S02 JOFOC REDACTED ATTACHMENT.pdf

Attachment 7: Request for Sole Source Justification Format >SAT Prescription Eyeglass Edger

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DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-23-AP-4502

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541-24-1-250-0007

2. Nature and/or Description of the Action Being Processed: Network Contracting Office

(NCO) 10 intends to award a new, firm fixed price, purchase order for a MEISystem, Inc., EasyFit Trend Max eyeglass machine, that will be sole sourced through MEISystem, Inc. The request is for a prescription eyeglass edger.

This procurement is 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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The request is to for an EasyFit Trend Max prescription eyeglass edger.

The Department of Veterans Affairs, CLE VAMC requires a purchase order for the procurement of a prescription eyeglass edger. The prescription eyeglass edger for use in the Specialty Optical Lab, includes the following:

3 EA EasyFit Trend Max 3 EA Power Supply Kit 1 EA Training

The Blind Rehab In-House Eyeglass Fabrication program began as an FY21 Innovators Network (iNET) Spark project, proceeded on to an FY22 Spread project, and was a winner of the 2022 VHA Shark Tank Competition and was deemed a gold status practice. The program now called the Specialty Optical Lab was recently presented to Cleveland elected leadership team (ELT) and approved for launch with a goal of the Cleveland Specialty Optical Lab fabricating all prescription eyeglasses for all VA low vision inpatient and outpatient clinics.

Procurement research began during the Spread project as the project expanded from Cleveland to four additional low vision clinics. Within the year, six additional clinics demonstrated interest and one facility was the winning bid for the Shark Tank Competition.

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To meet the expanded scope of work, research was done on the best lens edging device to continue to provide the prescription eyeglasses in a timely fashion while maintaining the highest quality.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: July 29, 2023

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR

6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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

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

Requires the Use of the Authority Cited Above (applicability of authority): Per FAR 11.105 Items peculiar to one manufacturer and 12.4-Unique Requirements Regarding Terms and Conditions for Commercial Items, MEISystems, Inc., is uniquely qualified to provide a prescription eyeglass edger based on the following:

The EasyFit Trend Max is the only block-free dry lens edger available at this scale / hourly production capacity of 20 orders per hour.

The high precision and reliability of milling technology;

Eco-friendly Dry Cut technology with saving 1 million liters / 264k gallons a year;

The “No Block” system that eliminates blocks and pads;

The new EasyFit Trend features an innovative tracing system that further increases the overall productivity, and a new modern and compact design; and MEISystem, Inc. has also integrated into this new machine the “Total Quality

Control” system, developed on top range products. The built-in inspection

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Accordingly, MEISystem, Inc. is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought, RFI 36C25023Q1072, was posted on SAM.gov, Contract Opportunities on August 17, 2023, with a response date of August 24, 2023, utilizing NAICS code 339115. No potential equals or vendor questions were received in response to posting. Also, see paragraph 8 for all market research completed to find other sources.

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

Reasonable: The CO will use a comparison of the proposed prices to historical prices paid for the same/similar items and a comparison of the proposed price to the IGCE, as well as any of the other price analysis techniques identified in FAR 13.106-3(a)(2)(ii)., as necessary, to determine the price to be fair and reasonable.

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 by the Contracting Officer and the service to identify available sources to meet the requirements as follows:

VetCert, Sources Sought, MSPV, DSBS, National Contracts, Interagency Contract Directory, GSA, FSS, ECAT, CM, FPDS and the Internet were reviewed with the following results:

In accordance with January 9, 2023, advisory for VetCert usage, VetCert was queried, as required, using NAICS 339115. The search provided 122 results. The SDVOSB and VOSB vendors in the market research were contacted to see if they can provide or are able to provide comparable equipment to no avail. Veteran Small Business Certification (sba.gov)

A Sources Sought, RFI 36C25023Q1072, was posted on SAM.gov, Contract Opportunities on August 17, 2023, with a response date of August 24, 2023, utilizing NAICS code 339115. No potential equals or vendor questions were received in response to posting to SAM.gov, Contract Opportunities.

The OEM, MEISystem, Inc., was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB authorized distributors and to determine in what country(ies) the prescription eyeglass edger is manufactured. The prescription eyeglass edger is manufactured in Italy. The OEM contact, Albert Hannah, stated that MEISystem Inc.

is the manufacturer of the prescription eyeglass edger, and currently does not use distributors for this prescription eyeglass edger.

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Medical Surgical Prime Vendor (MSPV) Contracts: MSPV Generation Z v1:

Medical/Surgical Prime Vendor (MSPV) Program - Office of Procurement, Acquisition and Logistics (OPAL) (va.gov). The Medical Supply Program Office (MSPO) in close coordination with several Clinician-Led Integrated Product Teams and VHA Procurement has developed and released the solicitation for the items that will supply the MSPV General Z v1 program.

Solicitation 36C10ZX22Q0151 for the MSPV Generation Z v1 Program is currently released via Contract Opportunities. The goal of the MSPV Gen-Z V1 distribution and supply management contractor(s) is to obtain medical/surgical products from VA authorized suppliers utilizing a distribution and supply management system that minimizes VA’s inventory stock on hand, promotes standardization, and allows product selection from a multitude of vendors. There are MSPV transition distribution contracts available for interim use. The MSPV product list was reviewed to determine if these items are available through the transition distribution contracts. The equipment required by this procurement is not included in the MSPV transition distribution contracts product list. Medical/Surgical Prime Vendor (MSPV) Program - Office of Procurement, Acquisition and Logistics (OPAL) (va.gov)

Small Business Administration (SBA) Dynamic Small Business Search (DSBS): A search was conducted on the SBA’s DSBS at https://web.sba.gov/pro-net/search/dsp_search -help.cfm?goto=Keywords in an attempt to find small business manufacturers of “prescription eyeglass edger” by selecting “manufacturing” in General Nature of Business and using keywords “prescription eyeglass edger” and NAICS code 339115. No results for applicable small business manufacturers were uncovered using this search. SBA - SBA Search Results

National Contracts, BPAs, and BOAs: A search the National Strategic Source Listing found at https://www.va.gov/opal/sac/index.asp. No national contracts are available for use for this requirement. Medical/Surgical Prime Vendor (MSPV) Program - Office of Procurement, Acquisition and Logistics (OPAL) (va.gov)

Interagency Contract Directory: A search of the Interagency Contract Directory tool at https://www.contractdirectory.gov/contractdirectory/ for a prescription eyeglass edger resulted in no contract vehicles available that offer the required equipment. Interagency Contract Directory Portal

GSA eLibrary: https://www.gsaelibrary.gsa.gov/ElibMain/home.do: Various GSA searches did not locate a GSA Federal Supply Schedule (FSS) contract that includes the items required and, therefore; GSA is not a source for this requirement. Search Results (gsaadvantage.gov)

Electronic Catalog (ECAT): https://www.medical.dla.mil/WAM/Home/consent;. A search on ECAT did not locate an ECAT contract that includes the items required and, therefore; ECAT is not a source for this requirement. DMMonline (dla.mil)

An additional search of the Category Management (CM) Quick Decisions Dashboard https://d2d.gsa.gov/report/metrics-cm-quick-decisions-dashboard was conducted using the

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Equipment Home (dla.mil)

Federal Procurement Data System (FPDS): https://www.fpds.gov. A search on FPDS, with “prescription eyeglass edger” in the search tool, located the following: FPDS-NG ezSearch-there were no results.

IAW MB Memorandum M-19-13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

The U.S. Food & Drug Administration (FDA) tool at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151706, was utilized. The MEISystem Inc., EasyFit Trend Max does not need a FDA 510(k) clearance:

Search | FDA

A search of the internet, with “prescription eyeglass edger” located only three contractors:

MEISystem Inc., Santinelli International, and Coburn Technology.

Additional market research conducted applicable via the Supplement to the Market Research Report.

Additional market research conducted applicable via the Supplement to the Market Research Report.

Various market research tools were deployed which demonstrate the subject equipment is the only option which will meet the CLE VAMC Specialty Optical Lab program’s unique and specific needs. In addition, MEISystem, Inc.; CLE VAMC (i) engaged two (2) other industry leading prescription eyeglass edger manufacturers to discuss item availably; (ii) sought subject matter expert (SME) advisory opinions with regard to the CLE VAMC unique requirements; and (iii) compared other relevant industry information.

The two firms engaged were Santinelli International and Gerber-Cobrun. Both companies verified that they would be unable to produce an item that has the ability to edge shelf bevel frames, such as the Wiley X and Hilco Leader frames, which are used in over 40%* of the current orders completed by the Specialty Optical Lab program.

(*At present, current CLE VAMC orders for these unique eyeglass frames are outsourced to third-party vendors. However, current outsourcing adds both unnecessary logistical and financial burdens to the CLE VAMC acquisition of these frames. Outsourced frames come with 2-5 days additional processing/shipping time; as well as increased costs estimated at

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$30-$85, per outsourced frame. Walman Optical, is the lab CLE VAMC currently utilizes for all lens cutting outsourcing at issue. They employ the MEISystem, Inc. to perform VAMC cutting at their national facilities.)

In addition to the firms discussed above, various subject matter experts were consulted under this market research effort:

Within the national Veterans Affairs Medical Centers (VAMC) network, the following SME’s were consulted:

A. Kris Hughes- Veterans Integrated Services Network (VISN) 10/12, Optical Lab

Program Manager.

In addition to the above VAMC employed expert, the following non-VAMC employed sME’s were consulted:

A. Mary Anderson- Walman Optical, Optical Lab Manager (Toledo).

B. Alex Ference-Lab manager, Chadwick Optical; and C. Jamie Brady- Professor, Michigan College of Optometry. SME Advisory

SME Opinions were as follows:

(A) Kris Hughes reported their VAMC station recently acquired three (3) of the larger sized MEISystem, Inc. edging machines. Under those procurement efforts, Mr. Hughes and his VAMC team found that many of the same potential vendors were contacted.

Further, their Market Research Report demonstrated the MEISystem, Inc. units to be far superior to other market competitor units. Their report found that MEISystem, Inc.

units were able to significantly reduce production times and vastly increased the range of bevels and prescriptions CLE VAMC can process onsite.

(B) Echoing the above stated efficiency gains and mirroring the processing time efficiencies discussed under item (C), below; Walman Optical’s Mary Anderson reported that implementation of MEISystem, Inc. units have reduced national turnaround times by over 70%, where deployed.

(C) In similar fashion, Chadwick Optical confirmed their recent MEISystem, Inc.

purchase improved turnaround time by roughly 70% when compared to the previous machines it utilized.

(D) Lastly, Professor Brady, as a licensed optician for over 40 years, stated with regard to the MEISystem Inc., EasyFit Trend Max, (in relation to a specialty lab) “…there is no

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A significant amount of time was devoted in an attempt to locate possible domestic manufacturers of a prescription eyeglass edger. The table below lists manufacturers of prescription eyeglass edger, the make and model of the prescription eyeglass edger, and place of manufacture of the prescription eyeglass edger, why this model would or wouldn’t work.

Manufacturer Make/Model Place of Manufacture Why this model would or wouldn’t work MEISystem Inc. EasyFit Trend Max Italy Is able to trace and edge shelf bevel frames which comprise about 40% of the work done through the specialty optical lab.

Santinelli International

ME-1500 Jacksonville, FL Does not trace and edge shelf bevel frames.

Gerber-Cobrun HPE-910 EXXPERT South Windsor, CT Does not trace and edge shelf bevel frames.

The NMR does apply to NAICS 339115, and SBA has not provided a class waiver for NAICS 339115 prescription eyeglass edger.

Based on the market research conducted, no two or more VetCert verified and capable SDVOSBs or VOSBs or DSBS verified and capable small business were identified and appeared capable of performing the requirement. The VA Rule of Two and SBA Rule of Two cannot be met.

There is a Buy American Act (BAA) and a Trade Agreement Act (TAA) issue to be concerned with. This system is currently made in the Italy and will need a Determination of Availability.

FITARA is not needed for this requirement, it is not IT related.

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9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

MEISystem, Inc.

Albeert Hanna

(630) 521-88588 x3004 a.hannah@meisystem.com

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: On-going research of the industry market place will be conducted to determine if there are new entrants into this product arena.

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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.

Denise Trice PMRS Supervisory, Blind Rehabilitation Specialist VISN 10, VA Northeast Ohio Healthcare System

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.

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO) 10

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.

Adam P. Weber Branch Chief – Supply Team 1 Network Contracting Office (NCO) 10

DENISE TRICE Digitally signed by DENISE TRICE Date: 2024.01.09 06:49:17 -05'00'

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2024.01.09 07:39:27 -05'00'