Redacted LSJ- VHP Sterilzer Evans Army Community Center.pdf

LIMITED SOURCES JUSTIFICATION (LSJ)

(1.) Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Hospital Supply Division is the contracting activity.

(2.) The justification is for the acquisition of the three (3) Vaporized Hydrogen Peroxide (VHP) Sterilizers as required by Evans Army Community Hospital (EACH) Fort Carson. The order will be placed under Equipment ECAT Solicitation SPE2DH-21-R-0002; contract SPE2DH-24-D-0011, which is valid through May 15, 2029.

(3.) The acquisition is for the purchase of the following items for EACH:

Item Description: Vaporized Hydrogen Peroxide (VHP) Sterilizer Manufacturer: Steris Manufacturer Part Number (P/N): VP50002101 Quantity: 3/EA Unit Price:

The total estimated dollar value of this action is

(4.) The authority waiving the competition requirements is FAR 8.405-6(a)(1)(i)(B), only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

The use of this authority is necessary to meet EACH’s requirements for low-temperature medical VHP Sterilizers. EACH requires this equipment for use within the medical center’s Sterile Processing Department (SPD). This device is necessary to sterilize medical equipment, control infection and prevent disease transmission.

The required VHP Sterilizer must satisfy all of the following minimum requirements established by

EACH:

a. Freestanding or Recessed Dimensions and Voltage Configuration – The device shall have a configuration that is freestanding or recessed and shall fit into EACH’s current SPD footprint. The device shall fit into the following dimensions: Cabinet: 33X40-15 / 16 X 72”, Recessed/Cabinet:

33X38-5 / 16 X 72”, Shelf clearance: Top- 6-15/16”, Bottom- 7-1/16”. The device shall be fully functional utilizing a standard electrical power connection that can withstand voltage fluctuations.

b. FDA Clearance—The device shall be cleared by Food and Drug Administration for terminal sterilization of medical devices.

c. Material Compatibility & Capability – The device shall be capable of sterilizing temperature sensitive tools and equipment currently in use at EACH including but not limited to scopes, in particular DaVinci Scopes, cameras, and light cords.

d. Hydrogen Peroxide Sterilant – The device shall use vaporized hydrogen peroxide as a sterilant.

e. No Presence of Plasma, Chamber Temperature – The device shall sterilize heat-sensitive medical devices without the presence of plasma. The device shall remove biproducts and residues without the presence of plasma. The device shall have a sterilization chamber temperature of fifty

(50) degrees Celsius during processing.

f. Chamber Volume, Load Weight, Robotic Endoscope Capacity – The device shall have a one hundred (100) percent usable chamber volume of one hundred thirty-six (136) liters that can fit a minimum of two (2) surgical instrument sets, weighing twenty-five (25) pounds each and provide a system that supports up to fifty (50) pounds. The device shall have the capacity to sterilize two (2) endoscopes within twenty-eight (28) minute cycle time.

g. Lumen Cycle, Cycle Time, Lumens Per Load– The device shall have the ability to run Lumen, Flexible, and Non-Lumen Cycles, with a minimum of three (3) cycles for Lumen (55 minutes), Flexible (30 minutes), Non-Lumen (28 minutes). The device’s shortest sterilization cycle time shall be under twenty (20) minutes.

h. Control Panel Trouble Shooting, Moisture Detection-- The device shall have touchscreen control panel display with monitoring, alarm alerts, and diagnostic information. Monitoring, alerts, and diagnostic errors displayed on control panel detect and manage moisture-related cycle errors that can lead to automatic cycle cancellations.

EACH’s Sterile Processing Department (SPD) requires three (3) Vaporized Hydrogen Peroxide (VHP) Sterilizers. The sterilizer shall be freestanding, with a recessed configuration, and functional utilizing a standard electrical power connection with ability to withstand voltage fluctuations. These dimensions and power configurations fit into EACH’s current SPD footprint. The limited space available in EACH’s SPD does not allow for sterilizers with counters or table-tops nor has the clearance for additional rack systems.

The device shall withstand voltage fluctuations to maintain safe and stable operation. The device shall be cleared by FDA for terminal sterilization of reusable medical devices. The use of non-FDA cleared sterilizers risks incomplete sterilization and potential damage to surgical instruments used at EACH.

The machine shall sterilize temperature sensitive and lumened tools and equipment including but not limited to cameras, light cords, scopes, and DaVinci endoscopes. The machine shall have the ability to run Lumen Sterilization cycles. Sterilization cycles, specifically lumen cycles, which will support the necessary usage of temperature sensitive equipment and instrumentation used in laparoscopic, endoscopic, arthroscopic, and robotic cases at ENT, urology, pain, warrior, pulmonology, sleep clinics and operating rooms at EACH. EACH’s SPD is responsible for the sterilization of highly unique and specialized items that include these temperature sensitive tools and instruments. A VHP sterilizer that does not sterilize these items would not meet the clinical requirement of the SPD of EACH.

The machine shall use Hydrogen Peroxide as a sterilant without the presence of plasma. The use of Hydrogen Peroxide as a sterilant without the presence of plasma ensures low temperature sterilization of equipment and instrumentation. The device shall remove byproducts and residues such as water vapor and oxygen without the presence of plasma. The presence of plasma in the sterilization and byproduct removal processes puts a strain on temperature sensitive devices and risks degradation. Additionally, the presence of plasma in the sterilization process increases the likelihood of cycle abortions which create operational delays and bottlenecks in EACH’s SPD. A sterilizer that utilizes Hydrogen Peroxide without the presence of plasma is necessary as it ensures complete sterilization while also preventing the degradation or premature replacement of temperature sensitive tools and equipment in use at EACH.

The sterilizer shall have a lumen specific sterilization cycle setting and execute sterilization cycles at a chamber temperature of fifty (50) degree Celsius. This chamber temperature provides a safe sterilization environment for temperature and moisture sensitive devices. At this temperature hydrogen peroxide vapor is able to penetrate lumens and small surfaces to eliminate microorganisms and spores. Sterilizers that are unable to meet this requirement run the risk of damage or inoperability of equipment and instrumentation used in operating rooms at EACH. Additionally, a sterilizer that does not have the ability to penetrate lumens and small surfaces in sterilization cycles can leave infectious microorganisms and spores on instruments. This fails to adhere to health and safety practices at EACH, risks exposure to surgical suites, operating rooms, patients and physicians, and degrades standard medical care at EACH.

The sterilizer shall have a one hundred (100) percent usable chamber volume of one hundred thirty-six

(136) liters capable of fitting a minimum of two (2) surgical instrument sets, weighing twenty-five (25) pounds each, or capable of supporting a system of up to fifty (50) pounds. This capacity allows EACH to process the sterilization of two (2) Da Vinci Endoscopes at once in a twenty-eight (28) minute cycle.

Additionally, the device’s shortest sterilization cycle time shall be under twenty (20) minutes. A lower chamber volume and load weight capacity of the system reduces the number of items able to be sterilized during the sterilization cycle. A longer sterilization cycle time risks delay in procedure schedules if sterilized instruments are not available. Due to the vast amount of instruments being processed, high surgical case number, and limited space in the SPD at EACH, a sterilizer with a higher chamber volume, increased load weight, and rapid-turnaround sterilization cycle are necessary.

The sterilizer shall have a touchscreen control panel with monitoring, alarm alerts, and diagnostic information for detection of moisture-related sterilization errors that lead to cycle cancellations. Detection and management of errors prevent prolonged cycles and total cycle cancellations. This feature is necessary as prolonged cycles or total cycle cancellations risk delays to scheduled surgeries when necessary instrumentation is not available for physician use at EACH.

(5.) The required Steris VHP Sterilizer is available on Equipment ECAT contract, SPE2DH-24-D-0011.

The contract pricing has previously been determined fair and reasonable via comparison with other than certified cost or pricing data. DLA Troop Support will seek an additional price reduction since the order will exceed the simplified acquisition threshold. The Contracting Officer determined that the subject procurement represents the best value to the Government in accordance with FAR 8.404(d).

(6.) In July 2026, EACH conducted market research, assessing whether manufacturers other than Steris could offer sterilizers that meet all their minimum requirements. Market Research findings indicate that two (2) additional manufacturers, and provide VHP sterilizers. However, and devices do not meet all of EACH’s minimum requirements as described below:

VHP Sterilizer does not satisfy minimum requirements

VHP Sterilizer does not satisfy minimum requirement .

DLA Troop Support conducted additional research in August 2026 to determine if any other DLA Equipment ECAT contract holders could meet all of EACH’s minimum requirements. Findings indicate that the Steris VHP Sterilizer is the only product that meets all of EACH’s minimum requirements. Steris is the only supplier on contract that offers a sterilizer that meets all the minimum requirements.

(7.) ECAT vendors have the opportunity to add new products that fall within the scope of the Medical

Equipment ECAT program on a quarterly basis. Therefore, any ECAT vendor may add products, including VHP Sterilizers, enhancing competition for future acquisitions.

(8.) DLA Troop Support continues to perform market research of sterilizers in order to locate other acceptable sources for future acquisitions. Furthermore, DLA Troop Support will continue to monitor the market. In the event that another vendor outside of the Equipment ECAT Program offers sterilizers, DLA Troop Support will encourage any such vendor/manufacturer to seek a contract under the Equipment ECAT Program.

(9.) As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

Date GINA DE SANTO- Contracting Officer

I hereby certify that the requirements, which form the basis of this justification, are accurate, that these supplies meet the Government’s minimum needs, and that this justification is accurate and complete to the best of my knowledge and belief.

Date

09/14/2026

9/22/2026

DE

SANTO.GINA.E.154

0330022

Digitally signed by DE

SANTO.GINA.E.1540330022

Date: 2026.09.14 10:21:56 -04'00'

CAI MEMORY 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