Attachment B Statement of Need.pdf

Attachment B

36C24822Q0893

Statement of Need

Background:

NF/SG Sterile Processing Service at 3 locations, currently has a need to add or replace 6 sterile driers due to end of life equipment and expanding services. Not having a working sterile drier causes delay in workflow for clinics and surgical cases. Sterile driers are used for RMD that must be dried before sterilization.

Driers will be replaced in the following locations:

• Gainesville VAMC Will Receive, Four Each

• Lake City VAMC Will Receive, One Each

• The Villages CBOC, Will Receive, One Each

Scope:

Sterile-Driers use HEPA-filtered air to reduce the threat of airborne pathogens re-contaminating wet, warm parts while they are drying. All heated air entering the drying chamber passes through a pre-filter first then a HEPA filter which is 99.97% efficient in removing all particles larger than 0.3 micron.

Recirculating air system efficiently recaptures heated air to dry parts faster, reduce use of electricity, and prolong filter life. Sterile-Driers can handle large loads with almost any combination of tubes and parts.

The NF/SG Sterile Processing Service utilizes Sterile Driers for drying and ventilation of Reusable Medical

Devices (RMD) prior to sterilization. When using low temperature sterilization all RMD must be completely dry. If not completely dry, the low temperature sterilization equipment will cause the system to abort.

Salient Characteristics: Offeror’s quote shall meet the following:

• Exterior Dimension:

46.5 in x 20.5 in x 86 in 118 cm x 52 cm x 218 cm

• Interior Size:

32 ft³ (0.91 m³)

• Doors

2 Transparent Doors

• Interior and Exterior Walls

Painted Aluminum with Epoxy (Rust Proof)

• Electrical Configurations

120V, 60Hz, 16A

• Plug Type

Hospital grade, 20amp, NEMA 5-20 (include 14ft Cord)

• Pre-Filter

Spun Fiber, Pre-Filter remove larger particle matter in Sterile Driers and Clean Driers

• Timer

Digital Timer can be set up to 4 hours. Displays time remaining and completion of cycle. Must also have setting for continuous run time.

• Temperature Adjustment Must have temperate adjustment using the front panel control knob marked 1 (lowest) through 10

(highest)

1. 1 (Low Setting) 75-95 F (24-35C)

2. 10 (High Setting) 130-160 F (55-71C)

• Regulation and Electrical Safety & Classification

• a. CSA 22.2 No. 1010.1

36C24822Q0893

• b. UL 61010-1

• c. Ordinary Equipment: (IPX)

• d. Installation Category II

• e. Pollution Degree 2

• f. Continuous Operation

• g. Indoor Use Only

• h. Class I Equipment

Technical Requirements:

• Shall be compatible with the current driers: Natus Olympic

• Must be able to be cleaned by NF/ SG VAMC approved product: Clorox Hydrogen Peroxide Wipes

• Contractor shall provide their current SOP for Driers

• Provide written warranty on all product equipment/supplies.

36C24822Q0758

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the

COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID- 19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

https://www.va.gov/covid19screen/

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3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

4. For indefinite delivery contracts: Contractor agrees to comply with VHA

Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.