36E77618R0055-003.docx

438-500 Pharmacy Addition for USP 800 Compliance – Sioux Falls 3-2-18

438-500 Pharmacy Addition for USP 800 Compliance – Sioux Falls 3-22-18

Scope of Work for Design-Build Pharmacy Addition for USP 800 Compliance for Sioux Falls, SD VAMC Project Number 438-500

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” (SOW Attachment 3 - USP 800).

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.

The upgrades specific to this scope of work include a separate and enclosed space for receiving supplies, upgrades to heating, ventilation, and air conditioning (HVAC) control, a separate area for processing medication for patient consumption (pill crushing), redundant sterile and non-sterile compounding containments, a separate space for sterile area cleaning supplies, and a mechanical and electrical space if required.

A. General Design Requirements:

1. The Architect Engineer (AE) 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 USP 797 and 800 guidelines (SOW Attachment 4 – USP 797 and 800 Chapters Aug 2017).

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

3. The AE shall provide a design for a new building (2300 square feet or less) to be located and attached to the northern most exterior wall with exterior door on the new oncology addition. A Space and Equipment Planning System (SEPS) model has been run to approximate the square footage required for each room. Those estimates can be found attached.

This new building shall include, at a minimum, the following:

i. Two independent sterile compounding rooms

a. These rooms shall have independent temperature and HVAC controls in order to maintain a negative pressure in this space, relative to surrounding areas. See USP 800 guidelines (SOW Attachment 3 - USP 800) for specifics.

b. These rooms shall be designed to be ISO Class 7 certified.

c. This rooms shall have the ability to become positively pressured in relation to the adjacent spaces in the event that this room must be used for processing other types of drugs.

ii. Two ante rooms which provides entry and egress to each sterile processing room.

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, and positive in relation to the compounding rooms. See USP 800 guidelines for specifics (SOW Attachment 3 - USP 800).

i. A separate enclosed supply receiving room.

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. See USP 800 guidelines for specifics (SOW Attachment 3 - USP 800).

b. This room shall also have a separate area within it to be used for pill crushing.

ii. Storage area for cleaning supplies, to be used in the sterile processing rooms only.

iii. The exterior appearance of the new building shall match that of the connecting oncology building. It shall have the same curved contour and exterior design features as the oncology building as well.

iv. Its own stand-alone air handling/HVAC unit. This unit shall have the ability to control the pressure in each individual room in accordance with the required pressure differences and air changes per hour (ACH) specified in USP 800 guidelines (SOW Attachment 3 - USP 800).

4. The AE shall provide a design for the addition of a segregated area, within the current pharmacy space, that may be utilized for medication processing (pill crushing).

5. The AE shall prepare a prioritized list of actions for construction based on the recommended configuration of the new building and the space within the existing pharmacy area.

6. The AE shall complete an analysis for tying into and/or relocating any utility or service line required to make the building fully functional.

7. The AE shall evaluate the exterior grounds of the building and provide design for any additional drainage that may be required. Evaluation area shall extend to the low areas currently to the north of the new Occupational Therapy Addition.

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

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

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

11. Environmental conditions shall be maintained to other spaces.

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

13. Design documents shall clearly show all infection control requirements. The Contractor shall coordinate with the station multi-disciplinary committee and infection control prevention staff to design infection control requirements.

B. Discipline Specific Requirements:

1. Architectural

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

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

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

d. Contractor shall verify door openings are adequate with a minimum door size of 39” wide x 78” high.

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

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

g. Provide ceiling openings for maintenance access as required.

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

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

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

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

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

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

2. Interior Design

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

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

3. Structural

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

b. Dependent on location of new structures, all physical security requirements shall be followed, which include but are not limited to the blast pressure values and charge weights. VA design standards and data definitions can be attained by filling out the information in SOW Attachment 6 – Contractor Confidentiality Cert PS Design Standards.

4. Electrical/Low Voltage

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

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

c. Design and Construction shall include all electrical plans, elevations, sections, details, diagrams and schedules showing existing power, new power, and low voltage.

d. Contractor 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.

e. 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.

f. Contractor shall design and construct 3-phase, 480V AC system as required.

g. 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)

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

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

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

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

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

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

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

p. Contractor shall follow and describe all junction box and wire duct/raceway guidance provided in vendor drawings.

q. Contractor shall include wiring with tails and labeling as indicated in vendor drawings.

r. Contractor shall include circuit breakers that meet load current rating and short circuit current rating described in vendor drawings.

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

t. Contractor shall include all grounding and bonding requirements.

u. Upgrade existing 120V systems to meet current National Electrical Code, (NEC).

5. Mechanical

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

b. Contractor 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.

c. Contractor shall study the capacity of existing air handling unit to support the required air exchanges.

d. Design for appropriate amount of air exchanges in accordance with VA HVAC design manual dated November 1, 2017.

e. The Contractor shall design and install necessary HVAC units to satisfy heating and cooling requirements to serve the equipment and people inside the space.

f. Whenever possible, use existing piping inside the building to minimize installation cost and hospital disruption.

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

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

i. Rebalance existing supply, return, and exhaust for the immediate imaging area and adjacent spaces. Rebalance existing air handler as required.

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

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

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

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

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

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

C. Proposed Schedule (calendar days):

Total Period of Performance – 549 calendar days

D. Attachments:

1. SOW Attachment 1 – Spec 01 00 00 General Requirements – 03-02-2018

2. SOW Attachment 2 - PG 18-12 VA Pharmacy Guidelines (No Appendix 5)

3. SOW Attachment 2 – PG 18-12 VA Pharmacy Guidelines – Appendix 5 – Pages 5-1 – 5-33

4. SOW Attachment 2 – PG 18-12 VA Pharmacy Guidelines – Appendix 5 – Pages 5-34 – 5-73

5. SOW Attachment 2 – PG 18-12 VA Pharmacy Guidelines – Appendix 5 – Pages 5-74 – 5-110

6. SOW Attachment 3 – USP 800

7. SOW Attachment 4 – USP 797 and 800 Chapters Aug 2017

8. SOW Attachment 5 – SFVA Site Overview

9. SOW Attachment 6 – Contractor Confidentiality Cert PS Design Standards

End of SOW