STATEMENT OF WORK (SOW) 2. Contract Title. HEPA Supply/Exhaust fans for Clean room USP 797 Compliance

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1 1. Contracting Officer s Representative (COR). STATEMENT OF WORK (SOW) Name: Oscar Garcia Section: Engineering Address: 3350 La Jolla Village Dr Phone Number: Fax Number: Address: Oscar.garcia2@va.gov 2. Contract Title. HEPA Supply/Exhaust fans for Clean room USP 797 Compliance 3. Background. An existing clean room within the facility is being utilized by the Pharmacy to enable them to perform chemo compounding. The two biological safety cabinets in the clean room are exhausted to the outside by individual exhaust systems. Replacement of the current fans and ductwork as well as the addition of a HEPA filter register will allow for USP 797 operational standards. 4. Scope. The contractor shall provide all labor, material to remove and replace exhaust fans and ducting, and install a HEPA filter register. Additionally, contractor shall provide all labor, materials and testing to achieve USP 797 compliance in the clean room. 5. Specific Tasks. The operational downtime of the room is to be minimized. Removal/replacement of the fan, hangers and associated ductwork will be performed on one hood prior to moving to the second hood. Air flow characteristics need to be established to assure certification of the room and biological safety cabinets. USP 797 room air exchange rates for a hazard type clean room shall be achieved. An existing light fixture in the ante-room shall be relocated to allow for the installation of a 2X2 HEPA filter register. A pressure differential gauge is required to monitor pressure between the ante-room and the outside room. The hood operational testing in relationship with the cleanroom shall conform to all testing relative to USP 797 standards. The majority of work will be conducted in an interstitial (asbestos containing) environment. Proper personnel protective equipment and current asbestos training certification is required to perform work. 6. Performance Monitoring The Government is required to monitor contractor performance and certify the work was done in accordance with the contract. This monitoring is done by the COR. The COR will require engineered construction documents for review and approval and contractor to adhere to infection control guidelines and interim life safety measurements. Contractor is responsible to provide construction schedule and CPM at construction kick off meeting. All safety and infection control parameters must be in place and monitored. COR will require all submittals prior to delivery and installation. COR will perform daily job inspections and daily safety inspections to ensure compliance. Contractor will be required to submit progress payment with invoice for approval before submitting for payment. Performance will be monitored according to progress and the construction schedule.

2 7. Security Requirements Contractor and all subcontractors will be required to apply for VA Badge and VA parking permit and obtain clearances. Parking on VA campus is restricted to General contractor team and all others will be responsible to find parking off site. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). N/A 9. Other Pertinent Information or Special Considerations. N/A 10. Risk Control COMPLIANCE WITH INFECTION CONTROL GUIDELINES: All personnel are expected to comply with the Infection Control Guidelines as outlined in the Infection Control Manual and Medical Center Bylaws. I. DEFINITIONS: Infection control measures should be applied in construction projects based on both the extent of demolition and construction (Construction activity type) and the potential vulnerability of patients seen or treated in the area (Infection Risk Groups). The construction activity types are defined by the amount of dust generated, the duration of the activity and the amount of shared HVAC systems. Contact the Infection Control office if any activity is questionable under these guidelines. A. Definitions of Construction Activity Types: 1. Type A: Inspection and non-invasive activities. Includes, but is not limited to, removal of ceiling tiles for visual inspection limited to 1 tile per 50 square feet, painting (but not sanding) wall covering,. Electrical trim work, minor plumbing and activities which do not generate dust or require cutting of walls or access to ceilings other than for visual inspection. 2. Type B: Small scale, short duration activities that create minimal dust. Includes but is not limited to installation of telephone and computer cabling, access to chase spaces, cutting of walls or ceiling where dust migration can be controlled. 3. Type C: Any work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies. Includes but is not limited to sanding of walls for painting or wall covering, removal of floor coverings, ceiling tiles and casework, new wall construction, minor ductwork or electrical work above ceilings, major cabling activities and any activity which cannot be completed within a single workshift. 4. Type D: Major demolition and construction projects. Includes but is not limited to activities which require consecutive work shifts, heavy demolition or removal of a complete ceiling system and new construction. II. EDUCATION: A. Facility Management Service will assume responsibility for reviewing the service's Infection Control policies and Medical Center Memorandum 11-33, Universal/Standard Precautions, with each new FMS

3 employee and with all FMS employees at least annually. Documentation of attendance will be maintained in Facility Management Service. B. The Facility Management Service Chief is responsible for assuring that all employees receive appropriate Occupational Exposure Control training annually. Documentation is to be maintained in the service. III. REVIEW AND REVISION OF INFECTION CONTROL GUIDELINES: A. Guidelines are to be reviewed at least biennially by the Chief of Facility Management Service and designees. B. All revisions/additions to the Infection Control Guidelines are to be submitted to the Infection Control Committee for approval prior to implementation. IV. PROCEDURES: The Chief, Facility Management Service, or designee will contact the Infection Control Section prior to beginning construction project adjacent to or in any patient care areas. Any of the following may be implemented to ensure a protected environment. A. Performance Requirements The Chief, Facility Management Service and Infection Control Practitioner will establish necessary and appropriate protective measures for patient care areas. 1. Infection control is critical in all areas of all facilities. All construction activities are to be assessed for the potential of causing disturbance of existing dust, or creating new dust. Construction will be conducted in tight enclosures cutting off any flow of particles into patient areas. 2. VAMC requires any contractor, sub-subcontractors, material suppliers, vendors, employees, or agents to be bound by these same requirements. Where appropriate and before construction on site begins, the Contractor s on-site management team shall participate in joint planning with FMS, Project Management, and Infection Control Section for dust control measures and instruction on precautions required. 3. HEPA equipped air filtration machines shall provide air flow into construction area not less than 100 FPM at barricade entrances with doors fully open. HEPA equipped air filtration machines shall be connected to normal power and ganged to a single switch for emergency shutoff and shall run continuously. 4. The Safety or Infection Control Section may modify performance requirements for certain activities. Any modifications made by VAMC's personnel do not relieve the Contractor of compliance with proper Infection Control procedures. B. Contract Submittals 1. Infection Control procedure requirements, including location and details of barriers will be included in all contract submittals. 2. Submit product data for products used in the Infection Control Program. C. Quality Monitoring and Control 1. The contractor is responsible for maintaining equipment and replacement of HEPA and other filters in accordance with manufacturer s recommendations.

4 2. The Safety Section and Infection Control Section will perform field inspection and testing. 3. Engineering Section will confirm specified air velocity/changes whenever barricades are erected or modified. 4. Personnel will monitor air quality throughout project as needed. D. Infection Control Release 1. An Infection Control Release is required for all Class III and higher projects and any activity in any Infection Control Group 4. Refer to shaded areas on Construction Activity/Infection Control Matrix. 2. The IC Release will be obtained from the Infection Control Section prior to beginning any demolition or construction work. 3. The Release will be displayed at the entrance to the work area during the entire construction period 4. The permit will be returned to Infection Control at the time of work completion. E. Products and Materials 1. Sheet Plastic: Fire retardant polystyrene, 6-mil thickness. 2. Barrier Doors: Solid core wood in metal frame, painted. 3. HEPA-Equipped Air filtration Machines: Forced Air 2000 HEPA equipped air filtration units as manufactured by Advanced Containment systems Inc. Houston, TX Provide HEPA filter, primary and secondary filters. 4. Exhaust Hoses: Heavy duty, flexible steel reinforced; Ventilation Blower Hose, WPG as manufactured by Federal Hose Mtg. Co Painsville OH or equal. 5. Adhesive Walk-Off Mats: Provide minimum size mats of 24 inches x 36 inches as manufactured by 3M,St. Paul, MN or equal. 6. Disinfectant: VAMC approved disinfectant or equal. 7. Control Cube: Portable Ceiling Access Module, Kontrol Kube Jr. with heavy duty vinyl enclosure as manufactured by Fiberlock Technologies inc. 680 Putnam Ave. Cambridge MA F. Barriers 1. Closed door with masking tape applied over the frame and door is acceptable for projects that can be contained 2. Construction, demolition or reconstruction not capable of containment within a single room must have the following barriers erected. a. Airtight plastic barrier that extends from floor to ceiling. Seams must be sealed with duct tape to prevent dust and debris from escaping.

5 b. Drywall barriers erected with joints covered or sealed to prevent dust and debris from escaping. c. Seal all penetrations in existing barrier airtight. d. Barriers at penetration of ceiling envelops, chases and ceiling spaces to stop movement of air and debris. e. Anteroom or double entrance openings that allow workers to remove protective clothing or vacuum off existing clothing. f. At elevator shafts or stairways within the field of construction. g. Overlapping flap minimum 2 feet wide at polyethylene enclosures for personnel access. G. Implementation 1. Implement the requirements of VAMC s Infection Control Risk Assessment (ICRA) team. ICRA Group may monitor dust in the vicinity of the construction work and require the Contractor to take corrective action immediately if the safe levels are exceeded. 2. Establish and maintain a dust control program as part of the contractor s infection preventive measures in accordance with the guidelines provided by ICRA Group as specified here. Prior to start of work, prepare a plan detailing project-specific dust protection measures, including periodic status reports, and submit to Resident Engineer for review for compliance with contract requirements in accordance with Section , SHOP DRAWINGS, PRODUCT DATA AND SAMPLES. 3. All personnel involved in the construction or renovation activity shall be educated and trained in infection prevention measures established by the medical center. 4. Medical center Infection Control personnel shall monitor for airborne disease (e.g. aspergillosis) as appropriate during construction. A baseline of conditions may be established by the medical center prior to the start of work and periodically during the construction stage to determine impact of construction activities on indoor air quality. In addition: a. The Resident Engineer and VAMC Infection Control personnel shall review pressure differential monitoring documentation to verify that pressure differentials in the construction zone and in the patientcare rooms are appropriate for their settings. The requirement for negative air pressure in the construction zone shall depend on the location and type of activity. Upon notification, the contractor shall implement corrective measures to restore proper pressure differentials as needed. b. In case of any problem, the medical center, along with assistance from the contractor, shall conduct an environmental assessment to find and eliminate the source. 5. In general, following preventive measures shall be adopted during construction to keep down dust and prevent mold. a. Dampen debris to keep down dust and provide temporary construction partitions in existing structures where directed by Resident Engineer. Blank off ducts and diffusers to prevent circulation of dust into occupied areas during construction. b. Do not perform dust producing tasks within occupied areas without the approval of the Resident Engineer. For construction in any areas that will remain jointly occupied by the Medical Center and Contractor s workers, the Contractor shall: 1. Provide dust proof fire-rated temporary drywall construction barriers to completely separate construction from the operational areas of the hospital in order to contain dirt debris and dust. Barriers

6 shall be sealed and made presentable on hospital occupied side. Install a self-closing rated door in a metal frame, commensurate with the partition, to allow worker access. Maintain negative air at all times. A fire retardant polystyrene, 6-mil thick or greater plastic barrier meeting local fire codes may be used where dust control is the only hazard, and an agreement is reached with the Resident Engineer & ICRA Team. 2. HEPA filtration is required where the exhaust dust may reenter the breathing zone. Contractor shall verify that construction exhaust to exterior is not reintroduced to the medical center through intake vents, or building openings. Install HEPA (High Efficiency Particulate Accumulator) filter vacuum system rated at 95% capture of 0.3 microns including pollen, mold spores and dust particles. Insure continuous negative air pressures occurring within the work area. HEPA filters should have ASHRAE 85 or other pre-filter to extend the useful life of the HEPA. Provide both primary and secondary filtrations units. Exhaust hoses shall be heavy duty, flexible steel reinforced and exhausted so that dust is not reintroduced to the medical center. 3. Adhesive Walk-off/Carpet Walk-off Mats, minimum 600mm x 900mm (24 x 36 ), shall be used at all interior transitions from the construction area to occupied medical center area. These mats shall be changed as often as required to maintain clean work areas directly outside construction area at all times. Adhesive walk off / carpet walk off mats at each entrance, exit, and in the anteroom shall be checked and replaced as necessary to maintain and control construction dust and debris from being tracked through the facility. Failure to comply may require VA to shutdown construction operations until the necessary corrections are made. 4. Vacuum and wet mop all transition areas from construction to the occupied medical center at the end of each workday. Vacuum shall utilize HEPA filtration. Maintain surrounding area frequently. Remove debris as they are created. Transport these outside the construction area in containers with tightly fitting lids. 5. The contractor shall not haul debris through patient-care areas without prior approval of the Resident Engineer and the Medical Center. When, approved, debris shall be hauled in enclosed dust proof containers or wrapped in plastic and sealed with duct tape. No sharp objects should be allowed to cut through the plastic. Wipe down the exterior of the containers with a damp rag to remove dust. All equipment, tools, material, etc. transported through occupied areas shall be made free from dust and moisture by vacuuming and wipe down. 6. Using a HEPA vacuum, clean inside the barrier and vacuum ceiling tile prior to replacement. Any ceiling access panels opened for investigation beyond sealed areas shall be sealed immediately when unattended. 7. There shall be no standing water during construction. This includes water in equipment drip pans and open containers within the construction areas. All accidental spills must be cleaned up and dried within 12 hours. Remove and dispose of porous materials that remain damp for more than 72 hours. 8. At completion, remove construction barriers and ceiling protection carefully, outside of normal work hours. Vacuum and clean all surfaces free of dust after the removal. H. Final Cleanup: 1. Upon completion of project, or as work progresses, remove all construction debris from above ceiling, vertical shafts and utility chases that have been part of the construction.

7 2. Perform HEPA vacuum cleaning of all surfaces in the construction area. This includes walls, ceilings, cabinets, furniture (built-in or free standing), partitions, flooring, etc. 3. All air ducts shall be cleaned prior to final inspection. Perform final clearance analysis prior to reentering area. I. Other requirements: 1. Temporary construction barriers and closures above ceilings shall be dust tight. 2. Removal of debris shall be in tightly covered containers. 3. Adhesive mats or carpets at barricade entrances and in the anteroom shall be kept clean and changed daily, or as necessary, to prevent accumulation of dust. 4. Any dust tracked outside of barrier shall be removed immediately. Cleaning outside barrier to be by HEPA filtered vacuum or damp mop. 5. Any ceiling access panels opened for investigation beyond sealed areas shall be replaced immediately when unattended. 6. Block off all existing ventilation ducts within the construction area. Method of capping ducts shall be dust tight and withstand airflow. 7. When openings are made into existing ceilings, use Control Cube or provide polystryrene enclosure around ladder sealing off opening, fitted tight to ceiling and floor. Provide thorough cleaning of existing surfaces that become exposed to dust. 8. Removal of construction barriers and ceiling protection shall be done carefully, outside of normal work hours. Vacuum and clean all surfaces free of dust after the removal. 9. When access panels are opened in occupied areas for work above ceilings. Use control Cube or polyethylene enclosure around ladder sealing off opening, fitted tight to ceiling and floor. 10. All vacuuming outside areas not under negative pressure to be with a certified HEPA filtered vacuum. 11. Construct anteroom to maintain negative airflow from clean area through anteroom and into work area. 12. Maintain equipment including mops, brooms, buckets, and clean wiping rags for cleaning fine dust from floors in adjacent occupied areas. 13. Cleanup dust tracked outside of construction area immediately. J. Specific Infection Control Measures by Project Class 1. Class I a. Execute work by methods to minimize raising dust form construction operations. b. Immediately replace any ceiling tile displaced for visual inspection c. Cleanup and disposal will be done following measures outlined in section H. Cleaning Procedures

8 2. Class II a. Provide active means to prevent air-borne dust from dispersing into atmosphere b. Water mist work surfaces to control dust while cutting c. Seal unused doors with masking tape d. Block off and seal air vents e. Wipe work surfaces with approved disinfectant 3. Class III a. Obtain Infection Control Permit from Infection Control Section before construction begins. b. Isolate HVAC system in area where work is being done to prevent contamination of duct system. c. Complete all critical barriers before construction begins or implement control cube method. d. Maintain negative air pressure within work site utilizing HEPA equipped air filtration units. e. Contain construction waste before transport in tightly covered containers f. Cover transport receptacles or carts. Tape covers. g. Wet mop and/or vacuum with HEPA filtered vacuum before leaving work areas. h. Place dust mat at entrance and exit of work area. i. Remove isolation of HVAC system in areas where work is being performed. 4. Class IV a. Obtain Infection Control Permit from the VAMC's Infection Control Section before construction begins. b. Isolate HVAC system in area where work is being done to prevent contamination of duct system. c. Complete all critical barriers or implement control cube method before construction begins. d. Maintain negative air pressure within work site utilizing HEPA equipped air filtration units. e. Seal holes, pipes, conduits, and punctures appropriately. f. Construct anteroom and require all personnel to ass through this room so they can be vacuumed using an HEPA vacuum cleaner before leaving work Site or they can wear cloth or paper coveralls that are removed each time they leave the work site. g. All personnel entering work site are required to ear shoe covers. Shoe covers must be changed each time the worker exits the work Area. h. Provide adhesive walk-off mats an entrance to work Area within the anteroom. Replace used mats with new mats in accordance with manufacturer s recommendations. i. Do not remove barriers from work area until completed project is inspected the Safety and Infection Control Sections and thoroughly cleaned by Environmental Management Section. j. Vacuum work area with HEPA filtered vacuums. k. Wet mop area with disinfectant. l. Remove barrier materials carefully to minimize spreading of dirt and debris associated with construction. m. Contain construction waste before transport in tightly covered containers. n. Cover transport receptacle or carts. Tape covering. o. Remove isolation of HVAC system in areas where work is being performed. 11. Place of Performance. Work will be performed on a Government site at the VA San Diego Healthcare campus in La Jolla, California The principal performance of work will take place on the VA San Diego Healthcare campus (building 1, third floor, East wing, room 3209,3209A).

9 12. Period of Performance. Period of performance is March 2016 to April Delivery Schedule. See period of performance.