Amendment 1 75H70122R00003.pdf

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 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 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.

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

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

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 APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER 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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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 (Number, 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)

Previous edition unusable

A0001

The purpose of this amendment is to answer pre-proposal inquiries.

Please page 2 for responses.

Indian Health Service – Division of Engineering Services 701 Fifth Avenue, Suite 1650 Seattle, WA 98104

SEE BLOCK 6.

75H70122R00003

1 3

10/28/2021

10/12/2021

75H70122R00003 – Software Based Medical Device Support Amendment 01

Here are Government responses to pre‐proposal inquiries:

1. Section C, 3.1, p.9 ‐ Are hosting requirements part of this contract? If so, does the Government prefer Gov

Cloud, FISMA moderate or other?

Response: Hosting requirements are not part of this contract.

2. Section C, 3.1, p.9 ‐ Are there any user log‐in authentication requirements, perhaps Personal Identity Verification

(PIV)?

Response: Username and password at a minimum. Integration with IHS SSO (single sign on) and PIV authentication would be beneficial, in particular for accessing any portion of the services/content that are contained in whole within the vendor’s system.

3. Section C, 3.1, p.9 ‐ Does IHS have preferred vendors or contract vehicles for purchasing medical equipment or software that the new system should interface with?

Response: This solicitation is not for the acquisition of medical equipment or medical device software. It is to support decision making, research, standardization (terminology), aggregate recall/alerts, and information specified in the SOW.

4. Section C, 3.1, p.9 ‐ Does the new system need to generate and/or place an order with the equipment vendors or simply flag when repair or replacement is needed?

Response: Recall alerts and end of life notification based on current assets would be beneficial and integrated into Nuvolo. This solicitation is not for the acquisition of medical equipment or medical device software. It is to support decision making, research, standardization (terminology), aggregate recall/alerts, and information

5. Section C, 3.1, p.9 ‐ Does the new system need to track new/ replacement orders?

Response: This solicitation is not for the acquisition of medical equipment or medical device software. It is to support decision making, research, standardization (terminology), aggregate recall/alerts, and information

6. Section C, 3.1, p.9 ‐ Is existing equipment inventoried? If not, Is the contractor responsible for identifying existing equipment, inventorying, and/or tagging equipment upon entry into system with standardized naming convention and developing basis for recall monitoring?

Response: Existing equipment is inventoried in Nuvolo and as such when new equipment is purchased, standardized equipment nomenclature is required. Tagging and inventorying of equipment will be maintained by IHS. Inventorying, tagging and data entry into the IHS CMMS is not part of this solicitation.

7. Section C, 3.1, p.9 ‐ Is the new system responsible for maintaining inventory control over equipment (e.g. track movement, in‐repair, transfer to another location, disposed?

Response: No, this is not part of the requirements for this solicitation.

8. Section C, 3.1, p.9 ‐ Is the new system responsible for storing purchase documents to support warranty, user manuals, device specifications, etc.?

Response: No, documentation needs to be available from vendors in order for IHS to import into our current Nuvolo system.

9. Section C, 3.2, p.9 ‐ Where is the Nuvolo CMMS hosted? Who is the owner of Nuvolo CMMS? What are the interface/connection standards needed to connect to the Nuvolo CMMS?

Response: Nuvolo is hosted in IHS FedRamp cloud. The application owner is the CMMS Coordinator where the ServiceNow instances owner is IHS Office of Information Technology. If out of box solution is currently not available within Nuvolo, then an API configuration will need to be developed with the application owner, current Nuvolo contract support vendor and IHS.

10. General RFP Question ‐ Based on the development nature of the requirements, is the incumbent, Emergency Care Research Institute (ECRI Institute) eligible to bid or are they OCI’d from this competition?

Response: The incumbent, ECRI, is eligible to provide a proposal for this competition. No proprietary information has been disclosed to Nuvolo /ECRI to provide an unfair advantage for this solicitation/resulting contract.

11. Section C, 3.2, p.9 ‐ Based on the development nature of the requirements, is Nuvolo eligible to bid on this contract?

Response: Nuvolo is able to bid on this contract. No proprietary information has been disclosed to Nuvolo /ECRI to provide an unfair advantage for this solicitation/resulting contract.

12. Section C, 3.1, p.9 ‐ Is there currently a database in place for IHS to directly access the medical device evaluation or are they going through Emergency Care Research Institute (ECRI Institute) for the information? If there is another database this information is storied, please share where?

Response: ECRI is currently available but some Areas also use FDA information and/or other independent research.

13. Section C, 3.2, p.9 ‐ Does Nuvolo Computerized Maintenance Management System database contain all the information provided by ECRI or will supplemental data need to be added?

Response: Currently, IHS Nuvolo CMMS is implementing ECRI source base data for standard nomenclature.

No, Nuvolo does not contain all of the information provided by ECRI. This solicitation is for a solution to provide all of the supplemental data that is equivalent to that which is available through the ECRI Sourcebase, ECRI SelectPlus, and ECRI Alerts Tracker, to include integration with the Nuvolo CMMS to import, or link to, that data to support decision making, research, standardization (terminology), aggregate recall/alerts, and information specified in the SOW.

14. Section C, 3.2, p.9 ‐ Is Nuvolo the medical device standard database currently being used by IHS?

Response: Nuvolo is the Computerized Maintenance Management System used by IHS.

15. General RFP Question ‐ If Nuvolo is the platform and Emergency Care Research Institute (ECRI Institute) provides the data, is the Government looking for a contractor to provide interoperability between the two solutions?

Response: Government not looking for a contractor to provide interoperability. Current Nuvolo contract already has the ECRI integration as a requirement. This solicitation is for a solution to provide all of the supplemental data that is equivalent to that which is available through the ECRI Sourcebase, ECRI SelectPlus, and ECRI Alerts Tracker, to include integration with the Nuvolo CMMS to import, or link to, that data to support decision making, research, standardization (terminology), aggregate recall/alerts, and information

16. Section C, 3.2, p.9 ‐ Does Nuvolo have standardization capabilities?

Response: Yes, Nuvolo does have standardization capabilities based on IHS processes being developed.

17. Section C, 3.1, p.9 ‐ Are there any other required integrations the new software would need to be repaired to connect with?

Response: This question would need clarification: ‘need to be repaired to’? This solicitation is not to provide medical equipment or software repair services.