Specification_Ultrasound Probe Disinfection System.pdf

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Ultrasound Disinfection System
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IHS1517633
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This document is a specifications document from the Indian Health Service (IHS), Department of Health and Human Services, soliciting an ultrasound probe reprocessing system for the Lawton Indian Hospital in Oklahoma. The specifications require a device like the Nanosonics Trophon 2 system with advanced high-level disinfection capabilities for various medical probes, meeting CE mark, FDA registration, and multiple international standards for bacterial, viral, fungal, and mycobactericidal efficacy. The system must eliminate clinically relevant pathogens including multi-drug resistant bacteria, blood-borne viruses, and HPV, and create digital records for audit compliance.

The contractor must provide the reprocessing system, a compatible printer, initial consumables (including medical instrument tags, cleaning wipes, and probe covers), and new equipment documentation within 90 days of award. Delivery is specified for the Lawton Indian Hospital, with strict requirements including a valid ID for the driver and no deliveries after 4:15 pm. The contractor must also provide an online training resource, a toll-free service number operational during standard business hours, and a designated point of contact for coordination and daily decision-making throughout the contract implementation.

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Department of Health and Human Services Indian Health Service

Specifications Ultrasound probe reprocessing system

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, an ultrasound probe reprocessing system is 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), Indian Health Services (IHS) has a requirement for an ultrasound probe disinfection system to augment services in the emergency department and women’s clinic.

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

2.1. The contractor shall supply an ultrasound probe reprocessing system like or equal to the Nanosonics

Trophon 2 system with the following features:

2.1.1. The contractor must provide a device that has the capability for automated high level disinfection technology for transvaginal, transrectal and surface probes to meet mandatory microbial efficacy test requirements for both CE mark and FDA registration.

2.1.2. The contractor must provide a system that meets required EN, ASTM, and AOAC standards to demonstrate:

2.1.2.1. Bacterial Efficacy

2.1.2.2. Virucidal efficacy (enveloped and non-enveloped viruses)

2.1.2.3. Fungicidal efficacy

2.1.2.4. Mycobactericidal efficacy

2.1.3. The contractor must provide a system that has demonstrated the ability to eliminate an extended range of clinically relevant pathogens including:

2.1.3.1. Multi-drug resistant bacteria, such as MRSA and VRE

2.1.3.2. Blood borne viruses sexually transmitted pathogens

2.1.3.3. Clostridium difficile spores

2.1.4. The contractor must provide a high-level disinfection system that has demonstrated ability and proven to kill high-risk HPV.

2.1.5. The contractor must supply a system that creates accurate digital records, accessible on the device to support audit-readiness in compliance with Joint Commission.

2.1.6. The contractor must supply a wall mount for the ultrasound probe reprocessing system.

2.2. The contractor must supply a printer compatible with the ultrasound probe reprocessing system to include:

2.2.1. Any cables needed to connect the printer to the ultrasound probe reprocessing system

2.2.2. An initial roll of printer paper

2.2.3. A wall mount

2.2.4. Power plug

2.3. The contractor must supply an initial supply of consumables to include but not limited to:

2.3.1. Medical instrument tags

2.3.2. Operator cards

2.3.3. Cleaning wipes

2.3.4. Dying wipes

2.3.5. Wipes wall mount

2.3.6. Disinfectants

2.3.7. Chemical indicators

2.3.8. Ultrasound probe cover

2.3.9. Curved probe positioner

2.4. The contractor must provide new equipment to include:

2.4.1. Any manufacturers booklets

2.4.2. Warranty information

2.4.3. Cabling

2.4.4. software

3. PERIOD OF PERFORMANCE

90 days from date of award

4. LEVEL OF EFFORT

4.1. Training: Contractor shall provide an online resource for training and initial use.

5. DELIVERABLES AND REPORTING REQUIREMENTS

5.1. 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.

5.2. 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.

5.3. 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.

6. CHANGES TO THE SPECIFICATIONS

Any changes to these specifications 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.

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