P09_SOW - Upgrad IV Mixing Room Construction 516 22 112 BB.pdf
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- Solicitation number
- 36C24826Q0548
About this file
This is a Statement of Work for Project No. 516-22-112, requiring upgrades to the Pharmacy IV Mixing Rooms at Lee County VA Health Care Center in Cape Coral, Florida, to achieve compliance with USP 797 and USP 800 standards for sterile and hazardous drug compounding environments. The contractor must perform construction, mechanical, electrical, and architectural upgrades to Rooms 1B164, 1B165, and 1B166 to address deficiencies in air quality, pressurization, hazardous drug containment, and workflow safety. The Department of Veterans Affairs is the federal agency involved.
The contractor is responsible for complete site preparation including demolition and alterations; compliance with VA design manuals, drawings, and specifications; and adherence to VA security procedures and badge requirements. Key operational requirements include confining activities to COR-approved areas, maintaining clear facility access, limiting material deliveries to two-day supplies, and minimizing disruption to 24/7 clinical operations. Utility coordination requires maintaining continuous service with minimum seven-day advance notice for routine shutdowns and 15 days for major shutdowns. The contractor must submit a phased construction plan with two-week advance notice before work begins in any room. Additional deliverables include a detailed Testing and Commissioning Plan with pre-testing and final testing in the COR's presence; continuously updated as-built drawings in PDF format submitted at each phase end; a Warranty Management Plan submitted 30 days before the pre-warranty conference with participation in 4-month and 9-month inspections; complete O&M manuals in electronic and hard copy formats; factory-trained personnel to conduct staff training; and VA-compliant construction signage. The contractor must also perform pre-construction condition surveys, protect existing conditions, manage environmental waste including PCB-containing equipment per EPA and DOT requirements, and restore all disturbed areas to original or better condition.
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Other files
| File | Type | Posted |
|---|---|---|
| P01_USP Room FINAL SET 2303 VA Lee County_BID DOCUMENTS.pdf | ||
| 36C24826Q0548.docx | DOCX document | |
| P01_BID Documents Specifications Lee County USP Rooms .pdf |
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Text version
STATEMENT OF WORK
Project No 516-22-112
Upgrade Pharmacy IV Mixing Room – USP 797/800 Compliance Lee County VA Health Care Center – Cape Coral, FL
1. Background and Objective
1.1. The Department of Veterans Affairs requires this project to upgrade the Pharmacy IV Mixing Rooms to achieve compliance with USP 797 and USP 800, which govern sterile and hazardous drug compounding environments. The existing IV mixing rooms do not fully meet current regulatory standards for air quality, pressurization, hazardous drug containment, or workflow safety Without these upgrades; the pharmacy cannot maintain required sterile compounding operations.
1.2. The objective of this project is to perform construction, mechanical, electrical, and architectural upgrades that bring Rooms 1B164, 1B165, and 1B166 into full USP-compliant operation, ensuring safe medication preparation for Veterans and staff. This project occurs within the operating Lee County HCC, requiring special attention to safety, infection control, security, and minimal operational disruption, as required in VA specification Section 01 00 00.
2. General Requirements
2.1. The contractor shall fully prepare the site for construction, including all demolition, alterations, and building work required
2.2. All work shall comply with VA design manuals, project drawings, and specifications
2.3. Contractor staff shall comply with VA security procedures and must obtain proper identification badges
3. Site Preparation and Intent
3.1. Prepare the site for construction operations, including removal of designated building elements and protection of existing finishes
3.2. Provide all labor, materials, tools, and equipment necessary to complete the project in accordance with contract documents
3.3. Coordinate site visits and access with the COR
4. Security and Access Control
4.1. Implement the VA-required Security Plan covering physical and administrative security for the duration of the project
4.2. Ensure all workers display badges and follow VA Police instructions
4.3. Secure all sensitive information and follow EDMS procedures for electronic document control
5. Operations and Storage Areas
5.1. Confine all construction activities and storage to areas approved by the COR
5.2. Maintain clear access to medical center roads, entrances, and pathway
5.3. Limit material deliveries into occupied buildings to no more than two days of supply
5.4. Minimize noise, vibration, and disruption to clinical operations
6. Utility Coordination
6.1. Maintain continuous utility service to the facility (water, electricity, communications, fire protection, HVAC)
6.2. Submit requests for utility shutdowns at least 7 days in advance; major shutdowns require 15 days notice
6.3. Provide temporary utility systems where needed to prevent operational interruptions
6.4. Ensure all utility work is coordinated with the COR
7. Construction Phasing and Scheduling
7.1. Work shall be phased to avoid disruption to 24/7 medical center operations.
7.2. Submit a phased construction plan detailing activities, dates, tempo protections, and system interruptions
7.3. Provide the COR with two weeks’ notice before starting work in any room or are
7.4. Coordinate all work to align with clinical scheduling requirements
8. Alterations and Protection of Existing Conditions
8.1. Perform a pre-construction survey of existing conditions, documenting surfaces, equipment, and finishes
8.2. Protect all existing materials, equipment, and building components from damage throughout construction
8.3. Immediately repair and restore any damaged utilities, finishes, or systems
8.4. At project completion, restore all disturbed areas to original or better condition
9. Environmental and Waste Handling
9.1. Remove all demolition debris, equipment, and waste from the site per VA requirements
9.2. Government-retained items must be stored where directed by the COR
9.3. PCB-containing equipment, if encountered, shall be disposed of according to
EPA and DOT requirements
10. Testing, Balancing, and Commissioning
10.1. Submit a detailed written Testing and Commissioning Plan before commencing work
10.2. Pre-test all systems prior to requesting final testing
10.3. Conduct final testing in presence of the COR and provide all instruments, labor, and materials required
10.4. All system components must be operating simultaneously during testing
(HVAC supply/return, exhaust, controls, etc)
11. Documentation and As-Built Requirements
11.1. Maintain two complete sets of continuously updated as-built drawings
11.2. Submit as-built drawings in electronic PDF format at the end of each construction phase
11.3. Apply the same requirements to all shop drawings
12. Warranty Management
12.1. Submit a Warranty Management Plan 30 days before the pre-warranty conference
12.2. Participate in joint 4-month and 9-month warranty inspections with the VA
12.3. Follow priority response codes (1, 2, 3) for warranty service, with response times ranging from 4 hours to 3 days
12.4. Tag all warranted equipment with VA-approved labels
13. Training and O&M Manuals
13.1. Provide complete operation and maintenance manuals (electronic and hard copy) for all installed equipment
13.2. Provide factory-trained personnel to conduct training for VA staff
13.3. Ensure training includes operation, maintenance, safety, and system integration
14. Construction Signage
14.1. Provide and install a VA-compliant construction sign as shown in project drawings
14.2. Maintain and remove signage at project completion
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