36E77619R0014-005.pdf

636-18-301 Correct USP 800 Deficiencies – Lincoln and Grand Island 20180811

Scope of Work (SOW) 1

Scope of Work for Design-Build Correct USP 800 Deficiencies – Lincoln and Grand Island

Project Number 636-18-301

1. 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.

2. 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.

3. Additionally, USP has published proposed updates to USP 795 “Pharmaceutical

Compounding – Nonsterile Preparations” and USP 797 “Pharmaceutical Compounding –

Sterile Preparations” (Attachment 009 and 010, respectively). The Design-Build (DB) team which consists of all members of this contract is required to treat these documents as final documents to guide design and construction.

4. 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 Lincoln and Grand Island sites. 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

Lincoln and Grand Island USP 800 Final Assessment reports are included as attachments to this scope of work, Attachments 002 and 003 respectively.

5. 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.).

6. The upgrades specific to this scope of work include renovating an existing space to meet

USP compliance requirements 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

General Design Requirements – Lincoln:

1. The DB 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. The DB shall provide a design for a renovation of existing pharmacy spaces in Building

45 of the Lincoln VA Healthcare Facility identified in this SOW.

3. The facility has undergone USP 797 related construction on/around 2010 and those construction drawings are provided as Attachment 008

4. The DB is required to have USP compliant compounding space prepared for pharmacy occupation prior to beginning construction on the current compounding spaces or prior to

01 November 2019 (whichever is earlier).

a. Most preferred option - preparation of temporary space within the facility (as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

b. Relocating the compounding spaces to a new area within the pharmacy area (as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

c. Least preferred option - preparation and placement of a temporary compounding trailer (as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

d. The DB shall design and construct the space to meet either current USP compliance or new (01 Dec 2019) compliance based on construction schedule.

Consideration must be given to the appropriate amount of time required for the facility to occupy the space and install any required equipment required to utilize the space as designed.

e. The DB shall bear all costs to bring the Pharmacy to compliance.

i. Testing/Certifications/Equipment Relocation/Renovations/etc.

5. 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).

6. The DB shall perform a complete assessment of the current HVAC system(s) that serve the pharmacy at this facility to verify that it is sufficient to supply the identified spaces with conditioned air per the HVAC Design Guide, USP documentation, and other guiding documents.

a. Major items of concern are

i. Air Changes Per Hour (ACPH)

ii. Pressurization

iii. Temperature and Humidity Control https://www.cfm.va.gov/TIL/spec.asp

Scope of Work (SOW) 3

7. Emergency electrical panels and/or circuits shall be added to accommodate all identified equipment including, but not limited to, air handling unit, air handling equipment, compounding hoods, refrigerators, and required computers.

a. VA staff and design guidance will dictate items to be on critical/emergency/normal power service.

8. Main supply and return trunks shall be cleaned at the end of the project.

9. Electrical and data circuits

a. Replace all electrical circuits in walls that are renovated back to the nearest junction box.

b. Add electrical circuits to allow for a proper placement of equipment and furniture in the new space.

c. Add data lines to match existing infrastructure to accommodate the relocation of equipment based on VA staff and design guidance.

10. The DB shall consider layout of equipment/power/data based on feedback provided by staff during design as well as design guides.

Specific Renovation Requirements – Lincoln

1. A schematic drawing (Attachment 012) has been provided as a potential proposed layout for the new space. The DB is urged to consider alternate layouts that may provide a better function within the limited space identified. This drawing was developed through Facility discussions. Drawings may not accurately depict final placement of walls, doors, equipment, etc.

2. References within this section are from the VA Pharmacy Design Guide (Attachment

005) and reference specific page numbers and room identifiers to assist the design team.

Additional VA guidance shall be referenced and followed while designing this space.

Each identified space is intended to operate and function as shown in the design guides, but be condensed to the size allocated by the facility. The DB shall consider all items identified in the design guides, but with a variation in quantity and size to meet the footprint of the space provided.

3. Construction of a new sterile HD buffer (PHHD1) room

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

b. See Pharmacy Design Guide Page 4-146 through 4-155 for Room Information

c. The contractor shall design for a similar layout to include a Work Area (PHSC3) similar to space as shown in the Design Guide

d. This room will be approximately 160 square feet.

4. Construction of a new sterile non-HD Buffer (PHSC1) room

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

b. See Pharmacy Design Guide Page 4-156 through 4-165 for Room Information

c. The contractor shall design for a similar layout to include a Work Area (PHSC3) similar to space as shown in the Design Guide

d. This room will be approximately 125 square feet.

Scope of Work (SOW) 4

5. Construction of a new anteroom (PHAR1)

a. This room shall have independent temperature and HVAC controls in order to maintain a positive 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.

b. The design of this room shall consider a small housekeeping closet (PHJC1) for storage of cleaning supplies for sterile processing rooms.

c. See Pharmacy Design Guide Page 4-134 through 4-144 for Room Information

d. This room will be approximately 125 square feet.

6. Construction of a new enclosed pharmacy receiving room (PHRB1)

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

b. The design shall consider combination of the HD storage room with the pharmacy receiving room.

c. See Pharmacy Design Guide Page 4-122 through 4-133 for Room Information

d. This room will be approximately 100 square feet.

7. Construction of a new HD storage (PHHD2) room

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

b. The design shall consider combination of the HD storage room with the pharmacy receiving room.

c. See Pharmacy Design Guide Page 4-134 through 4-144 for Room Information

d. This room will be approximately 100 square feet.

8. The pharmacy rooms detailed above shall:

a. Be designed to be completely integrated with the current Building Automation

System (BAS) and provide the local pharmacy the ability to monitor the temperature, pressure, ACPH, and humidity at the device. More information is provided in the design guidance below.

b. Be designed to accept equipment as detailed in the Pharmacy Design Guide

(Attachment 005) as well as the VA Pharmacy Equipment List (Attachment 007).

General Pharmacy Areas – Lincoln –

1. All ceiling tile and grid shall be reused if acceptable.

2. All flooring shall be reused if acceptable.

3. The DB shall design the project to reuse any acceptable lighting fixtures and add or replace fixtures only where necessary. Lighting shall be designed to be located in the most effective areas.

4. Diffusers shall be reused and relocated to more effective areas to provide a proper heating and cooling of the space.

5. Ductwork that is properly sized for the airflow can be reused.

a. Improperly sized ductwork shall be replaced back to the main trunk.

6. This space will be approximately 500 square feet.

Conference Room and Hallway – Lincoln

1. Space shall receive general replacement of ceiling and flooring to match existing.

2. Lighting shall be reused and/or relocated to accommodate the new layout.

Scope of Work (SOW) 5

3. Additional electrical circuits shall be added, or existing circuits extended to accommodate the new layout as minimally required.

4. This space will be approximately 400 square feet.

General Design Requirements – Grand Island

1. The Design Build team (DB) 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 and national VAMC construction specifications, and

USP 795, 797, and 800 guidelines.

2. The facility has undergone USP 797 related construction on/around 2010 and those construction drawings are provided as Attachment 013

3. The DB is required to have USP compliant compounding space prepared for pharmacy occupation prior to beginning construction on the current compounding spaces or prior to

01 November 2019 (whichever is earlier).

a. Most preferred option - preparation of temporary space within the facility (as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

b. Relocating the compounding spaces to a new area within the pharmacy area (as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

c. Least preferred option - preparation and placement of a temporary compounding trailer (as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

d. The DB shall design and construct the space to meet either current USP compliance or new (01 Dec 2019) compliance based on construction schedule.

Consideration must be given to the appropriate amount of time required for the facility to occupy the space and install any required equipment required to utilize the space as designed.

e. The DB shall bear all costs to bring the Pharmacy to compliance.

i. Testing/Certifications/Equipment Relocation/Renovations/etc.

4. 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)

5. The DB shall provide a complete design for a renovation of existing pharmacy spaces in

Building 1 Area SE101 of the Grand Island VA Healthcare Facility identified in this

SOW.

https://www.cfm.va.gov/TIL/spec.asp

Scope of Work (SOW) 6

Currently the pharmacy is fed by 2 different HVAC systems. One provides the necessary air to the drug compounding areas, the other provides air to multiple other service areas throughout the facility, including the non-compounding areas.

6. The DB shall perform a complete assessment of the HVAC system(s) that serve the pharmacy at this facility to verify current capabilities of the system. This information shall be provided to the facility to assist in the determination of the selection of an alternate as described below:

a. Alternate 1: The DB shall provide the necessary design and modifications to expand the existing drug compounding HVAC system to provide the entire pharmacy with the conditions as set by VA HVAC Design Guide, USP 800, USP

797, and all other necessary guidance. If conflicting direction is given, the most stringent guidance shall be followed. A complete narrative with a detailed explanation of equipment to be replaced and/or upgraded shall be provided along with a detailed pricing so that pricing and equipment can be compared against other proposals.

i. Existing AHU information is found on Grand Island USP 797 Drawings -

Attachment 13

b. Alternate 2: The DB shall provide the necessary design and modifications to add an additional HVAC system to provide the remaining pharmacy area with the conditions as set by VA HVAC Design Guide, USP 800, USP 797, and all other necessary guidance. Perform any additional modifications to existing drug compounding HVAC system to serve all drug compounding rooms. If conflicting direction is given, the most stringent guidance shall be followed. A complete narrative with a detailed explanation of equipment to be added shall be provided along with a detailed pricing so that pricing and equipment can be compared against other proposals.

c. In both Alternate scenarios described above:

i. Demolition of either existing system will not be performed. The existing system(s) shall be modified to be decommissioned from the area that will be fed by the selected alternate, if necessary.

ii. The final unit(s) 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 guidance, as well as other requirements as detailed in the VA HVAC Design Manual (November

2017) (Attachment 004).

iii. The final unit(s) shall be sized appropriately to serve the space and have

25% excess capacity to handle additional requirements or extreme weather.

d. All existing and/or new HVAC equipment that serves the pharmacy area shall be fed by emergency power so that the space can function as required during an electrical outage.

7. The DB shall design and add electrical panels and substations to accommodate the addition of items including, but not limited to, air handling unit, air handling equipment, compounding hoods, refrigerators, computers and other pharmacy equipment that will be purchased for this project.

Scope of Work (SOW) 7

a. All electrical service for the Pharmacy space shall be removed from their existing electrical panels and consolidated into a space identified by the facility within the

Pharmacy area.

b. Existing electrical infrastructure shall be assessed to confirm the ability to add additional branch panels.

c. Add electrical circuits to allow for a proper placement of equipment and furniture in the new space.

d. Staff and VA design guidance will dictate items to be on critical/life safety/normal power service.

8. Main HVAC supply and return trunks shall be cleaned at the end of the project.

9. Data circuits

a. Replace data circuits with CAT 6 in all renovated areas and replace all associated equipment to meet the new data line requirements.

10. The DB shall consider layout of equipment/power/data based on feedback provided by staff during design.

11. The DB shall investigate the existing mechanical chases within the Pharmacy space and relocate items into new locations that allow for a more functional usage of Pharmacy floor space.

Specific Renovation Requirements – Grand Island

1. A schematic drawing (Attachment 014) has been provided as a potential proposed layout for the new space. The DB is urged to consider alternate layouts that may provide a better function within the limited space identified. Drawings may not accurately depict final placement of walls, doors, equipment, etc.

2. References within this section are from the VA Pharmacy Design Guide (Attachment

005) and reference specific page numbers and room identifiers to assist the design team.

Additional VA guidance needs to be referenced and followed while designing this space.

Each identified space is intended to operate and function as shown in the design guides, but be condensed to the size allocated by the facility. The DB shall consider all items identified in the design guides, but with a variation in quantity to meet the size of the space provided.

3. Construction of a new sterile HD buffer (PHHD1) room -

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

b. See Pharmacy Design Guide Page 4-146 through 4-155 for Room Information

c. The DB shall design for a similar layout to include a Work Area (PHSC3) similar to space as shown in the Design Guide

d. This room will be approximately 110 square feet.

4. Construction of a new sterile non-HD Buffer (PHSC1) room

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

b. See Pharmacy Design Guide Page 4-156 through 4-165 for Room Information

Scope of Work (SOW) 8

c. The DB shall design for a similar layout to include a Work Area (PHSC3) similar to space as shown in the Design Guide

d. This room will be approximately 100 square feet.

5. Construction of a new ante-room (PHAR1)

a. This room shall have independent temperature and HVAC controls in order to maintain a positive 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.

b. The design of this room shall consider a small housekeeping closet (PHJC1) for storage of cleaning supplies for sterile processing rooms only.

c. See Pharmacy Design Guide Page 4-134 through 4-144 for Room Information

d. This room will be approximately 140 square feet.

6. Construction of a new enclosed pharmacy receiving room (PHRB1).

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

b. The design shall consider combination of this room with the pharmacy HD storage room.

c. See Pharmacy Design Guide Page 4-122 through 4-133 for Room Information

d. This room will be approximately 100 square feet.

7. Construction of a new HD Storage Room (PHHD2).

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

b. The design shall consider combination of this room with the pharmacy receiving room.

c. See Pharmacy Design Guide Page 4-134 through 4-144 for Room Information

d. This room will be approximately 100 square feet.

8. The pharmacy rooms detailed above shall:

a. Be designed to be completely integrated with the current Building Automation

System (BAS) and provide the local pharmacy the ability to monitor the temperature, pressure, ACPH, and humidity at the device. More information is provided in the design guidance below.

b. Be designed to accept equipment as detailed in the Pharmacy Design Guide

(Attachment 005) as well as the VA Pharmacy Equipment List (Attachment 007)

9. The design guide shows the general intent of the space; however, the layout will be more specific to the area provided at each site.

10. Construction of a new Dispensing/Consult Area (PHOW2)

a. This area shall be laid out to allow for proper patient privacy and staff access to the waiting area.

b. General layout and options shall be presented and discussed with staff during design.

c. Acoustics and noise control are very important in this area and the DB shall provide options to support speech intelligibility and patient privacy.

d. Use of 3-Form or similar material shall be considered during design to provide staff visibility while increasing patient privacy concerns.

e. See Pharmacy Design Guide Page 4-10 through 4-18 for Room Information

Scope of Work (SOW) 9

f. Some sample photos have been provided for a design that meets the intent of the space. (Attachment 015)

g. The design guide shows the general intent of the space; however, the layout will be more specific to the area provided at each site.

h. This area will be approximately 285 square feet.

i. Phasing for this area will be discussed during design and planning for a temporary consult and dispensing area should be anticipated.

General Pharmacy Areas & Areas not identified above– Grand Island

1. These areas should follow Pharmacy Design Guide guidance for finishes and layout preparation.

2. Entire area shall be repainted.

3. All ceiling tile and grid shall be removed and replaced

4. All areas with ACT shall receive 2x2 ACT that matches existing facility areas that have similar tile.

5. All flooring shall be removed and replaced – this flooring shall be designed to be non-porous and monolithic. It shall have an integral 4” base as well.

6. All lighting shall be replaced and designed to be placed in the most effective areas. LED lighting shall be used and designed per the VA Lighting Design Manual

7. Diffusers shall be replaced and relocated to more effective areas to provide a proper heating and cooling of the space.

8. Ductwork that is properly sized for the airflow can be reused.

a. Improperly sized ductwork shall be replaced back to the main trunk

9. Relocation of Pharmacy Equipment including hoods

a. Item 1

i. Manufacturer: TCGRx

ii. Model: ATP-320AO

b. Item 2

i. Manufacturer: ScriptPro

ii. Model: SP200

c. These machines shall have relocation coordinated through the equipment manufacturer to include possible need to contract the relocation through the manufacturer approved personnel.

d. These machines may need to be relocated due to phasing and shall be discussed while determining phasing needs.

10. This space will be approximately 2500 square feet.

General Design Requirements – Both Sites:

1. All design elements of this project shall follow VA and USP guiding documents to include, but not limited to the documents detailed in Section: Additional Resources, below.

2. Any design elements that do not meet the design parameters set in the above documents are required to be approved by the COR/CO prior to design of that element. Official justification for that waiver shall be placed into the as-built documentation.

3. The Design Build team shall review the edited 00 01 10 Specification indices. Each division will be reviewed and referenced with design selections and/or recommendations.

Scope of Work (SOW) 10

Applicable specifications will be applied (or removed) upon completion of the final building design.

a. COR/CO must approve the final construction specifications.

4. Level of demolition necessary will be determined by overall space requirements to the level identified in the contract documents to allow construction of required spaces.

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

5. It is acceptable for the DB to design one single set of construction plans that covers both facilities, however these drawings shall be numbered such that each site has clearly identifiable drawings. (e.g. LN-A1-1 and GI-A1-1)

a. If this cannot be done successfully – the documents shall be separated into different documents.

6. If the construction specifications can be clearly separated into 3 sections: General, Lincoln, Grand Island – it is acceptable to combine the specifications into a single document.

a. If this cannot be done successfully – the documents shall be separated into different documents.

7. 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.

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

10. Existing Pharmacy equipment (containment hoods, refrigerators, etc.) are intended to be reused in the new space as well as procurement of new equipment to meet the expanded space. All known information will be given to the DB during design, or as soon as it is known.

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 DB shall include

Facilities Engineering, Pharmacy, and Safety in all design meetings. The DB 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. Environmental conditions shall be maintained to other spaces.

13. 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, HVAC grilles, speakers, etc.

14. 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).

15. Design shall include a phasing plan to allow functional use of the pharmacy during renovation. It is desired that this construction take place in 3 or fewer phases per site. DB shall determine the feasibility of this based on the number of infrastructure upgrades required for the space and discussions with the VA.

Scope of Work (SOW) 11

a. Provided phasing is feasible, it shall be coordinated with the infrastructure modifications to keep the pharmacy 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.

c. 4 weeks shall be scheduled for the VA to occupy or vacate any space between phases. This can be adjusted through discussions with the facility staff and the schedule shall be updated accordingly.

16. Energy savings is a priority 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.

17. The DB is responsible for maintaining As-Built drawings and providing complete and accurate As-Built drawings for both sites in AutoCAD (.dwg), Revit (.rvt), and PDF

(.pdf) formats.

18. The DB shall provide a 3rd party commissioning agent as detailed in sections below and as described in Specification 01 91 00 – General Commissioning

19. The DB shall provide all required testing for ISO, CETA, USP and any other requirements verify complete and functional use of the space prior to occupation.

a. Some testing may not be possible until the space is occupied by Pharmacy staff and shall be coordinated with the facility to perform this testing as soon as possible.

b. Commissioning of the space will be required to be completed after installation of all Government Furnished Equipment (GFE).

Discipline Specific Requirements – Both Sites

Architectural

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

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

3. The use of wood in areas that are within or nearby the sterile and/or HD areas shall be prohibited. Items such as doors, millwork, wall blocking, shelf supports, etc. shall all be designed to be non-porous and sealed.

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

a. Life Safety and Fire Protection systems shall be commissioned via a 3rd party agent.

5. Doors and Door Hardware

a. Design door openings that are adequate with a minimum door size of 36” wide and match existing facility door heights.

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

Scope of Work (SOW) 12

c. 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.

d. Provide door and hardware schedules on appropriate drawings.

e. The doors entering directly into any Pharmacy space from a public space are required to be secured with staff specific access; e.g., keycard or keypad.

i. See VA Physical Security Manual and Appendices

f. Design shall consider automatic doors (sliding or swing) into the sterile and/or

HD areas. Door operators shall be touchless or foot actuated.

6. New signage shall be included for all new rooms added and room numbers shall coordinate with overall flow of the workspace. Replace any existing signs that are required to change to accommodate the addition of the new rooms.

a. New signage shall match the existing.

b. If existing cannot be matched, replacement of all signage within the pharmacy area is required.

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

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

9. Provide ceiling openings for maintenance access as required.

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

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

11. 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.

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

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

14. 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.

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

16. Pharmacy perimeter walls have additional security requirements that must be met. DB shall pay special attention to guidance that provides this information for proper construction.

17. For equipment that has not yet had a finalized purchase, the layout shall meet a more generic sense to fit multiple options of equipment. A range of dimensions will be provided during design.

18. All compounding areas shall be designed to be as visible to the outside work area(s) as best as possible. Windows shall be designed similarly to the Pharmacy Design Guide layout.

Interior Design

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

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

Scope of Work (SOW) 13

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

4. Refer to the Room Finishes, Door & Hardware Schedule Program Guide (PG 18-14) and the VA Pharmacy Design Guide for design guidance. DB shall consider the following key factors in the design process, which have an impact on the built environment:

a. Maintenance

b. Durability

c. Life Cycle Cost

d. Warranty

e. Specify appropriate materials to maximize infection control to include stainless steel or solid surface material.

Structural

1. 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.

2. Structural calculations shall be performed for any additional loads placed on rooftops or other locations where structural concerns may arise.

3. 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.

Electrical/Low Voltage/Security Systems

1. Commissioning shall be performed per 01 91 00 General Commissioning guidance.

2. Electrical engineer shall assess the existing electrical capacity of the facility and upgrade as necessary to meet the requirements of the project.

3. All existing electrical systems and components shall be field-verified by the DB’s electrical engineer.

4. Pharmacy areas required to be fed by critical/emergency power to include HVAC components that are serving these areas, refrigerators, compounding hoods, etc.

a. Refer to VA design manuals and facility staff for more guidance on emergency and normal power.

5. All electrical work shall meet current National Electrical Code (NEC) and VA requirements.

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

6. Design 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.

7. 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.

8. 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.

Scope of Work (SOW) 14

9. Contract 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)

10. Design shall install camera infrastructure and cameras as detailed in the Pharmacy Design

Guide.

a. Grand Island camera placement shall cover areas as shown in the Pharmacy

Design Guide for Inpatient Pharmacy

b. Lincoln camera placement shall cover areas that are being renovated that are identified in the Pharmacy Design Guide – Compounding Areas and at

Corridor/Receiving Entry point.

c. Some cameras need to feed to locally installed monitors for pharmacy staff visualization and safety.

d. All cameras need to feed remotely for police monitoring.

11. Coordinate electrical raceways and floor penetrations with all other work.

12. Coordinate to ensure the Fire Alarm System meets all applicable requirements.

13. Include fire alarm system with full area smoke coverage that is compatible with system at specific site.

14. Include circuit breakers, emergency off button, warning light and door switch connections.

15. 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.

16. For equipment that has not yet had a finalized purchase, the electrical components shall meet a more generic sense to fit multiple options of equipment. A range of will be provided during design.

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

18. Include all grounding and bonding requirements.

19. 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.

20. 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

1. Commissioning shall be performed per 01 91 00 General Commissioning guidance.

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

3. 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

Scope of Work (SOW) 15 proper airflow direction, as well as ensuring proper pressure reading by the space pressure monitoring sensors, and avoiding false alarms.

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

a. Design shall consider powered fan filtered units to minimize the effect of the terminal HEPA filtration on the HVAC system.

5. 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.

6. Design shall provide adequate means of in-situ testing of the HEPA filters.

a. 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.

7. 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.

8. For equipment that has not yet had a finalized purchase, the MEP layout shall meet a more generic sense to fit multiple options of equipment. A range of dimensions will be provided during design.

9. Design for appropriate amount of air exchanges in accordance with VA HVAC Design

Manual dated November 1, 2017 and USP documentation.

10. Design and install necessary HVAC units to satisfy heating and cooling requirements to serve the equipment and people inside the space.

a. Terminal cooling systems are prohibited in pharmacy areas per the VA HVAC

Design Manual

11. Design and install Building Automation System (BAS) infrastructure and software as required for any new or existing mechanical equipment within the renovated space. When the BAS infrastructure is already in place, equipment shall be selected to properly coordinate with the system already in place.

a. VA HVAC Design Manual provides guidance on the HVAC Control Systems and shall be referenced during design.

b. Final BAS system shall provide a complete, functional and operational interconnection and interfacing of all BAS elements (existing and new) in compliance with all applicable codes, standards and ordinances so as to provide a single coherent BAS as required by the facility.

c. Pharmacy staff shall have the ability to adjust the temperature in each individual room.

d. Pharmacy staff shall have the ability to monitor pressure, humidity, and ACPH in the identified rooms with integrated equipment within the space.

e. BAS system shall provide audible, visual, and digital alarms with adjustable setpoints.

Scope of Work (SOW) 16

f. All items shall also report to the main BAS station identified by engineering staff during design.

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

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

14. Main supply and return trunks shall be cleaned at the end of the project.

15. The design shall include all safety components required by the current ANSI/ASHRAE

Safety Code.

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

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

18. DB shall include any required modifications to the fire sprinkler system and verify compliance with all code requirements.

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

20. Design shall include eyewashes where required.

21. Touchless or handsfree equipment shall be discussed and included in areas where necessary to provide safe and efficient Pharmacy workflow.

22. Piping design shall comply with VA Plumbing design manual located at:

http://www.cfm.va.gov/til/dManual/dmPlbg.pdf

a. DB shall note the design requirements for Legionella prevention and include those in this design.

Proposed Schedule (calendar days):

1. Notice to Proceed – D-Day

2. Design Initiated – D+21

3. SD Submission – D+45

4. SD Review by VA Complete – D+61

5. DD Submission –D+85

6. DD Review by VA Complete – D+102

7. CD Submission –D+123

8. CD Review Completed by VAMC – D+137

9. Documents Complete (CD issue) – D+151

10. Mobilization Complete – D+185

11. Submittals Complete – D+225

12. Temp or Permanent Compounding Spaces Complete at Both Site – NLT 11/01/2019

13. Construction Complete – D+400

14. Total Period of Performance – 400 calendar days http://www.cfm.va.gov/til/dManual/dmPlbg.pdf

Scope of Work (SOW) 17

Additional Resources:

1. Attachment 1 – USP 800

2. Attachment 8 – Lincoln USP 797 Drawings

3. Attachment 9 – USP 797 Proposed Revisions

4. Attachment 10 – USP 797 Proposed Revisions

5. Attachment 11 – VA Electrical Design Manual

6. Attachment 12 – Lincoln – Final Schematic Drawing

7. Attachment 13 – Grand Island USP 797 Drawings

8. Attachment 14 – Grand Island – Final Schematic Drawing

9. Attachment 15 – Grand Island Dispensing and Consult

Ideas

Other Resources Available on the TIL (https://www.cfm.va.gov/til/index.asp).

Examples include:

1. VA HVAC Design Manual

2. VA Pharmacy Service Design Guide

3. VA Lighting Design Manual

4. VA Pharmacy Equipment List

End https://www.cfm.va.gov/til/index.asp