Attachment 1 Single Source Justification MPT to SAT.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

• Acquisition Plan Action ID: Acquisition Plan : 36C262-22-AP-4662

• Purchase Request via IFCAP : 664-22-3-072-0515 in the amount of $178,805.00

1. Contracting Activity: Department of Veterans Affairs, VISN22, in support of San Diego VA

Medical Center

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

VA San Diego Healthcare System in San Diego, CA requires the following Brand Name Items for use in the: Eyes/Nose/Throat (ENT) Operating room.

Itemscription Supplies/Services Qty Optics Carrier and Main Observation

0001 Leica M530 Optics Carrier for IVA/Top Plate 01 EA

0002 Leica Protective glass M50x, M620 02 EA

0003 Leica PROVIDO Stand (Standard) 01 EA

0004 Leica Power cable, 5m, North America 01 EA

0005 Leica M530 IVA Integr. Video Adapter, f=50mm 01 EA

0006 Leica Binocular tube var. 30-150°T,Typ II L 01 EA

0007 Leica Eyepiece f. spect. w´s 10x/21B, type II 02 EA

0008 Leica Certificate of installation 01 EA

Lateral Assistant

0009 Leica Stereo attachment for second observer 01 EA

0010 Leica Binocular tube var. 30-150°T,Typ II L 01 EA

0011 Leica Eyepiece f. spect. w´s 10x/21B, type II 02 EA

Video Accessory, Cameras and Recording

0012 Leica Leica HD C100 for OH's 01 EA

0013 Leica PROVIDO Docuset Holder Kit HD C100 01 EA

0014 Leica Documentation System Evo4K 01 EA

0015 Leica PROVIDO Docuset Holder Kit EVO4K 01 EA

0016 Leica 27" Medical HD Touch Monitor 01 EA

0017 Leica FSN 27’ Power Cable 01 EA

0018 Leica PROVIDO Monitorarm 01 EA

0019 Leica Dust Cover M600 01 EA

Installation, Calibration & On-Site Training for Device

0020 Installation, Calibration & On-Site Training 01 JB

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Government seeks to procure Leica M530 surgical microscope system for SDVAHCS surgical services to enhance continuity of patient care.

Leica is the standard for surgical microscopy across multiple VA Medical centers. Reason no other supplies or services can be used is based on primarily on standardization. This product is a proprietary build of a highly technical and complex medical device. The components are only interchangeable and interoperable with other Leica brand products.

https://www.acquisition.gov/?q=/browse/far/13

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Using other brands of products would negatively impact product warranty, accuracy of results given, workflow efficiency, and increase potential for staff procedure error and patient harm.

The need for standardizing procedural equipment is critical as different models have slightly different operating and maintenance procedures and user interfaces. A mixture of different models in the procedural suite increases the risk of user error, significantly increasing the risk to patient safety. Standardizing procedural equipment is a recognized best practice for reducing the risk of errors, increasing uniformity of practice and patient safety. See Zhang, J. et al., Evaluating & Predicting Patient Safety: From Research to Implementation, Vol 2:

Concepts and Methodology (Kerm Henriksen et al. eds., Agency for Healthcare Quality and

Research 2005).

The SDVAHCS ENT surgeons are currently familiar with the various control locations and features of their current Leica surgical microscopes, which are normally not consistent among different manufacturers. The SDVAHCS ENT surgeons conduct their practice at VAHCS locattions through southern California.

ENT surgeons reviewed other microscops and found that the Leica Provido M530 has the ability to use the same lense for both ear and larynx cases, less weight, and offers wider visual depth, color, contrast, and clarity. Zeiss Extaro-300 require to swap lenses between cases which increases surgical time and overall risk to patient care. Leica Microsystems provided a signed letter stating that the SDVSOB, Melling Medical is “the Sole Source Authorized Distributor of Surgical Microscopes into the Federal

Government. Melling LLC dba MellingMedical is a fully authorized distributor/dealer for all Leica

Microsystems products.”

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted in accordance with (IAW) Federal Acquisition Regulation (FAR) part 10 and VA Acquisition Regulation (VAAR) part 810. Mandatory and non mandatory sources were checked. Government databases like Vetbiz.vip.gov, GSA Advantage, GSA eLibrary, SAM.gov, SBA

DSBS , FPDS.gov, and commercial sites on the Internet found that this Leica product is not available on any mandatory contracts or GSA’s Federal Supply Schedule (FSS) contracts but are only available open market through authorized distributors.

36C26222Q1342 Source sought published from 7/22/2022-8/5/2022 resulted in 1 SDVOSB response from Melling Medical.

Conducted FPDS Search for M530 Microscope awarded within the previous year. All awards were awarded to Lecia, the OEM, or Melling Medical, an authorized SDVOSB.

An inquiry on authorized SDVOSB to the OEM resulted in no response.

The included quote for the EEG proposed an amount of $169,478.03 and a letter stating that Melling

Medical is the sole SDVOSB authorized distributor of Leica Products. A later email update included additional products that were missed and updated pricing to $178,805.00

Review of JOFOC for exact requirement 36C24922P0862 awarded 8/16/2022 to TNVAHCS in the amount of 157,165.92. There are 2 additional items for this requirement (0014 Leica Documentation

System Evo4K, and Leica PROVIDO Docuset Holder Kit EVO4K that result in the cost differential of

$21,639.08.

Notice to sole source under 36C25022Q0866 estimated the costs of this equipment to be $ 40,812.52.

with details that the parts are a specific software system compatible with the Leica systems to be used by surgical technicians in anticipation of what instruments the surgeon may need resulting in better patient care.

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Combining the two researched acquisitions demonstrates a discount of $19,173.44 for the combined purchase and fair and reasonable pricing to the government.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Prepared by CS April Graves

Name: Won Chae Date

Title: Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466