SPE2D1-16-R-0001_Integrated_Video_Imaging_Sharing_System_(IVISS)__AMENDMENT_0003.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

See Block 14

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE SPE2D1 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

CODE FACILITY CODE

SPE2D116R0001

X

2016 AUG 11

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

or (c) By separate letter or telegram 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 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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:

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc. ) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

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 (Type or print)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

16B. UNITED STATES OF AMERICA15B. CONTRACTOR/OFFEROR

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

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

(a) By completing Items 8 and 15, and returning

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSD

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

15C. DATE SIGNED 16C. DATE SIGNED

D. OTHER (Specify type of modification and authority)

3. EFFECTIVE DATE

Opening/Closing Date Changed to:

2016 OCT 19 / 2016 NOV 9 TIME 3:00 PM

See Attached Continuation Sheet(s).

(X)

CHECK ONE

PAGE OF PAGES

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

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

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

2016 OCT 14

X

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0003 2

(1.) The solicitation closing date is hereby extended until November 9, 2016, 3:00PM Local Time.

(2.) Vendor questions will be accepted until October 19,2016, 3:00PM Local Time.

(3.) IVISS Storage Requirements spreadsheet is added to the solicitation and is titled “ATTACHMENT # 8 -

IVISS STORAGE REQUIREMENTS.”

(4.) IVISS Workflow and Network Diagrams document is added to the solicitation and is titled

“ATTACHMENT # 9 - IVIIS WORKFLOW _NETWORK DIAGRAMS.”

(5.) Page 33 of the solicitation, section 5.2.1.3 is revised to read “The system provides a color printer for each exam room/workstation.”

(6.) Page 39 of the solicitation, section 5.4.3 is revised to read “System must have capability to crop digital video.”

(7.) Page 39 of the solicitation, add the following under section 5.4.3 “5.4.3.1 “System must have capability image files.”

(8.) Page 40 of the solicitation, section 5.7 – Data querying and manipulation, sub-section 5.7.2., sub-section 5.7.2. This requirement sated that the “System shall auto-populate demographic fields of videos being recorded if such fields are available from the video system being used at a specific site.” This requirement is deleted in its entirety.

(9.) Page 41 of the solicitation, section 6.7 is revised to read “A bidirectional interface to the Armed Forces Health Longitudinal Technology Application (AHLTA), Composite Health Care System (CHCS), and to the VA’s Veterans Health Information System and Technology Architecture (VISTA) is required and must be available prior to the kick-off meeting.”

(10.) Vendor questions were received and reviewed and below is the government’s response:

A. Vendor’s Question: Request the Government provide additional detail in the Instructions to Offeror.

The current ITO list several items that must be included in our response but provides no information on how to provide them e.g. page size/format, as consolidated volumes or individual files, file naming conventions etc. There are also submission requirements in other parts of the solicitation e.g.

requirement to provide ATO/ATC as applicable, “fill in the blank” clauses, work flow diagrams and transition plan etc.

DLA Troop Support’s Response: Please refer to:

1. Page 3: Caution Notice,

2. Page 70: 52.212-1 Page 70 Instruction to Offerors, and

3. Page 71: Special Instructions for the Submission of Proposal Information.

B. Attachment #1 – IVISS PRICE BOOK, TAB 17 - Delivery Schedule: The vendor must provide the estimated number of days to deliver and install the system at each site.

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0003 3

Vendor’s Question: While the definition of the time to deliver to each site is clear, it is not clear if the Government expects site delivery to be conducted in a serial or simultaneous fashion. Request the Government provide clarification as to the planned deployment model.

DLA Troop Support’s Response: For Phase I, the government is requesting simultaneousness installation and testing; with serial training (post installation) for the following three sites:

1. San Antonio Military Medical Center (SAMMC), Ft. Sam Houston, TX

2. Wilford Hall Ambulatory Surgical Center (WHASC), San Antonio, TX

3. South Texas Veterans Health Care System (STVHCS), San Antonio, TX

Upon completion of the three sites listed above, installation and testing with serial training for the remainder of the sites in Phase 1 will be in be in the following order:

4. Darnall Army Medical Center, Ft. Hood, San Antonio, TX

5. Madigan Army Medical Center, Jt. Base Lewis - McChord, Tacoma, WA

6. USAF Hospital, RAF Lakenheath, United Kingdom

For Phase II, the government is requesting installation and testing with serial training in the following order:

1. Joint Base Elmendorf/Richardson (JBER), AK

2. Bassett Army Community Hospital (BACH), Ft. Wainwright, AK

3. Tripler Army Medical Center (TAMC), Honolulu, HI

4. Yokota Air Base Japan

5. Landstuhl Regional Medical Center (LRMC) Germany

C. Page 36 of the solicitation, section 4.4, states “The system shall include local image storage (image cache) at each MTF, sufficient for up to 5 years of Integrated Video Image Sharing System (IVISS) studies based on the following information...”

Vendor’s Question: Request the Government provide either a total five- year storage requirement in gigabytes or the average time/length for the studies referenced in table 3 of the SOW.

DLA Troop Support’s Response: The IVISS Storage Requirements are added to the solicitation via the attached spreadsheet titled “ATTACHMENT #8 – STORAGE REQUIREMENTS.” The average video time is 5 minutes. Procedures can last between 10-30 minutes. Based on the original assumption that the average file size is 400 MB, the total five-year storage requirement is GB/yr - 9746; 5 yr = 49 TB, to which at a minimum the vendor must provide.

D. 2., Page 33 of the solicitation, section 2 - Workflow Description and Transition Plan states “The vendor shall provide a description and process flow diagram of the new workflow created by implementing the vendor’s solution for sharing endoscopic video and still images between the sites identified for Phase I. A plan for transitioning from the current workflow to the new workflow must be included with the proposal.

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0003 4

Vendor’s Question: Request the Government provide a current network connectivity diagram for the Phase I sites. Further request the Government provide the current workflow for “sharing endoscopic video and still images between the sites identified for Phase I.”

DLA Troop Support’s Response: The IVISS Workflow and Network Diagram is added to the solicitation via the attached word document titled “ATTACHMENT #9 WORKFLOW AND NETWORK DIAGRAMS.” The vendor should provide their bandwidth and latency requirements for this capability. IVISS Servers will be physically located in the MTF data center with end user components located in the ENT department.

The IVSS components will be logically located in a medical devices De-Militarized Zone (DMZ) portion of each MTF's local area network (see the Visio drawing depicting the BAMC Radiology network; a similar network architecture will be found at each MTF) and must transit a firewall for access to resources in the core network or access to the external data network (Non-classified Internet Protocol (IP) Router Network, abbreviated as NIPRNet). Data traffic between MTFs travels in VPN tunnels thru the NIPRNet.

E. Referencing page 40 of the solicitation, section 5.7 – Data querying and manipulation, sub-section

5.7.2. Sub-section 5.7.2. This requirement sated that the “System shall auto-populate demographic fields of videos being recorded if such fields are available from the video system being used at a specific site.”

Vendor’s Question: Request the Government eliminate this requirement or provide the specific video systems, including their interface specifications: 5.7.2, pg 40 System shall auto-populate demographic fields of videos being recorded if such fields are available from the video system being used at a specific site.

DLA Troop Support’s Response: This requirement is deleted via this amendment.

F. Page 41 of the solicitation, section 6 – Interoperability, sub-section 6.6 states “System must support storage of all studies to DICOM compliant archives, such as PACS vendor neutral archives.”

Vendor’s Question: Is all Archive media (video and image) to be converted to DICOM and stored in PACS/VNA or just media/studies associated with DICOM report? Request the Government provide requirement clarification.

DLA Troop Support’s Response: System must support storage of end user selected portion of studies (end user may select part or all of the study; parts selected may be still images or video with motion) in a DICOM compliant archive, such as PACS vendor neutral archives. All data will be converted to DICOM at the point of acquisition.

G. Page 41 of the solicitation, section 6.7 states “A bidirectional interface to the Armed Forces Health Longitudinal Technology Application (AHLTA), Composite Health Care System (CHCS), and to the VA’s Veterans Health Information System and Technology Architecture (VISTA) is required and must be available prior to the kick-off meeting.”

Vendor’s Question: Request the Government provide the anticipated contract award date and the maximum allowed time between contract award and the go-live date.

DLA Troop Support’s Response: We are unable to provide an anticipated award date at this time.

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0003 5

H. Vendor’s Question: Request the Government specify the sites that “limit or deny external access to their networks” as well as an explanation of any limitations. Further request the Government provide the percentage of time, by site location, that “connectivity and access may not always be available.”

DLA Troop Support’s Response: The vendor should not be denied access if utilizing the established DoD Business to Business (B2B) gateway. Once a vendor has established the B2B, the only time a vendor would be denied access is in the case of network outages that would result in the response time metric being waived until the network outage is resolved.

I. Page 37 of the solicitation, section 5.1.5 states “System must have the ability to add (or attach) PC files (i.e. MS Word documents, PDF, JPEG, etc.) to a patient file or case.”

Vendor’s Question: Request the Government provide a list of the unique file types required for attachment. The current list includes “etc.”, which is ambiguous.

DLA Troop Support’s Response: JPG, TIF, PNG, GIF, PPT, Excel, and other MS office programs allowed by current government regulations.

J. Page 37 of the solicitation, section 5.2.4 states “System must be capable of importing data from common Microsoft (MS) Office applications (such as MS Word, Excel, etc.).”

Vendor’s Question: Request the Government remove this requirement or provide significantly more detail on what is meant by “importing data.”

DLA Troop Support’s Response: The government’s requirement is to copy/paste/attach the structured MS office file to the patient record within the system. Importing data is not a requirement.

K. Page 38 of the solicitation, section 5.3.6 states “System must the have capability to append to digital video or image files.

Vendor’s Question: Request the Government provide additional information on their definition of “append to digital video or image files.”

DLA Troop Support’s Response: The system must have the capability to append, i.e., add a voice, text, arrow, drawing, or other piece (form) of data onto the file to highlight a particular portion of the exam.

L. Page 39 of the solicitation, section 5.4.3 states “System must have capability to crop digital video or image files.”

Vendor’s Question: Request the Government make this two separate questions: 5.4.3, pg 39 System must have capability to crop digital video or image files.

DLA Troop Support’s Response: The government has separated this requirement into two separate requirements.

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0003 6

M. Page 34 of the solicitation, section 3.1.1.8 states “Capture device must be FDA approved for use in the medical setting and must comply with NFPA99 rules for electronic/electrical medical devices.”

Vendor’s Question: Request the Government reword this requirement as follows: In accordance with FDA guidance the IVISS is a class one device and as such does not require submission of 510(k) forms.

The Offeror certifies that its solution includes only Class 1 devices and that these devices meet the FDA safety and quality criteria without requiring an FDA certification.

DLA Troop Support’s Response: We have reviewed the requirement’ and have determined for this program the FDA 510 (k) requirement is applicable, and remains a minimum requirement for this RFP.

No changes have been made.

N. Page 33 of the solicitation, paragraph 1. - Integrated/Interoperable Web-Based Platforms states “Integrated and interoperable systems are required to facilitate the long-term Government health plan to implement a longitudinal healthcare record capable of sharing medical data and images throughout the DoD, VA hospitals and commercial facilities. To support this goal, the contractor shall provide a web-based solution meeting the requirements specified herein.”

Vendor’s Question: We request that you amend the bid documents accordingly. We can offer local installation as client server, and provide access to the centralized and local database over the web/Citrix/terminal services and virtual environment for users to access the data, images and video.

DLA Troop Support’s Response: The vendor shall provide a secure web-based system, for use by authorized personnel, capable of securely transmitting and storing endoscopic video and still images electronically.

O. Page 34 of the solicitation, section 3.1.1.8 states “Capture device must be FDA approved for use in the medical setting and must comply with NFPA99 rules for electronic/electrical medical devices.”

Vendor’s Question: Request the Government reword this requirement as follows: In accordance with FDA guidance the IVISS is a class one device and as such does not require submission of 510(k) forms.

The Offeror certifies that its solution includes only Class 1 devices and that these devices meet the FDA safety and quality criteria without requiring an FDA certification.

DLA Troop Support’s Response: We have reviewed the applicability of the FDA 510(k) requirement under this solicitation. We have determined that the FDA 510(k) requirement is applicable. This requirement will remain a minimum requirement under this solicitation.

P. Page 34 of the solicitation, section 3.1.1.8 states “Capture device must be FDA approved for use in the medical setting and must comply with NFPA99 rules for electronic/electrical medical devices.

Vendor's Question: We request that you amend the bid documents accordingly so that we can submit our proposal.

DLA Troop Support’s Response: We have reviewed the applicability of the FDA 510(k) requirement under this solicitation. We have determined that the FDA 510(k) requirement is applicable. This requirement will remain a minimum requirement under this solicitation.

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0003 7

Q. Page 33 of the solicitation, section 5.2.1.3 states “The system provides the ability to print reports.”

Vendor’s Question: Please specify the number of printers desired for each site.

DLA Troop Support’s Response: The vendor must provide a color printer for each exam room/workstation.

R. Vendor’s Question: Whether companies from Outside USA can apply for this? (like, from India or Canada)

DLA Troop Support’s Response: The government will evaluate offers in accordance with the policies and procedures FAR Part 25 and Part 25.2 Trade Agreements. A vendor submitting a proposal under this solicitation must be a designated Trade Agreements Act (TAA) designated country and registered in SAM.GOV and meet all requirements as listed in the solicitation.

S. Vendor’s Question: Whether we need to come over there for meetings?

DLA Troop Support’s Response: The vendor will be required to attend meetings at the designated DoD and/or VA facilities.

T. Vendor’s Question: Can we perform the tasks (related to RFP) outside USA? (like, from India or Canada)

DLA Troop Support’s Response: DFARS 252.225-7021 Trade Agreements clause applies. The Contractor shall deliver under this contract only U. S.-made qualifying country, or designated country end products.

Vendor is required to also deliver, install and provide maintenance within the U.S. and at some OCONUS locations.

U. Vendor’s Question: Can we submit the proposals via email?

DLA Troop Support’s Response: No. Page 6, Block 9 provides the authorized method for proposal submissions.

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:

(a) By completing items 8 and 15, and returning or (c) By separate letter or telegram 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 RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

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

CHECK ONE 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.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

D. OTHER (Specify type of modification and authority)

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.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

2. AMENDMENT/MODIFICATION NO.

SPE2D1-16-R-0001

1 1

8/11/2016

The s 19

09/23/2016