36C26118R0541-0009002.pdf

STATEMENT OF WORK

FOR

DESIGN BUILD SERVICES

IPP USP 797/800 Compliance

PROJECT 654-18-831

2/15/2018 (Revised 7/24/2018)

VA SIERRA NEVADA HEALTH CARE SYSTEM

RENO, NEVADA

IPP USP 797/800 Compliance

PROJECT 654-18-831

DESIGN BUILD SERVICES

1. GENERAL

1.1. The Design Build (DB) contractor shall furnish:

1.1.1. Design: all design (AE) services, materials, supplies, equipment, investigations and project supervision, and construction period services associated with this contract. Design shall meet VA Design Guides and Design Criteria and VA Master Specifications. Design shall follow all current applicable codes, including International Building Codes (IBC), National Fire Protection Association (NFPA), Occupational Safety and Health Administration (OSHA) and all USP 797/800 standards/requirements.

1.1.2. Construction: all labor, materials, supervision, and administration for the construction phase of this contract.

1.1.3. Provide and install temporary leased USP 797/800 compliant pharmacy compounding trailer or equal temporary removable facility or install modular room into existing VA Space for VA staff pharmacy use during the construction period (the term ‘trailer’, ‘equal temporary removable facility’, or ‘modular room into existing VA space’ will be used interchangeably for ‘temporary swing space’). Provide all labor, materials, supervision, and administration for the installation of the temporary swing space. Temporary swing space is to have all necessary HVAC equipment, exhaust equipment, compounding hood equipment, electrical, plumbing, data/comm and furniture for a complete ready to function pharmacy rooms. The temporary swing space is to be connected to medical center electrical system. Contractor is to furnish design services for site selection, preparation, seismic requirements, electrical power distribution components, HVAC equipment and all labor and materials to deliver, install and connect temporary swing space. This temporary swing space for pharmacy is to be a turn-key installation. The temporary swing space is to have an entry room in the center with a non-hazardous buffer room (ISO-

7) with anteroom (ISO-8) on one end and a hazardous buffer room (ISO-7) with anteroom (ISO-7) on the other. The trailer is to be approximately 55’ by 8.5’. Modular rooms are to fit inside a space 32’x14’. The trailer and the modular room is to have an entry room in the center with a non-hazardous buffer room (ISO-7) with anteroom (ISO-8) on one end and a hazardous buffer room (ISO-7) with anteroom (ISO-7) on the other. The trailer will have all the necessary equipment and space on the trailer. The modular rooms will have all the necessary equipment and space inside the building or on the roof. Both temporary swing space methods with have distant utility system connections.

Contractor will provide all necessary periotic maintenance required to maintain temporary swing space in operational status that meets USP 797/800 compliance requirements.

1.1.4. For the temporary swing space, the contractor is responsible to provide a fully compliant USP 797/800 certified cleanroom with a full guarantee to certify and meet USP and Federal requirements. Certification is to be completed by a government (VA) approved third party. Contractor is required to remedy all issues identified by third party before rooms are turned over for use to the government. Compliance certification is to include temporary and/or remodeled rooms. Copy of certification is to be provided before final inspection

1.2. The project is located at the Sierra Nevada Health Care System located at 975 Kirman Ave, Reno, NV, 89502.

1.3. Estimated Construction Contract Price (design-to limitation): $350,000.00

1.4. Site is located at the VA Sierra Nevada Health Care System (VASNHCS) in Reno, NV.

1.5. The DB shall provide one proposal in three sections: a design proposal and a construction proposal for the remodeled space. A proposal for the temporary trailer (temporary swing space) and the site preparations to install the trailer (temporary swing space).

1.5.1. Design proposal (AE) shall be a complete and detailed fee proposal for completing all field investigation, design analysis, construction drawings, specifications, construction period services, inspections, testing, and other services required under this Statement of Work. Use the form provided by the

VA.

1.5.2. Construction proposal shall be presented in a schedule of values format to be utilized during the construction portion.

2. SCOPE

2.1 The design must renovate and upgrade the pharmacy rooms to meet all USP 797/800 standards and requirements for sterile compounding and sterile compounding of hazardous drugs. The design will include HVAC systems, hot/cold domestic water, waste drains and building management program modifications. Specific design and construction elements include:

2.1.1. Modification and upgrade of HVAC system serving the pharmacy rooms (G2640, G2642, G2644, G2656) to meet the USP 797/800 air flow and static pressure criteria. Modify and upgrade of HVAC system serving the pharmacy Bulk Storage and Unpacking room (G2656) to meet the USP 800 air flow and negative static pressure criteria. This includes any changes, modifications or upgrades to ducting, air handler controls, grilles, filters, pressure sensors and pressure controllers. The HVAC system must be modified to convert the system from constant air volume (CAV) boxes to actuated venturi valves that can adapt to a dynamic pressure environment that precisely controls static pressure in the rooms to the USP 797/800 criteria. The new controllers and sensors shall be directly compatible with the existing BMS (JCI Metasys). Design shall include any necessary programing and computer graphics updates to the existing building management system (NAE’s, AHU controllers, Metasys Computer in boiler plant).

2.1.2. Renovation of the HVAC system will require selective demolition and replacing of existing ceiling system as necessary.

2.1.3. Perform a T&B prior to design to establish baseline conditions and incorporate necessary adjustments/modifications to all existing duct branches affected by this project to match the baseline conditions.

2.1.4. All repairs to walls, ceilings, door, and door frames are to match existing.

2.1.5. All new electrical is to meet VA specifications and NFPA 70 for hospital use.

Include all necessary electrical for new HVAC equipment back to existing building electrical source (home runs to MCC’s).

2.1.6. Disconnect and remove existing hood from clean room G2644 (left hood when facing both units.) Turn hood over to government and relocate to designated onsite storage.

2.1.7. Demolish and remove existing sink. Install new floor mount stainless steel deep scrub sink, Surgikleen GAT-SURGI-KLEEN-1000-FM or equal on opposite wall from entry door in pharmacy anteroom G2642 to meet USP 797/800 criteria. New sink shall have temperature control, additional back splash panel and storage shelf options. Core drill as necessary to connect with existing hot/cold domestic water and waste drains below slab.

2.1.8. Include the installation of a wall mounted HEPA filtered pass through air lock to replace the existing between pharmacy work room and Clean room G2644. Pass thru to be Clean Air Products; CAP 18WHF or equal. Include alternate options (dedicated exhaust vent).

2.1.9. Include all necessary design/construction features for a complete project.

2.1.10. There is not any expansion (new square footage) associated with this project.

2.1.11. Erect a plastic construction barrier as necessary to prevent dust infiltration into the pharmacy area.

2.1.12. Adjacent areas must remain fully operational.

2.1.13. ICRA must be negative pressure. Provide alternate options.

2.1.14. All construction work is to be during normal hours, 7:30AM to 4:00PM. Any work that creates noise loud enough to impact patient operations, disturb patients or staff is to be accomplished after working hours.

2.1.15. Construction drawings to denote egress, construction site access, dumpster location, storage areas and temporary barriers. Parking is limited to offsite.

2.1.16. All outages and outages are after hours. Submit outage notice 14 days in advance of the outage date for approval.

2.1.17. Any modifications to lighting and electrical systems.

2.1.18. Any modifications to fire alarm and fire sprinkler systems.

2.1.19. All finishes that need to be replaced or repaired are to match existing finishes and comply with USP 797 and USP 800.

2.1.20. All signage changes and modifications are included in this contract.

2.1.21. Design shall include all requirements from the “VA Reno – Local Requirements for A/E Designs” document as applicable.

2.2. The scope of AE services shall include the following:

2.2.1. Preliminary site investigation of the planned project location and temporary trailer (temporary swing space) site location.

2.2.2. Development of a complete stamped and signed design package including all appropriate trades which, at a minimum, should include: architect, civil, structural, mechanical, electrical and plumbing for pharmacy area.

2.2.3. Development of a complete stamped and signed design package including all appropriate trades which, at a minimum, should include: architect, civil, structural, mechanical, electrical and plumbing for temporary pharmacy trailer (temporary swing space) site preparation and installation of trailer (temporary swing space).

2.2.4 Construction period services including, but not limited to: submittal review, RFI review and responses, weekly construction site visits, and reviews and emergency phone or on-site responses as issues arise.

3. SCHEDULE FOR DESIGN BUILD

ACTION CALEND

AR DAYS

AFTER …

Kick-Off Mtg/Preliminary Site Review 5 Notice to Proceed

35% Design Submittal & Mtg 20 Kick Off Meeting

35% VA Comments 7 35% Design Submittal & Mtg

65% Design Submittal & Mtg 20 35% VA Comments

65% VA Comments 7 65% Design Submittal & Mtg

100% Design Submittal & Mtg 20 65% VA Comments

100% VA Comments 7 100% Design Submittal & Mtg

Bid Documents Submittal 5 100% VA Comments

ACTION CALEND

AR DAYS AFTER …

Start Site Preparation for Trailer or Modular Rooms. 27 65% Design Submittal & Mtg

(Note Schedule Overlap)

Trailer Ready for Occupation 7 Start Site Preparation for Trailer or Modular Rooms

Pharmacy Area is Available for Construction Activities. 5 Trailer or Modular Rooms

Ready for Occupation

Pharmacy Area Construction Completed and Operational. 60 Pharmacy Area is Available for Construction Activities.

Certify 797/800 Compliance 7 Pharmacy Area Construction Completed and Operational

Vacate and Decommission Trailer/Modular Rooms 5 Certify 797/800 Compliance

Remove Trailer or Modular Rooms from Site and Return Site to Pre-existing Condition 7 Vacate and Decommission

Trailer or Modular Rooms

Contract End Date 7 Remove Trailer or Modular Rooms from Site and Return Site to Pre-existing Condition

TOTAL CONSECTUTIVE DAYS 150

3.1. All design review meetings to be held at the VA facility in Reno.

4. DESIGN REQUIREMENTS

4.1. VA design instructions, guide specifications and reference material are available at the

VA Office of Facilities Management website http://www.cfm.va.gov/TIL/. This design shall substantially meet all VA requirements.

4.2. Utilize AE Submission Instructions, Volume C as detailed at VA website http://www.cfm.va.gov/cfm/contract/ae/aesubmin.doc unless otherwise changed by this

SOW.

4.3. Site Design Data. The AE shall perform field reconnaissance, surveys, and site investigations required to obtain engineering information and design data for the accomplishment of the contract documents per this Statement of Work.

5. DESIGN DELIVERABLES

5.1. Construction Schedule. A construction schedule indicating phasing, durations, and critical site visit milestones for the AE (and consultants).

5.2. VA Criteria Deviation Log. VA criteria must be strictly followed unless approved otherwise by the Contracting Officer. Any approved deviations must be maintained in a Deviation Log.

5.3. Submittal Register identifying every submittal required by the drawing specifications.

The AE shall provide a draft submittal register at the 100% drawing submittal and a final submittal with the Bid Documents.

5.4. Drawings and Specifications. The items specified below may not include all required deliverables. Provide other required deliverables as required in the VA’s Technical Information Library.

5.5. Submittals

5.5.1. Hard Copy: Specifications shall be single spaced, double sided, 3-hole

(3/8th inch holes) punch, in a notebook. Drawings shall be on 24-lb bond http://www.cfm.va.gov/TIL/ http://www.cfm.va.gov/cfm/contract/ae/aesubmin.doc paper, bound unless otherwise noted. Drawing size: full size 42x30, half size 22x16.

5.5.2. Electronic Files (AutoCAD, PDF, Word, etc). Must be provided in editable format. Electronic filenames shall include both the drawing/spec number and the drawing/spec name in the order (ex:

5.5.3. 35% Design Submission: Hard copy: 1 full-size set of drawings, specifications (table of contents indicating intended spec sections.), and construction schedule. Electronic: One CD containing separate files for each drawing in AutoCAD and PDF; construction schedule; specs in MS Word.

5.5.4. 65% Design Submission: Hard Copy: 1 full-size set of drawings, 1 half size, specifications (table of contents indicating intended spec sections), construction schedule. Electronic: One CD containing separate files for each drawing and rendering (in AutoCAD and PDF), construction schedule, specs in both MS Word and PDF, VA Criteria Deviation Log, etc.

5.5.5. 100% Design Submission: Hard copy: 1 full-size set of drawings, 1 half size, specifications; construction schedule. Electronic: Electronic: One CD containing separate files for each drawing and rendering (in AutoCAD and PDF), construction schedule, specs in both MS Word and PDF, VA Criteria Deviation Log, design calculations, etc.

5.5.6. Bid Documents: Hard copy: 1 full-size sets of drawings (one loose), 2 half size set of drawings; 2 sets of specifications; construction schedule; design calculations. Electronic: one CD containing: separate files for each drawing in AutoCAD and PDF; one fully bookmarked PDF file containing all the drawings; one Word file containing all the specification sections; a Word file for each specification section; one PDF file containing all the specification sections; a PDF file for each specification section, submittal log; VA Criteria Deviation Log, construction schedule; design calculations.

5.5.7. Record Drawings: Hardcopy: One set full-size 24-lb bond paper.

Electronic copy: two CDs each containing: each drawing to be a separate file, both in DWG and PDF (the DWG format must be unprotected to permit future editing); and one fully bookmarked PDF file containing all the drawings.

6. CONSTRUCTION SUPPORT SERVICES

6.1. The AE shall perform field reconnaissance, surveys, and site investigations required to obtain engineering information and design data for the accomplishment of the contract documents. Specific site visit milestones will be identified in the construction schedule

– textual trip reports are required within two days following the visit. In addition to scheduled visits (weekly production meetings and specific construction schedule milestones) unscheduled visits, Submittal and Shop Drawing Reviews. The DB A-E shall perform submittal reviews and provide recommendations for the range of acceptance to rejection. Unless otherwise agreed, the VA will determine final outcome of submittals.

6.2. Production Meeting participation. Weekly production meetings will be held at the job site. If the A/E is within a 60-mile radius of the jobsite, then face to face attendance is required by the A/E, otherwise, phone attendance is acceptable.

6.3. Project record drawings - The DB contractor will maintain a set of construction documents (field as-built drawings) to record actual construction changes during the construction process as required by the RFP specifications. The project record drawings will be available for review by the COR at all times.

6.4. Perform submittal and shop drawing reviews. The AE shall perform submittal reviews and provide recommendations for the range of acceptance to rejection. Responses shall be due within 14 calendar days of receipt.

6.5. Provide site inspection visits as requested by the Contracting Officer or COR and provide immediate on-site comments. Forward formal inspection reports to the COR no later than seven (7) calendar days after the site visit.

6.6. Review and prepare response to construction contractor RFIs forwarded by VA within seven (7) calendar days from receipt.

6.7. Review USP 797/800 compliance certification reports. Submit recommendations to the government within seven (7) calendar days from receipt.

7. RISK CONTROL

7.1. The VASNHS is an active hospital and therefore will require consideration to those areas with patients and staff.

7.2. The Contractor shall be responsible for the administration and management of all aspects of this SOW. This includes responsibility for all Contractor employees, subcontracts, agents, and anyone acting for or on behalf of the Contractor.

7.3. The Government is authorized to restrict the employment under the contract of any Contractor employee or prospective Contractor employee, who is identified as a potential threat to the health, safety, security, general wellbeing, or operational mission of the installation and its population.

7.4. Contractor personnel shall present a neat appearance. Contractor personnel shall be easily recognizable while on the installation in conjunction with this contract. This shall be accomplished through the wear of distinctive clothing, overcoats, rain gear, or hats, bearing the company name or logo. The coloring or design of the items selected should be such that identifies personnel easily and quickly for reasons of safety and personal protection.

7.5. Contractor’s personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government.

7.6. All Contractor personnel are required to wear identification (I.D.) badges during the entire time they are on the VA grounds. See attached badge process.

7.7. The parties agree that the Contractor’s personnel working as a result of this contract shall not be considered VA employees for any purpose and shall be considered employees of the Contractor.

8. SECURITY

8.1. Contractors do not need and shall not be allowed access to any VA personnel or VA patients Personal Health Information (PHI) or Personally Identifiable Information (PII) in the performance of the requirements of this SOW. Additionally, the contractor does not need and shall not be allowed access to VA sensitive information in the performance of the requirements of this SOW.

8.2. The contractor shall not connect contractor-owned IT devices (laptop computer or remote connection from a contractor system) to a VA internal trusted (i.e., non-public) network. Computer certification and accreditation requirements do not apply, and a security accreditation package is not required.

8.3. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

9. APPLICABLE REFERENCES

# VA Standard Title/Section 1 Master Construction Specifications Index (PG-18-1) 2 VHA PROGRAM GUIDE (PG-18-3 Design and Construction Procedures) 3 National CAD Standard Details (PG-18-4) 4 Equipment Guide (PG-18-5) 5 Equipment Inspection Manual (Program Guide 7610.2) 6 Equipment Reference Manual (PG-18-6) 7 VA Handbook H-18-8, Seismic Design Requirements 8 Space and Facility Planning (PG-18-9) (Handbook 7610) 9 Design Manuals (PG-18-10) 10 Design Guides (PG-18-12) 11 Accessibility (PG-18-13) 12 Room Finishes, Door and Hardware Schedule (PG-18-14) 13 A/E Submission Instructions (PG-18-15) 14 A/E Design Submission Requirements (Submittal Guide PG-18-15) 15 Environmental Compliance Manual (PG-18-17) 16 Fire Protection Design Manual - Fourth Edition 17 VA Cost Estimating 18 Physical Security Design Manuals for VA Facilities - Mission Critical Facilities 19 VA Signage Design Guide 20 Sustainable Design and Energy Reduction Manual (Final Draft)

NATURAL DISASTERS NON-STRUCTURAL RESISTIVE DESIGN (formerly

CD-54)

22 International Building Code 2012 23 National Electric Code – Latest Edition 24 VHA Directive 1061 25 VA Plumbing Design Manual 26 VA OHI Report No. 13-01189-267

10. ATTACHMENTS

10.1. Site Location

10.2. Floorplan

10.3. Pharmacy project 654-07-177 record drawings

10.4. Current pharmacy HVAC Test and Balance