JOFOC_BelowSAT-ENT_SurgicalMicroscope.pdf

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: 36C249-22-AP-3842

1. Contracting Activity: Department of Veterans Affairs (VA), VISN 09, Network Contracting

Office (NCO) 9, on behalf of Tennessee Valley Healthcare System (TVHS), Nashville Campus, 1310 24th Avenue South, Nashville, TN 37212. PR/2237: 626-22-3-313-0242

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

Amount:

Product Model Number

Quality

Leica M530 Optics Carrier for IVA/Top Plate 10448700 1

Leica Protective glass M50x, M620 10446058 2

Leica PROVIDO Stand (Standard) 10448976 1

Leica Power cable, 5m, North America 10445664 1

Leica M530 IVA Integr. Video Adapter, f=50mm 10448691 1

Leica Binocular tube var. 30-150°T,Typ II L 10446797 1

Leica Eyepiece f. spect. w´s 10x/21B, type II 10448028 2

Leica Certificate of installation 10448628 1

Leica Stereo attachment for second observer 10448597 1

Leica Binocular tube var. 30-150°T,Typ II L 10446797 1

Leica Eyepiece f. spect. w´s 10x/21B, type II 10448028 2

Leica HD C100 for OH's 10449017 1

Leica PROVIDO Docuset Holder Kit HD C100 10448978 1

Leica 27" Medical HD Touch Monitor 10449040 1

Leica FSN 27’ Power Cable 10448885 1

Last Updated: 02/01/22 Page 2 of 3

Leica PROVIDO Monitorarm 10448997 1

Leica Dust Cover 10740017 1

SERVICES

Installation, Calibration & On-Site Training

Intended Use: Eyes/Nose/Throat (ENT) service seeks to expand their surgical operating room (OR) capabilities to both campuses- Nashville and Murfreesboro (Alvin C. York).

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

Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. The specific VAAR clause used is 819.7007 Sole source awards to a verified service-disabled veteran-owned small business The Government seeks to procure another Leica M530 surgical microscope system for TVHS surgical services to enhance continuity of patient care. TVHS procured direct from Leica Microsystems a Leica Arveo Premium M530 surgical microscope for neurosurgery under emergency procurement action in November 2019 using simplified acquisitions procedures to award purchase order (PO) 36C24920P0068 for $489,987.51. TVHS also procured direct from Leica Microsystems a Leica M525-F40 surgical microscope for ENT OR under emergency procurement action in August in 2016 using Leica’s then-active VA FSS contract V797P2082D under FAR part 8 procedures to award a task/delivery order (TO/DO) VA249-16-J-3575 for $85,422.73.

In essence, Leica has become the standard for surgical microscopy for TVHS.

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.

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 TVHS 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 TVHS ENT surgeons conduct their practice at both Nasvhville and Murfreesboro locations. The ENT section chief and ENT surgeons reviewed

Last Updated: 02/01/22 Page 3 of 3 the Zeiss Extaro-300 and the Leica Provido M530, which is an upgrade from the current Leica M525 F40 microscope ENT is currently using, 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.” The Leica authorized distributor/dealer for Tennessee state, namely SurgicalOne, confirmed that they cannot sell new Leica products to the Government rather they can only sell refurbished Leica products, and would pass all quote requests for new Leica products to Melling Medical for action.

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. Market research identified one Service-Disabled Veteran-Owned small business (SDVOSB) – Melling Medical, and one small business – SurgicalOne, Inc., as authorized distributers.

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.

7/28/2022

X Sascha Hertslet, CFCM NCO9, Contracting Officer Signed by: SASCHA HERTSLET