6525--telepathology system

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)

1

5

0001

00586

Department of Veterans Affairs

G.V. (Sonny) Montgomery VAMC

1500 E. Woodrow Wilson Dr.

Jackson MS 39216

10N16

Department of Veterans Affairs

G.V. (Sonny) Montgomery VAMC

A&MM Service (90C)

715 South Pear Orchard Road

Ridgeland MS 39157

To all Offerors/Bidders

36C25620Q1000

08-14-2020

X

X

X

1

THE PURPOSE OF THIS AMENDMENT IS TO PROVIDE RESPONSES TO SUBMITTED QUESTIONS

Page 5 of 5

Under the System Performance Requirements section, will any system that does not have FDA certification or cannot commit in writing to obtain it within 90 days of the award be considered, given the verbiage in line #12 (reproduced below for your reference)? We would value being considered for the award and are committed to pursuing FDA clearance, but, from a regulatory standpoint, cannot commit to a specific timeframe for the FDA to grant us clearance (as much of that process is not within our control.) Â

Yes, see the clarifying remarks to System Performance Objective 12 in the box below.

If we responded to the verbiage in line #12 as outline below and stated that our technology was not FDA cleared, but that we are committed to securing FDA clearance, would that be sufficient for our response to be considered, given the other technical merits of our system?

Yes, see the clarifying remarks to System Performance Objective 12 in the box below.

The system shall be certified FDA compliant for H&E primary diagnosis at or within 90 days after award, for those facilities who require scanners that are FDA certified for use in primary diagnosis. Â

Clarifying remarks: Â Offerors shall include a statement that details the scope (prerequisites, parameters, envisioned usage, limitations, and so forth) of their current or applied for FDA Certification for use in H&E primary diagnosis.

Failure to obtain FDA certification within 90 days of award (extendable at the Governments sole discretion if significant progress is being made) shall be cause for termination. Â

Clarifying remarks: Â Offerors shall commit to pursuing FDA Certification for use in H&E primary diagnosis and shall commit to due diligence in making this happen within 90 days of award. They shall not be held to this 90-day period for factors outside of their control.

As an alternative to termination for failure to obtain FDA certification for primary diagnosis within 90 days, the Contractor may, at the Government s sole discretion, install a system that is pending FDA certification for use in primary diagnosis at those facilities that require it for a period of up to one year. The Contractor shall understand and agree that all hardware or software costs required to upgrade the installed system upon receipt of FDA certification shall be the responsibility of the Contractor and that further failure to obtain FDA certification for primary diagnosis at the end of this one year period shall be cause for termination. Â

Clarifying remarks: Offerors shall commit to pursuing FDA Certification for use in H&E primary diagnosis and shall commit to due diligence in making this happen within 90 days of award. This 90-day period may be extended; however, the Government may choose not to accept having no solution implemented while waiting beyond this 90-day period. In this case, the Contractor shall install a solution for which FDA Certification for use in H&E primary diagnosis has been applied. Any future costs for equipment, software, or implementation efforts that are required to meet later FDA Certification shall be borne by the Contractor.Â

Additional questions regarding specifics:

How many scanners do you require? Eight, but not all require FDA Clearance for use in primary diagnosis. See Table 2a.

How many locations? Eight, see Table 2a.

How many FDA approved monitors to be included? Nine, see Table 2a.

Are there IT server and storage considerations? Â Yes, see System Performance Requirements (2, 3, 10), Performance Objective 10, and Privacy, Security, and Records requirements (note VHA form 6550 submission). Note: Storage requirements are for short-term, operational use only. There is no requirement for long-term, archival storage of slide images.

What volume of slides are to be scanned? Â 10-200 per day depending on site. See Table 2a.

Is it acceptable to submit more than one quote to reflect different configurations of the solution? Â

Only one quote per vendor will be accepted. Please ensure that the quote provides a thorough response to the requirement as outlined in the Statement of Objectives. As stated in the RFP, vendors may offer value-added incentives other than those listed in this document, and if accepted by the Government will be included in the resultant contract.

If not, could you provide more specificity on the minimum requirements you are seeking? See Table 2a; the third column clarifies what we want each site to be able to do.Â

Table 2a. Site Specific Equipment Objectives

Facility/Address

Equipment Needed

Clarification of Capability Needed

Alexandria Veterans Healthcare System 2495 Shreveport Hwy Pineville, LA 71360

-One small slide scanning system that is FDA certified for use in primary diagnosis

-One reading station that is FDA certified for use in primary diagnosis

Scan in a low volume of slides that can be read for either primary diagnosis or consultation purposes by any facility in VISN 16 on the reading stations provided under this contract or for consultation purposes on additional VA-provided workstations if possible.

Gulf Coast Veterans Healthcare System 400 Veterans Avenue Biloxi, MSÂ 39531

-One small slide scanning system that is FDA certified for use in primary diagnosis

-One reading station that is FDA certified for use in primary diagnosis

Scan in a low volume of slides that can be read for either primary diagnosis or consultation purposes by any facility in VISN 16 on the reading stations provided under this contract or for consultation purposes on additional VA-provided workstations if possible.

Veterans Healthcare System of the Ozarks 1100 N. College Avenue Fayetteville, ARÂ 72703

-One multi-slide slide scanning system that is FDA certified for use in primary diagnosis

-One reading station that is FDA certified for use in primary diagnosis

Scan in a moderate volume of slides that can be read for either primary diagnosis or consultation purposes by any facility in VISN 16 on the reading stations provided under this contract or for consultation purposes on additional VA-provided workstations if possible.

Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd Houston, TX 77030

- One multi-slide scanning system

-One reading station that is FDA certified for use in primary diagnosis

Scan in a moderate volume of slides that can be read for consultation purposes only by any facility in VISN 16 on the reading stations provided under this contract and on additional VA provided workstations if possible.

G. A. Sonny Montgomery VA Medical Center 1500 E. Woodrow Wilson Dr. Jackson, MSÂ 39216

-One small slide scanning system

-One reading station that is FDA certified for use in primary diagnosis

Scan in a low volume of slides that can be read for consultation purposes only by any facility in VISN 16 on the reading stations provided under this contract and on additional VA provided workstations if possible.

Central Arkansas Veterans Healthcare System 4300 West 7th Street Little Rock, ARÂ 72205-5484

-One multi-slide scanning system

- One reading station that is FDA certified for use in primary diagnosis

Scan in a moderate volume of slides that can be read for consultation purposes only by any facility in VISN 16 on the reading stations provided under this contract and on additional VA provided workstations if possible.

Southeast Louisiana Veterans Healthcare System 2400 Canal Street New Orleans, LA 70119

- One multi-slide scanning system

-One reading station that is FDA certified for use in primary diagnosis

Scan in a moderate volume of slides that can be read for consultation purposes only by any facility in VISN 16 on the reading stations provided under this contract and on additional VA provided workstations if possible.

Overton-Brooks VA Medical Center 510 E. Stoner Ave. Shreveport, LAÂ 71101-4295

-One multi-slide slide scanning system that is FDA certified for use in primary diagnosis

-Two reading station that are FDA certified for use in primary diagnosis

Scan in a moderate volume of slides that can be read for either primary diagnosis or consultation purposes by any facility in VISN 16 on the reading stations provided under this contract or for consultation purposes on additional VA-provided workstations if possible.

End of Document