Change Order Notice V.25.1 Fusion_UPDATED.pdf
PDF 1 MB Posted
- Attached to
- CHANGE ORDER NOTICE-Pharmacy System Amendment
- Solicitation number
- 26-444DHS-MIS44-B-52213
- Issued by
- Illinois
About this file
This Change Order Notice from the Illinois Department of Human Services (DHS) Chief Procurement Office for General Services documents an amendment to contract 4100222212 (P-85550) for the 24-OCAPS Pharmacy System. The change order adds the Fusion 360 software component to the existing pharmacy system contract to achieve compliance with new Federal Drug Supply Chain Security Act (DSCSA) requirements. The amendment increases the initial contract term by $197,600.00 and implements comprehensive functionality across ten DSCSA mandates, including supplier validation, historical and current data management (ASN and EPCIS), quarantine protocols for suspected illegitimate drugs, FDA and trading partner notification procedures, government authority response capabilities with reduced response times from 48 to 24 hours, serialization and lot number data validation, internal system integration, secure interoperability standards, and enhanced drug distribution security reporting with electronic tracing capabilities at the package level to support inspection requirements.
The Fusion 360 solution represents a tailored enhancement designed to address compliance gaps identified after the original contract execution, with the cost increase of $197,600.00 reflecting the necessity to integrate advanced pharmaceutical supply chain security features. This change order notice is being posted on the Bulletin/BidBuy for the required 14-day posting period per Section 33E-9 of the Criminal Code, as the modification exceeds the $25,000 threshold for contract cost increases requiring public notification. The amendment is considered germane to the original contract as signed and addresses Federal requirements that could not have been reasonably foreseen at the time of initial contract execution.
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| File | Type | Posted |
|---|---|---|
| Change Order Notice V.25.1 Fusion~1.pdf |
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Change Order Notice Chief Procurement Office for General Services Change Order Notice V.25.1 Page of Notice of renegotiated contracts and change orders that increase the cost of a contract by more than $25,000 or the time of completion by a total of 180 days or more shall be posted on the Bulletin/BidBuy for 14 days.
This Change Order Notice provides detail as to why the change order is needed and, pursuant to Section 33E-9 of the Criminal Code, that the circumstances said to necessitate the change in performance were not reasonably foreseeable at the time the contract was signed or the change is germane to the original contract as signed. Change orders are defined by Section 1-15.12 of the Procurement Code and Section 1.2067 of the CPO-GS' Administrative Rules.
Detailed explanation for this change order:
11.0.0.20130303.1.892433.887364
| CurrentPage: |
| PageCount: |
| DropDownList1: DHS - Human Services |
| ProcurementTitle: 24-OCAPS Pharmacy System RFP |
| BBREFNO.: 26-444DHS-MIS44-B-52213 |
| thedetails: Due to new Federal requirements, the agency is amending contract 4100222212 (P-85550) to add the Fusion 360 software component, increasing initial term by $197,600.00. The Fusion 360 solution is comprehensive and tailored to address all 10 DSCSA mandates: |
a. Validate Product Suppliers and Provide Suppliers Validation by Dispensers
b. Receive, Validate, & Store Historical ASN Data and now EPCIS Data
c. Quarantine Suspected Illegitimate Drugs in compliance with FDA Guidance as issued in March 2023
d. Notify FDA & Trading Partners of Suspect Illegitimate Drugs with Logging Tracked Form 3911 Submission
e. Provide Timely Response to Government Authorities and Trading Partners. Response Clock Time Decreasing from 48 Hours to 24 Hours
f. ATP Serialization Data Validation. Ensure Dispensers Only Buy and Sell Products Encoded with Product Identifiers (PIs)rec
g. ATP Lot Number Data Validation. Verify Every Product at the Product Package Lot # Level, Including the Serialized Numerical Identifier (SNI)
h. Integrate ASN/EPCIS Data Across Internal Operating Systems Within Each ATP
i. Provide Secure ATP Interoperability of DSCSA Compliance Data Exchange
j. Communicate Regulations and Establish Comprehensive Reporting of Enhanced Drug Distribution Security (EDDS) with Interoperable Electronic Tracing of Product at the Package Level in response to Onsite and Remote Inspection Requirements
| CheckBox1: 1 |
| CheckBox2: 1 |
File details come from the government source that posted it. Updated .