the table below.

The Contractor shall reference all Manufacturer item numbers in the submission of offer at the time of solicitation.

Item Quantity Audiology Equipment Description (Including Options/Accessories/Configurations)

Manufacturer Item #

Interacoustics Callisto

AUD/REM/VSP DD450 5

Interacoustics Callisto AUD/REM/VSP DD450 Package shall include the following options/accessories:

- Transducers: IP30 insert phones -DD450 (standard freqs only)

-B81 bone oscillator -HW: REM speaker & cables

-SW: AC440/REM440/VSP440

-Accessories: mic/monitor headset; pt resp switch;

binaural probe mic assembly; probe tubes; USB cable; carry case -Features: QuickSIN; MHA; wave files recorded speech tests

8531142

Wheeled Trolley 5 Wheeled Trolley

8004678

Interacoustics VIOT Video Otoscope 5

Interacoustics VIOT Video Otoscope -Package shall include the following options/accessories:

- VO w/ charging stand; USB cable -SW: VIOT Suite 8513389

-Accessories: speculum starter kit

Precision Yellow Probe Tubes 10 Precision Yellow Probe Tubes-120/pkg 1330090

4.0mm Speculum stacked 10 4.0mm Speculum stacked 8511728

2,5 mm Speculum stacked 10 2,5 mm Speculum stacked 8515083

Installation Services - Installation Services – Install and configure NOAH, Calisto, and VIOT software on government owned laptops N/A

Shipping and Handling Services - Shipping and Handling Services N/A

1. Introduction and Background
2. Service Description
3. General Requirements
4. Contractor Personnel Requirements
5. Contractor Requirements
6. Reporting Requirement and Deliverables
7. Conformance standards
8. Quality Assurance
9. Safety Precautions/ Bio-Hazard Safety
10. Schedule and Notification, Government Responsibility
11. Inspection and Acceptance Criteria, Government Responsibility
12. Location
13. Audiology Equipment and Services

File details come from the government source that posted it. Updated .