36C25019Q0628-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 610-19-2-279-0046 Pharmacy Clean Rooms (both stations) Ft Wayne & Marion, IN 46953 36C25019Q0628 04-30-2019 N 332311 Department of Veterans Affairs Network Contracting Office 10 1700 E 38th Street Marion IN 46953 Lillie Grey 765-677-6112 lillie.grey@va.gov Northern Indiana Healthcare System 1700 E 38th Street, Marion, IN 46953 2121 Lake Ave, Ft Wayne, IN 46805 46953

USA

lillie.grey@va.gov

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation for quote to be requested with no other written solicitations to be issued.

Solicitation number RFQ-36C25019Q0628 is issued as a request for quote. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-95/ 01-13-2017. The North American Industry Classification System (NAICS) number is 332311 and the business size standard is 750 employees.

Supply two (2) “drop-in” Modular Negative Pressure Pharmacy Compounding Clean Rooms at two (2) separate VA Medical Center locations as listed in the attached Statement of Work. Delivery of supplies, parts, materials, and installation to VA Northern Indiana Healthcare System, 1700 E 38th Street, Marion, IN 46953 and VA Northern Indiana Ft Wayne Medical Center, 2121 Lake Ave., Fort Wayne, IN 46805, Pharmacy Department (119).

The proposed contract listed here is Set-aside small business with FOB destination. Installation will be coordinating to the technically acceptable qualifications best matching the attached statement of work specifications.

Offerors must comply with all instructions contained in provision 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, and submitted by the bid due date and time via email as specified by the Contracting Officer.

The following additional provisions apply:

52.212-2, Evaluation-Commercial Items, the Government will award a contract/purchase order resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation and is determined to be the most advantageous to the government, technical, price and past performance considered. To be technically acceptable the offeror shall meet or exceed the Government's specifications as listed in the statement of work.

52.212-3, Offeror Representations and Certifications-Commercial Items, a completed copy of this provision shall be submitted with the offer unless SAM registered which must be noted in the quote.

52.212-4, Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price.

52.212-5, Contract Terms and Conditions-Commercial Items. The following additional clauses apply: Purchase order (SF 1449) will be awarded to the winning bid with submission of Invoice through Tungsten upon delivery of ALL items listed on spreadsheet.

From the VAAR the following apply:

852.232-72 Electronic submission of payment requests. All invoices must be submitted to Tungsten for payment processing. The PO number must appear on all invoices, packing slips, shipping labels, and/or correspondences to the contracting officer.

852.246-71 Inspection of all supply and parts delivered will be held. If goods are rejected, they will be held for 15 days, if not replaced, the rejected merchandise will be returned to the contractor at their risk and expense. Payment of invoice will be delayed.

Contact: Lillie Grey, Contracting Officer, via email at Lillie.grey@va.gov or FAX 765-677-3185. No telephone inquiries will be accepted. Only written inquires received directly for the offeror are acceptable. All quotes must be received by 10:00 am EST on Tuesday, April 30th, 2019 to Lillie Grey (Lillie.grey@va.gov).

STATEMENT OF WORK

PHARMACY COMPOUNDING “CLEAN ROOMS”

VA NORTHERN INDIANA HEALTH CARE SYSTEMS

BACKGROUND

United States Pharmacopeia (USP), Chapter 797, “Pharmaceutical Compounding, Sterile Preparations”, specifies International Organization for Standardization (ISO) 14644 as the standard for acceptable cleanroom airborne particulate concentrations and assessment procedures. Specifically, USP 797 requires sterile compounding in controlled ISO Class environments. This Statement of Work (SOW) is for the purchase of a prefabricated “cleanroom suite” for pharmaceutical compounding for VA Northern Indiana Health Care Systems at the following locations to comply with USP 797 and 800 revisions:

OBJECTIVE

Purchase and install pre-fabricated Pharmacy compounding rooms, also called cleanroom suites, that can be taken down and moved to another area if needed. All components of the cleanroom suite delivery and installation shall include required testing before use. All installations, equipment, and designs at all facilities must comply with USP 797 and 800 revisions.

DEFINITIONS

1. Buffer room – Section of the cleanroom suite where the Primary Engineering Control (PEC) is located and must maintain a specified airborne particle count to meet a specified cleanliness class.

2. Ante room - is a space leading into and out of the buffer room. This a transitional space in which activities, such as hand hygiene, garbing procedures, staging of components and other activities are performed. Ante room shall be at least an ISO class 8. Use of the Ante room prevents large swings in temperature.

SCOPE

1. Fort Wayne:

Vendor shall furnish and install all parts, labor, supervision, materials and testing equipment including transportation cost necessary for delivery of goods and performance of installation and testing for the drop-in cleanroom at the location designated in the attached drawings at the Ft Wayne campus, 2121 Lake Ave, Fort Wayne Indiana 46805. The drop-in clean room suite shall be self-contained, self-supporting, and shall include walls, ceilings, flooring, lighting, plumbing, fire suppression systems, electrical and air filtering equipment. The cleanroom suite shall each consist of a “Sterile Positive Pressure” buffer room, a “Sterile Negative Pressure” hazardous buffer room, a negative pressure hazardous drug storage room, and one shared “Positive Pressure Anteroom” connecting the two sterile buffer rooms. The hazardous buffer room shall have a PEC that is of Class II, Type B2 Laminar Airflow Biosafety Cabinet that will maintain ISO class 5 under dynamic work environment. The non-hazardous buffer room shall contain a laminar flow workstation PEC that will maintain ISO class 5 under dynamic work environment. All rooms shall meet ISO class 7 standards. Two Pass throughs shall be included. . One shall be located between the hazardous materials storage area and the negative pressure hazardous compounding room. The other pass through shall be located between the positive pressure clean room and the outside area. All pass-throughs shall not interrupt any EMS parameters and need to be of inter-locking design and allow for uninterrupted HEPA filtered first air.

The hazardous storage room shall have the following features:

space

• Shall maintain at least 12 ACPH

Marion:

Vendor shall furnish and install all parts, labor, supervision, materials and testing equipment including transportation cost necessary for delivery of goods and performance of installation and testing for the drop-in pharmacy compounding cleanroom at the designated location as illustrated in the attached drawings for the Marion campus, 1700 E 38th Street, Marion Indiana 46953. The unit shall be self-contained, self-supporting and includes walls, ceilings, flooring, lighting, fire suppression systems, electrical and filtering equipment. The unit shall consist of one positive pressure buffer room with a single pass through connecting the buffer room to the supply room. Buffer room shall maintain ISO class 7 standards while providing 30 ACPH and one positive pressure anteroom that maintains an ISO class 8 environment under dynamic operations standards while providing 20 ACPH.

All rooms, Fort Wayne and Marion shall have the following characteristics:

· Wall material shall allow for very high visibility (unless otherwise indicated).

· Intercom system to connect inside and outside work spaces

· Any pass-through that connects an unclassified space to an ISO classified space shall require independent HEPA filtration within the pass-through.

· Flooring designed for high traffic areas. Flooring design choice to be approved by the Pharmacy Team.

· Lighting – LED lighting to be determined by the engineering drawings and requirements.

· Wall returns shall be located at the low side of the walls and shall facilitate ISO Class requirements during dynamic operations.

· Doors entering/exiting ISO class environments shall be automated in design.

· Designed to operate with 30 air changes per hour (ACPH) (unless otherwise indicated).

· Designed to operate between 0.02 to 0.05 of W.C. between each sterile positive pressure ISO Classified space and be monitored by a pressure differential system.

· Designed to operate between -0.01 to -0.03 of W.C between each sterile and non-sterile negative pressure enclosure and be monitored by a pressure differential system.

· Designated areas for gowning and ungowning shall be clearly identified

· Exterior Sink – Stainless steel and hands free.

· Eyewash attached to sink

· HEPA filtration system

· Fan Filtering System – to be determined by location. Number of FFU’s to be approved by the Pharmacy Team.

· Flooring shall be highly resistant to abrasive cleaning materials and joined together to include coving to the sidewalls.

· Real Time Monitoring System monitoring each ISO classified space and non-classified storage – to measure at a minimum:

Humidity Differential pressure Temperature Data to be stored in the database and can be retrieved later. Data can be retrieved via charts, graphs, log files. System shall alert operators when system is “out of range” per the user set parameters. System shall alert via local alarm lights and/or audible alarms Data System with alert via email, local alarm lights and/or audible alarms

2. Contractor shall supply three (3) PEC’s able to maintain ISO class 5 environment during dynamic operations and that are 100% compatible with the clean rooms and shall provide installation in each of the buffer rooms per the attached drawings. All Laminar Airflow Biosafety Cabinets shall meet performance requirements of the NSF/ANSI 49. The hoods shall have the following characteristics:

Hood for Fort Wayne Negative Pressure Hazmat Compounding Clean Room

· Electrical: 115 VAC, 60 HZ including power cord

· Monolithic 16/18 GA Stainless Steel Interior and Exterior Construction

· Recessed and Removable Front Intake Grill

· 3/16” Diameter Stainless Steel Mesh Accessible Paper Catch

· Able to be maintenance 100% from the front

· 250% Filter Load Capacity

· 10° Sliding View Window

· TouchLink Control System w/ Intelliflow Airflow Probe

· Ultra-high Efficiency DC/ECM Motor

· Ultra-high Efficiency LED Lighting

· Certification Value Exhaust Requirement: 740 CFM @ 1.7” w.g.

· Concurrent Value Exhaust Requirement: 815 CFM @ 1.7” w.g.

· 8-Inch (203 mm) Access Opening Tempered Sliding Glass

· Metal Frame Supply HEPA Filter 99.99% @ 0.3 Micron

· Metal Frame Exhaust HEPA Filter 99.99% @ 0.3 Micron

· Stainless Steel Armrest

· Prop-Up Work Surface Tray

· Ability to hang six (6) IV bags on at least two vertical distances

· 560E126 Standard 115V 60Hz (3 Amp Max) Left Front Faring

· Outlet Plate Cover Right Front Faring

· Right Bottom Service Valve

· Left Middle Service Coupling

· Left Bottom Service Coupling

· Right Middle Service Coupling

· 4-foot (1.2 m) Telescoping Base Stand w/ Leg Levelers

· Manual Air-Tight Butterfly Damper

· Silicone Connection Sleeve Kit

· Minimum 5 Year Parts Warranty (Supply Filter Included)

· Custom: Smooth Interior

Hood for Fort Wayne Positive Pressure, Non-Hazardous Compounding Clean Room

· 6-foot (1.8 m), 30-inch (762 mm) Filter Height Bench hood

· Top Horizontal Laminar Airflow Workstation (115V)

· Minimum 5 Year Parts and Labor Warranty (Filters Included)

· Stainless Steel Work Surface with PVC Core

· Stainless Steel Sidewalls with Cord Pass Through each Sidewall

· IV Bar with 3 Height Locations and 6 Hooks

· 6 ft. (1.8 m) Telescoping Base Stand w/ Castors

Hood for Marion, Positive Pressure, Non-Hazardous Clean Compounding Room

· 4-foot, 30-inch Filter Height Bench Top

· Horizontal Laminar Airflow Workstation (115V)

· Minimum 5 Year Parts and Labor Warranty (Filters Included)

· Stainless Steel Work Surface with PVC Core

· Stainless Steel Sidewalls with Cord Pass Through each Sidewall

· Ability to hang six (6) IV Bags at least three different heights

· 4 ft. Telescoping Base Stand w/ Castors

3. Vendor shall provide design recommendations and drawings for review and approval by Pharmacy team. VA NIHCS (VA Northern Indiana Health Care Systems) shall check drawing specifications furnished for approval of design, equipment and materials. The contractor shall compare and verify the dimensions prior to laying out the work and shall be responsible for any errors.

4. Design sShall include walls, flooring, lighting, electrical, filtering equipment, hands free sink, real-time monitoring system, fan filer unit, lighting, HEPA filtration system and swing doors or auto opening doors, whichever is deemed the best fit by the Pharmacy team. All equipment shall comply with the most current revision of USP 797/800 and ISO Class codes. VA NIHCS shall approve color and texture choices where applicable.

5. Vendor shall provide testing and certification when install is complete. Warranty period on all equipment and components shall begin upon complete installation and certification. This includes the structure to be free from defects in material and workmanship. The vendor shall provide VA NIHCS with a preventative maintenance plan and the equipment’s manufacturer’s operation manuals. The VA NIHCS shall be responsible to keep records of the maintenance activities.

6. Design and installation methodology shall be coordinated with designated VA Project Manager and in accordance with nationally accepted practices. When the final design has been approved by VA NIHCS, vendor shall proceed with the ordering of materials and equipment.

7. Upon completion and start-up of the environmental system the vendor shall conduct training sessions to review the maintenance required to the system and to review the controller. Vendor shall conduct a minimum of one training session at each campus.

8. VA NIHCS shall remove all existing equipment and debris from the designated areas to allow the vendor to start the build in a clean working space. The vendor shall demo the existing drop ceiling in the designated area and tie the ceiling into the new walls.

CERTIFICATION

1. Vendor shall guarantee compliance to the performance standards of the USP 797/800 standards. VA shall initiate a service agreement for maintenance and periodic certifications once the equipment has been purchased.

2. Equipment shall be calibrated to standards that are traceable to the National institute of Standards and Technology (NIST) in accordance with their established cycle. Certificates for each instrument shall be supplied by the vendor to VA NIHCS at time of certification. It shall be the responsibility of the vendor to address and correct all equipment performance deficiencies and ensure 100% functionality.

AIRBORNE PARTICLE ASSESMENT OF PHARMACEUTICAL CLEANROOMS

The following table provides the ISO maximum allowable concentration limits for particles larger than 0.5 microns. USP 797 and 800 requires ISO Class 5 cleanliness for compounding cabinets and isolators, ISO Class 7 for compounding rooms (buffer areas) and ante-rooms (support areas) located outside the buffer area.

1. General ISO Testing – The initial particulate data closely reflects the quality of air supplied. USP 797 requires ISO particulate sampling every 6 months and when renovations occur. During sampling, cleanroom activities shall be designated as “operational” or “at-rest” (ISO 14644-1, 3.1). Operational testing verifies the particulate count during normal work procedures. No clean room activities shall occur during “at-rest” testing. Specific activities shall be recorded during sampling. The operation of the room controls shall also be documented during the sampling period (airflow volumes or velocity tests, air pressure differentials, containment or filter leakage).

2. Test Report and Equipment – The ISO 14644 standard specifies the test report shall include the name of testing organization: ISO reference; test and sample locations; identification of the test equipment and calibration certificate, any use of an equivalent test method (deviation from the ISO test method), test results, data analysis and particle concentration data (ISO 14644-1, 4.4). Test reports shall state assessment compliance with ISO (Annex B and C) or the equivalent methodology. The ISO standard specifies the use of the light scattering particle counter capable of displaying or recording particle count and size (ISO 14644-1, B2). On site calibration is performed per the manufacturer specifications. Sample probe inlet shall be positioned into the direction of room air flow or face upward if air flow direction is not controlled or predictable (ISO 14644-1, B4). ISO 14644-2 standard specifies a written plan designating the sample locations; minimum air volume and sample time; particle size(s) and limits; and procedures to address high particle counts if the room exceeds the ISO particle limits.

COMPLIANCE STANDARDS

1. Recommendations by the Department of Veterans Affairs, Office of Construction & Facilities Management include biological safety cabinets for use in hazardous clean rooms, Laminar airflow workstations for use in non-hazardous clean rooms (shall be 100% re-circulatory type).

2. The recommended class for this project is ISO class 7/8 (International Organization for Standards) for the Class 7 clean room limits the maximum concentration of particles to 10,000 particles per cubic feet (352,000 per cubic meter of 0.5 microns or larger). The buffer room or “clean room” at both campus shall be an ISO Class 7. The Ante room at Marion shall be an ISO Class 8 and at Ft Wayne shall be an ISO Class 7 facilitate the use of hazardous materials.

VA NIHCS REPONSIBILITIES vs VENDOR RESPONSIBILITES

Contractor VANIHCS Responsibilities

Clean suitable floor for the enclosure installation, condensate drain for connecting the HVAC system to the points of connection. VANIHCS shall provide required electrical hook up as agreed upon during the drawings phase. VANIHCS shall also provide humidity controls and plumbing hook-ups to vendor provided points of connection. VANIHCS shall make connection to the vendor provided points of connection for the compressed air, steam, chilled water, fresh water, or tower water lines, and fire sprinkler. VANIHCS shall provide an area for vendor to put their storage container, parking with parking passes and necessary clearance badges for vendor personnel. VANIHCS shall provide contact to vendor for any changes that need to be made. Vendor is responsible for all excess material and debris disposal.

Vendor Responsibilities

Contractor shall provide draft drawings of the Fort Wayne and Marion clean room suites within 30 days of contract award for VA approval. Contractor shall deliver clean rooms to the respective locations and shall have all units installed, tested, certified, and shall have staff trained within 30 days of VA site preparation completion. Clean room suites shall be 100% certified and functional prior to November 1, 2019.

HOURS OF WORK AND SCHEDULE

Hours of work shall be Monday through Friday from 8:00am to 4:30pm, excluding Federal holidays. Any modifications to the products or work to be done in this contract shall only be through an SF-50 signed contract modification document as approved by the VA and issued by a warranted VA Contracting Officer.

TESTING, CERTIFICATION AND TRAINING

Vendor to perform all testing and initiate a 3rd party certification. Once 3rd party certification has been completed, vendor shall provide training on equipment and testing and recording software at each campus. Vendor shall conduct a minimum of 1 training and up to 3 trainings at the request of VA NIHCS at each campus.

VA Responsibilities

VA shall have the installation sites fully prepared according to the approved drawings by July 1, 2019.prior to delivery. VA shall provide access to the work sites for vetted, clearly identified employees of the contractor to allow installation to be completed. Updated scheduling and timeline information will be submitted to the awarded vendor prior to installation and is subject to change.

Marion Pharmacy Clean Room Location )Site Visit

Site visit is recommended for interested bidders, but not mandatory. Walk through will take place at 9:00 am, March 14, 2019 at the Marion campus and the same day at 1:00 pm at the Fort Wayne campus. Please RSVP to the contracting officer if you will be attending via email ( HYPERLINK "mailto:Lillie.grey@va.gov" Lillie.grey@va.gov) or phone (765-677-6112).

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