C01 JUSTIFICATION ATTACHMENT.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

Pentero Microscopes

36C250-24-AP-2644

Effective Date: 02/01/2022 Page 1 of 9

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-24-AP-2644

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

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

Transaction: 541-24-3-250-0220

2. Nature and/or Description of the Action Being Processed: This procurement is for the Pentero 800 S microscope and accessories 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 procurement will be completed as a new firm-fixed-price Purchase Order.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The Department of Veterans Affairs, CLE VAMC, Surgery Service (SS) requires a purchase order for the procurement of Pentero 800 S microscopes. The Pentero 800 S microscope includes the following:

2 EA Pentero 800 S microscope 2 EA Tiltable Tube 2 EA Working Distance 200-625 mm 2 EA Coobservation Face to Face with foldable tube and 2 eyepieces 2 EA 4k Camera 2 EA Integrated Video Recording 2 EA Adjustable Monitor 2 EA Microscope XY Movement 2 EA Laser Autofocus 2 EA 24” Monitor 2 EA Multivision Display IMPAC 2 EA Navigation Interface 2 EA HFC Foot Control

Effective Date: 02/01/2022 Page 2 of 9

The Pentero 800 S microscopes will be used mainly by the SS in the operation room (OR) shared by Ear Nose and Throat Service (ENT) and Spinal Cord Injury (SCI) Service. There is currently one (1) Pentero 800 S microscope being used in the OR and by procuring additional microscopes the CLE VAMC would be able to standardize the microscope drapes needed and overall maintain consistency with equipment /servicing issues.

This system allows the surgeons to optimize performance case by case, which equates to less time being spent on each case. It has functions such as ZooMemory which allows the surgeon to immediately switch from low magnification to a high magnification that they have saved. It is a benefit to save OR time. It can take about 30 second to a minute for the surgeon to adjust the magnification during a surgery. Many of the spine and ENT surgeries are repetitive in the sense of the steps the surgeon takes, and what settings they like to work at. This helps cut down on overall time of surgery; AutoBalance - is a one touch balancing system to completely balance the microscope. This is helpful for the staff, that they can quickly within 15 seconds set the microscope up and get it ready for surgery.

Nurses that do not have much experience with a microscope, can quickly balance the microscope with the AutoBalance system; AutoDrape assists during surgery, and the microscope is draped in a sterile bag. The sterile drape is big and baggy, and can lead to discomfort the surgeon, as instruments can get in the way of the drape, as well as vision obstruction. The Pentero 800 S microscope has a one touch button that sucks the air inside the drape bag out of the microscope so the drape is tight and has no air. It allows for smoother surgeries as instruments and comfort are not interrupted by a bag in the field of view; and AutoFokus is a feature that allows the surgeon to press a button and the microscope will automatically focus in the field to the anatomy they are looking at. It is a time saving feature as well as a benefit for the surgeon. They can position the microscope in the field and the working distance of the microscope ranges from 200MM- 625MM. They can within seconds be in focus wherever they are working.

ESTIMATED DOLLAR VALUE: $606,752.42

REQUIRED DELIVERY DATE: 90 Days ARO

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

Effective Date: 02/01/2022 Page 3 of 9

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Carl Zeiss Meditec, Inc. USA ., is uniquely qualified to provide a Pentero 800 S microscope based on the following:

The CLE VAMC currently uses the Pentero 800 S microscopes in the operating rooms, and by procuring additional Pentero 800 S microscopes, the CLE VAMC is able to have a standardized environment in which the surgeons perform operations thereby supporting critical patient safety measures. Additionally, standardization of the microscopes allows for the use of the same drapes and accessories needed during surgical operations thus saving CLE VAMC funds by not having to buy new accessories; a cost that would not be overcome via competition. Furthermore, economies of scale will be realized for the overall maintenance and service of multiple Pentero 800 S microscopes versus having different brands of microscopes in the operating rooms, thereby saving additional VA funds. There is no other microscope in the commercial marketplace that can meet the requirements with the unique salient characteristics the Pentero 800 S microscope provides.

The Pentero 800 S microscope comes equipped with an array of enhanced features and customizable options that are unique:

• The system has an add-on option called Qevo microdissection tool for ability to use an endoscope integrated into microscope. This allows the surgeon to look behind corners during surgery with a small endoscope like tool.

• The advanced visualization system of the Pentero 800 S microscope is the state-of-the-art microscope from Zeiss has many features that create an advanced visualization system. The microscope comes with a 4K video system for external monitors and a 3-chip camera that provide the clearest most crisp video of surgery. This is a great feature for surgeons and residents to see procedure, along with staff to follow along with surgery.

• The Pentero 800 S microscope also has an option for storing video procedures into the Zeiss cloud, as well as live stream current procedures. The cloud videos can be retrieved through a Zeiss app password and username protected.

• The Microscope can also add on feature called depth plus, which allows the surgeon under the microscope to increase the depth of field during the procedure. This allows surgeons to have more anatomy in focus saving time from having to readjust the microscope to be in focus.

• The microscope also has an add-on feature called the resolution enhancer.

Microscopes normally range from 1 x magnification to 12 x magnification. As a microscope magnifies in it does not gain any resolution, which is the clarity of the image they are looking at. Some procedures, Plastic surgery in particular, needs more magnification, with more resolution to see the highly magnified

Effective Date: 02/01/2022 Page 4 of 9 image. The resolution enhancer adds 60 percent more magnification while adding 50 percent more resolution.

• Zeiss has a 170-degree foldable tube for the surgeon to view through. The foldable tube allows surgeon to double the magnification through the binoculars.

It allows surgeon to go from 12 x magnification to 24 magnification. Using the resolution enhancer, it would double up to 48 X magnification. It is a benefit to the surgeon to increase magnification on a super micro vessel or anatomy that is sub 1 mm. The ability to turn on/off with a button makes it ideal for surgeons in Plastics, spine, and ENT.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought, RFI 36C25024Q0944, was posted on SAM.gov, Contract Opportunities on August 12, 2024, with a response date of August 15, 2024, utilizing NAICS code 339112. Responses were received from the following companies:

PROAIM America’s, LLC-Small business Heather Cochran 16024 Manchester Rd.

Suite 200 Ellisville, MO 63011

(844) 467-7624 x710 heather.cochran@proaim-medical.com www.proaim-medical.com (Distributor for Carl Zeiss)

PROAIM provided information on the Penetro 800 S microscope.

Melling Medical LLC-SDVOSB Anne L. Ross 658 S. Columbus St.

Alexandria, VA 22314

(484) 994-1015 aross@mellingmedical.com mellingmedical.com (Distributor for Leica)

Melling Medical provided information on the Leica M530 OHX. The product was reviewed and it was determined that it does not have a fully-integrated 4k 3D camera system for system certainty, as well as no micro inspection tool, no hybrid ability and no wireless foot control panel that controls up to fourteen different functions.

mailto:heather.cochran@proaim-medical.com http://www.proaim-medical.com/ mailto:aross@mellingmedical.com https://www.mellingmedical.com/

Effective Date: 02/01/2022 Page 5 of 9

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, as follows, was conducted by the Contracting Officer and the service to identify available domestic sources to meet the requirements:

VetCert was queried, as required, using NAICS 339112, with 667 results [Veteran Small Business Certification (sba.gov)]. Market research was unable to identify any SD/VOSBs that manufacture the product.

The OEM, Carl Zeiss Meditec USA, Inc., was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB-authorized distributors. The OEM stated that they currently only use PROAIM America’s, LLC, a small business, as their authorized distributor.

A Sources Sought, 36C25024Q0944, was posted on SAM.gov, Contract Opportunities on August 12, 2024, with a response date of August 15, 2024, utilizing NAICS code 339112.

Responses from the following companies were received:

PROAIM America’s, LLC-Small business, authorized distributor for Carl Zeiss Meditec USA Heather Cochran 16024 Manchester Rd.

Suite 200 Ellisville, MO 63011

(844) 467-7624 x710 heather.cochran@proaim-medical.com www.proaim-medical.com Microscope: Pentero 800 S – MFR Carl Zeiss Meditec USA, Made in Germany

Melling Medical LLC-SDVOSB-authorized distributor for Leica Microsystems, Inc.

Anne L. Ross 658 S. Columbus St.

Alexandria, VA 22314

(484) 994-1015 aross@mellingmedical.com mellingmedical.com Microscope: M530 OHX - MFR Leica Microsystems Inc., Made in Germany https://veterans.certify.sba.gov/ https://veterans.certify.sba.gov/ mailto:heather.cochran@proaim-medical.com http://www.proaim-medical.com/ https://www.mellingmedical.com/

Effective Date: 02/01/2022 Page 6 of 9

The M530 OHX is not a domestic end product. Additionally, this unit does not include the unique features as stated in paragraph (2)(i) above.

A search was conducted in Small Business Administration (SBA) Dynamic Small Business Search (DSBS) (SBA - SBA Search Results) under NAICS CODE 339112 and key words “surgical microscope” with the following results:

Transamerican Technologies International was contacted and they stated they do not re-sell surgical microscopes, only optical component, video adapters, surgical cameras, and optical devices.

A search was conducted on the Interagency Contract Directory (Interagency Contract Directory Portal) with key words “surgical microscope” with no results.

A search was conducted on GSA eLibrary [(Search Results (gsaadvantage.gov)] with key words “surgical microscope” with no results.

A search was conducted on NAC [VA National Acquisition Center Contract Catalog Search Tool] with key words “surgical microscope” with the following results: plastic tubes, membrane valves, sheaths, nasal accessories, sinus accessories.

A search was conducted in Federal Procurement Data System (FPDS) (FPDS-NG ezSearch) with “surgical microscope” with the following results: Wild Surgical Microscope: did not include description of microscope, Olympus America: tissue microscope, Leica Microscope: Four Points Technology: is a distributor, Metro Medical Equipment & Supply, Inc.: is a distributor, Leeds Precision Instruments, Inc.: is a distributor, Leica Microsystems Inc.; PROAIM Americas, LLC: is a small business authorized distributor, and Carl Zeiss Meditec USA: Meridian Medical: is a lab microscope.

A search was conducted of the Defense Logistics Agency Electronic Catalog (ECAT) at dla.mil with the following results: Seiler Medical:, is a colposcope, and a dental microscope, LABOMED: is a lab microscope, a lens, a tissue culture microscope, a contrast microscope, objective lens, and stereo microscope, Meridian Medical: LLC is a lab microscope, Optronics is a zoom microscope, Carl Zeiss: this is a lens holder, Optronics: is a lab microscope, and a lens, and a tissue culture microscope.

A search was conducted on MSPV DMMonline Home Page (dla.mil) with no results.

A search was conducted on SCMC VA Supply Chain Master Catalog (sharepoint.com) with muscle biopsies, nerve biopsies, renal biopsies, surgical dental microscopes, microscope https://dsbs.sba.gov/search/dsp_profilelist.cfm?RequestTimeout=180 https://www.contractdirectory.gov/contractdirectory/error.html https://www.contractdirectory.gov/contractdirectory/error.html https://www.gsaadvantage.gov/advantage/ws/search/advantage_search?q=0:8eyeglass%20machine&db=0&searchType=0 https://www.vendorportal.ecms.va.gov/NAC/MedSurg/List?cboContractNumbers=&cboBPAContractNumbers=&cbo_fss_schedule_number=&cboContractorName=&cboBOAContractNumbers=&cbo_Contract_Types=&cbo_SIN_Number=&cbo_SIN_Description=&cbo_SIN_Id=&txtCriteriams=surgical+microscope&Sort=1&Count=20&search=Search https://www.vendorportal.ecms.va.gov/NAC/MedSurg/List?cboContractNumbers=&cboBPAContractNumbers=&cbo_fss_schedule_number=&cboContractorName=&cboBOAContractNumbers=&cbo_Contract_Types=&cbo_SIN_Number=&cbo_SIN_Description=&cbo_SIN_Id=&txtCriteriams=surgical+microscope&Sort=1&Count=20&search=Search https://www.fpds.gov/ezsearch/fpdsportal?indexName=awardfull&templateName=1.5.3&s=FPDS.GOV&q=prescription+eyeglass+edger&x=0&y=0 https://www.fpds.gov/ezsearch/fpdsportal?indexName=awardfull&templateName=1.5.3&s=FPDS.GOV&q=prescription+eyeglass+edger&x=0&y=0 https://www.medical.dla.mil/WAM/home/index https://dvagov.sharepoint.com/sites/VHAPLO/Logistics/OPR/SCMC/SitePages/Home.aspx?xsdata=MDV8MDJ8fDAzNGE4MmI5MjZkNDRlOTM0NzQwMDhkYzQ3NzVkN2M3fGU5NWYxYjIzYWJhZjQ1ZWU4MjFkYjdhYjI1MWFiM2JmfDB8MHw2Mzg0NjM4MTg2MzY2NzQ4ODB8VW5rbm93bnxWR1ZoYlhOVFpXTjFjbWwwZVZObGNuWnBZMlY4ZXlKV0lqb2lNQzR3TGpBd01EQWlMQ0pRSWpvaVYybHVNeklpTENKQlRpSTZJazkwYUdWeUlpd2lWMVFpT2pFeGZRPT18MXxMMk5vWVhSekx6RTVPalV3TXpGa01EZzJMV0UwTkRVdE5HUXdNaTA1TVRWbExUazBOVFE1T0dZMFpEaGlNRjlpTVdZMk1XSTFPUzAwWXprekxUUXhOakl0T1Raak1DMHlaREl5TkRCbE5EYzRObUZBZFc1eExtZGliQzV6Y0dGalpYTXZiV1Z6YzJGblpYTXZNVGN4TURjNE5UQTJNamt4TUE9PXwzYzk3MDY1YjNhYjQ0MjQyNDc0MDA4ZGM0Nzc1ZDdjN3xiYzgzYzM5YmVlMmQ0MjZlOWEyMzExNTk2M2ZlMThlMg%3D%3D&sdata=a0wxOC9ycHdXVVpnVGxwdVhqNkd3aW0wS3c5MjNmMkZwaXdzRDBKZElCND0%3D&ovuser=e95f1b23-abaf-45ee-821d-b7ab251ab3bf%2CRachelle.Hamer%40va.gov&OR=Teams-HL&CT=1710785287103&clickparams=eyJBcHBOYW1lIjoiVGVhbXMtRGVza3RvcCIsIkFwcFZlcnNpb24iOiIyNy8yNDAyMDExOTMwMyIsIkhhc0ZlZGVyYXRlZFVzZXIiOmZhbHNlfQ%3D%3D

Effective Date: 02/01/2022 Page 7 of 9 protection filters, microscope accessories, slit lamp accessories, slit light cameras, expert opinions, and drape microscopes.

A search was conducted on DLA Troop MedPBD DMMonline Home Page (dla.mil) with no results.

IAW OMB 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).

A search was conducted of the U.S. Food & Drug Administration (FDA) website (www.fda.gov) using “surgical microscope” with no results.

Seiler Medical manufactures the XR6 microscope and dental microscopes. The XR6 microscope is for ENT procedures, not Neuro, plastic and reconstructive as the Pentero 800 S microscope is. This microscope does not have the unique features, available on the Pentero 800 S microscope.

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.

The Pentero 800 S microscopes is a brand name requirement and will be competed between the OEM, Carl Zeiss, Meditec, USA, and their authorized distributor, PROAIM America's LLC.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

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

PROAIM America’s, LLC-Small Business Heather Cochran

(844) 467-7624 x710 heather.cochran@proaim-medical.com

Melling Medical LLC-SDVOSB Anne L. Ross

(484) 994-1015 aross@mellingmedical.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 https://www.medical.dla.mil/WAM/home/index http://www.fda.gov/ mailto:heather.cochran@proaim-medical.com

Effective Date: 02/01/2022 Page 8 of 9 services required: On-going research of the industry market place will be conducted to determine if there are new entrants into this product arena that offer products that meet the needs of the Government.

Effective Date: 02/01/2022 Page 9 of 9

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.

Matthew Fleming Program & Management Analyst 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 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx