N6264517R0022_Amendment_0001.pdf

N6264517RCES008

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to:

1. Provide Questions and Answ ers to all interested vendors.

2. Correct the delivery timeframe for CLIN 0003 - Medical Device Risk Assessment.

The closing date and time remain the same. Offerors are responsible for reading all of this amendment and the solicitation in its entirety.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 7

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

16C. DATE SIGNED

BY 15-May-2017

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

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

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X N6264517R0022

X 9B. DATED (SEE ITEM 11)

20-Apr-2017

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

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 Offer is extended, X is not extended.

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

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

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)

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

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

15-May-2017

CODE

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

N62645 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

N6264517R0022

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

QUESTIONS AND ANSWERS

Questions/Comments & Answers - N6264517R0022 Amendment 0001

1. [General Questions] A. Are these two separate systems or two locations working on one database?

Answer: These are two separate systems working on two separate databases

B. Is the NAICS code for this solicitation modifiable?

Answer: The NAICS Code will remain the same. Companies can add NAICS to their SAM profile.

2. [Page 2: ITEM NO. 0003 Medical Device Risk Assessment FFP –]

10% Holdback of total award amount until completed Gold Section returned to Naval Medical Logistics Command (NMLC) within seven (7) days after award

A. Where is this holdback procedure explained? Page 7, INSTRUCTIONS TO OFFERORS, Volume I – Technical. Conformance to Navy Cybersecurity Requirements says “Offerors shall submit a completed Medical Device Risk Assessment (MDRA) Questionnaire (blue section only).” Page 14, Evaluation Factor B: Conformance to Navy Cybersecurity Requirements says “– The government will evaluate the capability of the proposed system to meet Navy Cybersecurity requirements. The evaluation will be based on the information provided in the completed “Blue Section” of the Medical Device Risk Assessment (MDRA) form.”

This MDRA Blue section is required to be submitted with the proposal. There are no provisions providing for a post-Proposal submission of a “Gold Section”.

Answer: The CLINs represent how the Goverment anticipates the contract to be constructed. The holdback is applied to the Gold Section which is only due post award from the awardee. Only the blue section is due with the proposal.

3. [Page 4: STATEMENT OF REQUIREMENTS, NAVAL MEDICAL CENTER SAN

DIEGO]

and [Page 5: STATEMENT OF REQUIREMENTS, NAVAL HOSPITAL CAMP LEJEUNE]

Be capable of storing and retrieving images from digital cameras and other digital imaging systems that are used for endoscopic procedures.

A. How much storage is required for future cases? Should the offeror make assumptions regarding the number of years and the amount of data required for each case?

Answer: The system at NMC San Diego shall be capable of storing 15,000 new procedures per year for an estimated life expectancy of at least 8 years. The system at NH Camp Lejeune shall be capable of storing 3,500 new cases per year for an estimated life expectancy of at least 8 years. The typical procedure file size to calculate required storage capacity should be at the vendor’s discretion.

4. [Page 3: STATEMENT OF REQUIREMENTS, NAVAL MEDICAL CENTER SAN

DIEGO]

and [Page 4: STATEMENT OF REQUIREMENTS, NAVAL HOSPITAL CAMP LEJEUNE]

Be capable of bidirectional communication with Cerner Millenium including but not limited to importing patient identifiers, demographic information, pathology/cytology results and exporting reports and images.

A. Is the proposed pricing supposed to include the cost of an interface to Cerner Millenium?

Answer: No. The requirement is for the CAPABILITY of bidirectional communication with Cerner Millenium (now referred to as Cerner MHS Genesis). The interface is HL7 – based and is not required to be active at time of delivery.

B. If yes, can the government provide the specifications for the required interface?

Answer:N/A

5. [Page 4: STATEMENT OF REQUIREMENTS, NAVAL MEDICAL CENTER SAN and [Page 4: STATEMENT OF REQUIREMENTS, NAVAL HOSPITAL CAMP LEJEUNE]

Be capable of exporting procedural reports with text and images to the Armed Forces Health Longitudinal Technology Application (AHLTA) Healthcare Artifact and Image Management Solution (HAIMS).

A. Is the proposed pricing supposed to include the cost of an interface to AHLTA?

Answer: Yes

B. If yes, can the government provide the specifications for the required interface?

Answer: The exact specifications of the interface can only be determined after award however, the methodology currently employed by Navy Medicine for exporting reports to AHLTA is via an interface with CHCS. Please refer to the example CHCS Interface Control Document (ICD), provided in the attachment.

6. [Page 4: STATEMENT OF REQUIREMENTS, NAVAL MEDICAL CENTER SAN and [Page 4: STATEMENT OF REQUIREMENTS, NAVAL HOSPITAL CAMP LEJEUNE]

Include nine (9) procedure room stationary workstations with combined image capture and report writing capability, including software to enhance medical transcription and report generation.

A. What specific software or other tools are required to meet the “medical transcription and report generation” requirement?

Answer: Specific software or other tools are at the vendor’s discretion.

7. [Page 4: STATEMENT OF REQUIREMENTS, NAVAL MEDICAL CENTER SAN

DIEGO]

and [Page 4: STATEMENT OF REQUIREMENTS, NAVAL HOSPITAL CAMP LEJEUNE]

Be capable of data migration from Olympus Endoworks to the proposed solution.

A. For the migration of historical data, how many cases would need to be migrated to have an idea of how much storage is needed for historical data for each site?

Answer: Naval Medical Center San Diego is replacing an Olympus Endoworks system which contains approximately 22,000 procedure reports. Naval Hospital Camp Lejeune is replacing an Olympus Endoworks system which contains approximately 8,000 procedure reports. The typical procedure file size to calculate required storage capacity should be at the vendor’s discretion.

B. Is it correct to assume that the government has the responsibility to work with Olympus Endoworks to provide access to the data?

Answer: Yes, the government will take the necessary action to provide access.

8. [Page 5: Enhancing Factors for Both NMCSD and NHCL systems]

A single unlimited site license.

A. What does “a single unlimited site license” mean? Is the single unlimited site license limited to the users at the point of care workstations? If not, what are the other kinds or classes of users that the site wants included under the site license?

Answer: A single unlimited site license would cover an unlimited number of users of all classes for the system at one site (the requirement is for two sites, NMC San Diego and NH Camp Lejeune). Other desired classes of users besides users include administration.

B. What is the estimated number of additional users that the site projects they would want to have covered under the site license?

Answer: NHCL: 30 Admin, 10 Users.

NMCSD: 30 Admin, 15 Users.

9. [Page 5: Enhancing Factors for Both NMCSD and NHCL systems] Server virtualization.

A. Could the government provide more details regarding what is meant by server virtualization, and the specific benefits it is seeking to achieve utilizing virtualization?

Answer: Server virtualization entails using a separate software partition on existing Hospital hardware to host a system server.

10. [Page 10: CYBERSECURITY REQUIREMENTS, DHA Business to Business (B2B)

Gateway.] Contractors will connect to the B2B gateway via a contractor procured Internet Service Provider (ISP) connection and assume all responsibilities for establishing and maintaining their connectivity to the B2B gateway. This will include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the DHA VPN device. Maintenance and repair of contractor procured VPN equipment shall be the responsibility of the contractor.

A. Should/can vendors include the cost of acquiring a VPN device and maintenance and repair of the VPN in the quote?

Answer: Please note that this is required for remote system access; if the system does not require remote system access to fully function, then the B2B gateway VPN device is not necessary. The cost per CLIN is all inclusive.

B. Our product is not a medical device. We do not complete an MDS2 for our other customers, but alternatively, supply a letter indicating our software is not a medical device. Could a letter be used in this instance?

Answer: The MDRA form is required. A letter is not sufficient.

C. Are you accepting solicitation responses from those who have neither started or have just begun the RMF certification Process?

Answer: The requirement is that the awardee be capable of completing the RMF process, NOT that the RMF process need already be completed. All offers received will be evaluated according to the criteria specified in the solicitation.

11. [Page 14: Evaluation Factor C: Performance Test – Minimum Requirements.] If the offeror passes Evaluation Factors A and B, the Government will conduct an evaluation of the vendor’s program. If the offeror passes Evaluation Factors A and B, the Government will request that the offeror ship software and any separate hardware needed for proper demonstration, to the Government location at Naval Medical Center San Diego at no expense of the Government, along with detailed instructions on how to complete tasks that will demonstrate the ability to meet the criteria listed below. No vendor shall be physically present for performance testing. Return charges for the equipment and software will be at the vendor’s expense. Offeror’s performance test will be evaluated on a Pass/Fail basis. A Pass rating will be given if all criteria identified below are successfully performed.

A. In the previous versions of the Statement of Requirements that were posted last year, the Performance Test was not an evaluation factor. What was the reason for including this Performance Test as an evaluation factor this time?

Answer: It was determined to be in the best interest of the Government to include the evaluation factors included in the solicitation.

B. As far as the vendor knows, there is no Cerner Millenium installed at NMCSD and the AHLTA system is not approved for external interface with CIS systems. Such communication would require significantly more information to develop the solution. Given that this is the case, how does the government propose the vendor demonstrate that it is capable of these requirements?

Answer: Cerner Millenium, now referred to as Cerner MHS Genesis, is currently being implemented at all DoD Medical Treatment Facilities according to a prescribed roll-out schedule. The requirement is for the CAPABILITY for an HL7-based interface. The methodology currently employed by Navy Medicine for exporting reports to AHLTA is via an interface with CHCS.

C. Will the vendor be allowed to provide on-site support prior to the ‘Performance Test” to install, configure and provide limited applications training to the staff performing the performance test?

Answer: No vendor support will be permitted prior, during or after Performance testing.

D. Considering the vendor shall not be physically present for performance testing, what trained personnel will be present to ensure the software and hardware are properly installed and that the solution is properly used?

Answer: No vendor support will be permitted prior, during or after Performance testing.

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0003

The CLIN extended description has changed from:

10% Holdback of total award amount of completed Gold Section returned to Naval Medical Logistics Command (NMLC) within seven (7) days after award to usn.detrick.navmedlogcomftdmd.list.mdra@mail.mil.

To:

10% Holdback of total award amount of completed Gold Section returned to Naval Medical Logistics Command (NMLC) within ten (10) days after award to usn.detrick.navmedlogcomftdmd.list.mdra@mail.mil.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule item for CLIN 0003 has been changed from:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

7 dys. ADC 1 NAVAL MEDICAL LOGISTICS COMMAND

CODE 03 - PACS

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

301-619-9349 FOB: Destination

N62645

To:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

10 dys. ADC 1 NAVAL MEDICAL LOGISTICS COMMAND

CODE 03 - PACS

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

301-619-9349 FOB: Destination

N62645

TABLE OF CONTENTS

The below Table of Contents has been added

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

Attachment 1 Example CHCS Interface

Control Document (ICD)

100 11-MAY-2017

(End of Summary of Changes)