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101-20-4-2061-0052 Electronic Sterilization Database Subscription Service OFOC SOP Revision 10 Original Date: 03/22/11 Revision 08 Date: 09/10/2020 Page 3 of4 DEPARTMENT OF VETERANS AFFAIRS Justificat... 101-20-4-2061-0052 Electronic Sterilization Database Subscription Service OFOC SOP Revision 10 Original Date: 03/22/11 Revision 08 Date: 09/10/2020 Page 3 of4 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C245-20-AP-2670 Contracting Activity: Department of Veterans Affairs, Regional Procurement Office-East, Network Contracting Office 5 (NCO), 849 International Drive, Linthicum, MD 21090 Organization Activity: Department of Veterans Affairs, VHA, VACO Station 101- National Program Office for Sterile Processing (NPOSP) 10NC6, 810 Vermont Avenue, NW, Washington, DC 2009 Funding: 101-20-4-2061-0052 Nature and/or Description of the Action Being Processed: The National Program Office for Sterile Processing requests a follow-on firm-fix contract with Best Practice Professionals, Inc. DBA Onesource Document Management Service for continuation of Electronic Sterilization Database subscription service. The period of performances for subscriptions is September 29, 2020 through September 28, 2021 and the total estimated cost of is $1,427,750. This electronic database provides real time access to manufacturer s instructions in the adequate reprocessing of reusable medical equipment and is critical in the assurance of the highest quality of care to our Nations Veterans. The specialized electronic database services provide a comprehensive management tool for patient safety with benefits starting at a system level and reaching to every Veteran provides online access to major manufacturers Instructions for Use (IFU) documents for decontamination, assembly, and sterilization of reusable instruments equipment, and provides online access to major manufacturers IFU documents for cleaning equipment outside of the sterile field, such as compression sleeves and pumps. Access inclusive to dental online access to major manufacturers IFU documents for decontamination, assembly, and sterilization of reusable instruments, Safety Data Sheets/ Material Safety Data Sheets (SDS/MSDS) and information needed for dental consumables. Description of Supplies/Services Required to Meet the Agency s Needs: VHA National Program Office for Sterile Processing and The Healthcare Technology Management Program Office stakeholders require access to a comprehensive electronic database of manufacturer s instructions for the cleaning/reprocessing, sterilization/disinfection/surgical instrumentation and equipment, as well as IFU s for Dental, Tissue/Implants and Biomedical equipment Preventive Maintenance Service Manuals for various Department of Veterans Affairs (VA) facilities including Community Based Outpatient Clinics, hospitals and VA Central Office. The anticipated cost for the Electronic Sterilization Database subscription service: s $1,427,750 for 12 months as follows. SIED Database Qty 170 Tissue & Implants Database Qty 170 Biomedical Integration Qty 170 Client Discount $80,960 Estimated total cost: $1,427,750 Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1. (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR .302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Per the memorandum dated 01/01/2019, signed by the Under Secretary for Health for Operations and Management, the National Program Office of Sterile Processing and the Office of Healthcare Technology Management jointly developed enterprise-wide standards that define functional objectives, technical requirements, and nomenclature for Information Technology Service (ITS). The CensitTrac Instrument tracking System made by Censis Technologies is the Deato standard ITS that all facilities shall utilize. CensitTrac is a proven product that meets all VA requirements. Onesource Document Management Service is the only known company who can provide the CensitTrac. CensiTrac Instrument Trac is an electronic tracking and data management system for surgical instruments. The purpose of this web-based application is to provide information on the history and utilization of surgical instruments. CensiTrac Instrumental can be hosted either in the Cloud or on-premise. Sterile Processing Service Programs, have the current documents needed to stay in compliant with requirement for such access by: The Joint Commission/Accreditation Association for Ambulatory Health Care/American National Standards Institute/Advancing Safety in Health Technology/Content Management System/ Det Norske Vertitas Healthcare National Integrated Accreditation for Healthcare/Occupational Safety and Health Administration. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Intent to Sole Source was posted on FBO.GOV on 09/09/20-09/15/20; the synopsis number was: 36C24520Q0713 zero responses received. Brief Description of Synopsis: The Department of Veterans Affairs, in accordance with FAR 6.302-1 (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirement) intends to make a sole source award to a company with the capability of providing electronic database subscription services. Access to manufacturer s instructions in the adequate reprocessing of reusable medical equipment is critical in the assurance of the highest quality of care. The anticipated source is Onesource Document Management Service, 1475 Military Way, Salt Lake City, UT 84103 This is not a formal solicitation or request for quote. This synopsis of intent is to give notice of the Government s intent to make a sole source award. Contractors who can provide the Department of Veterans Affairs with the required services are invited to electronically submit an affirmative written response indicating a bona fide ability to meet this specific requirement. Specifications for this requirement are as follows: The Contractor shall provide a comprehensive web-based electronic database of manufacturer's instructions for the cleaning/reprocessing, sterilization/ disinfection / preventive maintenance of medical/ surgical instrumentation and equipment, as well as IFU's for Dental instrument s and Tissue and implant IFU' s to 170 VA facilities and all satellite clinics with the capability to save frequently used and favorite IFU documents for immediate access with no interrupt ion in service. The contractor must be able to provide a continuation of the current VA document Library currently in use by the field with no interruption in service. The contactor must have the ability to provide Censitrac linkage for the management of surgical instrument inventory. The Censitrac linkage package must allow direct access to IFU document within Censitrac linkage. The contractor must be ISO 9001:2015 registered the scope of Services is for both Sterile Processing and the Biomedical Equipment PM Document Database subscription service is for all VHA Healthcare Systems. In addition to intent to sole source posting, the VHA port al was searched, CensiTrac web port al was reviewed. No other sources were identified. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the government is considered fair and reasonable based since the pricing did not change from the previous contract 36C24519C0231. The quote provided by with Best Practice Professionals, Inc . OBA Onesource Document Management Service , Q-61791, the pricing remains unchanged. Description of the Market Research Conducted and the Results. or a Statement of the Reasons Market Research Was Not Conducted: Market Research conducted on FBO.GOV, VIP, GSA, no other sources were found. Any Other Facts Supporting the Use of Other than Full and Open Competition: Best Practice Professionals, Inc . OBA Onesource Document Management Service provided a proprietary letter, stating they are the only company that offers one platform for accessing in a digital format manufacture's Feder al Drug Administration validated instructions for use and service manuals. Listing of Sources that Expressed, in Writing. an Interest in the Acquisition: Onesource Document Management Servi ce 1475 Military Way, Salt Lake City, UT 84103. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Market Research will continue to be conducted by the Program Office. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. Kearston A. Sil ver Date Program Analyst National Program Office for Sterile Processing (10NC6) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Veronica 8. Dillard Contracting Officer NCO5 Date Acquisition Plan Action ID: 36C245-19-AP-1910 One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. Amy Ritchey Date DC Services and 101 Cent ral Office Branch Chief NCO5 Director of Contractor Review and Approval (Required for HCA approval.) Scott Sands NCO 5, Director of Contracting Date VHA SAO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700Kto $68 million) for other than full and open competition. Joseph P. Maletta Date Executive Director, VHA Regi on al Procurement Office East