SPE2D1-16-R-0001_Integrated_Video_Imaging_Sharing_System_(IVISS)__AMENDMENT_0006.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

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

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 NOV 9

X

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0006 2

(1.) The solicitation closing date remains November 29, 2016, 3:00PM Local Time.

(2.) Vendor questions will be accepted until November 15, 2016, 3:00PM Local Time.

(3.) ATTACHMENT #10 is added to the solicitation and is titled “ATTACHMENT #10 - Radiology

Network Architecture (Amendment 0006).”

(4.) ATTACHMENT #11 is added to the solicitation and is titled “ATTACHMENT # 11 - Cross

Functional Diagram_ENT (Amendment 0006).”

(5.) ATTACHMENT #2 titled “Integrated Video Imaging Sharing System (IVISS) Response Form_V2” is replaced with “ATTACHMENT# 2- Integrated Video Imaging Sharing System (IVISS) Response

Form_V3 (Amendment 0006).”

(6.) Page 34 of the solicitation, section 3.1.1.8 is deleted and replaced with the following: "3.1.1.8.

Vendors shall identify how their device is classified and provide the appropriate approval or exemption documentation that is issued by the FDA for their system. The system must still comply with NFPA99 (National Fire Protection Association) rules for electronic /electrical medical devices."

(7.) DELETE the following from page 46 of the solicitation, paragraph 11.4.2.: "The above response time applies to all CONUS sites. OCONUS response times will be established on a site specific basis."

(8.) Reference page 47 of the solicitation and page of 3 of Amendment 0001. The first sentence of Section

12.5. is changed as follows: “The vendor must fill out and submit Attachment #2 - Medical Device Risk

Assessment Questionnaire with their proposal.”

(9.) Additional vendor questions were received and reviewed and below is the government’s response:

A. Vendor’s Question: Government answers to questions stated SOW 5.7.2 would be eliminated and you did so via Amendment 3, paragraph 8. However, Amendment 4, paragraph deleted the amendment 3 change, thus having the effect of reinstating this requirement. Therefore, we renew our request that the Government eliminate this requirement or provide the specific video systems, including each one’s detailed interface specifications including the definition of “demographic fields of video,” and the format/method (serial port, embedded etc.) in which the IVISS system would receive this data.

DLA Troop Support’s Response: Please refer to Amendment 0004, page 2, paragraph 5 as this requirement was deleted in its entirety.

B. Vendor’s Question: Amendment 1 provided Attachment 2, IVISS Response form as a MS Word file, while Amendment 4 Reissued it as an Adobe Acrobat file with the SAME file name. Since there is a significant amount of text entries required on this form, request the Government reissue it as a MS Word file with a unique file name (one was V2 and the other was Ver 2, implying both were the same version).

DLA Troop Support’s Response: Attachment #2 is being updated to provide the document is Microsoft

Word format. See paragraph 5 above.

C. Vendor’s Question: Amendment 1 provided a “cut and paste” change for this requirement, however, the working of the change is identical to the original solicitation? Did the Government intend to make a change to this requirement? Additionally, there is no discussion of access to facilities after work hours. If support personnel arrive after work hours, will each facility have personnel available to provide entry into required work areas, including all workstations and the server room? Request the Government specify that the “4 hour on site response” after exhausting 4 hours of initial support be dependent on the business hour

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0006 3

time frame of 0800-1700 hours, i.e. if 4-hour remote support expires after business hours then the 4 hour on-site support time clock begins at 0800 the next day.

DLA Troop Support’s Response: Amendment 0001 did not change the requirement at Section 11.4 paragraph 11.4.2 of the statement of work. This section was provided in Amendment 0001 to reiterate the requirement. Per the access to facilities, this will be discussed during the kick-off meeting with the resultant awardee.

D. Vendor’s Question: SOW 11.4.2 states, in part, “OCONUS response times will be established on a site specific basis” But, the IVISS price book requires offerors to propose prices for support at the OCONUS sites. Request the Government provide significant detail of what is required for support at each OCONUS site e.g. STANAG, Host Nation Support Agreements, base/facility access requirements/ limitations, operating hours etc. If this detailed information request the Government modify the Solicitation to allow pricing for

OCONUS maintenance to be negotiated after contract award.

DLA Troop Support’s Response: Paragraph 6 above deletes the following: “The above response time applies to all CONUS sites. OCONUS response times will be established on a site specific basis."

E. Vendor’s Question: The answer to the first question on page 4 indicated that attachment 9 included three diagrams: 1) Workflow; 2) BAMC Radiology Network and 3) Detailed depiction of NIPRNet with VPN

Tunnels – only the workflow diagram was present. Request the Government provide the described diagrams stated to be in attachment 9 provided with Amendment 3.

DLA Troop Support’s Response: Attachment #10 is being provided to further explain workflow and network diagrams. See paragraph 3 above.

F. Vendor’s Question: Page 71 of the RFP requires that our submission include Attachment 3, Medical

Device Risk Assessment Questionnaire V1.1, while the SOW and Attachment 2 state Attachment 3 is due at contract award. Please clarify when we must submit Attachment 3.

DLA Troop Support’s Response: The documents have been updated and the requirement is that the vendor must fill out and submit Attachment #3 - Medical Device Risk Assessment Questionnaire with their proposal.

Document must be provided at time of proposal submission.

G. Vendor’s Question: Request the Government reconsider its decision concerning the mandatory 510(k) certification and reword it 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. Please note that this requirement, as currently written will significantly reduce competition on this solicitation.

If the Government insists on keeping the 510(k) requirement, request you specify requirements/features make

IVISS a Class II or III device since our initial discussions with certifying officials indicate that they WILL

NOT entertain registration, listing or premarket review of the IVISS system. Additionally, request the

Government allow offerors to submit their 510(k) forms upon award.

DLA Troop Support’s Response: Page 34 of the solicitation, section 3.1.1.8 is deleted and replaced with the following: "3.1.1.8. Vendors shall identify how their device is classified and provide the appropriate approval or exemption documentation that is issued by the FDA for their system. The system must still comply with NFPA99 (National Fire Protection Association) rules for electronic /electrical medical devices."

SPE2D1-16-R-0001 – IVISS – AMENDMENT 0006 4

H. Vendor’s Question: Amendment 4 changed the requirement in paragraph 6.6 of Attachment 2 in a manner that it is now not consistent with paragraph 6.6 of the SOW i.e. it added the requirement that “All data will be converted to DICOM at the point of acquisition. “Request the Government rephrase the last sentence from Paragraph 6 of Attachment 2, IVISS Vendor Response Form to state; “All data will be converted to the DICOM at the server level.

DLA Troop Support’s Response: Amendment 0004 did not reference or change this requirement; however, Amendment 0003 gave an explanation for this requirement. No changes will be made to the requirement under section 6.6 of the statement of work.

I. Vendor’s Question: This requirement requires configuring auto-archive files to central server, but the overall SOW does not define a “Central IVISS Server” and it is not clear whether the media required to auto-archive is media residing on a Regional IVISS Server. Request Government delete this requirement or provide significantly more detail as to the Government’ network and storage architecture.

DLA Troop Support’s Response: The government is not requesting a "Central IVISS Server" as a priced line item in the vendor's proposed solution. The government is requiring that capability to auto archive files to a central server, which is government provided. The intent of this requirement (Solicitation, page 43, paragraph 8.14) is to state that the IVSS has the ability to off-load data from its local storage (aka cache) into a long term archive.

J. Vendor’s Question: Request the Government delete the requirement for Offerors to provide bandwidth and latency requirements and instead include the Government’s bandwidth and latency constraints in the

Network diagrams to be provided with amended attachment 9.

DLA Troop Support’s Response: Attachment #10 is being provided to further explain workflow and network diagrams and bandwidth and latency requirements are further explained in this attachment. See paragraph 3 above.

K. Vendor’s Question: Due to the multiple changes in the Solicitation, included an amendment to an amendment and providing three separate versions of the IVISS Vendor Response form, there are several disconnects between the requirements in the RFP, SOW and IVISS Vendor Response from. Strongly recommend the Government provide a conformed copy of the RFP.

DLA Troop Support’s Response: The government does not intend to release a conformed solicitation.

L. Vendor’s Question: In regards to Amendment 0003 and below question/ response, we are requesting that the FDA requirements for this bid be removed completely. As per the below link to FDA website, the FDA does not intend to enforce compliance for Medical image storage devices subject to 21 CFR 892.2010, and

Medical image communications devices subject to 21 CFR 892.2020.

DLA Troop Support’s Response: Page 34 of the solicitation, section 3.1.1.8 is deleted and replaced with the following: "3.1.1.8. Vendors shall identify how their device is classified and provide the appropriate approval or exemption documentation that is issued by the FDA for their system. The system must still comply with NFPA99 (National Fire Protection Association) rules for electronic /electrical medical devices."

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