36E77619R0019-006.pdf

437‐18‐101 Renovate Pharmacy for USP 800 Compliance – Fargo 1‐08‐2019

Scope of Work (SOW) 1

Scope of Work for Design‐Build

Renovate Pharmacy for UPS 800 Compliance ‐ Fargo, ND Project Number 437‐18‐101

The United State Pharmacopeia (USP) has published its latest update to its standards for the practice and quality standards for handling hazardous drugs, “General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings” (USP 800), Attachment 001.

Under these new guidelines, upgrades must occur to current process to accommodate the safe handling of hazardous drugs. Handling these drugs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non‐sterile preparation of drugs.

VISN 23 chartered a USP 800 Assessment Team consisting of architects and engineers from industry and government agencies to develop a site assessment report related to the USP 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 800 compliance – but shall not be the only considerations taken when designing for USP 800 compliance. The Fargo USP 800 Final Assessment report is included as an attachment to this scope of work (Attachment 002).

The DB will combine the findings from the original report, updated best practice information on pharmacy technology, updated USP 800 compliance information, and lessons learned from other VISN facilities undergoing similar upgrades to develop the design. All current USP standards remain effective and the design team shall maintain knowledge and compliance with all other current standards (ex.

795,797, 800, etc.).

The upgrades specific to this scope of work include renovating existing space (BASEMENT LEVEL AND

FIRST FLOOR, ALONG WITH OTHER ANCILLARY SPACES AS DETERMIEND DURING DESIGN TO

ACCOMMODATE HVAC ISSUES, ETC.) to meet USP 800 before the compliance deadline, which is currently 01 December 2019. Areas include, but are not limited to the following location(s): storage areas, ante‐room, 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.

Scope of Work (SOW) 2

Figure 1 – Potential Basement USP‐800 Pharmacy Location/Layout

Work shall include, but shall not be limited to these additional items:

1. Pharmacy operations (hours of operation, work days, etc.) shall remain the same and be accounted for by the design‐build contractor.

2. Remove existing carpet in first floor pharmacy, replace with USP 800 compliant flooring.

3. Replace first floor shelving with similar shelving (with 18” clearance for fire sprinklers).

4. Remove dumbwaiter (at both inpatient and outpatient pharmacy locations).

5. Remove flooring/storage on West side of first floor pharmacy.

Scope of Work (SOW) 3

Figure 2 – Existing First Floor USP‐800 Pharmacy Location To Renovate

A. 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. A copy of the USP 795, 797, and 800 guidelines are in Attachments 001, 006 and 007.

2. The facility goal is to have a USP 800 compliant space prior to 01 December 2019. The DB shall work with the Fargo VA to try and meet this deadline or another mutually agreeable completion date.

3. Prior to beginning the construction phase of the project – the design documents shall be at 90% complete (minimum) and the project shall have the following VA approved documents:

a. Construction schedule

b. Construction phasing plan

c. Interim life safety measures (ILSM).

d. Infection control risk assessment (ICRA).

e. Pre‐Construction Risk Assessment (PCRA).

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

Scope of Work (SOW) 4

5. The DB shall provide a design for a renovation of existing (BASEMENT/1ST FLOOR) pharmacy space. The DB Contractor and the Fargo VA staff shall work together to provide space and square footages similar to the Figures 1 and 2 previously included in this document.

This renovation shall include, at a minimum, the following:

i. Demolition of identified spaces to allow construction of required spaces.

a. Demolition shall be detailed as to show what systems will remain functional during demolition

ii. Construction of a new sterile HD compounding room

a. These rooms shall have independent temperature and HVAC controls in order to maintain a negative pressure in this space, relative to surrounding areas. See USP 800 guidelines (Attachment 001) for specifics.

b. Follow USP‐800 for pressure relationships and the attached drawing. If conflicts arise seek VA clarification prior to proceeding with design or construction work.

iii. Construction of a new ante‐room which provides entry and egress to the new sterile (non‐HD) compounding room and to the new sterile HD compounding room.

a. This room shall have independent temperature and HVAC controls in order to maintain a negative pressure in this space, relative to the connecting hallway/work areas, positive in relation to the HD compounding rooms, and negative in relation to the non‐HD compounding room. See USP 797 and 800 guidelines for specifics (Attachments 001 and 007).

b. This room shall include a small housekeeping closet for storage of cleaning supplies for sterile processing rooms only. Coordinate size requirements with the Fargo VA staff.

c. Follow USP‐800 for pressure relationships and the attached drawing. If conflicts arise seek VA clarification prior to proceeding with design or construction work.

iv. Construction of a new HD storage room.

a. This room shall have independent temperature and HVAC controls to maintain a negative pressure in this space, relative to surrounding areas.

See USP 800 guidelines for specifics (Attachment 001).

b. Follow USP‐800 for pressure relationships and the attached drawing. If conflicts arise seek VA clarification prior to proceeding with design or construction work.

v. Construction of a new non‐sterile HD compounding room.

a. This room shall have independent temperature and HVAC controls to maintain a negative pressure in this space, relative to surrounding areas.

See USP 800 guidelines for specifics (Attachment 001).

b. Follow USP‐800 for pressure relationships and the attached drawing. If conflicts arise seek VA clarification prior to proceeding with design or construction work.

vi. The rooms detailed above shall have active pressure monitoring devices installed to be tied to the Building Automation System (BAS) and also provide the local pharmacy the ability to monitor the pressure at the device locally just outside each room.

Scope of Work (SOW) 5

6. Use of the existing HVAC unit is acceptable, but a dedicated stand‐alone air handling/HVAC unit should be investigated and provided as the first option for the compounding area. This unit shall have the ability to control the pressure in each individual room in accordance with the required pressure differences and air changes per hour (ACH) specified in USP 800 (Attachment 001), as well as temperature requirements as detailed in the VA HVAC Design Manual (November 2017) (Attachment 003).

7. The DB shall provide a design for a pill‐crushing (medication processing) area within the

Hazardous Non‐Sterile room.

8. The DB shall prepare a prioritized list of actions for construction based on the recommended configuration of the space within the existing pharmacy area.

9. The DB shall complete an analysis for tying into and/or relocating any utility or service line required to make the renovated area fully functional.

10. 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.

11. 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.

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

13. Environmental conditions shall be maintained to other spaces.

14. 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.

15. 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).

16. 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.

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

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

Scope of Work (SOW) 6

17. 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.

B. Discipline Specific Requirements:

1. 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. DB shall design door openings are adequate with a minimum door size of 39” wide x 78” high.

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

iii. 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.

iv. 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.

2. Interior Design

a. Interior design shall include finishes to provide a safe, comforting space for workers.

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

c. USP guidance shall also be reviewed during selection of finish material to verify compliance.

All code compliance outweighs staff preference during material selection.

Scope of Work (SOW) 7

3. 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 slab‐on‐grade (SOG) and demolition shall minimize the removal of existing structural steel and shall include the addition of structural steel when a loss occurs.

4. Electrical/Low Voltage/Security Systems

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

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

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

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

DB.

d. Design and Construction shall 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.

e. 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.

f. 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.

g. 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)

h. 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.

Scope of Work (SOW) 8

i. 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.

5. Mechanical

a. Field verify existing conditions. Design for installation and replacement/repair of 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 since the existing exhaust duct may not be removed until the new chemo hoods are operational. In all cases, chemo hood downtime must be kept to an acceptable minimum to meet VA needs and requirements.

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 (typically 0.01‐0.03 inches of water column or higher) 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.

j. Design for appropriate amount of air exchanges in accordance with VA HVAC Design Manual dated November 1, 2017 and USP documentation. Attachments 001 and 003.

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

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

h. Provide new Variable Air Volume (VAV) boxes with digital controls and incorporate them into the smoke control zoning as required.

Scope of Work (SOW) 9

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

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

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

l. Provide all necessary isolation valves. Include replacement of existing isolation valves that may need replacement due to age.

m. All equipment shall be specified to achieve the highest practical level of energy efficiency.

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

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

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

n. Design to include eyewashes where required.

o. 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.

C. Proposed Schedule (calendar days):

1. Notice to Proceed – D‐Day

2. Design Initiated – D+14 calendar days

3. SD Submission – D+45 calendar days

4. SD Review by VA Complete – D+59 calendar days

5. DD Submission – D+85 calendar days

6. DD Review by VA Complete – D+99 calendar days

3. CD Submission – D+123 calendar days

4. CD Review Completed by VAMC – D+137 calendar days

5. Documents Complete (CD issue) – D+151 calendar days

6. Mobilization Complete – D+185 calendar days 7 Submittals Complete – D+185 calendar days

8. Construction Complete – D+277 calendar days Total Period of Performance – 277 calendar days after issuance of Notice to Proceed (NTP)

D. Attachments:

1. SOW ‐ Attachment 001 ‐ USP 800 12‐01‐2017

2. SOW ‐ Attachment 002 ‐ VA Fargo USP 800 Assessment – Final

3. SOW ‐ Attachment 003 ‐ HVAC Design Manual ‐ Nov 2017

4. SOW ‐ Attachment 004 ‐ Pharmacy Service Design Guide ‐ April 2018

5. SOW ‐ Attachment 005 ‐ Lighting Design Manual ‐ December 2015

6. SOW ‐ Attachment 006 ‐ USP GC 795 Proposed Revision

7. SOW ‐ Attachment 007 ‐ Proposed Revisions GC 797

8. SOW ‐ Attachment 008A ‐ Pharmacy Floor Plans 1st Floor ‐ Existing

9. SOW ‐ Attachment 008B ‐ Pharmacy Floor Plans Basement ‐ Existing

10. SOW ‐ Attachment 008C ‐ Pharmacy Floor Plans Basement ‐ New Plan

11. SOW ‐ Attachment 009 ‐ VA Electrical Design Manual

Scope of Work (SOW) 10

12. SOW ‐ Attachment 010 ‐ Fargo Standard Finishes

13. SOW ‐ Attachment 011 ‐ Update Cameras VA Pharmacy Equipment List

14. SOW ‐ Attachment 012 ‐ Room Finish Door and Hardware Schedule

15. SOW ‐ Attachment 013 ‐ SEPS Questions 268 Pharmacy Service SPC

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