Amendment 001 - 75H70425Q00004sol.pdf
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- Attached to
- Adverse Event Reporting System
- Solicitation number
- 75H70425Q00004sol
About this file
This document is an amendment to a solicitation for an Adverse Event Reporting System (Solicitation No. 75H70425Q00004sol) issued by the Department of Health and Human Services' Indian Health Service. The key details are:
The solicitation is for a Commercially Available Off-the-Shelf (COTS) Adverse Event Reporting System database that is FedRAMP certified or able to operate within the IHS network. The amendment provides responses to 25 questions from potential offerors, covering topics such as the current system, training, reporting volumes, pricing, data migration, and support. Notable responses include: the current system is operated by the incumbent contractor; over 27,000 events were reported in 2023; the requirement is not for a Software as a Service approach; and IHS will provide Tier-1 support to users. The solicitation due date has been extended to November 25, 2024, and offerors can submit pricing in Excel format.
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(x)
75H70425Q00004 x x 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 ACKNOWLEDGEMENT 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.
x
Rockville MD 20857 5600 Fishers Lane, Mailstop 09E70 Division of Acquisition Policy Indian Health Service
11/08/20240001
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning
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
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
FACILITY CODE CODE
10B. DATED (SEE ITEM 13)
10A. MODIFICATION OF CONTRACT/ORDER NO.
9B. DATED (SEE ITEM 11)
9A. AMENDMENT OF SOLICITATION NO.
CODE
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY
PAGE OF PAGES
4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)
1. CONTRACT ID CODE
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
11/08/2024
CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.
ORDER NO. IN ITEM 10A.
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
The purpose of this Amendment is to answer the below questions. Government response is provided proceeding each question.
1. Is this an example of the adverse event reporting IHS would like to see? Some context around the interventions would be very helpful.
Government Response: The current system used by the IHS is offered by the incumbent contractor, RL Datix. The technical requirements for the government's requirements are outlined in the Performance Work Statement.
2. Furthermore PWS section 1.6.4Place of Performance states that the work will be performed virtually. However, in the above section in person training is mentioned.
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16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)
15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED
(Signature of person authorized to sign) (Signature of Contracting Officer)
STANDARD FORM 30 (REV. 11/2016)
Prescribed by GSA FAR (48 CFR) 53.243
Previous edition unusable
Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
NAME OF OFFEROR OR CONTRACTOR
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(A) (B) (C) (D) (E) (F)
75H70425Q00004/0001
Government Response: Virtual training would be expected.
3. For pricing purposes, having a sense of volume would be very helpful. What is a rough estimate/ ranges of the volume of reports annually?
Government Response: In CY 2023, more than 27,000 events were entered into I-STAR.
4. Within the PWS section 1.2, non-compliance is discussed. Are there any strategies being employed to increase reporting compliance (not related to reporting system being used)?
Government Response: The agency has ongoing reviews of the system to ensure consistent use and encourage reporting through utilization report dissemination, trainings, and office hours.
5. In PWS section 1.3, one of the objectives listed is a system that is FedRAMP certified or able to operate inside the IHS network. Is the
RL Datix I-Star vesion deployed inside an IHS network?
Government Response: The current system is operating within the IHS network.
6. In Posting and E, in L.1. there is a reference for the template for the proposals that will be found in L.4. I do not see a L.4 template but I do have a quotation section template in L.5. Is the one in L.5, the correct format?
Government Response: Yes, L.5 is the correct format.
7. Is there a pricing spreadsheet or template that should be used or is a simple quote sufficient?
Government Response: Your price summary can be inputted onto the RFQ SF1449 form.
8. Does the government intend to replace the existing I-STAR system?
Government Response: The purpose of the competition is to recompete the requirements for
I-STAR. The successful bid would form the basis for the I-STAR platform going forward.
9. Can the government share the current challenges with the existing I-STAR system?
Government Response: The requirements for the
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NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
Sponsored by GSA
FAR (48 CFR) 53.110
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(A) (B) (C) (D) (E) (F)
75H70425Q00004/0001 contract are outlined in the performance work statement.
10. Does the government prefer SaaS pricing or
Perpetual/Maintenance-type pricing?
Government Response: The requirement is not for a
Software as a Service approach.
11. How many account holders and account managers are expected to log into the new system concurrently?
Government Response: There are approximately
1200 current I-STAR login users.
12. What is the average number of adverse events reported per year?
Government Response: In CY 2023, more than
27,000 events were entered into I-STAR.
13. What is the average number of users, excluding account holders and managers, who directly report adverse events per year in I-STAR?
Government Response: All IHS employees have access to and report events as identified.
14. What functionality will be accessible to the users who are neither account holders nor managers in the new system?
Government Response: Non-login users will only have the ability to enter events into I-STAR.
15. Can you provide a count of the adverse event records that will be migrated from the I-STAR legacy system into the new system?
Government Response: The count will continue to increase; however, it is nearly 172,000 individual events as of this writing.
16. Will the new system go-live only after all the legacy data has been migrated over during the
90-day conversion period?
Government Response: The legacy data can be migrated after the go live of the awarded system.
17. Will IHS have a support staff team for the new system to provide Tier-1 support before escalating to the contractor?s support staff for
Tier-2 and Tier 3 Support? Tier-1 support in this context will include addressing usability
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75H70425Q00004/0001 questions raised by users and account holders and performing basic troubleshooting and administrative tasks pertaining to user access and security configuration.
Government Response: Yes, IHS will have an admin team that will address basic troubleshooting, admin tasks pertaining to user access and security configuration after go-live.
18.Page 1, Item IV - The NAICS Code for this RFQ is 513210, Software Publisher. We are a services provider for a COTS case management product and have the 541519 NAICS code.
Are offerors who do not have that NAICS Code still allowed to submit a response?
Government Response: We can accept responses from offerors who do not have the specific NAICS code listed in their SAM profile, provided you meet the size standard for the NAICS code assigned to the solicitation. Offerors who do not have 513210 in their SAM profile can still submit a response, but they must certify that they meet the size standard for 513210.
19. Page 2 - Quotes are due November 23 at 5pm.
November 23 is a Saturday. Would the government consider shifting this to a business day such as Monday, November 25?
Government Response: Solicitation due date is extended to Monday, November 25 at 10:00am est.
20. For the Price Volume part of the proposal, are offerors allowed to submit a pricing document in Microsoft Excel?
Government Response: Excel would be an acceptable/preferred format.
21. Is it permissible to send along a narrative with our Price Volume?
Government Response: Yes, provided a pertinent information is contained in the price volume, separate from the narrative.
22. Page 5, 1.6.8. Key Personnel. The Key
Personnel is defined as the "Contract Manager."
Did you mean the Project Manager? Or, are you only interested in receiving the resume of the person who handles contractual issues and questions.
Please define the Contract Manager role.
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Government Response: With respect to the
Performance Work Statement (PWS), a Contract
Manager would be the lead company official accountable for the day to day compliance of the terms of the contract under the PWS. Whether that person is a project manager or contract manager in a commercial sense, is not essential;
compliance with the PWS is.
23. On page 3, L.2.3 RELEVANT PAST PERFORMANCE.
It says, "Offerors are instructed to complete the past performance questionnaire template (See Appendix A) for three (3) contracts." We did not find Appendix A anywhere in the RFQ materials on SAM. Can the government identify where to find the questionnaire template?
Government Response: "Appendix A" has been updated into solicitation.
24. In the combined + synopsis+-+IStar+Posting pdf, in line vi. There is a reference to
"providing an in person and virtual training program to certify and license individuals to conduct interventions with American Indian and
Alaska Natives that seek assistance in quitting commercial tobacco use. See the attached
Performance Work Statement (PWS) for more details." However, in the PWS, I see no references to these interventions or commercial tobacco use.
Government Response: This Statement has been taken out and is not applicable for this requirement.
25. On page 1, Item VI it says "The purpose of this fixed price purchase order is to secure the services of one (1) contractor to provide an in
Person and Virtual Training Program to certify and license individuals to conduct interventions with American Indian and Alaska Natives
AI/AN) that seek assistance in quitting commercial tobacco use. See the attached
Performance Work Statement (PWS) for more details." Was this a mistake? There are no items in the PWS referring to assistance in quitting commercial tobacco use.
Government Response: This Statement has been taken out and is not applicable for this
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75H70425Q00004/0001 requirement.
Period of Performance: 12/01/2024 to 11/30/2025
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
File details come from the government source that posted it. Updated .