36C24125Q0406.docx

SUBJECT*

Surgical Equipment

GENERAL INFORMATION

SET-ASIDE

VAMC Togus

1 VA Center

Augusta ME

CONTACT INFORMATION

VA CENTRAL WESTERN MASSACHUSETTS HCS

Acquisitions-90 421 North Main Street Leeds MA 01053-9764

POINT OF CONTACT*

Contract Specialist Sean Genereux Sean.Genereux@va.gov 802-295-9363

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Presolicitation Notice Presolicitation Notice

INTENT TO SOLE SOURCE TO SB OEM_PROPRIETARY

Presolicitation Notice

Presolicitation Notice Presolicitation Notice

DESCRIPTION

Page 1 of

Presolicitation Notice

Page 1 of Pre-Solicitation Notice under $25K sole-sourced firm-fixed price to the OEM.

Pre-Solicitation Notice.

VHA Network Contracting Office 1 New England (NCO1) intends to solicit a SB Sole-Source Firm-Fixed priced to Shuerch Corp. (Dba ShureMed) (OEM) for the goods/services described below.

OEM: Shuerch Corp. (Dba ShureMed) (SB)

452 RANDOLPH ST

ABINGTON, MA 02351

UEI: HANABM62JEK6

A Sole Source Letter has been provided by the SB OEM describing the proprietary nature of the ShurMed TKR Knee Positioner establishing this product as being peculiar to Shuerch Corp, the SB OEM. The letter states that only the OEM is authorized distribute this product domestically. Per Shuerch, no other vendors in any class, aside from the OEM are authorized to distribute this product as a distributor or a reseller in the US.

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 8.405-6(a)(1)(i)(B).

The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 339113. The most current Business Size Rating for this NAICS is 800 employees.

NCO1 intends to obtain the following: This procurement is for four (4) each thirty inch (30”) TKR Knee Positioners, and four (4) each CAM-LOK Rail Clamps as replacements for the current 30” TKR Knee Positioners and CAM-LOK Rail Clamps.

PURPOSE: The purpose of this procurement is to replace the current ShureMed TKR Knee Positioners and CAM-LOK Rail Clamps currently is use at VAMC Togus.

EQUIPMENT:

800-0171: TKR Positioner, 30", is a ball-track system for total knee replacements. The ball joint at the heel of the leg holder places the operative leg in extension, flexion, tilt and rotation. Smooth sliding motion for effortless leg positioning. Locks in any position with a simple turn of the wrist. Easy to-use and completely rigid once locked. All components are autoclavable. Easily attaches to side rail of surgical table with required CAM-LOK Clamp.

· 800-0271: The CAM-LOK Rail Clamp is designed for use in the sterile field. Attaches to the operating table rail at any location over multiple drapes and accepts accessories with round posts up to 5/8"D (1.6 cm) and flat mounting posts to 1" x 3/8"D. Patient weight capacity is 500 lbs.

SCOPE: The Contractor shall provide new ShureMed 30” TKR Knee Positioners and CAM-LOK Rail Clamps to VAMC Togus for immediate use. VA Togus HCS requires Total Knee Positioners for knee surgeries done in the OR for the Orthopedic department.

Total Knee Positioners feature the following (800-0171): The Contractor shall provide a fully functional system that meets the following characteristics:

The NEW Custom Sterilization Tray included with purchase.

· Track Locking Bracket securely locks the Base Plate to the table with two thumb screws.

· Locks in any position with a simple turn of the wrist

· Smooth sliding motion for effortless leg positioning

· Well leg lies flat – eliminating the need for well-leg positioners.

· All components are autoclavable.

· 30″ (76 cm)

· Includes (1) TKR Boot Liner CAM-LOK Rail Clamps (800-0271):

· Required for use with 30” TKR Knee Positioners (800-0171)

AREAS TO BE SERVICED:

Togus VA Medical Center 1 VA Center Augusta, ME 04330-6795

Since the items are exclusively available from the OEM and its authorized distributors, no solicitation will be posted to Contracting Opportunities SAM.gov. This procurement is subject to prohibitions in the VA Acquisition Regulation (VAAR), including 852.212-71 Gray Market Items and 852.212-72 Gray Market and Counterfeit Items.

Interested persons may contact the Contracting Officer/Contract Specialist via email at: deidra.thomas@va.gov regarding this procurement. The determination of the acquisition strategy based on responses to this notice is within the discretion of the Contracting Officer.

Capable parties may identify their interests and authorization to respond to this requirement by 04/29/24 at 10:00AM (EDT).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

Performance Work Statement (PWS) Design and Content

1.0 Introduction

The VA Togus HCS requires Total Knee Positioners for knee surgeries done in the OR for the Orthopedic department.

2.0 Background

Our goal in the VA is to provide veterans the world-class benefits and services they have earned and to do so by adhering to the highest standards of compassion, commitment, excellence, professionalism, integrity, accountability, and stewardship. This is a piece of equipment that is designed for improving orthopedic surgeries for knees in the OR.

3.0 Scope (Provide an overview of the PWS emphasizing the most important aspects of your requirement and defining the boundaries of the contractor’s performance responsibilities).

Total Knee Positioners feature the following:

· The NEW Custom Sterilization Tray included with purchase.

· Track Locking Bracket securely locks the Base Plate to the table with two thumb screws.

· Locks in any position with a simple turn of the wrist

· Smooth sliding motion for effortless leg positioning

· Well leg lies flat – eliminating the need for well-leg positioners.

· All components are autoclavable.

· Available in 24″ (61 cm) & 30″ (76 cm)

· Includes (1) TKR Boot Liner L i

4.0 Applicable Directives (List all documents referenced in the next section 5.0, Performance Requirements, with which the contractor will have to comply in performance of the contract effort. If only portions of a given document apply, specifically identify the applicable portions).

The system must meet the manufacturer’s specifications and be designed and implemented within the vendors 510K system design as an FDA regulated medical device/system.

5.0 Performance Requirements (Identify what the contractor is required to do (major tasks and subtasks).

N/A.

6.0 Deliverables (List all data required to manage or monitor contractor performance).

N/A.

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 - Justification for Limiting Sources (LSJ) For Limiting Sources (<SAT) Acquisition Plan Action ID:________36C241-25-AP-1885_____________ Contracting Activity:

Department of Veterans Affairs, Network/Program Contracting Office 01, located at 421 North Main Street Leeds MA 01053-9764, in support of VISN 01 VA Health Care System at Togus VA Healthcare System 1 VA Center Augusta ME 04330-6795. The contracting agency responsible for this procurement is NCO 01 RPOE (36C241), and the organizational activity responsible is the Surgical-Admin team at VAMC Togus, program code 112. Please reference Purchase Request # 402-25-2-7915-0246.

Description of Action: This procurement is for four (4) each thirty inch (30�) TKR Knee Positioners, and four (4) each CAM-LOK Rail Clamps as replacements for the current 30� TKR Knee Positioners and CAM-LOK Rail Clamps at VAMC Togus that was ordered on order number# 36C24118N0659.

Order against: FSS Contract Number: 36F79721D0200

Description of Supplies or Services: The estimated value of the proposed action is $19,032.84

Item 1) ShureMed Part # 800-0171 (4 Ea): is a TKR Positioner, 30", is a ball-track system for total knee replacements. The ball joint at the heel of the leg holder places the operative leg in extension, flexion, tilt and rotation. Smooth sliding motion for effortless leg positioning. Locks in any position with a simple turn of the wrist. Easy-to-use and completely rigid once locked. All components are autoclavable. Easily attaches to side rail of surgical table with required CamLoc Clamp #800-0271 (sold separately). TrackLocking Bracket securely locks the Base Plate to the table with two thumb screws. Includes (1) TKR Boot Liner #800-0146.

· The use of the ShureMed TKR Positioners (Part # 800-0171), and clamps (Part # 800-0271) are already in use at VAMC Togus. This procurement supports standardization to ShurMed Orthopedic equipment already in use at VAMC Togus. Procuring the ShurMed Knee Positioning equipment maximizes cost efficiencies by reducing costs to procure a new, integrated system of Orthopedic equipment, and best affords operational efficiency and patient safety. The ShurMed equipment is compatible with and fully-integrates with existing ShurMed equipment: fit, form, and function. Continued use of the ShurMed brand facilitates direct replacement, which also helps to maintain efficiency in scheduling and performing surgeries.

· Standard Operating Procedure (SOP) for Total Knee Positioning were derived from the SOP from ShurMed and according to the equipment manual. All staff possess knowledge and training of the ShurMed TKR Knee Positioning equipment. This streamlines orthopedic procedures and increases Veteran safety by affording continuity of high-quality healthcare. The sterilization department has also developed sterilization SOPs based on ShurMeds instructions.

· Purchasing another brand would adversely impact surgical schedules with delays of scheduling and could result in surgery cancellation for Veterans. Acquiring the new ShurMed TKR Knee Positioning equipment is essential to orthopedic care at VAMC Togus and will best support the orthopedic healthcare mission at Togus.

Item 2) ShureMed Part # 800-0271 (4 Ea): The CamLoc Rail Clamp is designed for use in the sterile field. Attaches to the operating table rail at any location over multiple drapes and accepts accessories with round posts up to 5/8"D (1.6 cm) and flat mounting posts to 1" x 3/8"D.Patient weight capacity is 500 lbs.

· The CAM-LOK Rail clamp (Part # 800-0271) is a required item for the use of the TKR Knee Positioner. The ShureMed Part # 800-0171 will not work as intended without the use of the ShureMed Part # 800-0271.

Market Research Results:

· The market research indicates that there is only one source (SCHUERCH CORPORATION DBA ShureMed) capable of providing the required items (ShureMed TKR Positioners Part # 800-0171) (CAM-LOK Rail clamp Part # 800-0271). IAW FAR subpart 10.0

· The requirements of this procurement are available on a FSS contract (36F79721D0200) with SCHUERCH CORPORATION (DBA ShureMed).

· GSA market research reports states there is only one (1) capable source or FSS that can meet the requirements. IAW FAR subpart 10.0

· An SBA DSBS search results determined that there are no SD/VOSBs capable of meeting the requirements. Therefore, there is no expectation to receive quotes from SD/VOSBs that can perform the work. IAW VAAR 810.001-70, VAAR 810.001-70

· An SBA DSBS search was used to determine that SCHUERCH CORPORATION (DBA ShureMed) is a certified small business.

· VetCert research indicates and certifies that there are no SD/VOSBs capable of meeting the requirements. Therefore, there is no expectation to receive quotes from SD/VOSBs that can perform the work. IAW VAAR 810.001-70, VAAR 810.001-70

· AbilityOne research determined that the requirements are not available on AbilityOne.

Nonmanufacturer Rule (NMR) Findings: No SD/VOSBs manufacture the product, the SB OEM (Shuerch Corp.) manufactures the required product; there is no NMR waiver for NAICS code 339113 applicable to this requirement, no SD/VOSBS meet 13 CFR 121.406(b)(1)(i), (b)(1)(ii), (b)(1)(iii), market research determined that there is one (1) SB FSS holder for contract (36F79721D0200), the SB OEM (Original Equipment Manufacturer) who can meet this requirement.

Recommendation: The recommendation is for a single source award to the SB OEM Shuerch Corp., IAW FAR 8.405-6(b) (i): one (1) manufacturer; one (1) source. There is no NMR Waiver, IAW VAAR 819.7003(d) a SDVOSB set-aside cannot be applied. This requirement would be typically eligible for a Straight SB Set aside IAWFAR 19.502-2(a) by applying the SBA NMR Exception; the requirement is under SAT.

Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; (FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

A Sole Source Letter has been provided by the SB OEM describing the proprietary nature of the ShurMed TKR Knee Positioner establishing this product as being peculiar to Shuerch Corp, the SB OEM. The letter states that only the OEM is authorized distribute this product domestically. Per Shuerch, no other vendors in any class, aside from the OEM are authorized to distribute this product as a distributor or a reseller in the US.

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 8.405-6(a)(1)(i)(B).

The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 339113. The most current Business Size Rating for this NAICS is 800 employees.

Rationale/explanation to support cited authority:

The best value to the Government is via a single source, FSS Schedule award for the brand purchase of the ShurMed TKR Knee Positioner and the required ShurMed CamLoc Rail Clamp, IAW (in accordance with) FAR 8.405-6(b). There is one manufacturer, Shuerch Corp, the SB OEM. Shuerch is the sole holder of the IDV contract carrying the ShurMed parts, FSS Schedule 36F79721D0200. Direct procurement from the SB OEM via their FSS IDV (Indefinite Delivery Vehicle (affords the best value to the Government. The ShureMed TKR Knee Positioner and ShureMed CAM-LOKs, affords continued operational efficiencies and best affords continuity of patient care via standardization.

FSS pricing is deemed to be fair and reasonable IAW FAR 8.404(d).

Sean Genereux Contract Specialist

VISN 01/NCO 01

Deidra Thomas Contracting Officer/Designee VISN 01/NCO 01

Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

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