36E77619R0017-017.pdf

568‐19‐107 Renovate Pharmacy for USP at FM/HS (Black Hills) 02‐11‐2019

Scope of Work (SOW) 1

Scope of Work for Design‐Build Renovate Pharmacy for USP at FM/HS

Project Number 568-19-107

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), SOW 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” (SOW Attachments 007 and 008, 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 Fort Meade and Hot Springs 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 Fort Meade and Hot Springs USP 800 Final Assessment reports are included as attachments to this scope of work, SOW 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, Pharmacy Service SEPS Guide (SOW Attachment 015), 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 ‐ Fort Meade:

1. The DB shall provide a complete design for a renovation of existing pharmacy spaces in Building 113 (Basement and 1st floor) of the Fort Meade VA Healthcare Facility identified in this SOW.

2. 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 December 2019 (whichever is earlier).

a. Proposed Solutions:

i. Most preferred option - 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. This is shown in the Fort Meade Schematic Layout that is discussed within this document. (SOW Attachment 009)

ii. Preparation of temporary space within the facility (as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

3. The DB shall design and construct the space to meet either current USP compliance or new (01DEC2019) 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 to utilize the space as designed.

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

a. Testing/Certifications/Equipment/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).

e. The COR/CO may authorize the demolition of required spaces prior to the 90% complete design, provided the DB has a COR approved demolition plan.

6. A dedicated stand-alone HVAC system shall be designed and installed to supply air to all

USP compliant rooms including HD storage, HD buffer, Anteroom, non-HD buffer, and remaining basement Inpatient Pharmacy space identified in the schematic drawing.

a. This system shall have the ability to control the pressure in each required room in accordance with the required pressure differences and air changes per hour (ACPH) specified in USP 800 (SOW Attachment 001), as well as other requirements as detailed in the VA HVAC Design Manual (November 2017) (SOW Attachment 004).

b. This system shall operate independently of other air handling systems within the facility and shall include, but is not limited to, air handling units, chillers, dampers, VAV’s, CAV’s, DDC controls, exhaust fans, terminal HEPA fan filtered units, and associated ductwork.

Scope of Work (SOW) 3

c. This system will be sized appropriately to serve the newly constructed basement space and have 30% excess capacity to handle additional space or extreme temperature/humidity changes.

7. The DB shall design and add electrical circuits, 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 both VA and DB provided that will be purchased for this project.

a. Existing electrical infrastructure shall be assessed to confirm the ability to add additional circuits or branch panels.

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

c. If cost effective, the DB may consider a general relocation of all electrical circuits to new panels within the pharmacy for ease of installation. All existing circuits shall be removed back to the existing panel, or junction box where last active connection remains.

Specific Renovation Requirements – Fort Meade

1. A schematic drawing (SOW Attachment 009) 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 (SOW 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.

3. 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.

4. Asbestos abatement must be conducted in the Fort Meade basement area to include 1,285 SF of Flooring and Mastic and 150 LF of Air Cell piping.

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

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 150 square feet.

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

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 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 105 square feet.

Scope of Work (SOW) 4

7. Construction of a new anteroom (PHAR1) - basement

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 110 square feet.

8. Construction of a new enclosed pharmacy receiving room (PHRB1) - basement

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

c. This room will be approximately 115 square feet.

9. Construction of a new HD storage (PHHD2) room – basement

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 basement HD storage room with the non-sterile HD compounding room.

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

d. This room will be approximately 100 square feet.

10. Construction of a new non-sterile HD compounding room - basement

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 HD storage room.

c. This room will be approximately 100 square feet.

11. Construction of a new HD storage (PHHD2) room – first floor

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

b. This room shall have a new exhaust fan added to be compliant with all USP, VA, and other requirements.

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

d. This room will be approximately 65 square feet.

12. The pharmacy rooms detailed above shall:

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

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

b. Be designed to accept equipment as detailed in the Pharmacy Design Guide (SOW Attachment 005) as well as the VA Pharmacy Equipment List (SOW Attachment 013)

13. General Inpatient and Outpatient Pharmacy Areas – Fort Meade – identified on the schematic drawing for both 1st floor and basement areas. The remaining space within the basement area will be allocated for the operation of the Inpatient Pharmacy – and will have a functional space as detailed by the Pharmacy Design Guide. The schematic drawing may not show all wall locations and the DB shall allocate for additional wall

Scope of Work (SOW) 5 construction with associated power, data, lighting, HVAC, and other items to source the layout once designed. The 1st floor General Pharmacy Area will be allocated for the operation of the Outpatient Pharmacy.

a. BHHCS has established Standards and Finishes that are referenced in SOW Attachment 012 and shall be followed unless no compliant material is provided in the attachment that meets the USP or VA guiding documents. Further options shall be provided in this case.

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

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

d. The Hazardous Waste Storage and Pharmacy Receiving rooms shall have a ceiling that is scrubbable and moisture resistant.

e. 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.

f. 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.

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

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

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

j. All rooms shall be tied to the BAS for central monitoring.

k. This space will be approximately 670 square feet in the basement and 1800 square feet on 1st floor of BLDG 113.

General Design Requirements – Hot Springs:

1. The DB shall provide a complete design for a renovation of existing pharmacy spaces in Building 12 of the Hot Springs VA Healthcare Facility identified in this SOW.

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

a. Proposed Solutions:

i. Most preferred option - preparation of temporary space within the facility

(as allowed and approved by the facility leadership) for hazardous and non-hazardous compounding.

ii. 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.

3. The DB shall design and construct the space to meet either current USP compliance or new (01DEC2019) 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 to utilize the space as designed.

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

a. Testing/Certifications/Equipment/Renovations/etc.

Scope of Work (SOW) 6

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)

e. The COR/CO may authorize the demolition of required spaces prior to the 90% complete design, provided the DB has a COR approved demolition plan.

6. A dedicated stand-alone HVAC system shall be designed and installed to supply air to all

USP compliant rooms including HD storage, HD C-SCA, Anteroom, non-HD buffer, and other rooms identified during design.

a. This system shall have the ability to control the temperature in each individual room in accordance with the required pressure differences and air changes per hour (ACH) specified in USP 800 (SOW Attachment 001), as well as other requirements as detailed in the VA HVAC Design Manual (November 2017) (SOW Attachment 004).

b. This system shall also be sized to accommodate the Pharmacy Vault that is adjacent to the anteroom.

c. This system will be sized appropriately to serve the newly constructed basement space and have 30% excess design capacity to handle additional space or extreme temperature/humidity changes.

7. The existing HVAC on the room will need to be downsized due to a significant reduction in service area.

8. The DB shall design and add electrical circuits, 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.

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

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

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

d. Relocate electrical panels GS-N3 and GS-C2 from the current location to a location that is code compliant through discussions during design.

i. Extend or shorten electrical feeders based on new locations. Replace feeders back to substation if capacity of panels is diminished during relocation.

ii. Include the relocated panels in the assessment of the electrical infrastructure and its ability to maintain current capacity.

9. Windows and exterior penetrations within the Pharmacy Compounding area(s) will be required to be removed or relocated. Fill existing penetrations with brick that matches adjacent existing adjacent brick. Wall shall be insulated to current code requirements.

Scope of Work (SOW) 7

Specific Renovation Requirements – Hot Springs

1. A schematic drawing (SOW Attachment 010) 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 (SOW 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.

3. Asbestos abatement must be conducted on 1,788 SF of Flooring and Mastic and 100 LF of Air Cell piping.

4. 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 size of the space provided.

5. Construction of a new HD Containment Segregated Compounding Area (C-SCA)

a. This room is not detailed in the Pharmacy Design guide, but is detailed in USP

800. It shall be designed similar to the HD Storage Room but has a pressure monitoring requirement similar to the HD Buffer Room.

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

c. This room will be approximately 105 square feet.

6. Construction of a new sterile non-HD compounding 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. Window will be permanently removed due to moisture condensation risk. The wall, interior, and exterior paint, texture, shine, material will match the surrounding window area to minimize visual signs a window existed.

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

d. This room will be approximately 80 square feet.

7. 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. Window will be permanently removed due to moisture condensation risk. The wall, interior, and exterior paint, texture, shine, material will match the surrounding window area to minimize visual signs a window existed.

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

e. This room will be approximately 90 square feet.

8. 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.

Scope of Work (SOW) 8

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

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

d. This room will be approximately 215 square feet.

9. 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 also combine the ability to perform Non-Sterile Compounding within this space.

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

d. This room will be approximately 135 square feet.

10. The pharmacy rooms detailed above shall:

a. Be designed to connect to the existing BACnet Schneider “Building Operation

WebStation” StruxureWare 1.9 system that is supported by Temperature Technology and provide the local pharmacy the ability to adjust temperature setpoints as well as locally monitor pressure, ACPH, and humidity at the device.

More information is provided in the design guidance below.

a. All new BAS infrastructure shall support existing infrastructure needs and shall also be capable of migrating to a new system (i.e. Johnson Controls, Alerton, etc.) in the near future.

b. Be designed to accept equipment as detailed in the Pharmacy Design Guide (SOW Attachment 005) as well as the VA Pharmacy Equipment List (SOW Attachment 013)

11. Construction of a Staff Lounge/Breakroom

a. This room shall take into consideration suggestions from staff and Pharmacy

Design Guide during design for proper layout and finishes.

b. This room will be approximately 175 square feet.

General Pharmacy Areas – Hot Springs - all pharmacy areas that are not identified above but identified on the drawing

1. BHHCS has established Standards and Finishes that are referenced in SOW Attachment 012 and shall be followed unless no compliant material is provided in the attachment that meets the USP or VA guiding documents. Further options shall be provided in this case.

2. All ceiling tile and grid shall be removed and replaced with 2x2 ACT that matches the adjacent areas.

3. The phase plan schedule will include repainting of entire pharmacy.

4. All flooring shall be removed and replaced – since this entire area will have the potential for hazardous drug movement through it – this flooring shall be designed to be non-porous and monolithic. It shall have an integral 4” base as well.

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

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

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

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

Scope of Work (SOW) 9

8. Currently the vault has little or no air circulation. This renovation will include climate control for vault storage area and additional data/power lines.

a. Work in this areas shall be planned to be phased to allow for monitored access to this area.

9. This space will be approximately 1400 square feet.

General Design Requirements – Both Sites:

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 (see Spec Section 00-01-00 Master Specification List), 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. Specifications shall be provided in Microsoft Word, PDF format and bound hard copy (labeled on both the spine and front cover) format. The Contractor shall prepare a submittal log based on the specifications. The Contractor shall review with the VA a format for the submittal log based on standard industry practice and approved by the

COR/CO.

3. All design elements of this project shall follow VA and USP guiding documents to include, but not limited to the attachments detailed in the Solicitation Package.

4. 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.

5. 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.

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

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

6. Expansion of any existing VA infrastructure or systems shall be compatible with existing components already in place, unless approved by the COR/CO.

7. Sterile Compounding and Buffer/Ante room cannot have an exterior window or window sill ledge.

8. 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.

9. 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. FM-A1-1 and HS-A1-1)

a. If a single set cannot be approved by the COR/CO – the documents shall be separated into different documents.

10. If the construction specifications can be clearly separated into 3 sections: General, Fort Meade, Hot Springs – it is acceptable to combine the specifications into a single document.

Scope of Work (SOW) 10

a. If a single set cannot be approved by the COR/CO – the documents shall be separated into different documents.

11. 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.

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

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

14. Procurement, Installation, and Relocation of Pharmacy Equipment shall be in accordance with SOW Attachment 013 – VA Pharmacy Equipment List, SOW Attachment 016 VA Pharmacy Existing Equipment List - Fort Meade, SOW Attachment 017 VA Pharmacy Existing Equipment List – Hot Springs, and SOW Attachment 019 Pharmacy Hoods. Relocation of existing equipment will be identified by the DB in the phasing plan. Manufacture support is required to move some of the equipment and is identified in SOW Attachments 016 and 017. DB shall bear the cost to have the manufacture move the identified equipment. Pharmacy Hoods will be Government Provided and Contractor Installed. The Specs for new hoods are included in SOW Attachment 019 Pharmacy Hoods. The number and locations for the hoods shall be as follows:

a. Model number NU-813-400, Non-sterile hoods for the HD storage rooms (1 at HS and 1 at FM) both sites will have the 4ft model.

b. Model number NU-140, IV laminar flow hoods for non-hazardous sterile IV compounding. 1 at HS will be 4ft length and 1 at FM will be 5ft length. These hoods will be place in the Non-hazardous IV rooms.

c. Model number NU-540 these are the A2 biosafety cabinets for hazardous IV compounding. 1 at HS and 1 at FM both sites will have the 4ft model. These hoods will be placed in the Hazardous IV rooms at both sites.

15. Design Review Submissions:

a. The DB shall plan for a kick-off meeting with Facilities Engineering, Safety, Fire and Police Departments, Infection Control, Patient Safety, and Pharmacy to walk the site, pull as-built drawings, review design requirements, and verify understanding of the full scope of the project requirements.

b. The Design-Build Team A/E (DB A/E) shall prepare and submit complete construction documents for review and approval by the VA in accordance with standard professional practice, the Department of Veterans Affairs Specs (VA Specs), and prevailing codes.

c. The documents may be divided into multiple review submission packages. The VA will review as many as six (6) package submissions (examples: demolition, civil, architectural, structural, mechanical, electrical, plumbing etc.) to facilitate the start of construction.

d. All submission packages will be reviewed at SD, DD, and CD completion stages.

If any package is not complete for the required stage a post review may be required and the cost of which will be borne by the DB Team.

e. Each review submission package shall include 1 electronic set on Submittal Exchange. The package will include an index of drawings (by sheet number and

Scope of Work (SOW) 11 title) and specifications (by section number and title) submitted. The packages will be distributed to the VA COR. Final CD will have two (2) hard copies provided in addition to the electronic set in accordance with Spec 01-00-00- General Requirements.

f. The DB shall include Facilities Engineering, Pharmacy, and Safety in all design meetings. Additional attendees to consider include but are not limited to the following Fire and Police Departments, Infection Control, and Patient Safety.

g. The DB team shall allow a minimum of 21 calendar days for each VA review.

i. The VA’s receipt of the design review submission package.

ii. The review meeting.

iii. DB teams receipt of comments from the VA.

iv. One exception to the 21 calendar day review cycle is the “SD Review by

VA Complete,” which will be 14 calendar days.

v. Receipt of the DB design review via submittal exchange and onsite review with the DB team management will constitute the beginning of the VA review cycle. This electronic dataset must be complete enough for the VA to coordinate an offsite 3rd party Life Safety review.

16. Design Review Meetings:

a. A review meeting to resolve design issues will be held for each design review package submitted. The meeting will include discussion of VA comments on functional relationships and technical peer review comments (by others).

b. Participants will include VA Staff and DB team members as appropriate for the specific package to be reviewed and others. The DB team members will each allow for one (1) full day for each discipline/package design review meeting. DB team management will be present at each review meeting.

c. Coordination of the review meeting schedules will be the responsibility of the VA COR and the DB Team Project Manager (for the DB Team). See section H.

Quality Assurance/Quality Control.

17. Environmental conditions shall be maintained to other spaces.

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

19. 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).

20. 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. DB phasing plan must be approved by the COR/CO.

a. Provided phasing is feasible, it shall be coordinated with the infrastructure modifications to keep the pharmacy functioning during each phase of 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) 12

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 approved by the COR/CO the schedule shall be updated accordingly.

21. 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.

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

23. The DB shall provide all required testing for ISO, CETA, USP and any other requirements to 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).

c. Partial Commissioning may be utilized to maintain pharmacy operations, but must be identified in the VA approved phasing schedule.

24. Phasing

a. The phase plan schedule will include DB moving all equipment as detailed.

b. Phase plan schedule will include DB coordinating all USP compliance testing and certification(s).

c. Construction shall be phased such that the facility pharmacy can maintain operation during normal working hours. DB may utilize temporary office and storage facilities to maintain pharmacy operations and DB will bear the cost of temporary facilities.

d. The phase plan schedule shall include time for preparation of temporary or permanent power relocation (standard/emergency) to support moving existing equipment to ensure pharmacy is operational.

e. The phase plan schedule must include seven (7) calendar days to allow for the installation of a 3 inch steam line in BLDG 113 basement (installation is not to be conducted by the DB team). The seven (7) calendar days will be between the demolition of the space and construction of the space. For planned location of the steam line see SOW Attachment 018 – Fort Meade Planned Steam Line in BLDG 113 Basement.

Discipline Specific Requirements – Both Sites

Architectural

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

a. BHHCS has established Standards and Finishes that are referenced in SOW Attachment 012 and shall be followed unless no compliant material is provided in the attachment that meets the USP or VA guiding documents. Further options shall be provided in this case by the DB for the COR/CO to approve.

Scope of Work (SOW) 13

2. Design and construct all spaces using current NFPA, VA design standards, and VA design standards specific to the site. 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 that will be coordinated by the DB team and approved by the COR/CO.

5. Doors and Door Hardware

a. DB shall design door openings with a minimum door opening of 36” wide x 78” high.

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

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. Service doors to Receiving should be double leaf and large enough to accommodate supplies on pallets to be easily moved into the Receiving Area.

i. Work conducted in accordance with the VA Physical Security Manual and Appendices

f. Design shall consider automatic doors (sliding or swing) into the sterile and/or HD areas. Consideration shall be given to touchless equipment, where feasible.

Interlocking doors shall be considered to prevent the loss of pressurization requirements.

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 and be approved by the COR/CO.

b. If existing cannot be matched, replacement of all signage within the pharmacy area is required and signage must be approved by the COR/CO.

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.

a. 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.

Scope of Work (SOW) 14

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 and functional 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.

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) (SOW Attachment 014), and BHHCS Standards and Finish Schedule (SOW Attachment 012) for room finish guidance. Additional guidance is provided in Pharmacy Design Guide (SOW Attachment 005). The most stringent guidance shall be considered during design. 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.

Scope of Work (SOW) 15

Electrical/Low Voltage/Security Systems

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

2. Refer to VA Electrical Design Manual (SOW Attachment 011), VA Lighting Design

Manual (SOW Attachment 006), and other USP and VA documents for additional electrical requirements.

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

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

5. Electrical and data circuits

a. Replace all electrical in walls that are renovated.

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

c. Replace all existing pharmacy data circuits and punch panels in data closet to support CAT6 with 50% spare capacity for expansion for future needs.

i. Each data drop shall support 1 Data/1 Voice outlet.

d. The DB shall consider layout of equipment/power/data based on feedback provided by staff during design and final layout must be approved by COR/CO.

6. 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 manuals and facility staff for more guidance on emergency and normal power requirements.

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

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

8. 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.

9. 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.

10. 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.

11. 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)

12. Design shall include cameras as detailed in the Pharmacy Design Guide.

a. Cameras and associated infrastructure shall be compatible with current facility.

Current software is Milestone Corporate 2019.

b. Fort Meade cameras shall all be replaced and/or added and shall cover areas as shown in the Pharmacy Design Guide for Inpatient and Outpatient Pharmacy.

c. Hot Springs cameras shall all be replaced and/or added and shall cover areas as shown in the Pharmacy Design Guide for Inpatient and Outpatient Pharmacy.

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

Scope of Work (SOW) 16

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

13. Utilize site-specific construction specifications for low voltage and telecommunications.

14. Door access system shall be compatible with the existing facility system, currently utilizing P2000 Corporate V3.14 SP4 for the security management system. Door readers must output Wigand in a 64-bit stream and have two way authentication with a PIV/ PIV- I/ CAP card chip.

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

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

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

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

19. 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.

20. 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. The DB will provide a range of dimensions and power requirements during design that will be approved by the COR/CO.

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

22. DB shall include all grounding and bonding requirements.

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

24. 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 DB design engineer shall take into consideration maintenance of pressure differentials and calculate actual required airflow differences as required to maintain required pressures. The DB 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.

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

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

Scope of Work (SOW) 17

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. The DB will provide a range of dimensions and HVAC requirements during design and approved by the COR/CO.

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 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 with-in the required range.

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 has complete control over temperature, pressure, humidity, and ACPH from the control system.

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

g. All items shall also report to the main BAS station and be identified in the design and approved by the COR/CO.

Scope of Work (SOW) 18

h. Fort Meade existing BAS system is Metasys, Johnson Controls…