Sole Source Justification - Endoscopic Equipment Lease.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification IAW VAAR 819.7008/9

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 8 Revision: 03 Effective Date: 06/15/2024

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition

Acquisition Plan Action ID:

PR IFCAP 2237:

JOFOC Tracker Number:

1. Contracting Activity:

Department of Veterans Affairs Network Contracting Office 19 (NCO 19) 6162 South Willow Drive, Suite 300 Greenwood Village, Colorado 80111

Organizational Activity:

Department of Veterans Affairs Salt Lake City Medical Center 500 Foothill Drive Salt Lake City, Utah 84148

2. Nature and/or Description of the Action Being Approved: This procurement is for a base plus four (4) option year, firm-fixed price contract for the lease of Karl Storz urology endoscopes and equipment, along with servicing of the equipment and on-site endoscopic technician for the Salt Lake City VA Medical Center.

3. Description of Supplies/Services : The Salt Lake City VA Medical Center currently has a contract to lease Karl Storz urology endoscopes and equipment, with a service agreement through SDVOSB, L1 Enterprises Inc, contract 36C25921P1097. The contract is currently in its second option year out of four. The Salt Lake City VA Medical Center does not plan to exercise the remaining option years but intends to start a new contract after the end of the current option year. A new contract is necessary because the surgery service needs to have additional equipment and an on-site endoscopic specialist, which goes beyond the scope of the current contract. This requirement is for the lease of Karl Storz endoscopes and equipment that are used for pre-operative and post-operative care, a service agreement, and an onsite endoscopic technician that will help setup, takedown, and troubleshoot the Karl Storz equipment. This equipment includes video ureteroscopes, flexible uretero-reno fiberscopes, kits, and accessories. In addition, leasing provides access to labor, replacement parts and loaner equipment should any of the equipment fail. The operating room is currently experiencing high volume of procedures involving these types of scopes, these required scopes will help decrease patient backlog tremendously and improve patient care. The following equipment which is specific to Karl Storz will be provided over the course of the contract:

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 2 of 8

Effective Date: 06/15/2024

Item Description Qty

0001 (27005BIA) HOPKINS II 30 DEGREE PDD TELESCOPE WITH ENLARGED

VIEW, 4MM X 30CM, AUTOCLAVABLE 13

0002 (27502) LUER-LOCK CONNECTOR WITH STOPCOCK 13

0003 (27094BY) ADAPTOR FOR USE WITH RESECTOSCOPE SHEATHS 13

0004 (27050E) WORKING ELEMENT WITH SPRING ACTION AND MOVABLE

THUMB SUPPORT 13

0005 (27072BSA) OPTICAL BIOPSY FORCEPS WITH EXTRA LARGE DOUBLE

ACTION JAWS 13

0006 (27072FSA) OPTICAL GRASPING FORCEPS FOR STENT REMOVAL, DOUBLE

ACTION JAWS 13

0007 (277KB) MONOPOLAR HIGH FREQUENCY CORD WITH 8MM PLUG,

LENGTH:300CM 13

0008 (495ND-UG) LIGHT CABLE, 3.5MMX 300CM (9.8') 13

0009 (27026DAK) 19FR CYSTO-URETHROSCOPE SHEATH WITH OBTURATOR 13

0010 (27026CAK) 20FR CYSTO-URETHROSCOPE SHEATH WITH OBTURATOR 13

0011 (27026BAK) 22FR CYSTO-URETHROSCOPE SHEATH WITH OBTURATOR 13

0012 (27040SLK) 26FR CONTINUOUS FLOW RESECTOSCOPE SHEATH WITH

OBLIQUE BEAK AND FIXED INNER TUBE 13

0013 (27050BE) ESHGI VISUAL OBTURATOR FOR 24/26FR SHEATHS 13

0014 (27040EB) BIPOLAR WORKING ELEMENT ONLY WITH SPRING ACTION

AND MOVABLE THUMB SUPPORT 13

0015 (495ND-UG) LIGHT CABLE, 3.5MMX 300CM (9.8') 13

0016 (UH801) BIPOLAR HIGH FREQUENCY CORD, 400CM 13

0017 (KSZ-39312C-Z) LAYER STERILIZATION CONTAINER SYSTEM DM: 23.5"L X

11"W X 8"H 13

0018 (27005AA) HOPKINS II 0º TELESCOPE, 4MM X 30CM, AUTOCLAVABLE 12

0019 (27005BA) HOPKINS II 30º TELESCOPE, 4MM X 30CM, AUTOCLAVABLE 12

0020 (27005CA) HOPKINS II 70 DEGREE TELESCOPE, 4MM X 30CM,

AUTOCLAVABLE 12

0021 (39301CS-ZBZ) TRAY, UDEL, 2 RIGID SCOPES 10MM X 33CM 36

0022 (27010LA) SEMI-RIGID 6º URETERO-RENOSCOPE W/STRAIGHT EYEPIECE,

TIP;7FR, LENGTH: 43CM, AUTOCLAVABLE 3

0023 (495ND-UG) LIGHT CABLE, 3.5MMX 300CM (9.8') 3

0024 (27502) LUER-LOCK CONNECTOR WITH STOPCOCK 3

0025 (27014Y) LUER CONNECTOR FOR FLEXIBLE UROLOGY SCOPES, FOR USE

WITH PORT SEALS 3

0026 (27001RA) CLEANING ADAPTOR FOR INSTRUMENT PORTS 3

0027 (27001E) INSERTION AID FOR GUIDE WIRE FOR URETERORENOSCOPY 3

0028 (39301LC-ZBZ) STRAIGHT EYEPIECE URETEROSCOPE STERILIZATION TRAY,

31.75" X 5.25" X 3" 3

0029 (27293AA) HOPKINS 6º PERC NEPH TELESCOPE WITH ANGLED EYEPIECE,

25CM, AUTOCLAVABLE 2

0030 (495ND-UG) LIGHT CABLE, 3.5MMX 300CM (9.8') 2

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 3 of 8

Effective Date: 06/15/2024

0031 (27293BD) 26FR PERC NEPH OPERATING SHEATH, FOR CONTINUOUS

SUCTION/IRRIGATION 2

0032 (27293BL) 26FR HOLLOW OBTURATOR AND FASCIAL DILATOR FOR

OPERATING SHEATH 2

0033 (27502) LUER-LOCK CONNECTOR WITH STOPCOCK 2

0034 (27290K) GRASPING FORCEPS W/RING HANDLE, FENESTRATED DOUBLE

ACTION JAWS WL:38CM 2

0035 (KSZ-39312J) CONTAINER SYSTEM, DM: 23.5" X 11" X 4" 2

0036 (27292AMA) HOPKINS 6º PERC NEPH TELESCOPE WITH PARALLEL

EYEPIECE, WL:25CM, AUTOCLAVABLE 2

0037 (27290M) GRASPING FORCEPS WITH RING HANDLE, SERRATED DOUBLE

ACTION JAWS, WL:38CM 2

0038 (27290K) GRASPING FORCEPS W/RING HANDLE, FENESTRATED DOUBLE

ACTION JAWS WL:38CM 2

0039 (27290H) 3-PRONG RETRACTABLE GRASPING FORCEPS F/STONE

FRAGMENTS W/U-SPRING HNDL.WL:38CM 2

0040 (27293BD) 26FR PERC NEPH OPERATING SHEATH, FOR CONTINUOUS

SUCTION/IRRIGATION 2

0041 (27293CD) 24FR PERC NEPH OPERATION SHEATH, FOR 24FR PERC NEPH

OPERATION SHEATH, FOR 2

0042 (27293BL) 26FR HOLLOW OBTURATOR AND FASCIAL DILATOR FOR

OPERATING SHEATH 2

0043 (27093GM) ADAPTOR, FOR USE WITH PCN SHEATHS, FOR INTRO OF FLEX

CYSTO-URETHRO-FIBERSCOPES 2

0044 (495ND-UG) LIGHT CABLE, 3.5MMX 300CM (9.8') 2

0045 (27502) LUER-LOCK CONNECTOR WITH STOPCOCK 2

0046 (KSZ-39312J) CONTAINER SYSTEM, PCNL DM: 23.5" X 11" X 4" 2

0047 (UG130U-KT) SLIM DESIGN SURGICAL CART W/OPEN SIDES KIT WITH CO2

TANK HOLDER 2

0048 (WD350-KT-UG) SMARTSCREEN AND SOFTWARE LICENSE FOR UPDATES

AND UPGRADES 1

0049 (TM220-UG) 27" HD MONITOR, 1920X1080 16:9 ASPECT RATIO 1

0050 (TL410US) 6000K LED LIGHT SOURCE 1

0051 (WU1333-UG) MEDICAL GRADE PRINTER FOR USE W/USB AND WIRELESS

PRINTING 1

0052 (UF101-UG) ONE PEDAL FOOTSWITCH, ONE-STAGE 1

0053 (TC205US-KT) Connection Kit 1

0054 (TC305US) LINK MODULE, FOR USE W/ CAMERA HEAD 1

0055 (TH113US) FULL HD PENDULUM CAMERA HEAD 2

0056 (39301PHTS-UG) TRAY, UDEL, PENDULUM/INLINE CAM HEADS DM:

15.15#X 10.10# X 2.61# 2

0057 (495NAC-UG) LIGHT CABLE, 3.5MM X 230CM (7.6') AUTOCLAVABLE,

WITH LOCKING MECHANISM 2

0058 (27005BIA) HOPKINS II 30 DEGREE PDD TELESCOPE WITH ENLARGED

VIEW, 4MM X 30CM, AUTOCLAVABLE 2

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 4 of 8

Effective Date: 06/15/2024

0059 (27005CIA) HOPKINS II 70 DEGREE PDD TELESCOPE WITH ENLARGED

VIEW, 4MM X 30CM, AUTOCLAVABLE 2

0060 (27040SLK) 26FR CONTINUOUS FLOW RESECTOSCOPE SHEATH WITH

OBLIQUE BEAK AND FIXED INNER TUBE 2

0061 (27094BY) ADAPTOR FOR USE WITH RESECTOSCOPE SHEATHS 2

0062 (27224ALO) CONNECTOR WITH TUBE AND LOCKING DEVICE FOR

EVACUATOR 2

0063 (27050BE) VISUAL OBTURATOR FOR 24/26FR SHEATHS 2

0064 (27072BSA) OPTICAL BIOPSY FORCEPS WITH EXTRA LARGE DOUBLE

ACTION JAWS 2

0065 (27175A) FLEXIBLE GRASPING FCPS, DBL ACTION JAWS FOR FOREIGN

BODY REMOVAL, 7FR X 40CM 2

0066 (27026BAK) 22FR CYSTO-URETEROSCOPE SHEATH WITH OBTURATOR 2

0067 (27040EB) BIPOLAR WORKING ELEMENT ONLY WITH SPRING ACTION

AND MOVABLE THUMB SUPPORT 2

0068 (27025GF) TELESCOPE BRIDGE WITH 2 INSTRUMENT CHANNELS 2

0069 (KSZ-39312D) TELESCOPE BRIDGE WITH 2 INSTRUMENT CHANNELS 2

0070 (27830KAA) NEPHROSCOPE F/MIP M, 12FR., AUTOCLAV., CHNL 6.7 FR. 2

0071 (27001GP) INSTRUMENT PORT W/SEALING SYSTEM + QUICK RELEASE

LOCK, 1 CHANNEL 2

0072 (27550N) INSTRUMENT PORT SEALS FOR 10/PKG, NON-STERILE, SINGLE

USE 2

0073 (27502) LUER-LOCK CONNECTOR WITH STOPCOCK 2

0074 (27001GG) LARGE INSTRUMENT PORT W/SEALING SYSTEM 2

0075 (7037595) CONE FOR USE WITH INSTRUMENT PORT 2

0076 (7624890-10) RUBBER TIP WITH HOLE. DIA 0.8MM 2

0077 (27830AB) ONE STEP DILATOR,W/DISTAL CURVED CHANNEL F/GUIDE

WIRE DEFL, F/USE SHEATH 2

0078 (27830BB) 16.5/17.5 OPERATING SHEATH F/CONTINUOUS IRRIGATION

AND SUCTION, WL:15CM 2

0079 (27830CF) APPLICATOR FOR SEALING F/USE WITH OPERATING SHEATHS 2

0080 (27830BBS) 16.5/17.5FR OPERATING SHEATH F/CONTINUOUS FLOW,

F/SUPINE POSITION, WL:18CM 2

0081 (27830CFS) APPLICATOR F/SUPINE POSITION F/SEALING F/USE W/OPER.

SHEATHS 2

0082 (27830FK) FLEXIBLE GRASPING FCPS, DBL ACTION JAWS FOR FOREIGN

BODY REMOVAL, 5FR X 40CM 2

0083 (27830H) GRASPING FORCEPS FOR LARGE STONE FRAG. 3 EXPANDING

JAWS, SMALL FIXAT. SPIKES 2

0084 (KSZ-39312M) CONTAINER SYSTEM, MIP DM: 23.5" X 11" X 4" 2

0085 (27020AA) HOPKINS TELESCOPE 0°, 2.9MM 3

0086 (26020FA) HOPKINS II 12º TELESCOPE, 2.9MM X 30CM AUTOCLAVABLE,

FOR GYNECOLOGY 3

0087 (26120BA) HOPKINS II 30º TELESCOPE, 2.9MM X 30CM AUTOCLAVABLE,

FOR GYNECOLOGY 3

0088 (495ND-UG) LIGHT CABLE, 3.5MMX 300CM (9.8') 3

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 7 of 8

Effective Date: 06/15/2024

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by FAR Subpart

5.2 and, if not, which exception under FAR 5.202 applies: Market research was conducted as described in paragraph 8 below and L1 Enterprises Inc. is a responsible SDVOSB and sole source award will be completed to meet the needs of the Salt Lake City VA Medical Center and maintain the endoscope equipment lease and service. This strategy is determined to be in the best interest of the Government as L1 Enterprises Inc is the only responsible source capable of providing the requirement.

Sources Sought Synopsis 36C25924Q0506 requesting information on sources capable of fulfilling this requirement was issued on May 29, 2024, and closed on June 5, 2024. Only one response was received in response to the Source Sought from L1 Enterprises Inc.

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

The anticipated cost will be analyzed in accordance with FAR 13.106-3(a)(2). The price will be compared to the Independent Government Cost Estimate (IGCE) as well as previous prices paid by the Government by searching the Federal Procurement Data System (FPDS) for similar requirements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market research indicates this requirement is only available from L1 Enterprises Inc. This was determined by contacting Karl Storz and asking them if they have any small business authorized distributors that are capable of fulfilling this requirement. A letter dated May 29, 2024, provided by , Director Corporate Accounts, confirmed Karl Storz is the sole manufacturer and service provider for the required equipment and that their technology is proprietary.

The letter also stated that the acquisition can only be made through SDVOSB, L1 Enterprises Inc. On July 10, 2024, confirmed by email that Karl Storz onsite endoscopic specialists are the only trained and authorized providers to operate, service, and repair their proprietary equipment.

On July 12, 2024, a The results showed awards to Olympus America Inc., Karl Storz Endoscopy-America Inc., and L1 Enterprises Inc.

Additionally, on the same date, a VetCert search was performed using NAICS 334510, yielding three hundred and ten (310) findings. A search was also carried out on July 12, 2024, using the SBA Dynamic Small Business Database, which resulted in no findings. It was also determined that the requirement was not available through any VA mandated or strategic sources.

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:

L1 Enterprises, Inc. (SDVOSB)

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: Karl Storz lease and services agreements are specific to Karl Storz Endoscopy-America Inc. Due to the existing Karl Storz infrastructure, no other products will integrate with the current system. Karl Storz confirmed the lease and service could only be provided through their SDVOSB lessor agent; L1 Enterprises Inc. The contracting office will continue to evaluate the market in order to increase competition.

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 8 of 8

Effective Date: 06/15/2024

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.

Acquisition Utilization Specialist Salt Lake City VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Contracting Officer Network Contracting Office (NCO) 19

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.

Contracting Officer, Branch Chief

Director of Contracting

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Executive Director, Regional Procurement Office West Head of Contracting Activity