66--Justification and Approval for Steris Decontamiation System ARD and Victory

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION FOR ACQUISITIONS NOT EXCEEDING $650K less than br greater than 1. Agency/Contracting Activity: Mission & Installation Contracting Command - Dugway Proving Ground less than br greater than 2. Description of Action: Large capacity laboratory decontamination for Bldg. 2029, Bldg. 2028, and new LSD Annex facilities. less than br greater than Nature: New Requirement less than br greater than Pricing: Firm-Fixed Price less than br greater than Funds: Other Funds: Direct Funds less than br greater than Name of Contractor /Vendor: less than br greater than Street Address: less than br greater than Steris Corporation less than br greater than 5960 Heisley Road less than br greater than City, State, Zip Code: less than br greater than Mentor, Ohio 44060-1834 less than br greater than Phone: less than br greater than +1 (555) 000-0000 less than br greater than 3. Description of Services or Supplies: The estimated value of the proposed action is $208,701.00. less than br greater than Large capacity laboratory decontamination for Bldg 2029, Bldg. 2028, and new Life Sciences Division (LSD) Annex facilities. Vendor will provide a vaporized hydrogen peroxide (VHP) decontamination system that is capable of complete low humidity room decontamination for Biological Safety Level 3 without degradation to sensitive scientific electronic devices. Vendor to provide three (3) VHP decontamination systems, two (2) Victory decontamination systems and one (1) Ambulance and Room Decontamination (ARD) system. Vendor will provide all shipping, parts, operator's manuals, initial setup and calibration to NIST or ISO standards, onsite machine training, and cycle development and validation to specific laboratory rooms. Provide warranty for parts, maintenance and technical support for a period of one year from purchase date. less than br greater than Vendor will provide all necessary on-site training for each unit, along with calibration set-up and initial quality inspection of two (2) Victory units and tri-scale real-time monitoring module and, one (1) ARD with calibration of one (1) tri-scale real-time monitoring module and, 2000 gram desiccant pack and ensure units were shipped correctly and operational. A Technical Engineer will provide on-site cycle development for each machine to include all areas and projected areas where decontamination will be conducted. Technician will validate all cycles with real-time trials validated with biological indicators and chemical color change strips and provide data necessary to verify efficacy of decontamination to LSD. less than br greater than The requiring activity for this requirement is the West Desert Test Center's (WDTC) LSD. less than br greater than 4. Authority: (Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following, but other exceptions may be used.) less than br greater than FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 10 USC 2304(c)(1). less than br greater than 5. Reasons for Authority Cited: less than br greater than FAR 6.302-1 or FAR 6.302-2 cited above] STERIS is the only contractor with a proprietary cycle that has single loop design that allows for constant humidity control throughout the cycle that is a patented technology the other competitors do not utilize. STERIS technology produces gaseous, non-condensing; vapor hydrogen peroxide concentrations via a programmed four phase cycle, other competitors cannot guarantee the steady concentration control. STERIS utilizes a desiccant to produce a 5% relative humidity air stream to generate maximum vapor hydrogen peroxide vapor concentrations. STERIS' low humidity operation is critical to maintain proper operation of the sensitive electronic equipment used inside the laboratories. High levels of humidity used by other vendors cause the 35% hydrogen peroxide to become condensed due to high levels of humidity used making the process very corrosive to circuit less than br greater than board and copper components. This becomes extremely important with high cost sensitive government equipment that needs to be routinely decontaminated from a hazardous environment. Any decontamination modality is harsh on sensitive equipment; however the dry technology afforded by the patented STERIS VHP is the least harsh due to the control of non-condensate of the peroxide keeping it in a vapor state and not condensing into concentrated levels of oxidizing peroxide on sensitive components or sensitive pieces of equipment. If the peroxide is allowed to condensate it corrodes or degradates materials rendering the equipment inoperable or nonfunctional and/or unsafe to use. To date, other competitors are not patented for the dry VHP technology. less than br greater than Steris uses an EPA registered sterilant, Vaprox, which is widely recognized and accepted in the environmental assessments and planning for future programs. less than br greater than STERIS' patented low humidity cycle provide the added capability to decontamination laboratory areas within a timely manner could gravely affect the overall mission of LSD. Without the ability to properly decontaminate laboratories to proved a safe working condition for technician, building mechanics, and preventative maintenance technician's machinery and laboratory safety equipment cannot be maintained and maintenance in accordance to manufacture requirements. This would result in thousands of dollars in delayed testing, purchasing on new equipment and possible exposure to deadly pathogens. less than br greater than In addition an established decontamination plan is required by the U.S. Army, Safety commissioning team and the Center for Disease Control and Prevention (CDC) for the commissioning of new laboratory spaces. Without the added capacity to establish a decontamination plan new laboratory areas resulting in millions of dollars of construction will not be utilized until appropriate methods have been established. LSD currently lacks the technology to achieve this requirement. (DA Pam 385-69, Safety Standards for Microbiological and Biomedical Laboratories, Paragraph 10-2(d), pg 19. CDC BMBL 5th Edition, Appendix less than br greater than B, Decontamination of Large Spaces, pg. 331. less than br greater than 6. Actions to Increase Competition: Pursuant to FAR 5.202(a) (1), Contracting activity will continue to advocate brand name or equivalent specification for equipment purchased by WDTC LSD and personnel will continue to monitor and seek to identify other vendors that may meet LSD's specialized needs. less than br greater than 7. Market Research: Based on the explanation provided in paragraph 5 above, full-and-open competition is not feasible for this requirement. less than br greater than 8. Procurement History: less than br greater than Previous Purchase Order or Contract: No less than br greater than 9. Additional less than br greater than 11. Fair and Reasonable Price Determination: : As contracting officer, I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based upon comparable pricing charged to a different Government facility in May 2014. In accordance with 15.403-4, certified cost and pricing data is not required for this requirement since the estimated monetary value is below the $700,000 regulatory threshold. less than br greater than 13. Contracting Officer's Approval: I hereby certify that this justification is accurate and complete to belief. Based on the foregoing, I approve this sole source justification subject to availability of funds, a and supplies herein described have otherwise been authorized for acquisition. less than br greater than Signature: Date: 26 August 2014 less than br greater than Name: Paul E. Frailey less than br greater than Title: Contracting Officer 2/10/2013