Attachment B - SOW Pharmacy USP 797800.docx

590-100 Renovate Pharmacy USP 797/800 and Install USP Mobile Trailer

7-23-2020

Design/Build SCOPE OF WORK Renovate Pharmacy USP 797/800 and Install USP Mobile Trailer Project 590-100 VA Medical Center Hampton, VA

PROJECT IDENTIFICATION

Project Title: Renovate Pharmacy USP 797/800 and Install USP Mobile Trailer

Project Location: 100 Emancipation Drive, Hampton, VA 23667

PROJECT DESCRIPTION

VAMC is soliciting the expertise of an A/E firm to design/Build (DB) for the construction, and renovation of the Pharmacy Area in the Hampton VA Medical Center (VAMC), to meet and comply with the new U.S. Pharmacopeial Convention (USP), USP 800 and 797 codes, regulations, requirements, and compounding standards. In addition, the firm shall design, procure and install a mobile USP trailer to be utilized as temporary compounding space during construction and to remain in place for future contingency plan.

Hampton VA Medical Center contracted a firm to develop a site assessment report related to the USP 797/800 compliance issues related to the main Medical Center Pharmacy spaces. This report can be used as a guide to help develop the design need for USP 797/800 compliance – but shall not be the only considerations taken when designing for USP 797/800 compliance. The Final Assessment report is included as an attachment to this scope of work (Attachment 001).

The DB will combine the findings from the original report, updated best practice information on pharmacy technology, updated USP 797/800 compliance information, and lessons learned from other VISN facilities undergoing similar upgrades to develop the design. Design shall comply with the VA Technical Information Library (TIL). Where the TIL and USP are in conflict, the contractor shall identify the conflict immediately to the COR for a determination. All current USP standards remain effective and the design team shall maintain knowledge and compliance with all other current and impending standards (ex. 795,797, 800, etc.).

The DB shall also procure, design and install a mobile USP trailer at the most cost-effective location shown on Attachment 002. During the initial design, if identified, an additional site location could be considered if shown to be more cost effective and/or feasible. The DB will be responsible of designing the site preparation for the trailer and the installation of the trailer in the approved by VA location. The trailer installation shall be completed before DB start construction in the renovation area and will remain onsite and operational at the completion of the project. The DB shall obtain the necessary certifications to operate the temporary trailer prior to the VA taking possession. The contractor shall be responsible during construction of the renovation area, while the VA shall be responsible and take ownership after renovation area is accepted in order to maintain the operational certification of the trailer.

The upgrades specific to this scope of work include renovating existing space in Building 110B ground floor to meet USP 797/800. Areas include but are not limited to the following location(s): storage areas, anteroom, compounding(buffer) rooms, and other associated existing pharmacy space. Upgrades include but are not limited to the following items: heating, ventilation, and air conditioning (HVAC) systems and controls, low voltage systems, plumbing, fire protection, architectural, and electrical systems.

Figure 1 – Existing USP‐797/800 Pharmacy Location/Layout to renovate

General Design Requirements:

1. The Design Build team shall develop a formal schematic design, design development, construction documents and submissions, to include construction cost estimates in accordance with the VA’s master construction guidelines, outlined in the Technical Information Library (TIL), located here: https://www.cfm.va.gov/TIL/spec.asp, and also in accordance with local VAMC construction specifications, and USP 795, 797, and 800 guidelines.

2. Prior to beginning the construction phase of the project – the design documents shall be at 95% complete (minimum) and the project shall have the following VA approved documents:

a. Construction schedule

b. Construction quality and safety plan

c. Construction phasing plan

d. Interim life safety measures (ILSM).

e. Infection control risk assessment (ICRA).

f. Pre‐Construction Risk Assessment (PCRA).

3. The DB shall conduct a survey of the VA facility and all areas where work will be conducted.

4. The DB shall provide a design for a renovation of existing (GROUND FLOOR) pharmacy space and site preparation design for the mobile USP 797/800. The DB Contractor and the Hampton VA staff shall work together to provide space and square footages similar to the Figures 1 previously included in this document.

5. This renovation shall include, at a minimum, the items included in the assessment provided in Attachment 001.

6. The DB shall completely survey all existing spaces affected by the renovation. Survey shall include architectural, electrical, mechanical (including medical gases), structural, and low voltage systems.

7. The DB shall meet with site staff to review details of the equipment drawings and to gather comments after each design submission (SD, DD, CD). The Contractor shall include Facilities Engineering, Pharmacy, and Safety in all design meetings. The Contractor shall also plan for a kick‐off meeting with Facilities Engineering and Pharmacy to walk the site, pull as‐built drawings, review design requirements, and verify understanding of the full scope of the project requirements.

8. New and modified building automation controls shall be included to ensure all systems are operational.

9. Environmental conditions shall be maintained to other spaces.

10. Design documents shall clearly show all demo, existing, re‐located, and new raceways, wireways, and cabling to/from equipment, lights, medical gases, monitors, sprinkler heads/distribution lines, smoke detectors, electrical outlets, patient lifts, HVAC grilles, speakers, etc.

11. Design documents shall clearly show all infection control requirements. The DB shall coordinate with the station multi‐disciplinary committee and infection control prevention staff to develop and design the infection control risk assessment (ICRA).

12. Design shall include a renovation phasing plan. Phasing shall be kept to a minimum and the DB shall determine the feasibility of this based on the number of infrastructure upgrades required for the space and discussions with the VA.

13. Provided phasing if feasible, it shall be coordinated with the infrastructure modifications to keep each phase functioning during construction.

14. Discussions during design will assist in the development of acceptable phasing areas and potential areas of concern that may require off‐hours work.

15. Energy savings is a goal for the VA. The design should incorporate features that would minimize energy use such as LED lighting, occupancy sensor switches, and other efficient means to minimize energy use as long as it doesn’t affect USP 797/800 compliance.

Discipline Specific Requirements:

Architectural

a. Design and construction shall include finishes for immediate and adjacent spaces affected by construction.

b. Design and construct all spaces using current VA design standards and design standards specific to the site. DB shall field verify all room measurements and impacted existing conditions.

c. DB shall provide code compliance review. Drawing set shall include code analysis sheet.

i. Provide a separate Life Safety code compliance drawing – this drawing shall show the fire and smoke barrier boundaries for the associated areas.

d. Doors and Door Hardware

i. The VA Design and Program Guides provide guidance on door hardware and guidance shall be followed unless facility guidance alters this guidance.

ii. The VA shall receive a narrative of each hardware group used detailing how the door functions in relation to the hardware/programming that is on the specified door.

iii. Provide door and hardware schedules on appropriate drawings.

e. Reflected ceiling plan shall show structural support, ceiling tiles/construction, overhead lighting, HVAC, sprinklers, speakers, detectors, RFID, etc.

f. Provide required maintenance and servicing clearances. Clearly indicate on floor plan.

g. Provide ceiling openings for maintenance access as required.

i. Special attention shall be given to areas that have a gypsum board ceiling to ensure access to all required equipment is available.

h. DB shall design and construct all wall blocking for equipment mounting.

i. DB shall be provided with specific purchase orders that will describe accessory items. DB shall be responsible for locating, detailing, and building accessory mounting systems.

j. DB shall coordinate electrical raceways and floor penetrations with all other work.

k. Lighting and structural support modifications shall be included in the design and construction.

l. Relocations and modifications of HVAC, electrical and plumbing shall be included in the design and construction, as necessary to bring up to code or as needed to support new equipment.

m. New data and phone cabling shall be included in the design and construction.

Interior Design

a. DB shall work with the VA Interior Designers for finish schedule. Provide color board for each site when finishes have been selected.

b. USP guidance shall also be reviewed during selection of finish material to verify compliance. All code compliance outweighs staff preference during material selection.

Structural

a. DB shall be responsible for design and detail of floor, wall, and ceiling structures in accordance with the weights, moments, and forces as shown in design documents.

b. The DB shall consider the work on the crawlspace/interstitial and demolition shall minimize the removal of existing structural steel and shall include the addition of structural steel when a loss occurs.

Electrical/Low Voltage/Security Systems

a. All existing electrical systems and components shall be field‐verified by the DB electrical engineer.

b. Pharmacy areas will be required to be fed by critical/emergency power to include HVAC components that are serving these areas.

c. All electrical work shall meet current National Electrical Code (NEC) requirements.

d. USP may have additional requirements that shall be met during design and verified by the DB.

e. Design and Construction shall include all electrical plans, elevations, sections, details, diagrams, and schedules showing existing power system, electrical closets, power distribution systems, auxiliary power systems, new power systems, lighting fixtures, and outlets.

f. DB shall show all necessary normal and emergency service panels, circuits, cabling, wiring, conduit, relays, switches, and disconnects for a complete and usable electrical system to support the new suite including any new HVAC systems and ancillary equipment. All components shall be identified and labeled on design drawings.

g. Incoming power supply for equipment shall be dedicated back to source, isolated, and insulated from any other equipment such as elevators, generators, HVAC systems, etc.

h. DB shall include all low voltage systems necessary to meet code and VA standards. The low voltage systems include; fire alarm, public address, voice, data, wireless systems, and Radio‐ frequency identification (RFID)

i. Utilize site‐specific construction specifications for low voltage and telecommunications.

j. DB shall coordinate electrical raceways and floor penetrations with all other work.

k. DB shall coordinate to ensure the Fire Alarm System meets requirements.

l. DB shall include fire alarm system with full area smoke coverage that is compatible with system at specific site.

m. DB shall include necessary cable trays/ducts/conduits, correctly sized and located in accordance with vendor equipment drawings.

n. DB shall include circuit breakers, emergency off button, warning light and door switch connections.

o. DB shall include layout for equipment cabling. There are cable length limitations that shall be assessed and described on drawings. Design shall include raceways and floor penetrations.

p. Electrical specifications shall include requirement to test and verify equipment power supply to ensure it meets specifications.

q. DB shall include all grounding and bonding requirements.

r. Design shall include all lighting, switching, and associated power for area. Designer shall research current lighting best practices to promote efficient and effective workflow and incorporate into the design.

s. Consider LED lighting in all areas, A/B switching in office/administrative areas, occupancy sensors in areas of intermittent use, task lighting, and smooth/sealed light fixtures in all areas required by various code requirements.

Mechanical

a. Field verify existing conditions. Design for installation and replacement/repair of AHU, ductwork, VAV boxes, controls, valves, and all other components, as needed.

b. The DB shall investigate the sizing and routing of the existing chemo hood exhaust duct to determine suitability for reuse. If the existing duct is not adequately sized it shall be replaced or a new duct installed with the DB team providing alternative routes for review by the VA.

c. In designated areas, the design engineer shall take into consideration maintenance of pressure differentials and calculate actual required airflow differences as required to maintain said pressures. The designer shall include elements such as tightness of room, door, and window crack leakage areas which impact room pressurization. The design intent shall be to provide sufficient differential pressure as required by USP 797/800 between the subjected room and adjacent space to maintain proper airflow direction, as well as ensuring proper pressure reading by the space pressure monitoring sensors, and avoiding false alarms.

d. Design shall include terminal HEPA filtration into required pharmacy rooms. (Buffer, anteroom, HD storage, etc.)

e. All ductwork and ductwork appurtenance and equipment downstream of the HEPA filters for required pharmacy applications shall be stainless steel. This includes, but is not limited to, dampers, VAV boxes, ductwork, diffusers, etc.

f. Design shall provide adequate means of in‐situ testing of the HEPA filters.

g. Provide for testing of the HEPA filter after installation. Allowances shall be made for the ability to provide aerosol photometry tests (commonly known as DOP/PAO testing) of the HEPA filters in situ. This test utilizes an aerosol photometer as the measuring device and an aerosol generator to produce an aerosol challenge to the filter. The aerosol challenge must be homogeneously mixed before entering the filter. Provide sufficient upstream straight run of duct or a dispersion plate at the HEPA housing. All HEPA filters shall be tested in situ, testing of HEPA filters shall be included in project specifications.

h. DB shall include all mechanical plans, elevations, sections, details, schedules for controls, sequence of operations, pumps, valves, piping systems, gages and other devices to support the installation of the new mechanical systems.

i. DB shall study the capacity of existing air handling unit to support the required air exchanges and replace if necessary.

j. Design for appropriate amount of air exchanges in accordance with VA HVAC Design Manual and USP documentation.

k. DB shall design and install necessary HVAC units to satisfy heating and cooling requirements to serve the equipment and people inside the space including summer and winter humidity.

l. Design submission shall include psychometric charts to show environmental conditions compliance at design points as well as part load conditions, for both heating and cooling. Provide estimate of the number of hours when either temperature or humidity will be out of range over 8760 hours of operation.

m. DB shall design and install Building Automation System (BAS) infrastructure and software as required for any new mechanical equipment.

n. Rebalance existing supply, return, and exhaust for the entire pharmacy area and any adjacent spaces that were affected during construction. Rebalance air handler as required.

o. A complete “BAS Design” shall be provided, including; sequence of operations, instrumentation drawings, and points list.

p. The design shall include all safety components required by the current ANSI/ASHRAE Safety Code.

q. DB shall include any required modifications to the fire sprinkler system.

r. Contractor shall provide a commissioning plan with checklists for all HVAC equipment.

s. Contract shall include sinks, bathrooms, piping, connections to existing facility piping, valves, drains, etc.

t. Piping design shall comply with VA Plumbing design manual located at: http://www.cfm.va.gov/til/dManual/dmPlbg.pdf DB shall note the design requirements for Legionella prevention and include those in this design.

Proposed Schedule (calendar days):

· Notice to Proceed – D‐Day

· Design Initiated – D+14 calendar days

· SD Submission – D+45 calendar days

· SD Review by VA Complete – D+66 calendar days

· DD Submission – D+96 calendar days

· DD Review by VA Complete – D+117 calendar days

· CD Submission – D+147 calendar days

· CD Review Completed by VAMC – D+168 calendar days

· Documents Complete (CD issue) – D+198 calendar days

· Mobilization Complete – D+228 calendar days

· 7 Submittals Complete – D+228 calendar days

· Construction Complete – D+320 calendar days

Total Period of Performance – 320 calendar days after issuance of Notice to Proceed (NTP)

APPLICABLE REFERENCES

The references listed below are not intended to be all inclusive. The Contractor shall ensure that all applicable references and/or standards are followed.

Attachments:

1. SOW ‐ Attachment 001 ‐ Site assessment report

2. SOW ‐ Attachment 002 ‐ options location mobile pharmacy

NOTE: All Contractors’ personnel, including subcontractors, shall be required to undergo a COVID-19 Screening. Each person is required to complete the Coronavirus Screening upon entering the facility and worksite thereof and/or while on the hospital campus.

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