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USP 797/800 Upgrades

Client

Ascension Health

Industry

Healthcare

Delivery Method

CM at Risk

Architect

Project Profile

Michuda Construction successfully completed USP 797/800 compliance upgrades for Ascension Health, ensuring that the infusion therapy labs met the revised pharmacy compounding standards mandated by the United States Pharmacopeia (USP). The phased renovation maintained operational continuity, protecting both patients and staff while ensuring compliance with strict regulatory requirements.

PROJECT PROFILE

Ascension Health USP 797/800 Compliance Upgrades Location: Illinois Delivery Method: Construction Manager at Risk

PROJECT OUTCOME

Michuda Construction completed USP 797/800 compliance upgrades for Ascension Health, ensuring that the infusion therapy labs met the revised pharmacy compounding standards mandated by the United States Pharmacopeia (USP). The phased renovation maintained operational continuity, protecting patients and staff while ensuring compliance with strict regulatory requirements.

PROJECT SCOPE

Michuda Construction managed the comprehensive upgrade of Ascension Health’s infusion therapy labs to meet USP 797 and USP 800 standards. These standards mandate enhanced environmental controls to protect personnel and maintain the sterility of compounded pharmaceuticals, including hazardous drugs.

Key Elements of the Project:

  • Hazardous Drug Compliance: Installed dedicated HVAC systems to create negative-pressure hazardous drug compounding areas with independent air-handling and filtration systems.

  • Sterile Environment Controls: Renovated sterile compounding areas to achieve ISO Class 7 certification, incorporating HEPA filtration, laminar flow hoods, and pressure monitoring systems.

  • Mechanical System Enhancements: Upgraded HVAC systems with precise temperature and humidity controls to meet USP environmental requirements.

  • Space Reconfiguration: Redesigned workspaces to separate hazardous and non-hazardous compounding operations while optimizing workflows.

  • Safety Features: Integrated protective barriers, eye wash stations, and exhaust systems to ensure worker safety when handling hazardous compounds.

  • ICRA Protocols: Implemented Infection Control Risk Assessment (ICRA) measures to ensure patient safety and minimize disruptions during the project.

CHALLENGES & SOLUTIONS

Maintaining Infusion Lab Operations:

  • Challenge: Ensuring continuous access to infusion therapy labs throughout the project.

  • Solution: Phased construction enabled uninterrupted service delivery, with temporary lab spaces established during each phase.

Adherence to Regulatory Standards:

  • Challenge: Ensuring strict compliance with USP 797/800 standards and local building codes.

  • Solution: Worked closely with engineers and hospital compliance teams to validate all systems, supported by rigorous testing and certification processes.

Occupied Facility Considerations:

  • Challenge: Executing renovations in an active hospital environment without impacting patient care.

  • Solution: Conducted construction activities during off-peak hours and maintained clear communication with hospital staff to coordinate workflows.

VALUE TO THE CLIENT

The USP 797/800 compliance upgrades delivered a state-of-the-art pharmacy compounding environment that not only met but exceeded regulatory requirements. The project safeguarded staff and patient safety, minimized disruptions, and reinforced Ascension Health’s commitment to providing high-quality care aligned with the latest healthcare standards.

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