36C26119R0002_0003.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION

OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADM

INISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and d ate specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 3

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO

MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 12-21-2018 640-19-1-5294-0001 640-19-1-092-0006 640-19-907 36C261 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Sierra Nevada Health Care System 975 Kirman Avenue Reno NV 89502-2597 36C261 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Sierra Nevada Health Care System 975 Kirman Avenue Reno NV 89502-2597 To all Offerors/Bidders

36C26119R0002 12-04-2018

X X X January 15, 2018, 3:00 PM Pacific Time 640-19-1-092-0006 in accordance with the statement of work. Contractor shall prepare the site and have the triler built concurrently, and then land the trailer on the site.

The solicitation closing date has also been extended to January 15, 2018 at 3:00 PM Pacific Time.

A second line of funding has also been edded for the trai ler.

All other terms and conditions shall remain unchanged.

Charee Harris Contract Specialist

STATEMENT OF WORK

1. SERVICES:

Contractor shall provide a USP 797 and USP 800 certified mobile compounding pharmacy trailer as specified in the salient characteristics document including transportation to the location, setup, commissioning, and training. Contractor’s proposed trailer and manufacturer shall be presented with the initial resume due on January 15, 2018.

COMMISSIONING & CERTIFICATION

· Period of performance 240 days from NTP

· Delivery to VA Palo Alto Health Care System into parking lot 100E as shown in attached exhibits

· Hours of delivery expected between 5am-7am Weekdays or 8 am to 4 pm Weekends

· Set-up – to include trailer stability and levelling on existing concrete pad

· Trailer shall be connected to existing electrical, sewer and water. Contractor is responsible for making final utilities connection

· On-site Test & Balance Certification of internal systems and components

· To include hoods, air balance, hazardous storage cabinets

· Contractor shall follow design timelines specified the site prep SOW to design the pharmacy trailer(s)

· Contractor shall deliver the trailer(s) during the hours from 5 am to 7 am on weekdays or 8 am to 4 pm on weekends

· Contractor is responsible for trailer stability and levelling on concrete pad

· Contractor is responsible for all utilities connection including but not limited to electrical, sewer, water, and date, etc

· Contractor is responsible for onsite test and balance certifications including but not limited to hoods / hazardous storage cabinets, and other applicable commissioning certs for electrical and data system

· Trailer manufacturer shall have executed similar type work in the last five years.

The trailer sub must demonstrate their experience in manufacturing these trailers by providing a minimum of 3 similar projects within the last 5 years. The prime contractor to use the trailer sub-contractor who is familiar with manufacturing these pharmacy trailers. It is advised that contractors do not utilize a typical construction contractor to build these trailers.

SALIENT CHARACTERISTICS USP TRAILER

Company is to design and build a rectangular semi-trailer with two separate enclosed ante rooms, one sterile hazardous drug compounding room, one sterile non-hazardous drug compounding room, one hazardous drug storage room, one receiving room, one IT closet, and one cleaning closet that meets USP 800 code compliance. If the rooms listed above do not fit in a single semi-trailer, then company needs to design a multi trailers system that have sufficient space for the required rooms above. Access between trailers need to be sterile to comply with USP 800 code.

Company to provide 3 conceptual drawings for selection and obtain approval from the VA prior to manufacturing. The Drawings/Semi-trailer shall comply with the features listed below:

ROOMS & AREAS

· Ante Rooms ISO 7

· Housekeeping Sterile Compounding Room located within Ante Room

· Receiving Room

· Sterile Hazardous Drug Buffer Room ISO 7 that is vented to the outside

· Sterile Hazardous Drug Storage Room ISO 7

· Sterile Non-Hazardous Drug Buffer Room ISO 7

· Isolated, secured, and fully function IT closet

· Self-Supporting Modular Design inclusive of walls, roof / ceiling, flooring, lighting, electrical & filtering equipment.

· Exterior partitions between the pharmacy and surrounding spaces shall be 15-minute forced entry construction and extend from slab to roof.

· All surrounding partitions and walls, floor, and ceiling shall be permanently constructed and attached to each other. To provide visual evidence of attempted entry, all construction, to include above the false ceiling and below a raised floor, shall be done in such a manner as to provide visual evidence of unauthorized penetration.

· Partitions and walls surrounding the perimeter of the pharmacy shall be reinforced, slab to roof, with 9-gauge expanded metal. The expanded metal shall be spot welded every 6 inches (150 mm) to vertical and horizontal metal supports of 16-gauge or greater thickness that has been solidly and permanently attached to the true floor and true ceiling.

· Windows or skylights below 18 feet (4 m) from ground level or the roof of a lower abutment, or less than 18 feet (4 m) from windows of an adjoining building, or accessible by a building ledge leading to windows of other floor rooms, shall have forced entry construction of stainless steel woven security mesh.

· All lighting, security devices, and power shall be backed by emergency electrical system in accordance to VA Electrical Design Manual. Refer to VA Electrical Design Manual for specific loads to be connected to the EES.

· All doors to be equipped with sensors and handles for easy access and during emergency.

· Main door to have security system preferably card reader and intercom.

· A security system with following features o Fixed cameras with recording capability at drug storage room and manufacturing area o Motion detectors at drug storage room, manufacturing area, and entrances o Glass break sensor at all windows o Door contact sensors at all exterior doors and entrances o Duress / panic alarm at manufacturing area and storage areas o Card reader and intercom at drug storage room and manufacturing area. o Exterior lighting to help with camera visibility

· All vents, ducts, and similar openings more than 96 square inches (620 cm2) that enter or pass through a perimeter partition to the pharmacy shall be protected with either bars or grills. Where bars are used, they shall be 1/2-inch (12.7 mm) diameter steel welded vertically and horizontally six inches (150 mm) on center; where grills are used, they shall be of 9-gauge expanded steel.

· All ducts shall be treated to provide sound attenuation.

· Openings in construction above ceilings or below raised access floor shall be protected as above.

· All temperature and pressure monitoring equipment to be capable of producing data output for viewing or downloading.

· Modular Clean Room seismic integrity provisions where necessary.

· Finishes - Non-porous and cleanable surfaces, ceilings, walls, and floors subject to wet cleaning. Solid, nonporous countertop with a smooth seamless appearance. Easy to clean and maintain and with proper cleaning does not support the growth of mold. An acrylic-based solid surface product. Standard thickness of 1”, and a 4” butt backsplash/curb. Also referred to as a work surface or work top. Used in lab and other hospital areas requiring optimum physical and chemical resisting properties.

ANTE ROOMS

· 2 Scrub sinks with eye wash station positioned at least 3’ from the Sterile HD Buffer Room door

· Clean Personal Protective Equipment (PPE) Storage Bin

· Shelves

· Soiled PPE Waste Bin

· Staff Changing Bench

· Environmental Services Closet

· Interlocking HEPA filtered Pass-Thru Chamber from Receiving Room STERILE HAZARDOUS DRUG BUFFER ROOM Equipment

· 2 ISO 5 Class II Type B2 Biological Safety Cabinets (BSC) with 100% Dedicated Outside Air Supply and Exhaust - 3ft each

· Interlocking HEPA filtered Pass-Thru Chamber from Sterile Hazardous Drug Storage Room

· Stainless Steel Workstation

· RFID Refrigerator for inventory control

· Soiled PPE Waste Bin

· Storage Cabinet for sterile hazardous drugs HAZARDOUS DRUG STORAGE ROOM Equipment

· USP 800 Compliant Refrigerator

· Shelves STERILE NON-HAZARDOUS DRUG BUFFER ROOM Equipment

· 2 ISO 5 Horizontal Laminar Airflow Workbench (LAFW) - 4ft

· Stainless Steel Workstation

· USP 800 Compliant Refrigerator

· Soiled PPE Waste Bin

· Non-Hazardous Drug Storage Cabinet

· Wall mounted double locked cabinet to store controlled substances

RECEIVING ROOM

· Interlocking HEPA filtered Pass-Thru Chamber to HD Storage and Ante Room

· Stainless steel work station with network capability

IT ROOM

· One IT relay rack seismically anchored to the floor

· A vertical cable management raceway and horizontal cable management between patch panels

· A grounding bus bar. Electrically ground relay racks using wire # 6

· All horizontal cable to be terminated end to end, label and tested. Company to provide all equipment necessary to fully terminate including but not limited to CAT 6 cable, patch panels, RJ45 ice cubes, modular keystone jacks, faceplates, cable tray, j-hooks.

· Provide and install APC 1500 switch with network card at bottom of relay rack • Comply with VA Palo Alto OIT Code of Practice

MECHANICAL ROOM

· Back-up Generator with Automatic Transfer Switch and by pass switch to turn on emergency power.

· Water Storage Tanks (Fresh & Gray) with gravity drained that could be hooked up to drainage system

UTILITY REQUIREMENTS

· Electrical: 208V 3-Phase 200 Amps. Emergency panel ready to be hooked up to facility emergency power.

· Water: 1" Potable Water Line

· Sewer: 4" Standard Sewer Line

WHEELCHAIR RAMP

· ADA Compliant

· Aluminum ramp with guardrails, landing, and stairs

· Width: 4'

· Installation on site

ENVIRONMENTAL CONTROLS

· All Facility & Engineering Controls Compliant with new USP 800

· HVAC requirements shall comply with the HVAC Design manual and Pharmacy Design Manual including humidity, noise, cooling and heating temperatures, and humidity requirements.

· Physically separated Ante Room and Sterile Hazardous Drug Buffer Room and Sterile Non-Hazardous Drug Buffer Room and Hazardous Drug Storage Room and Receiving Room

· C-PEC Containment Primary Environmental Control: (BSC or LAFW) Controls) o ISO 5 Biological Safety Cabinet (BSC) located in the Sterile HD Buffer Room o ISO 5 LAFW located in Sterile Nonhazardous Buffer Room

· C-SEC Containment Secondary Environmental Controls (Room Controls) o ISO 7 Ante Room Environmental Controls:

· Positive pressure (less positive than adjacent sterile non hd buffer room)

· Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 800

· High Efficiency Particulate Air (HEPA) filtered supply air • 24/7 Real-time Environmental Room Monitor providing:

· Temperature

· Humidity

· Differential pressure

· Airborne particle count o ISO 7 Sterile HD Buffer Room Environmental Controls:

· Negative pressure between 0.01” to 0.03”

· Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 800

· 100% Outside Supply Air (into room)

· High Efficiency Particulate Air (HEPA) filtered supply air

· Externally Vented 100% of Air Exhausted Directly Outside

· Zero recirculation of HD Buffer Room air

· 24/7 Real-time Environmental Room Monitor providing:

· Temperature

· Humidity

· Differential pressure

· Airborne particle count

· 24/7 Real-time Monitoring of RFID Refrigerator interior temperature to ensure drug safety o ISO 7 Sterile Non-HD Buffer Room Environmental Controls:

· Positive pressure (more positive than the adjacent Ante Room)

· Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 800

· High Efficiency Particulate Air (HEPA) filtered supply air • 24/7 Real-time Environmental Room Monitor providing:

· Temperature

· Humidity

· Differential pressure

· Airborne particle count

· 24/7 Real-time Monitoring of RFID Refrigerator interior temperature to ensure drug safety o Hazardous drug storage room requires 35ACPH and negative airflow requirements o Receiving area has a negative or neutral airflow requirement

COMMISSIONING & CERTIFICATION

· Delivery

· Set-up

· On-site Test & Balance Certification

· HEPA Filtration

· Certification Supervision

· On-site Training

· Follow VA Commissioning Manual