Amendment 1 36C10G25R0049.docx

AMENDMENT 1 36C10G25R0049

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

08-14-2025

None 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 To all Offerors/Bidders

36C10G25R0049 07/23/2025

X

Amendment 1 is issued to respond to industry questions.

See CONTINUATION Pages

Anthony Zibolski Contracting Officer

CONTINUATION Pages

QUESTIONS 1:

1. The last line in the introduction of the subfactors states: “In addition to meeting or exceeding the salient characteristics listed in the Combined Synopsis/Solicitation Notice, the technical evaluation process will consider the following technical subfactors and assign an adjectival rating”. What are the “adjectival ratings” that will be used? What is the definition for each “adjectival rating”? How will the “Evaluation Sub-factors” “adjectival rating” be combined with the evaluation of compliance with the salient characteristics to assign an overall Technical Evaluation Rating?

Agency Response:

1. The Government is not required to disclose the adjectival ratings that will be utilized.

2. The Government is not required to disclose the adjectival rating definitions that will be utilized.

3. The Agency will evaluate first determine compliance with the salient characteristics. Product meeting the salient characteristics will then be evaluated using the technical evaluation subfactors and assigned an overall adjectival rating. After evaluating compliance with the salient characteristics and assigning adjectival ratings to the sub-factors, the government will assign an overall Technical Evaluation Rating. This overall rating will reflect the perceived advantages and disadvantages of the technical proposal.

2. On page 16 of Attachment D, the introduction to the “Design” Subfactors states: “Design features and functions of the offered device will be evaluated. Elements include the following:”. Will other subfactor elements not included in the listed elements be evaluated? If so, please list all other subfactor elements that will be used to perform the evaluation.

Agency Response:

Elements to be evaluated are listed in the solicitation.

3. The 1st Design bullet states: “Types of devices (of the same brand) that the Perimeter will communicate/interface with.” 1) Please clarify the types of devices you require or would consider important to this subfactor. 2) Please clarify what is the definition of “communicate/interface”. 3) Does the term “types of devices” include devices that are not required to perform the functions of Ophthalmic Perimeters? Has the government market research identified Ophthalmic Perimeters that communicate with devices that are not required to perform the functions of Ophthalmic Perimeters? If so, how many different Ophthalmic Perimeters that communicate with devices that are not required to perform the functions of Ophthalmic Perimeters have been identified?

In addition, the “Types of devices (of the same brand)” and the ability to “communicate/interface with” the proposed Ophthalmic Perimeter is not a salient characteristic nor similar to or an extension of any of the existing salient characteristics. If it is to be considered as such, this is a significant additional requirement that should be either a salient characteristic or a clearly stated requirement as it expands the scope and requirements of the required Ophthalmic Perimetry devices.

For example, the Brand Name Zeiss HFA3 Model 860 connects with Zeiss’ brand name Cirrus HD-OCT (Ocular Coherence Tomography), Zeiss’ brand name Clarus 500 fundus camera and Zeiss’ brand name Glaucoma Workplace Station. Zeiss collectively identifies these capabilities as the Integrated Diagnostics Imaging Platform for Glaucoma. Zeiss is the only manufacturer that has connected these other devices, which are not used in visual field examinations nor used to determine visual field defects, with its Ophthalmic Perimetry Brand Name Zeiss HFA3 Model 860. The ambiguous and undefined phrase “types of devices (of the same brand)” could allow evaluators to consider the expanded Zeiss offering, thereby, expanding the scope of the Solicitation requirements beyond the Salient Characteristics for perimetry instruments. Under the terms of the current Solicitation, this Integrated Diagnostics Imaging Platform for Glaucoma feature or the Zeiss HFA3 Model 860’s ability to connect to elements of the Integrated Diagnostics Imaging Platform for Glaucoma feature could become an evaluation consideration even though it would create a de facto sole source award without justification and expand the scope of the solicitation without disclosure to other offerors or ability for other offerors to compete intelligently and on a relatively equal basis.

Please confirm or eliminate the possibility that the actual “Types of devices (of the same brand)” could become an expansion of the scope of the solicitation, in a manner described above or otherwise, during the evaluation process.

Agency Response:

It is not a requirement that the Ophthalmic Perimeter communicate (share information/test results) with specific devices. Provide all devices your proposed device communicates with.

4. The 2nd Design bullet states: “Ability to send and retrieve reports to and from CPRS and Cerner”. Salient Characteristic 10 already requires that the perimetry system “integrate and function with both Vista/CPRS and Cerner”. 1) Please explain what additional features will be evaluated beyond those of Salient Characteristic 10 based on this Design bullet. 2). What type of reports are to be evaluated?

Sending and receiving reports to and from CPRS and Cerner is an element of the “integrate and function with” in Salient Characteristic 10. If the Government is going to evaluate the ability to send different types of “reports”, please define what are those “reports”?

Agency Response:

The Agency will be evaluating the ease of sending and retrieving reports. Reports refer to the patient test results performed by the perimeter. Provide the method used to provide reports/results.

5. The 3rd Design bullet states: “Ability to use previously stored data to create progression analysis reports”. Salient Characteristic 6 states “Must provide perimetry progression/analysis results.” Progression analysis in perimetry is used to determine whether a patient's visual field is deteriorating, assess the rate of change, and to help clinicians decide if treatment needs to be adjusted. It compares a patient’s sequential visual field tests over time, looking for statistically significant changes that suggest real disease progression rather than just natural variability or test noise.

Since progression analysis requires the use of test results over time, by definition this subfactor would appear to be included in Salient Characteristic 6. 1) Please define “ability to use” in this context. 2) Please identify the type of data that will be used in the evaluation of this subfactor.

Agency Response:

Ability to use refers to how the perimeter can use its own patient data to generate test results regarding progression analysis.

6. The 4th Design bullet states “user interface features and ease of use”. All perimetry systems that meet the salient characteristics will have a user interface. 1) Which specific features will be evaluated to rate “user interface features” within the “adjectival ratings scale”. 2) What element(s) will be used to evaluate “ease of use” and within the “adjectival ratings scale”.

Agency Response:

Provide the information as it relates to your offered device. What are your user interface features and how easy are they to use.

7. On page 16 of Attachment D, the introduction to the Performance Subfactors states: “Device will be evaluated for its ability to perform its intended function. Elements include the following:”. Will other subfactor elements not included in the listed Subfactor elements be evaluated? If so, please list all other subfactor elements that will be used to perform the evaluation.

Agency Response:

Elements to be evaluated are listed in the solicitation.

8. The 1st Performance bullet states “Quantity and Quality of fixation controls”. 1) Salient Characteristic 2 states “Must have at least 3 Fixation Control options”. How will additional fixation control(s) be evaluated with regard to the reliability of the visual field test? 2) Please clarify how you will evaluate between i) fixation controls that prevent fixation loss, so a test does not have to be repeated, and ii) the type of fixation controls that only monitor fixation loss requiring a clinician to determine if fixation losses are at a level that requires a visual field test to be repeated from the beginning? 3) Are there specific fixation controls that are desirable elements in the offered perimetry system?

Agency Response:

This provides the opportunity to elaborate on any additional fixation controls that your offer might provide. Please provide information on all your fixation control options.

9. The 2nd Performance bullet states “Modalities to test the (central visual field) macula and the peripheral retina (peripheral visual field)”. Modalities in the Zeiss HFA 3 Model 860 Instructions for Use refers to DICOM modalities not testing. DICOM® — Digital Imaging and Communications in Medicine — is the international standard for medical images and related information. It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use. It is the same license for all users.

In visual field examinations, you use specific patterns or programs to test the (central visual field) macula and the peripheral retina (peripheral visual field). 1) Please confirm you are asking for the types of specific patterns or programs used to test the (central visual field) macula and the peripheral retina (peripheral visual field). 2) If you are not asking for the types of specific patterns or programs used, please define the term “modalities” as would be used in a visual field examination. 3) Are there preferred patterns or programs for testing the (central visual field) macula and the peripheral retina (peripheral visual field) and within the “adjectival ratings scale”?

Agency Response:

List all of your methods/patterns/programs used to test the central visual field and peripheral visual field. For the purpose of this subfactor modality=method=mode=approach=tactics=strategies.

10. The 3rd Performance bullet states: “Types and duration of testing modalities”. Modalities in the Zeiss HFA 3 Model 860 Instructions for Use refers to DICOM modalities not testing.

In visual field examinations, when you use “types and duration” you are discussing testing strategies and test duration. 1) Please confirm you are asking for types of testing strategies and test duration. 2) If you are not asking for the types of testing strategies and test duration, please define the term “modalities” as would be used in a visual field examination. 3) Are there preferred testing strategies and test duration in evaluating this subfactor element and within the “adjectival ratings scale”?

Agency Response:

Agency will evaluate types of testing strategies and test duration. Provide the information related to your proposed device. Duration is the length of time to perform the test. For the purpose of this subfactor modality=method=mode=approach=tactics=strategies.

11. The 4th Performance bullet states: “Correction of refractive error”. 1) Please clarify the type of refractive correction technique(s) that are desirable. 2) Please describe how you will evaluate one refractive correction technique vs. another refractive correction technique and within the “adjectival rating” scale.

Agency Response:

Provide the information for your device on what options it offers to correct refractive errors for patients.

12. The 5th Performance bullet states “Ability to provide remote access to data/reports and images, other than at the device itself, immediately upon completion of the test.” 1) What are the elements of remote access that will be evaluated? 2) Is there a preferred type of remote access? 3) Are all reports and images required to be available remotely?

Agency Response:

Please provide the details of what your device has to offer regarding what reports and images are available remotely and how a clinician will access the report and images from the locations other than the device itself.

13. On page 17 of Attachment D, the introduction to the Quality Subfactors states: “Aspects of the construction and quality of material of the device will be evaluated. Elements include:”. 1) Will other subfactor elements not included be evaluated? If so, please list all other subfactor elements that will be used to perform the evaluation. 2) The Quality Subfactor elements include warranty and maintenance/service but not directly “Aspects of the construction and quality of material of the device”. How will you evaluate and rate based on the “adjectival ratings scale” the “Aspects of the construction and quality of material of the device”?

Agency Response:

Elements to be evaluated are listed in the solicitation.

14. The 1st Quality bullet states: “Warranty Coverage and duration”. 1) Please clarify how you will evaluate based on the “adjectival ratings scale” the coverage and duration of one perimetry device vs. another perimetry device. 2) Will breath of coverage be evaluated? Will length of coverage be evaluated? 3) Are there other elements that will be evaluated under this Subfactor?

Agency Response:

The Agency will evaluate the terms and conditions of the warranty. Provide details of what your warranty covers and the duration of the warranty.

15. The 2nd Quality bullet states: “Maintenance/service agreement”. 1) CLIN 0003 is Zeiss OPTIME Service Agreement. The OPTIME Service Agreement has 3 distinct maintenance/service levels: OPTIME Prevent, OPTIME Advanced, and OPTIME Complete. Each distinct maintenance/service level has different coverage and a different price/cost. 1) Which level of OPTIME is CLIN 0003 – OPTIME Prevent, OPTIME Advanced, or OPTIME Complete? 2) What are the specific OPTIME elements for the OPTIME maintenance/service level you require in CLIN 0003 (and based on the previous answer). 3) Are there preferred, expected or required elements of the maintenance/service coverage and within the “adjectival ratings scale”?

Agency Response:

List and provide details of any and all service agreements you offer.

16. CLIN 0003 in the Attachment A – Price/Cost Schedule is for the price/cost of the Zeiss OPTIME Service Agreement. The quantity in CLIN 003 is the same as the number of perimetry units being sold in each year. The Zeiss OPTIME Service Agreement requires annual renewal payments. The Price/Cost Schedule does not have a separate CLIN for the Zeiss OPTIME Service Agreement renewal price/cost in each subsequent year. We request inclusion of a CLIN for the Zeiss OPTIME Service Agreement renewal price/cost. This will accurately account for the overall procurement costs under this solicitation.

Agency Response:

The quantity is only an estimate and includes renewals and new.

17. Page 3 of the Solicitation states: “This acquisition is for FAR Part 16.5 for Zeiss ® Brand Name or equal Ophthalmic Perimeters as identified in ATTACHMENT A – PRICE COST SCHEDULE - NX EQ Ophthalmic Perimeters.” Page 15 of Attachment D states: “This acquisition is unrestricted and is being conducted in accordance with FAR Part 15.” Under which FAR Part is this Solicitation being conducted?

Agency Response:

The procurement is being conducted in accordance with FAR Part 15. The resulting requirements contract will be in accordance with FAR 16.5.

18. OPTIME Service Agreement The pricing list references “OPTIME.” Zeiss currently offers OPTIME Prevent, OPTIME Advance, and OPTIME Complete, a general "OPTIME" does not exist on its website. For comparison and pricing of our service agreement, what specific requirements and services are included in "OPTIME" service agreement?

Agency Response:

List and provide details of any and all Service Agreements you offer.

19. Evaluation of Salient Characteristics and Technical Subfactors The solicitation outlines both salient characteristics and technical evaluation subfactors. Could you clarify how these will be assessed? Do the salient characteristics and subfactors carry different weight in the evaluation scoring?

Agency Response:

The salient characteristics are evaluated on a pass/fail basis. The technical subfactors are weighed evenly.

20. Device Communication Subfactor The subfactor referencing “types of devices (of the same brand) that the perimeter will communicate/interface with” is unclear. Is this intended to mean:

· Other Zeiss devices?

· Devices of the same brand as the offeror’s proposed unit?

· Also, in the absence of a name-brand-only justification, could you clarify why brand-specific communication is considered relevant if the unit is capable of interfacing with multiple devices from various manufacturers?

· Would the government consider removing any reference to same or name brand?

Agency Response:

It is not a requirement that the Ophthalmic Perimeter communicate (share information/test results) with specific devices. Provide all devices your proposed device communicates with.

21. Correction of Refractive Error To ensure accuracy of testing, we respectfully recommend specifying that refractive error correction should include both sphere and cylinder. Would the Government consider this clarification?

Agency Response:

Provide the information for your device on what options it offers to correct refractive errors for patients.

5. System Platform Compatibility To reduce long-term cost and avoid compatibility issues, we suggest the solicitation specify that the perimeter should operate on a non-proprietary version of Windows. This would allow the VA to perform Windows upgrades without disruption or added cost. Would the Government consider including this as a requirement?

Agency Response:

Making a non-proprietary version of Windows a requirement would restrict competition. Responses can include this if available.