Att 1 FAR 13.5 Sole Source Justification_CensiMark_signed.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 5

REVISION: 01

Acquisition ID#: 36C242-25-AP-3309

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C242-25-AP-3309__

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Network Contracting

Office, 3495 Bailey Ave., Building 3, Buffalo, NY 14215 procuring the requirement for Department of Veterans Affairs, VISN 02, NY Harbor Healthcare System, Manhattan Campus, 423 East 23rd Street, New York, NY 10010.

2237: 630-25-3-4520-0503

2. Nature and/or Description of the Action Being Processed: This procurement action is for the establishment of a sole source contract for CensiMark instrument laser marking, data commissioning and data optimization in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This is a firm fixed price sole source contract for Censis laser engraving/marking service that will include data optimization.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Laser marking instruments are scanned in CensiTrac which is a surgical instrument tracking software that provides real time instrument tracking through the sterilization process. This tracking provides visibility and accountability of the trackable VA surgical instruments and interfaces with OR schedulers, sterilizers, washers, and other SPS equipment to ensure the instruments have gone through the proper sterilization process.

Censis Technologies provides service for CensiMark which is a laser marking service which helps maintain instrument inventory and instrument tracking through the sterile process.

CensiMark includes instrument marking, data commissioning and data optimization. Once instruments are laser marked, they will be commissioned into the system so that they are traceable and ready for use. Data optimization service standardizes vendors, catalog numbers, substitutes, and maintenance requirements in the system. This will increase consistency, productivity, safety, and accuracy regarding instrument workflow.

The contractor shall provide onsite instrument marking, data commissioning and data optimization. Automated Instrument Tracking System called Censitrac is a software used in Sterile Processing Service (SPS) Department Staff. Sterile processing professionals are guided through proper sterilization procedures; tracks the location, usage, and maintenance of every uniquely identified via CensiMark laser marking instruments and scopes. With the use of individual instrument marking, the facility can manage the instrumentation inventory and maintenance schedules and provide tray quality down to the single instrument level, to include case tracking. The Automated Instrument Tracking applications provide reusable medical equipment instrument management systems for use in Department of Veterans Affairs Medical Center to improve operational efficiency and patient care. Censitrac automated tracking for surgical instruments, scopes and equipment, improves infection control and provides the data for meaningful benchmarking, continuous process

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Acquisition ID#: 36C242-25-AP-3309 improvement and root cause analysis. This system will help to improve any adverse events, improve clinical outcomes, streamline workflow and optimize reusable medical equipment through tracking and management.

CensiTrac solutions has been endorsed by the National Program Office for Sterile Processing (NPOSP) as the official workflow system of record for all Sterile Processing Services (SPS) across the VHA enterprise. By installing the ITS baseline system in all medical facilities, the VA is positioned to utilize the locating capability to improve patient care in many different aspects. Having a standardized solution provided by Censis can alleviate issues tied to integration with multiple instrument tracking products, lessen the training burden and provide VISN-level SPS data.

The period of performance for marking services is estimated 17 weeks from the contract award. The period of performance for the work for standardizing vendor names and catalog numbers, removing incorrect or duplicate data and identifying substitutes, etc. is 10-12 weeks. However, services shall begin no later than one (1) week after the award and must be completed six (6) months after work begins. The estimated value of the proposed action is $280,250.00 for the total duration of the contract.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

As one of the base applications in the Department of Veterans Affairs Real Time Location System (RTLS) program, the Sterile Processing Workflow Application is anchored by the Censitrac Instrument Tracking Software which requires laser marked instruments to be scanned into the software for tracking workflow. Instruments are scanned by a laser mark and this mark is only recognized by CensiTrac which is a proprietary system which only Censis Technologies Inc can implement. Censis Technologies provides service for CensiMark which is a laser marking service which helps maintain instrument inventory and instrument tracking through the sterile process. CensiMark includes instrument marking, data commissioning and data optimization. Once instruments are laser marked, they will be commissioned into the system so that they are traceable and ready for use. Data optimization service standardizes vendors, catalog numbers, substitutes, and maintenance requirements in the system. This will increase consistency, productivity, safety and accuracy regarding instrument workflow.

Effective Date: 11/15/24 Page 3 of 5

Censitrac is the preferred national standard established by the National Program Office for SPS Workflow, and the Veterans Health Administration (VHA) has chosen Censitrac as the standardized instrument tracking system (ITS). Infrastructure is currently in place and hardware upgrades will be added on to the existing system.

It is essential laser marks on the instruments application be compatible with existing VA internal CensiTrac system software, OEM barcode reader, sterilizer interface, and data currently in use by the facility.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Posted a notice of intent to sole source on Contract Opportunities, SAM.gov (36C24225Q0806) from 7/2/2025 – 7/10/2025 which received one response from SDVOSB Martin AIJS, LLC who says they can provide services utilizing NuTrace Lasers which are stand-alone systems to apply applications to the equipment and then needs to be read within the Censis Software. When asked to provide a letter from the original equipment manufacturer (OEM), Censis Technologies, Inc. they stated, “I am not an authorized provider of Censis.”

Received a sole proprietary letter from Censis Technologies, Inc. which states their products are protected and registered with the United States Patent and Trade Office.

They also stated, “no other entity may sell, market, mass upload data, implement, or instruct the use of CensiTrac® without the express written consent of Censis Technologies, Inc. Censis Technologies, Inc. is the sole authorized provider of CensiTrac® for the North American market.”

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The CO anticipates cost will be considered fair and reasonable. The basis for this determination will be a comparison of the proposed price against the prices provided on contract # 36C24224P1404 for the NY Harbor Healthcare System, Brooklyn campus for the same requirement to provide CensiMark instrument laser marking, data commissioning and data optimization for an estimated amount of 25,000 pieces, POP 7/3/2024 – 6/30/2025, purchase order 630C40248 (CLIN 0001 CensiMark Equipment Mobilization fee, 1 EA, Unit Price $2,000.00, CLIN 0002 Data Optimization , 1 EA, Unit Price $9,500.00, and CLIN 0003 Marking Services- Single Instrument, 25,000 EA, Unit Price $10.87 for total contract cost $283,250.00.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: Market research was conducted through a search of the Veteran Small Business Certification (VetCert) database utilizing NAICS 811210 which produced 320 results. The website does not give the ability to further sort to relevant results.

Conducted a search of SBA Dynamic Small Business Search (DSBS) utilizing NAICS 811210 and keywords “CensiTrac", "CensiMark", "laser marking", or "barcode tracking” which produced one result, small disadvantaged business, Sterling Arsenal Works & Tactical Supply, LLC for laser marking. Sterling did not respond to the Notice of Intent to sole source.

Effective Date: 11/15/24 Page 4 of 5

Acquisition ID#: 36C242-25-AP-3309

Conducted a search on FPDS-NG utilizing keywords “CensiMark laser” which produced similar requirements contracts 36C24221P0451 for Buffalo VAMC for 15,000 pieces for laser marking and data validation services in the amount of $113,925.00; 36C24224P1404 for NY Harbor Healthcare System, Brooklyn campus for 25,000 pieces for laser marking and data optimization services in the amount of $283,250.00, and 36C24223P0991 for Castle Point campus VAMC for the supply purchase of CensiMark Laser Marking Equipment in the amount of $47,500.00.

Conducted a GSA Library search for “Censis Technologies” produced FSS contract GS- 35F-0462X for supplies.

Conducted a NAC MedSurg search for “CensiMark” which produced no results.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Manhattan VAMC currently has the Censis data management system installed at the facility and implementing a new system would not be beneficial or price effective for the government.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Censis Technologies Inc. and Mertin AUS, LL

11. 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:

No actions are planned to foster competition for future requirements of this nature due to Censis Technologies Inc. being OEM and sole distributor of the Censis equipment and sole provider of engraving and data management for their system.

12. 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.

Wendy Bobadilla Date

Staff Assistant/COR NY Harbor Healthcare System, Manhattan campus

Effective Date: 11/15/24 Page 5 of 5

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. 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.

Dolores Sachuk-Thompson Date

Contracting Officer, RPO-East, NCO 2, Buffalo VA Medical Center

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Janine Childs Date

Branch Chief, Services Team II RPO-East, NCO2, Buffalo VA Medical Center https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx