7 - Amendment 03.docx

N6264520Q0007

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

AMENDMENT 00003

The purpose of this amendment is to provide answers to questions submitted by vendors, see below.

Question: Since the customer is asking for the ability to switch the washers back and forth between steam and electric, will they want the same ability with the sterilizers?

Answer: Please review the previous amendment. The requirement is not for the washer/decontamination units to automatically switch from steam to electric heat mid-cycle. The washer/decontamination units shall have the ability to utilize in-housed steam heat or electrical heat.

The steam sterilizers shall utilize the house steam as currently stated in the minimum requirements.

Question: Could you please confirm if the customer wants the drying ability in their Ultrasonic?

Answer: No, drying is not required. Instruments will go into a washer/disinfector after this process. The Essential Characteristics section of the solicitation has been updated to remove the drying option.

Offerors shall acknowledge this and all other amendments by returning a signed copy as part of the proposal, see the Administrative/Business Volume.

The following have been modified:

ESSENTIAL CHARACTERISTICS

The Naval Medical Logistics Command, on behalf of Naval Medical Center (NMC) Camp Lejeune, has a requirement for three (3) sterilizing units, steam, bulk [ECRI# 16-141], one (1) washer, labware/surgical instrument, ultrasonic [ECRI# 14-263], and two (2) washer/decontamination units [ECRI# 17-671] for NMC Camp Lejeune. The three (3) steam sterilizing units, one (1) ultrasonic washer, and two (2) washer/decontamination units shall be fully operational by 10 July 2020. The three (3) steam sterilizing units, one (1) ultrasonic washer, and two (2) washer/decontamination units shall not require facility modifications for installation and operation based on NMC Camp Lejeune’s enclosed floor plan. Note the “Keyed Notes” on the floor plan are not applicable to this project. The Contractor shall be responsible for installation of the new units, as well as de-installation and removal of the currently installed steam sterilizers, ultrasonic washer, and washer/decontamination units. The units shall comply with infection control standards as set forth by the Joint Commission, American National Standards Institute (ANSI), and Association for the Advancement of Medical Instrumentation (AAMI) standard ST79:2017: A comprehensive guide to steam sterilization and sterility assurance in health care facilities. The Contractor shall provide operational training for a minimum of two (2) personnel, subsequent to the installation. The Contractor shall provide biomedical engineer training for a minimum of two (2) personnel, subsequent to installation. All training shall be completed by 10 July 2020. The Contractor shall provide a minimum of two (2) operator and two (2) service manuals, each in English.

The Contractor shall provide one (1) medium steam sterilizer and two (2) large steam sterilizers. The steam sterilizers shall be capable of sterilizing surgical instruments with moist heat and pressurized steam. The pressurized steam shall eliminate microbes on the surgical instruments during the sterilization process. The one (1) medium steam sterilizer shall be a floor mounted free standing sterilizer that can be recessed into the wall. The two (2) large steam sterilizers shall each be pass through units, allowing the instruments to be loaded into the sterilizer on the dirty side and to be unloaded on the clean side of the Sterilization Department. The steam sterilization units shall each have automatic powered horizontal doors. The steam sterilization units shall be capable of various pre-programmed cycles, including pre-vacuum, gravity, and leak tests, and shall have the option to sterilize equipment according to the manufacturer instruction for use. The steam sterilization units shall utilize the house steam. Each steam sterilizer shall be capable of sterilizing porous and non-porous loads at a temperature of at least 270˚ F (degrees Fahrenheit). The one (1) medium steam sterilizer shall be capable of maintaining a minimum daily workload of 9 cycles. The two (2) large steam sterilizers shall each be capable of maintaining a minimum daily workload of 9 cycles each. Each unit shall include a minimum of two (2) loading/transfer carts. The steam sterilizer units shall be compatible with the currently installed, electricity, heat dissipation, facility water and drainage based on NMC Camp Lejeune’s enclosed floor plan. The one (1) medium steam sterilizer unit shall be a floor mounted free standing steam sterilizer with a dimensional footprint no greater than 76x30x47 inches (HxWxD, height by width by depth). The two (2) large steam sterilizer units shall each be a floor-mounted, pass-through steam sterilizer with a dimensional footprint no greater than 76.5x59x78 inches (HxWxD). The electrical requirements for each unit are 208V (volts), 60Hz (hertz), 15A (amps), 3-Phase.

The Contractor shall provide one (1) single chamber ultrasonic washer. The single chamber ultrasonic washer shall be capable of sterilizing surgical instruments by ultrasonic cavitation. The ultrasonic washer unit shall produce high energy ultrasonic cavitation utilizing 4000 watts of power at a frequency of 38 kHz (kilohertz). The ultrasonic washer shall include an ultrasonic cleaning tank, a heating element, immersion baskets and electronic controls. The ultrasonic washer shall be capable of various preset cycles including pulsed cannulated irrigation and rinse options. The self-contained unit shall be capable of automatically progressing through filling, detergent dispensing, ultrasonic washing, rinsing, instrument air purging and draining cycles. The unit shall have a built-in chamber heater to ensure accurate water temperature. The unit shall include a minimum of two (2) immersion baskets. The one (1) ultrasonic washer shall be capable of maintaining a minimum daily workload of 15 cycles. The ultrasonic washer shall be compatible with the currently installed electricity, heat dissipation, facility water and drainage based on NMC Camp Lejeune’s enclosed floor plan. The ultrasonic washer shall be a stand-alone, floor-mounted unit with a dimensional footprint no greater than 53x75x41 inches (HxWxD). The electrical requirements are 208V, 60Hz, 30 A, 3-Phase.

The Contractor shall provide two (2) washer/decontamination units. The two (2) washer/decontamination units shall be capable of washing surgical instruments through automated cleaning, disinfecting, and heated drying cycles. Each washer/decontamination unit shall be a steam-heated, single-chamber pass through washer/disinfector. The units shall be capable of automatic loading and unloading when the chamber doors are opened. The units shall have automatic powered doors. The washer/decontamination units shall be capable of various pre-programmed cycles, including cold prewash, detergent wash, rinse, distilled-water rinse, rinse/lubricate, and dry. Each unit shall have status indicators for each cycle to allow users to monitor progress of wash cycles. Each unit shall have pre-programed visual and audible alarms including but not limited to the following conditions: component failure, an unlocked door, and temperature is below the set point. The washer/decontamination units shall have the ability to switch from the in-housed steam heat to electrical heat. The two (2) washer/decontamination units shall be capable of maintaining a minimum daily workload of 18 cycles each. Each unit shall include a minimum of one (1) five shelf instrument rack. The Contractor shall provide one (1) pre-heat tank to reduce cycle times. The washer/decontamination units shall be compatible with the existing electricity, heat dissipation, facility water and drainage based on NMC Camp Lejeune’s enclosed floor plan. Each washer/decontamination unit shall be a floor-mounted, pass-through with a dimensional footprint no greater than 78x44x39 inches (HxWxD). The electrical requirements for each unit are 208V, 60Hz, 30 A, 3-Phase.

The units, including claims made for the products, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The units shall be installed in compliance with the Occupational Safety and Health Administration (OSHA) requirements.

The Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the Contractor shall be responsible for uncrating the units, transporting them through the facility to the location of intended use for installation, and removing of all trash created in this process. The Contractor shall be responsible of de-installation and removal of current equipment. If interim storage is required, the Contractor shall make arrangements for the storage. The Contractor shall also be responsible for the initial instrument operational and performance validations.

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