6540--Amend 1 - Eye Clinical Zeiss Upgrades EHRM

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5

Original Date: 10/12/17

Revision 04 Date: 06/10/20

Description

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

2. This is a Brand Name Request for Quote (RFQ) and the solicitation number is 36C26022Q0848. The Government anticipates awarding a firm-fixed price supply order from this solicitation.

3. This is a solicitation for Zeiss Equipment Upgrades and Licensing. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-07 published August 10, 2022.

4. This solicitation is 100% set-aside for Small Business. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 (Electromedical and Electrotherapeutic Apparatus), with a small business size standard of 1250 employees and the PSC is 6540 (Ophthalmic Instruments, Equipment, and Supplies). There is a SBA Non-Manufacturer Rule Class waiver for the NAICS for this requirement.

All interested small businesses shall provide quotations, for the brand name equipment and licensing listed below.

5. Equipment Needed:

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

2.00

EA

______________

______________

Puget Sound HCS - American Lake Equipment: CIRRUS HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11. Includes GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic

with Trade-in

0002

1.00

EA

______________

______________

Puget Sound HCS - American Lake Equipment: IOL Master 700 WIN 10 Upgrade (Requires Software V1.9)

0003

1.00

EA

______________

______________

Puget Sound HCS - American Lake Equipment: Matrix 800 - New Humphrey Matrix

0004

1.00

EA

______________

______________

Puget Sound HCS - American Lake Equipment: SL 800 System with Trade-in

0005

2.00

EA

______________

______________

Puget Sound HCS - American Lake - Equipment: Zeiss Forum 3rd Party Instrument License

0006

2.00

EA

______________

______________

Puget Sound HCS - American Lake Equipment: Zeiss Instrument License+ Design

0007

1.00

EA

________________

_______________

Puget Sound HCS - American Lake Equipment: HFA3 860 Version 1.5

0008

1.00

EA

________________

_______________

Puget Sound HCS - American Lake Equipment: Zeiss Forum 3rd Party Instrument License

0009

2.00

EA

______________

______________

Puget Sound HCS - American Lake Equipment: Zeiss Instrument License+ Design

0010

1.00

EA

______________

______________

Puget Sound HCS - Mount Vernon CBOC Equipment: CIRRUS HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11. Includes GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic

0011

1.00

EA

______________

______________

Puget Sound HCS - Mount Vernon CBOC Equipment: Zeiss Forum 3rd Party Instrument License

0012

1.00

EA

________________

_______________

Puget Sound HCS - Mount Vernon CBOC Equipment: Zeiss Instrument License+ Design

0013

1.00

EA

______________

______________

Puget Sound HCS Seattle Equipment: CIRRUS HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11. Includes GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic

0014

1.00

EA

______________

______________

Boise VAMC Equipment: Clarus 500 Fixation Device

0015

1.00

EA

_____________

_____________

Boise VAMC Equipment: Zeiss Instrument License+ Design

0016

1.00

EA

______________

______________

Boise VAMC - Caldwell CBOC Equipment: CIRRUS HD-OCT (Model 5000). Includes GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic

0017

1.00

EA

______________

_____________

Boise VAMC - Caldwell CBOC Equipment: Clarus 500 Fixation Device

0018

1.00

EA

________________

_______________

Boise VAMC - Caldwell CBOC - Equipment: HFA3 860 Version 1.5

0019

3.00

EA

_____________

______________

Boise VAMC - Caldwell CBOC Equipment: Zeiss Instrument License+ Design

0020

1.00

EA

______________

______________

Roseburg VAMC - Eugene CBOC Equipment: HFA3 860 Version 1.5 Trade-in

0021

1.00

EA

______________

______________

Roseburg VAMC - Eugene CBOC Equipment: Zeiss Forum 3rd Party Instrument License

0022

1.00

EA

______________

______________

Roseburg VAMC Equipment: HFA3 860 Version 1.5 with Trade-in

0023

2.00

EA

______________

______________

Roseburg VAMC Equipment: Zeiss Forum 3rd Party Instrument License

0024

1.00

EA

______________

______________

Mann-Grandstaff VAMC Equipment: Clarus 500 Fixation Device

0025

2.00

EA

______________

______________

Mann-Grandstaff VAMC - Equipment: HFA3 860 Version 1.5 with Trade-in

0026

3.00

EA

______________

______________

Mann-Grandstaff VAMC Equipment: Zeiss Instrument License+ Design

0027

1.00

EA

________________

_______________

Mann-Grandstaff VAMC Equipment: IOL Master 700 with Swept source OCT. Includes Keyboard, Mouse, Total Keratometry.

0028

1.00

EA

______________

______________

Mann-Grandstaff VAMC - Wenatchee CBOC Equipment: CIRRUS HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11. Includes GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic

0029

1.00

EA

______________

______________

Mann-Grandstaff VAMC - Wenatchee CBOC Equipment: HFA3 860 with Trade-in

0030

1.00

EA

_____________

______________

Mann-Grandstaff VAMC - Wenatchee CBOC Equipment: Zeiss Instrument License+ Design

0031

1.00

EA

______________

______________

White City VAMC Equipment: CIRRUS HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11. Includes GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic.

0032

1.00

EA

______________

______________

White City VAMC Equipment: HFA3 860 Version 1.5 with Trade-in

0033

1.00

EA

_____________

______________

Jonathon M Wainwright VAMC Equipment: Clarus 500 Fixation Device

0034

1.00

EA

______________

_____________

Jonathon M Wainwright VAMC - Equipment: Zeiss Instrument License+ Design

0035

1.00

EA

______________

______________

Jonathon M Wainwright VAMC Equipment: Atlas 500

GRAND TOTAL

______________

NOTE: All Equipment shall have a minimum one-year warranty and will include two Operators and two Service manuals.

6. Salient Characteristics/Statement of Work:

Zeiss Eye Care Imaging Device Upgrades

Background

The VA Northwest Health Network, Veterans Integrated Service Network (VISN) 20, is responsible for providing health care to Veterans in the states of Alaska, Washington, Oregon, most of the state of Idaho, and one county each in Montana and California. VISN 20 encompasses 135 counties which cover approximately 23% of the United States land mass; 17% of which are classified as health professional shortage areas. 67% of these same counties had a 2001 per capita income below $25,000. There are approximately 1.2 million Veterans living in the Pacific Northwest and Alaska, 18% of whom received VA services.

The VISN 20 network of eight (8) health care facilities is comprised of (7) medical centers and one (1) rehabilitation center. Two of the health care facilities are three (3) two-division campuses. These ten (10) health care sites support thirty-six (36) Community Based Outpatient Clinics.

Scope

VISN 20 requires an upgrade to networked eye imaging devices that are currently running on an unsupported operating system and supplemental equipment in support of the VA Electronic Health Records Modernization (EHRM) Cerner Initiative. Per VA Directive 6550, VA prohibits procurement of medical systems with an unsupported operating system (OS). Where possible, medical equipment running a Windows 10 OS should use the Windows 10 LTSC (Long Term Servicing Channel) version which are guaranteed to receive patches and updates for ten years after their initial release.

The imaging devices must be (Digital Imaging and Communications and Management (DICOM) compliant with ability to interface with the site s Zeiss Image and Data Management System (Zeiss Forum), an eye care image and data management picture archive and communication system (PACS) specifically designed for hospitals to improve their workflow efficiency.

Place of Performance

Table 1. VISN 20 Site Shipping and Installation Addresses

Station

Installation Address

Shipping Address

531-VA Boise Medical Center (BOI) - Caldwell

4521 Thomas Jefferson Drive Caldwell, ID 83605

4521 Thomas Jefferson Drive Caldwell, ID 83605

531-VA Boise Medical Center (BOI)

500 West Fort Street Boise, ID 83702

500 West Fort Street Boise, ID 83702

653-VA Roseburg Health Care System Roseburg Campus (ROS)

913 Garden Valley Boulevard

Roseburg, OR 97470

913 Garden Valley Boulevard

Roseburg, OR 97470

653-VA Roseburg Health Care System Eugene CBOC (EUG)

3355 Chad Drive

Eugene, OR 97408

913 Garden Valley Boulevard

Roseburg, OR 97470

663-VA Puget Sound Health Care System Seattle Division (SEA)

1660 South Columbian Way

Seattle, WA 98108-1597

1660 South Columbian Way

Seattle, WA 98108-1597

663-VA Puget Sound Health Care System American Lake Division (AML)

9600 Veterans Drive

Tacoma, WA 98493

9600 Veterans Drive

Tacoma, WA 98493

687-Jonathan M. Wainwright Memorial VA Medical Center (WWW)

77 Wainwright Drive

Walla Walla, WA 99362

77 Wainwright Drive

Walla Walla, WA 99362

692-VA Southern Oregon Rehabilitation Center and Clinics (WCO)

8495 Crater Lake Highway

White City, OR 97503

8495 Crater Lake Highway

White City, OR 97503

Mann-Grandstaff VA Medical Center (SPO)

4815 N. Assembly Street Spokane, WA 99205

4815 N. Assembly Street Spokane, WA 99205

Mann-Grandstaff VA Medical Center - Wenatchee (WEN) CBOC

2530 Chester-Kimm Road Wenatchee, WA 98801

4815 N. Assembly Street Spokane, WA 99205

Specific Tasks

Zeiss Forum Eye Care Image and Data Management System

All sites currently use Zeiss Forum (Eye Clinic PACS System) to manage, store, and transmit to the patient s electronic health record (EHR).

All image acquisition components must work seamlessly with the Zeiss Forum database system.

All devices must be DICOM Compatible and quoted if not include.

Vendor shall provide onsite data transfer from older device to newer device.

Zeiss forum license shall be included where applicable.

Installation and Training

Vendor will be required to provide two user manuals for each system per site.

Vendor will be required to provide two service manuals for each system per site.

Vendor will be required to provide on-site installation for each system per site.

Vendor will be required to provide on-site training on the proper use and setup of each system per site.

Vendor will be required to provide the cleaning methods/guidelines for each system including accessories.

All employees who will be utilizing the equipment, including Physicians, Technicians, Clinical Engineering, and Clinic staff members, must be trained by an authorized representative prior to using the System.

Installation and training will occur on a mutually agreeable date and time between the POC and Vendor.

Devices that will be traded in will have their hard drive removed by facility biomed.

Table 2: Project scope by site is as follows:

Site

Location

Description

Replace with Model

BOI

Caldwell

Optical Coherent Tomography

Cirrus HD-OCT 5000

BOI

Caldwell

Visual Field Analyzer

Clarus 500

BOI

Boise

Visual Field Analyzer

Clarus 500

BOI

Caldwell

Visual Field Analyzer

HFA3 860

PUG

AML

Optical Coherent Tomography

Cirrus 5000 w/AngioPlex OCT

PUG

AML

Visual Field Analyzer

Matrix 800

PUG

AML

Optical Biometer

IOL Master S/N 1183251 computer OS upgrade

PUG

AML

Slit Lamp

SL 800

PUG

AML-Blind Rehab

Visual Field Analyzer

HFA3 860

PUG

AML-Blind Rehab

Optical Coherent Tomography

Cirrus 5000 w/AngioPlex OCT

PUG

MTV

Optical Coherent Tomography

Cirrus 5000 w/AngioPlex OCT

PUG

SEA

Optical Coherent Tomography

Cirrus 5000 w/AngioPlex OCT

ROS

EUG

Visual Field Analyzer

HFA3 860

ROS

ROS

Visual Field Analyzer

HFA3 860

SPO

SPO

Visual Field Analyzer

HFA3 860

SPO

SPO

Fundus Retina Camera

Clarus 500

SPO

SPO

Optical Biometer

IOL Master 700

SPO

SPO

Visual Field Analyzer

HFA3 860

SPO

WEN

Optical Coherent Tomography

Cirrus 5000 w/AngioPlex OCT

SPO

WEN

Visual Field Analyzer

HFA3 860

WCO

WCO

Optical Coherent Tomography

Cirrus 5000 w/AngioPlex OCT

WCO

WCO

Visual Field Analyzer

HFA3 860

WWW

WWW

Corneal Topography System

Atlas 500

WWW

WWW

Fundus Retina Camera

Clarus 500

7 Zeiss Forum DICOM Interface License to 3rd party (non-Zeiss) Instrument

14 Zeiss Forum-DICOM Interface License to Zeiss Instrument

Cirrus 5000 OCT with Protection Program

Table 3: Trade-in:

Site

Location

Description

Model

Serial Number

PUG

AML

Optical Coherent Tomography

Cirrus 5000

500018824

PUG

AML

Slit Lamp

SL 220

97072000045

PUG

AML

Optical Coherent Tomography

Cirrus 5000

500019838

PUG

SEA

Optical Coherent Tomography

Cirrus 5000

500018825

ROS

EUG

Visual Field Analyzer

HFA3 860

860-11189

ROS

ROS

Visual Field Analyzer

HFA II

750I-13601

SPO

SPO

Visual Field Analyzer

HFA3 860

860-10785

SPO

WEN

Visual Field Analyzer

HFAII

750I-40348

WCO

WCO

Visual Field Analyzer

HFA II

750I-40262

Delivery/Performance Period

Upgrades to begin within 90 days after receipt of order. Total timeframe for installation is expected to take 12 months.

Other Pertinent Information or Special Considerations

Identification of Possible Follow-on Work: N/A

Identification of Potential Conflicts of Interest (COI): N/A

Identification of Non-Disclosure Requirements: N/A

Packaging, Packing and Shipping Instructions:

Devices shipped per Table 1. PO# must be included on Shipping Address.

Inspection and Acceptance Criteria:

Device has been installed, set up, and training has been provided.

Remote effort to provide remote support with on-site VA personnel to network device and connect with Zeiss Forum.

Security Requirements

All contractor employees are subject to the same level of investigation as VA employees who have access to VA sensitive information or access to VA facilities. The background investigation includes the following requirements: 1) Completed documentation 2) Fingerprints 3) Completion of OPM s e-QIP Questionnaire. The Contractor is required to fulfill all of the security requirements. The Contractor, upon completion of fingerprinting, and an initial suitability determination, may be authorized tentative access to start the performance period of the contract, but only on condition of completion of all security requirements. This requirement is applicable to all subcontractor personnel requiring the same access. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the contractor shall reimburse the VA within 30 days.

All contractor personnel that are not properly badged shall be escorted.

Inspection and Acceptance Criteria.

The facility POC is responsible for certifying that the work done under this contract is performed to standard. The POC is also responsible to assure the inspection and acceptance of products provided incidental to services.

Place of Performance.

Work will primarily be performed at the various medical centers identified in table1. Some work will be done remotely at the contractor s facility as pertaining to remote diagnostics and troubleshooting.

Delivery Schedule.

The delivery will start within 90 days of contract receipt. Project is expected to be completed within one year.

(end Salient Characteristics/SOW)

7. Place of Delivery:

See Table 1 in the statement of work.

F.O.B. Destination is the preferred delivery within 60-90 days after placing the order. All deliveries will be coordinated with the VISN 20 Primary Point of Contact.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

8. FAR 52.212-1, Instructions to Offerors Commercial Items , applies to this acquisition and the following clauses and instructions are added as addenda:

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL

52.204-7

Solicitation Provisions Incorporated by Reference (FEB 1998)

52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

52.233-2

Service of Protest (SEPT 2006)

(a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

(b) Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

(d) Any award made as a result of this solicitation will be made on an All or Nothing Basis.

(e) Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations.

(f) All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below.

(g) All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote.

(End of Addendum to 52.212-1)

9. FAR 52.212-2, Evaluation-Commercial Items : The Government may award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

1. Offeror must be a manufacturer authorized provider for the items provided. A letter from the manufacturer stating as much must be included with any response to this solicitation.

2. Price.

The government intends to make a best value determination based on, but not limited to, authorized provider/distributor validation and price.

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

10. Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

11. FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018)

ADDENDUM to FAR 52.212-4 The following clauses are included as a part of the addendum:

52.203-16

Preventing Personal Conflicts of Interest (JUN 2020)

52.203-17

Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (JUN 2020)

52.204-4

Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011)

52.204-13

System for Award Management Maintenance (OCT 2018)

52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

52.232-40

Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

852.212-71

Gray Market Items (APR 2020)

852.212-72

Gray Market and Counterfeit Items (MAR 2020) (DEVIATION)

852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020). The following clauses are incorporated by this clause:

852.203-70

Commercial Advertising

852.219-74

Limitations on Subcontracting Monitoring and Compliance (JUL 2018)

852.232-72

Electronic Submission of Payment Requests.

852.233-70

Protest Content/Alternative Dispute Resolution

852.233-71

Alternate Protest Procedure.

12. The following subparagraphs of FAR 52.212-5 are applicable:

FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference;

52.204-10

Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note)

52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020) (31 U.S.C. 6101 note)

52.219-6

Notice of Total Small Business Set-Aside (NOV 2020)

52.219-28

Post Award Small Business Program Representation (MAY 2020) (15 U.S.C 632(a)(2))

52.222-3

Convict Labor (JUN 2003) (E.O. 11755)

52.222-19

Child Labor Cooperation with Authorities and Remedies (JUL 2020) (DEVIATION)

52.222-21

Prohibition of Segregated Facilities (APR 2015)

52.222-26

Equal Opportunity (SEP 2016) (E.O. 11246)

52.222-35

Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212)

52.222-36

Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793)

52.222-37

Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212)

52.222-40

52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496)

52.222-50

Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627)

52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513)

52.225-5

52.225-5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

52.225-13

Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury)

52.232-33

Payment by Electronic Funds Transfer System for Award Management (Jul 2018) (31 U.S.C. 3332)

13. There are no additional contract requirements, terms or conditions.

14. The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.

15. Quotes must be emailed to robert.hamilton8@va.gov and received no later than 15:00 AM EST on 09/19/2022. Quotes may be submitted on this document or the vendor s own form. Any offer that provides an item that is not a brand item must provide supporting documentation to show that the product meets or exceeds the salient characteristic. Any offer that does not provide supporting documentation will be considered non-responsive.

No late quotations will be accepted. The Government intends to make award without discussions.

16. For information regarding the solicitation, please contact Robert Hamilton at Robert.hamilton8@va.gov.