9. Sole Source Justification 25-007413 20250602.pdf

Date: May 24, 2025

From: David Ram, Supervisor of Biomedical Engineering—NIH Clinical Center

Subject: SOLE SOURCE JUSTIFICATION AND APPROVAL

To: NIH, CLINICAL CENTER, CONTRACTING OFFICER

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

David Ram, supervisor of Biomedical Engineering National Institute of Health Clinical Center 9000 Rockville Pike Bethesda, MD 20892 AO’s Name, contact information: Kevin Doty 301-496-5314

Contracting Activity:

NIH Clinical Center Office of Purchasing and Contracts 6707 Democracy Blvd Bethesda, MD 20892

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

There is an urgent need to replace the Procedure, Vascular Access, Conscious Sedation (PVCS) Surgical Diagnostic Imaging System Technology.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED, INCLUDING THE DELIVERY

SCHEDULE AND/OR THE PERIOD OF PERFORMANCE and DOLLAR VALUE OF THE

ACQUISITON.

The CC uses only Olympus Bronchoscope, Endoscope, and ENT Surgical Diagnostic Imaging Systems for the past 2 decades. These systems and software integrations are part of many patients enrolled protocols at NIH for nearly two decades. The Clinical Center's Procedure, Vascular Access, Conscious Sedation (PVCS) provide endoscopic procedures for both clinical and research criteria for patients enrolled in protocols at NIH. The ENT Clinic's Head and Neck (H&N) physicians need to view and capture high-definition images during patient exams.

The CC needs to upgrade to the newest Surgical Diagnostic Tower technology, CV-1500 Video Systems, to be compatible with our current Olympus 190 HD scopes and by replacing our Olympus Series 190 processors with the CV 1500 Series. The CV-1500 processors are a replacement of equipment only and will still interface with current CC flexible and rigid scopes, system application and electronic medical record. Our current video equipment is beyond their estimated useful lives as defined by the American Hospital Association (AHA).

Procurement is for: Three (3) Surgical Diagnostic Tower: CV-1500 Video Systems

4. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN

COMPETITION.

X FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g. urgency, inclusive licensing agreements, brand name, or industrial mobilization).

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE

NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED

Usage in the Clinical Center: Olympus Surgical Diagnostic Imaging Systems has been used in the

Clinical Center since 1999. The systems have a proven history of dependability and have been exceptionally maintained by Olympus support. CC-Wide Clinical staff are trained and have experience with Olympus systems and therefore additional training on a system by a new manufacturer is not necessary.

CRIS and Provation Application: The Olympus Surgical Diagnostic Imaging System has already been tested and is currently using the Provation Application that is used within the Clinical Center, i.e. GI, PVCS, ENT Clinic and Operating Room. The Provation Application is currently utilized with CRIS, the electronic medical record of the Clinical Center.

Sole Source Impact: If any other bronchoscopy system were considered the impact would be great and patient safety could be compromised:

o The IT staff would need to evaluate a new Surgical Diagnostic Imaging System manufacturer for compatibility with the current application and interface.

o If a Surgical Diagnostic Imaging System from a different manufacturer was purchased, the IT staff would have to build and test the new system to have the system interface with the electronic medical record.

o Possible incompatibility with the current system application requiring the purchase of a new system application and interface.

o The CC HD Flexible scopes will not work with any other system o Inconsistency of applications within the Clinical Center could pose a patient safety issue.

Olympus Corporation is the industry leader in Surgical Diagnostic Imaging System and Scope technology:

o The EVIS X1 CV-1500 Video System Center combines video processor and LED light source in one box, resulting in a more compact and lightweight design. Additionally, cross compatibility between EVIS EXERA III and EVIS LUCERA ELITE lead to a vastly extended portfolio of compatible endoscopes. The CV-1500 features multiple special observation modes that support physicians in every step during endoscopic procedures.

o Conventional white light.

o NBI (Narrow Band Imaging).

o AFI (Auto Fluorescence Imaging).

o TXI (TeXture and color enhancement Imaging) optimizes the structure, color tone and brightness of the mucosal surface.

o RDI (Red Dichromatic Imaging) improves visibility of deep blood vessels and bleeding points.

o BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) improves brightness in darker portions of the endoscopic image.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS

MANY POTENTIAL SOURCES AS PRACTIABLE

This is a sole source item. No other brand can provide the requirements listed in question 5.

7. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE

The actual cost of this device is consistent and lower when compared to non-dedicated systems. Cost comparison was measured against past procurements, ECRI market analysis, and industry standards. The Products are available via small business and by Alliant's ECAT Contract # SPE2D1-20-D-7008

8. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF

THE REASON MARKET RESEARCH WAS NOT CONDUCTED

Researched sources include ECRI equipment comparison and guidance charts; ECRI Select Plus Market Intelligence Reports.

Consultation and information gathering from the CC's Standardization Committee members, equipment managers, attendance at AAMI and HIMSS Technology Conference and Expositions.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION.

Alliant is the sole distributer for this product.

10. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THE

ACQUISITION.

No other source expressed interest in acquisition.

11. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITION FOR

THE REQUIRED SUPPLIES OR SERVICES.

There are currently no barriers

12. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

David Ram, Supervisory Biomedical Engineer, COR

[YOUR NAME, SIGNATURE, AND TITLE]

Administrative Officer or COR

13. CONTRACTING OFFICER’S CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”.”

[NAME AND SIGNATURE]

Contracting Officer