P03 LSJ E Orange Pentax lease 36C242-22-AP-0954 -2.pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

36C242-22-AP-0954

Last Updated: 02/01/2022 Page 1 of 6

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:__________ 36C242-22-AP-0954___________

(1) Contracting Activity: : Department of Veterans Affairs, Network/Program Contracting Office NCO 2, located at 2875 Union Road, Suite 3500, Buffalo NY 14227, in support of VISN 02 East Orange VA Health Care System at 385 Tremont Avenue East Orange NJ 07018

2237# 561-22-2-733-0016

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501

Order against: FSS Contract Number: __________36F79721D0031__________________

Name of Proposed Contractor: PENTAX OF AMERICA, INC.

Street Address:

3 PARAGON DR

City, State, Zip: MONTVALE, NJ 07645

Phone: 201-571-2300

(3) Description of Supplies or Services:

The estimated value of the proposed action is $

The East Orange VA Medical Center, located at 385 Tremont Ave, East Orange, NJ 07018, requires a 36 month lease of the following Pentax endoscopes and ancillary equipment to include service agreement to be performed by authorized Pentax technicians:

2 - ED34-I10T2-US: DEC HD Video Duodenoscope with Sterile Disposable Elevator Cap

2 - EG27-I10-US: HD Videoscope (i10/K10 series) 2 8C 9 0T 1050L

3 – EG29-I10-US: HD Videoscope (i10/K10 series) 3 2C 9 8T 1050L

5 – EC38-I10L-US: Channel Diameter (m): 3.8:13.2, Working Length (mm): 1,700, Angulation (Up/Down) 180 degrees/ 180 degrees, Angulation (Right/Left: 160 degrees/ 160 degrees, Angle of View 140 degrees

36C242-22-AP-0954

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2 – EC34-I10TH-US: Retroview Colonoscope- i10 Series-210degrees bending section and CloseDocus focal range Channel Diameter: 3.2mm, Ins. Tube Diameter: 11.6mm, Angulation (Up/Down):210 degrees /180 degrees, (Right/Left): 160 degrees/160 degrees, Angle of view:

140 degrees

1 – EG34-J10U-US: Slim Linear Array Ultrasound Gastroscope

1 – EG36-J10UR-US: 360 Degree Radial Array Ultrasound Gastroscope

2 – EPK-I7010-US: AS-IS OPTIVISTA EPK-i7010 HD video processor

2 – VIDEO/MON CABLE PK: Scope Processor/Monitor Integration Pkg

3 – NDS90X0702: 32” Radiance Ultra HD Monitor

1 – EB19-J10-US J10 Video HD Bronchoscope

1 – M70246 Preirus EUS-J10 Software Upgrade Step 5.5

1 – PUN-JBP1: Junction box required to connect EUS J10 and EB19-J10U to Preirus Scanner

2 – EG38-J10UT-US Large Channel Linear Array Ultrasound Gastroscope

The purpose of this lease is to ensure that the Gastrointestinal and Ears, Nose and Throat Departments of the East Orange VA Medical Center has the appropriate surgical equipment to diagnose and treat veterans seeking medical attention. This will be a firm-fixed price task order off FSS contract 36F79721D0031for the anticipated period of performance of April 1, 2022 to March 31, 2025. The annual cost of leasing the endoscopes and ancillary equipment is for a total of for the complete lease period. Pricing was agreed upon to be an equal annual cost between Pentax of America, Inc. and accepted by the VA NAC.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

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

FAR 8.405-6(a)(1)(B): 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;

Market research indicates that Pentax of America, Inc. is the only vendor that has an FSS contract that includes line items for the lease of Pentax endoscopes and ancillary equipment.

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FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

Price reasonableness shall be determined through comparing the annual pricing provided in the received quotes to those of the four procurements this requirement is to replace: Pentax endoscope lease (Task Order 36C24219F0178 off of Pentax’s FSS contract V797D-30172, 03/01/2019-02/28/2022, $ ,); Service agreement to support leased equipment under FSS task order 36C24219F0178 (36C24219P0177, 03/01/2019-02/28/2022, $ ,); Pentax endoscope lease (Task Order 36C24219F0254 off of Pentax’s FSS contract V797D-30172, 04/01/2019-03/31/2022, $ ,); and Service agreement to support leased equipment under FSS task order 36C24219F0254 (36C24219P0768, 03/01/2019-02/28/2022, $ ,).

The total dollar value of the annual pricing of the four procurements to be replaced is $ which is a 9% more than the annual price received in the quote of $359,076.24. As a result, the pricing has been determined to be fair and reasonable.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

A search on the VetBiz website using NAICs Code 339112 and keyword “Pentax” identified two SDVOSB (Bitterroot Services & Technology LLC and The Janz Corporation), and one VOSB (Endoscopy Medical Systems Corp.) that could possibly meet the requirements of this procurement. A review of their VIP profiles confirmed that they could not meet the requirements of this procurement.

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A search on GSA elibrary using keyword “Pentax” has identified that Pentax of America does have a FSS contract (36C79721D0031) that does contain line items for both the leasing of endoscopes and service agreements for leased endoscopes.

A search on DSBS using NAICs code 339112 and keyword “Pentax” did not identify any small business that could possibly meet the requirements of this procurement.

A search on Google using keywords “Pentax endoscope leasing and service agreements” did not identify any additional vendors that could possibly meet the requirements of this procurement.

An Intent to Sole Source notice was posted on sam.gov (36C24222Q0348) from 01-25-2021 through 02-08-2022 and received no responses

Pentax of America has provided a memorandum stating that only Pentax is authorized to repair Pentax Endoscope and that repairs performed by third parties will void any warranties associated with the repaired equipment.

(7) Any Other Facts Supporting the Justification:

This procurement was previously awarded as four separate procurements: two FSS task orders (V797D-30172/36C24219F0178 and V797D-30172/36C24219F0254) for leased Pentax endoscopes, two open market purchase orders (36C24219P0177 and 36C24219P0768) for service maintenance agreements for the corresponding leases listed above. All four procurements were sole sourced to Pentax of America Inc. The reason for separating of the leases from the service agreements was due to FSS contract V797D-30172 not having line items to support service agreements.

Deputy Under Secretary for Health and Management’s (DUSHOM) Memo “VHA National Standardization of Endoscopes” dated 12/06/2010 states that all endoscopes shall be leased off of the Original Equipment Manufacturers (OEM) Federal Supply Schedule (FSS) approved government leasing contract.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

This requirement is being procured in accordance with Deputy Under Secretary for Health and Management’s (DUSHOM) Memo “VHA National Standardization of Endoscopes” dated 12/06/2010. No further actions can be taken to overcome any barriers that led to this restricted consideration.

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(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

Emmanuel Sherman Biomedical Engineer Biomedical .

NAME TITLE SERVICE LINE/SECTION

East Orange VAMC

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER SIGNATURE DATE

Michael Spivack __ NCO 2, Service Team 1

NAME AND TITLE FACILITY/NCO/PCO

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Cheryl Brimmer Branch Chief/NCO 2 Service Team 1

EMMANUEL

SHERMAN

Digitally signed by EMMANUEL

SHERMAN

Date: 2022.03.01 17:08:23 -05'00'

MICHAEL

A. SPIVACK

336645

Digitally signed by

MICHAEL A.

SPIVACK 336645

Date: 2022.03.02 14:04:16 -05'00'

Cheryl M Brimmer 113171

Digitally signed by Cheryl M Brimmer 113171 Date: 2022.03.02 15:00:24 -05'00'

Last Updated: 02/01/2022 Page 6 of 6

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Joseph P. Maletta DATE Executive Director, RPO East VHA Head of Contracting Activity (HCA)

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2022.03.02 16:34:22 -05'00'