Sole Source Justification - video colposcope_signed KE.pdf

DHA PGI 213.5, Attachment 1 (06-21-2018)

CUI - Source Selection Information – See FAR 2.101 and 3.104 POC: Jennifer Collins / jennifer.e.collins23.civ@health.mil qty 2 $51,998 qty 2 $5,000 qty 1 $600 qty 1 $172

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

ATTACHMENT 1

JUSTIFICATION AND APPROVAL (J&A) TEMPLATE

for

Sole-Source (Including Brand-Name) Acquisitions of Commercial Items Conducted Pursuant to FAR Subpart 13.5

(June 21, 2018)

Justification and Approval for Other than Full and Open Competition Sole Source Acquisition

1. Identification of the agency and contracting activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division, San Diego, CA, on behalf of the Navy to meet the requirements of Naval Health Clinic (NHC) Oak Harbor Gynecology Department.

2. Nature and/or Description of Action being approved:

The proposed action is conducted in accordance with Defense Health Agency (DHA) Procedures, Guidance, and Information (PGI) 210.002-90. The Gynecology Department at NHC Oak Harbor, the customer, requests procurement of quantity two (2) DYSIS video colposcopes, to include appropriate accessories.

3. Description of Supplies/Services:

The Gynecology Department at NHC Oak Harbor requires quantity two (2) DYSIS digital video colposcopes with relevant accessories. DYSIS colposcope has the ability to record and map cervix during procedure. This computer aided cervical mapping is an innovative technology that provides additional data that helps healthcare professionals detect cervical lesions and will aid in diagnostic purposes.

Supply - Delivery date: 1 July 2023

DYSIS view digital colposcope

Extended Warranty (1 year)

Acetic Acid Applicator

Reusable DYSIS Speculum (small)

Reusable DYSIS Speculum (medium/narrow) qty 4 $688

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

DHA PGI 213.5, Attachment 1 (06-21-2018)

CUI - Source Selection Information – See FAR 2.101 and 3.104 POC: Jennifer Collins / jennifer.e.collins23.civ@health.mil

Reusable DYSIS Speculum (large/narrow) qty 2 $344

Reusable DYSIS Speculum (large/wide offset) qty 2 $344

Delivery Charge qty 2 $500

Estimated value TOTAL: $59,646.00

Type of Funding: Operations and Maintenance (O&M)

Contract Type: Firm-fixed price

4. Statutory Authority Cited permitting other than full and open competition:

Acquisition of commercial item(s) conducted pursuant to FAR Subpart 13.5 in accordance with 41 U.S.C. 1901 Simplified Acquisition Procedures below the Simplified Acquisition Threshold (SAT).

5. Rationale Justifying Use of the Statutory Authority Cited:

Based on market research, it has been determined that DYSIS Medical, Inc. is the only source interested and capable of providing the needed supply and training of the DYSIS View Digital Video Colposcope and is utilizing TRYCO Inc. as its sole distributor. A letter stating that DYSIS is authorizing TRYCO Inc. as the sole distributor of the colposcope has been provided to the Government (see enclosure 1).

DYSIS Medical, Inc. is the manufacturer for the DYSIS View Digital Colposcope. The training and equipment requested by the gynecology department is proprietary to DYSIS Medical, Inc. No local outsourced company will be able to provide consistent and quality technical expertise to include proprietary repair parts within contract than the manufacturer. Furthermore, DYSIS Medical, Inc.

provided a letter of propriety stating that there are no other manufacturers of the colposcope and as the Original Equipment Manufacturer (OEM) of the DYSIS Video Colposcope and is the only authorized vendor able to meet the Government’s minimum requirements (see enclosure 2).

6. Efforts to Obtain Competition:

Market research was conducted by technical experts in March 2023. This research consisted of reviews of similar previous procurements, using search engines to review open market contractors. Search engines utilized include Federal Procurement Data System-Next Generation (FPDS-NG), Ability One, Unicor, Dynamic Small Business Search, Google, GSA Advantage, ECAT, Medical Master Catalog, Defense Logistics Agency and Department of Veterans Affairs. The requirement was synopsized on www.sam.gov on 13 June 2023 as required at FAR Subpart 5.2.

DHA PGI 213.5, Attachment 1 (06-21-2018)

CUI - Source Selection Information – See FAR 2.101 and 3.104 POC: Jennifer Collins / jennifer.e.collins23.civ@health.mil

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price with prices found reasonable on previous purchases and a comparison of the price to the independent Government estimate provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research:

Market research was conducted by technical experts in March 2023. This research consisted of reviews of similar previous procurements, using search engines to review open market contractors. Search engines utilized include Federal Procurement Data System-Next Generation (FPDS-NG), Ability One, Unicor, Dynamic Small Business Search, Google, GSA Advantage, ECAT, Medical Master Catalog, Defense Logistics Agency and Department of Veterans Affairs. A Sources Sought was posted from 26 April 2023 to 9 May 2023 on SAM.gov in order to ascertain if any responsible sources were able to meet the Government's requirement for a digital video Colposcope that met the requirement capabilities. It was revealed that DYSYS Medical, Inc. is the only source capable of providing supply and service maintenance on DYSIS View Digital Video Colposcope equipment. As the OEM of the DYSIS View Digital Video Colposcope, DYSIS Medical, Inc. is the only authorized vendor able to meet the Government's minimum requirements.

9. Other Facts:

DYSIS Medical, Inc is the OEM and is utilizing TRYCO Inc. as the exclusive distributor of the DYSIS View Digital Video Colposcope.

10. Interested Sources:

There are no other notable interested sources.

11. Actions to overcome barriers:

The Department of the Navy and the DHA Western Markets Contracting Division will continue to survey and engage the market of diagnostic equipment and consider competing future requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for service maintenance of diagnostic equipment.

DHA PGI 213.5, Attachment 1 (06-21-2018)

CUI - Source Selection Information – See FAR 2.101 and 3.104 POC: Jennifer Collins / jennifer.e.collins23.civ@health.mil

COORDINATION:

12. Technical/Functional Representative:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

Randy Fisher Date

Purchasing Agent, NHC Oak Harbor

13. Requirements Certification:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

Candace Foura Date

Department Head, OBGYN, NHC Oak Harbor

14. Fair and Reasonable Cost Determination: Provide the basis for this determination (e.g., describe techniques utilized, or to be utilized, to determine cost/price fair and reasonableness, such as cost analysis, price analysis, audit, should cost, independent Government estimate). As part of this basis, indicate whether certified cost or pricing data will be required or if one of the exceptions in FAR Part

15.403 will apply. Contracting Officer to include the following determination:

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

Date Kennette Esguerra Contracting Officer DHA-CA WMCD Delta Branch

DHA PGI 213.5, Attachment 1 (06-21-2018)

CUI - Source Selection Information – See FAR 2.101 and 3.104 POC: Jennifer Collins / jennifer.e.collins23.civ@health.mil

APPROVAL:

Note: The below approval block(s) shall be moved to “Coordination” above, based on the approval level required (see DHA PGI 213.5 for the appropriate approval authority). Delete signature blocks for higher level authorities that are not required. For example, if the Competition Advocate is the Approval Authority, delete the Head of Contracting Activity and Senior Procurement Executive signature blocks.

15. Contracting Officer: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval (J&A). Include the following statement:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Date Kennette Esguerra

Contracting Officer

DHA-CA WMCD Delta Branch

CPT is a registered trademark of the American Medical Association. 0354-01247 R2

DYSIS Medical Inc.

24 Superior Drive • Natick, MA 01760 info@dysismedical.com • 844-DYSISMED

November 8, 2021

To Whom It May Concern:

This letter is to confirm that the DYSIS Colposcope with Computer-Aided Cervical Mapping is a sole source product, manufactured and sold in the United States exclusively by DYSIS Medical Inc. To our knowledge, no other company is currently marketing a colposcope with computer-aided cervical mapping.

The DYSIS Colposcope with Computer-Aided Cervical Mapping must be purchased directly from

DYSIS Medical Inc. at the address listed below. In the United States, there are no other agents or dealers authorized to represent or sell this product.

Computer-aided cervical mapping is an innovative technology that provides additional data that may help healthcare professionals detect cervical lesions. Using a DYSIS Colposcope, healthcare professionals perform a standard colposcopic examination while the DYSIS proprietary software quantifies the acetowhitening effect by measuring its speed, intensity, and duration. Then, DYSIS calculates dynamic curves and assigns distinct colors (DYSISmap™), which may assist the clinician in identifying potential areas of concern on the cervix.

The IMPROVE-COLPO study demonstrated an increased detection of patients with high-grade lesions by 44% when the DYSISmap was used for biopsy selection after a thorough visual colposcopic assessment.

In addition to offering the DYSISmap, the DYSIS Colposcope has many advantages compared to a traditional colposcope, including video playback, exam comparison and comprehensive exam documentation.

When using the DYSIS Colposcope with Computer-Aided Cervical Mapping, there is an add-on CPT® code for cervical mapping that is billed in addition to your primary colposcopy code(s).

If you need additional information, please contact our offices at 844-397-4763 or visit our website dysismedical.com.

Sincerely, Darin Hammers

Chief Executive Officer

DYSIS Medical Inc.